National Advisory Eye Council (NAEC) | NEI

Meeting minutes are pending.

175th National Advisory Eye Council (NAEC) Meeting Agenda

NIH Videocast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened at 10:00 a.m. on Friday, March 20, 2026. All participants attended virtually. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Hyo-Jung (Anna) Han, PhD, served as the Executive Secretary. The meeting was closed to the public for the review of grant and cooperative agreement applications.

CLOSED SESSION
The meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS

NAEC members considered 731 grant and cooperative agreement applications on which NEI was the primary Institute; these applications requested a total of $259,753,494 (direct costs year 01). The Council also considered 502 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $41,357,764 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 1233 applications.

ADJOURNMENT

The meeting of the National Advisory Eye Council was adjourned at 10:42 a.m. on March 20, 2026.

CLOSED SESSION ATTENDEES

Council Members Present:

Dr. Michael F. Chiang, Chair
Dr. Hyo-Jung (Anna), Executive Secretary
Dr. Maria B. Grant
Dr. Donald Mutti
Dr. Victor Perez Quinones
Dr. Pradeep Ramulu

NIH Staff Members Present:

Shawn Adolphus
Neeraj Agarwal
Houmam Araj
Sangeeta Bhargava
Rylee Brauer
Nathan Brown
Karen Colbert
Tiffany Coo
k Aurea De Sousa
Kathryn Demott
Donald Everett
Martha Flanders
Ashley Fortress
Shaojian Gao
Alexandra Gavrilovic
Susan Gillmor
Tony Gover
Nataliya Gordiyenko
Steven Henle
Stephanie Kennedy
Jimmy Le
Paekgyu Lee
Renee Livshin
Barbara Mallon
George Mckie
Kiyoharu Miyagishima
Donald Mutti
Lisa Neuhold
Robert O'Hagan
Melanie Reagan
Maryann Redford
Merideth Shifflett
Azadeh Shoaibi
Hongman Song
Joanna Szczepanik
Santa Tumminia
Bronte Williams Washington
Cheryl Wiggs
Charles Wright

CERTIFICATION
We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Hyo-Jung Han, PhD
Executive Secretary
National Advisory Eye Council

Meeting Minutes

The National Advisory Eye Council (NAEC) convened its 173rd meeting virtually at 9:00
a.m. on Friday, February 13, 2026. The meeting was publicly broadcast by the NIH
videocast system. Dr. Michael F. Chiang, Director of the National Eye Institute (NEI),
presided as Council Chair. Dr. Hyo-Jung (Anna) Han served as Executive Secretary. The
meeting was open to the public from 9:00 a.m. and adjourned at 12:20 p.m.

Council Members Present:
Dr. Michael F. Chiang, Chair
Dr. Anna Han, Executive Secretary
Dr. Maria Grant
Dr. Donald Mutti
Dr. Pradeep Ramulu
Dr. Victor Perez Quinones

NIH Staff Members Present:
Shawn Adolphus
Neeraj Agarwal
Houmam Araj
Kapil Bharti
Sangeeta Bhargava
Rylee Brauer
Nathan Brown
Alysia Champagne
Karen Colbert
Roland Colbert
Jeffrey Cozart
Tiffany Cook
Aurea De Sousa
Kathryn Demott
Martha Flanders
Ashley Fortress
Shaojian Gao
Alexandra Gavrilovic
Tony Gover
David Higgins
Steven Henle
Stephanie Kennedy
Jimmy Le
Paekgyu Lee
Richard Lee
Renee Livshin
George Mckie
Melanie Reagan
Carissa Reilly-Weedon
Maryann Redford
Azadeh Shoaibi
Merideth Shifflett
Hongman Song
Afia Sultana
Joanna Szczepanik
Santa Tumminia
Leslie West-Bushby
Keturah Williams
Bronte Williams Washington
Cheryl Wiggs
Charles Wright
Michael O’Hagan
Nataliya Gordiyenko
Kiyoharu Miyagishima

WELCOME AND INTRODUCTIONS
— Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Michael Chiang opened the 173rd meeting of the National Advisory Eye Council, welcoming attendees and expressing appreciation for conducting the session virtually to ensure efficiency, particularly given the smaller-than-usual Council slate. He thanked Council members for their participation and acknowledged the efforts of Dr. Hyo-Jung (Anna) Han—Acting Director of the Division of Extramural Activities—and Nathan Brown, along with the broader DEA team, for organizing the meeting.

COUNCIL PROCEDURES AND RELATED MATTERS
—Dr. Anna Han, Executive Secretary,
NAEC, and Acting Director, Division of Extramural Activities (DEA)

Dr. Hyo-Jung (Anna) Han welcomed Council members, NEI staff, members of the advocacy community, colleagues from the Center for Scientific Review, and members of the public viewing via videocast. She reintroduced herself as the Acting Director of Extramural Activities, Executive Secretary, and Designated Federal Official for the National Advisory Eye Council. Dr. Han noted that this gathering marked the 173rd meeting of the Council and extended appreciation to the broader NEI team, including grants management specialists and program officers, for their continued dedication. She also thanked Nathan Brown for his exceptional coordination and support in organizing the meeting.

Dr. Han explained that the current session constituted the open portion of the Council meeting. A separate closed session would take place in March after completion of peer reviews and staff evaluations. She expressed gratitude for the Council’s ongoing flexibility throughout the planning process.

Before proceeding to the agenda, Dr. Han reviewed virtual meeting etiquette. Participants were asked to:

Identify themselves by full name when speaking, particularly to support attendees who are visually impaired.
Ensure their full name appears correctly in Microsoft Teams for accurate
documentation.
Keep video off unless they are Council members or actively speaking.
Mute themselves unless presenting and use the “Raise Hand” function to ask
questions.
Refrain from using the Teams chat, as videocast viewers cannot access it and all comments in a public meeting must remain accessible.
She reminded Council members that, as Special Government Employees, they may not engage in lobbying activities while receiving federal compensation.

Dr. Han noted that upcoming Council meeting dates are listed in the open session agenda and on the NEI website, with the next meeting scheduled for Friday, June 5. She added that meeting minutes are available in the Electronic Council Book for review and comments. She then turned the floor back to Dr. Chiang for his Director’s Report.

NEI DIRECTOR’S REPORT 
—Dr. Michael F. Chiang

Dr. Chiang began by emphasizing a collaborative tone and encouraging input from Council members throughout the discussion. He first reviewed leadership transitions across NIH that intersect with NEI priorities. At NHLBI, Dr. Gary Gibbons retired after a distinguished tenure beginning in 2012 that included leading seminal work in prevention and treatment of heart, lung, and blood diseases, with particular progress on sickle cell disease through the Cure Sickle Cell initiative—culminating in the FDA’s first approvals of gene therapies within five years of launch. Dr. David Goff is serving as Acting Director. At NINDS, Dr. Walter Koroshetz stepped down after notable leadership across high-risk/high-reward programs including the BRAIN Initiative and HEAL; NEI collaborations have spanned CVI, Common Fund efforts, PRIMED AI, and the REPeats project. Amy Adams is now Acting Director. Dr. Chiang also noted that Dr. Rick Woychik (formerly NIEHS Director) transitioned to the Office of the Director as Senior Advisor for the NIH “Make America Healthy Again” strategy, which includes significant attention to real-world data. In the Office of the Director’s DPCPSI, Nicole Kleinstore was named Deputy Director; she previously led NICEATM at NIEHS and has been an important partner on NEI’s growing NAMs footprint.

DPCPSI Reorganization and “Science of Science”

Dr. Chiang summarized a proposed DPCPSI reorganization designed to strengthen NIH’s “science of science” capabilities. A new Office of Research Innovation, Validation and Application is slated to focus on NAMs, housing divisions that accelerate innovation in biomedical research and expand NICEATM’s interagency work on alternative test methods. In parallel, an Office of Research Economics, Planning and Analysis would consolidate planning, performance and reporting, portfolio analytics, and a new Office of Replication and Reproducibility. Taken together, these moves aim to modernize how NIH validates methods, analyzes portfolios, and scales credible findings—areas where NEI already has considerable momentum (e.g., data science, AI, and robust preclinical models).

Awards and Recognition

The Director spotlighted achievements relevant to the vision community. The NIH Sayer Vision Research Lecture & Award was recently presented to Mike Zepaya of Université de Montréal, whose lecture on targeting cellular senescence in retinovascular disease integrated multiple NEI-priority themes. He also noted the National Academy of Sciences Pradel Research Award (2026) to Sebastian Seung of Princeton University for foundational contributions in learning algorithms, neural networks, convolutional methods, and connectomics—work long supported by NEI and influential across modern computational neuroscience.

NEI Strategic Plan and Community Engagement

Dr. Chiang revisited NEI’s current five-year Strategic Plan (2021–2026), which organizes portfolio priorities across seven cross-cutting areas—genetics, neuroscience, immunology, regenerative medicine, data science, quality of life, and population health— while recognizing that clinical portfolios remain organized by anatomy and disease. He stressed that the plan is community-built, drawn from RFIs and expert groups rather than top-down edict, and reiterated that alignment with the plan will increasingly inform funding decisions for investigator-initiated applications. Looking ahead to the 2026–2031 plan, NEI will issue a new RFI and is actively seeking advice on deeper outreach beyond established channels. During the discussion, Dr. Maria Grant proposed using the ARVO platform and a director’s overview to amplify the RFI to a large audience that can propagate the message across labs and institutions. Dr. Donald Mutti encouraged a deliberate strategy to engage “diagonal” experts—researchers who work across methods and diseases—so the next plan better captures cross-cutting innovation.

Mission Focus

The Director reaffirmed NEI’s mission: to eliminate vision loss and improve quality of life through vision research. He framed recent efforts around four pillars, driving innovative research, fostering collaboration, strengthening the workforce through recruitment and training, and educating stakeholders about impact. He highlighted specific areas that align especially well with NIH priorities and NEI’s strengths: training future scientists, replication and reproducibility, real-world data, AI, NAMs, and outcomes that are clinically measurable and meaningful.

Funding Mechanics, NOFO Streamlining, and Highlighted Topics

Dr. Chiang described NIH’s effort to streamline the number of NOFOs across Institutes and Centers—reducing administrative burden and making it easier for investigators to pursue innovative, investigator-initiated work. NEI historically maintains a lean set of NOFOs, but will align with broader NIH consolidation, including new parent announcements. To signal interest in emerging areas without proliferating NOFOs or NOSIs, NIH is introducing Highlighted Topics—time-limited signals (typically one year) that encourage investigator-initiated applications addressing priority directions. The Director noted that multi-year funding policies remain in evolution and reminded investigators to read the NEI Strategic Plan and speak with program staff early to optimize fit and impact. He referenced the Unified NIH Funding Strategy articulated by Jay Bhattacharya, which pivots emphasis away from rigid pay lines toward portfolio stewardship aligned with mission, peer-reviewed scientific merit, investigator context (career stage, geography, cumulative NIH support), and opportunity cost.

Workforce Development

NEI’s R38 “STAR” Program continues to support extended research training within residency—building clinician-scientist capacity via 5–6-year tracks that include 1–2 dedicated research years. Initial cohorts at Stanford, Johns Hopkins, and UCSF show promise, and the next competition is planned for October 2026. NEI’s “Eye on the Future” high-school video contest remains a cornerstone of early-pipeline inspiration, with the current year’s deadline on April 19, 2026.

Replication and Reproducibility (Common Fund)

The Council turned to replication and reproducibility—central to credibility, translation, and efficient resource use. Dr. Chiang outlined a Common Fund concept (recently presented; vote postponed pending refinements) to establish Replication Centers focused on worthy preclinical/basic studies, paired with a meta-science testbed to define metrics and incentives across academia, industry, and publishing, and supported by education/outreach and coordination hubs. He distinguished this approach from replicating full clinical trials, which would consume budgets and timelines disproportionately; instead, NEI aims to raise front-end rigor and generalizability so large trials can be more trustworthy and applicable. In discussion, Dr. Maria Grant underscored that journals often do not encourage detailed, reproducible protocols; she advocated that NIH/NEI engage editors to normalize rich method sections (and not bury rigor/reproducibility in little-read appendices), which would save substantial time for labs attempting to reuse validated techniques and likely increase citations of the original work. Dr. Donald Mutti supported the focus on preclinical replication and emphasized that for clinical trials, NEI’s strongest lever is rigorous design and generalizability upfront. He also flagged accountability challenges in data sharing, where differing models can produce different conclusions from the same dataset; clarifying analysis plans, adjustment choices, and reporting standards will be important as NEI advances open science.

New Approach Methodologies (NAMs)

Dr. Chiang provided a concise update on NAMs, noting the growing emphasis across NIH and FDA on human-based models, organoids, AI, digital twins, and cell-based systems that complement or reduce animal use. He referenced an NIH Common Fund challenge conducted with NASA Tournament Labs, organized in three phases to deliver integrated human-based solutions in three years, with Phase 1 idea proposals due soon and subsequent phases described via the posted materials. The Director highlighted RPE Digital Twins as a landmark: the first subcellular-resolution digital twin of a differentiated primary human cell, built from iPSCs with AI trained to segment nuclei and subcellular structures, quantify shape, volume, and polarity, and assemble a reference atlas to catalyze new discoveries. He recognized David Aldolan and Kapil Bharti for leading this work.

Vision-Related Quality of Life (ePRO Platform)

NEI is developing a dynamic, patient-centered electronic PRO for vision-related quality of life that is content-valid, psychometrically sound, clinically interpretable, and intended for FDA qualification. Led by Negin Atri and a cross-functional NEI team, the platform aims to be broadly applicable across the spectrum of visual function—akin to the universality of visual acuity—so clinical trials and practice can capture meaningful patient outcomes.
Contracts were awarded to Digital Infusion (platform), Delphi (psychometrics), and Roe Federal (clinical evaluation). NEI will engage clinicians, researchers, and patients across diverse settings and populations to ensure relevance, usability, and adoption.

Budget Context

Dr. Chiang closed the report by noting that NIH is funded at $47B for FY 2026 through October 1, 2026. He indicated that NEI continues to manage programs in alignment with mission priorities and evolving NIH funding strategy, and that updates will be provided as necessary.

Council Discussion and Closing

The Council discussion reinforced several operational priorities: amplify outreach for the 2026–2031 Strategic Plan RFI at ARVO and through targeted engagement of cross-disciplinary experts; pursue journal partnerships to normalize detailed protocols and visible rigor/reproducibility sections; clarify data-sharing accountability through transparent analysis plans and reporting; continue to build the clinician-scientist pipeline via R38 STAR; and scale NAMs and quality-of-life measurement so preclinical models and patient-reported outcomes evolve alongside advances in AI and human-cell systems. Dr. Chiang thanked members for their thoughtful perspectives and reiterated NEI’s commitment to open dialogue with the vision community as initiatives move forward.

BRAIN Initiative Update —Dr. Pradeep Ramulu

Dr. Pradeep Ramulu provided an in-depth overview of the ongoing work supported through the BRAIN Initiative, emphasizing its multi-component structure and broad methodological ambitions. He explained that the initiative begins by mapping and characterizing neuronal circuits at multiple levels—from individual cells and cell types to their molecular features and anatomical connectivity. Building from this structural foundation, investigators then examine patterns of neuronal activity across time and space and develop increasingly sophisticated ways to manipulate neural circuits, including through optogenetic techniques. These manipulations allow researchers to test the functional significance of specific circuits and activity patterns, ultimately linking neural dynamics to behavioral outcomes in both controlled laboratory contexts and real-world environments. Dr. Ramulu emphasized that the data generated in these efforts are extraordinarily extensive and complex, requiring deep integration of theoretical modeling and advanced statistical frameworks to meaningfully interpret them. A parallel priority of the initiative is to translate these approaches into human neuroscience, supported by advances in fMRI, EEG, PET imaging, and deep-brain stimulation technologies. Because the success of these tools depends on widespread adoption, the initiative also includes a strong training and dissemination component to equip the scientific community with the expertise needed to use the new technologies effectively.

He noted that the initiative has been highly productive, involving nearly 2,000 principal investigators across more than 300 departments and institutions, with a similarly high number of awards and a publication record that grew steadily before plateauing around 2021. The program’s budget has fluctuated as well, including contributions from the Cures Act; while there is a slight projected increase for 2026, it remains below the peak funding levels observed from 2020 to 2023.

Dr. Ramulu shared representative scientific accomplishments, including the Nature Methods “Method of the Year” recognition for the electron-microscopy-based connectome of the entire Drosophila brain and the “microns” project, which reconstructed one cubic millimeter of mouse cortex—revealing a level of structural intricacy reminiscent of the density of galaxies in the Hubble Deep Field image. Additional advances highlighted at recent BRAIN meetings include work from Northwestern University demonstrating fully wireless optogenetic stimulation in freely moving mice, enabling manipulation of brain activity to guide reward-related behavior with roughly 80% accuracy, and proving that spatial and temporal precision in light-driven stimulation meaningfully affects behavioral discrimination.

He concluded by outlining active and upcoming BRAIN Initiative funding opportunities, many of which focus on methods development—such as tools for recording and modulating the nervous system, archiving data, probing cell-specific processes, and designing next-generation neural devices. Although NIH is overall reducing the number of NOFOs, he noted that the BRAIN portfolio remains robust, and investigators can easily track new announcements and program updates through the initiative’s website and associated blog. Dr. Chiang thanked Dr. Ramulu for the presentation, noting its methodological relevance to both neuroscience and vision science.

NAMS —Dr. Kapil Bharti

Dr. Hyo-Jung (Anna) Han opened the segment and invited Dr. Kapil Bharti to brief the Council on the NIH Common Fund’s initiative in New Approach Methodologies (NAMs). Dr. Bharti began by clarifying a widespread misconception: NAMs were conceived to complement traditional animal research, not replace it. While the portfolio focuses primarily on human-based models to improve efficiency and translational relevance, NAM elements can (and, in some cases, should) be integrated into animal studies to extend insight into disease biology and pathogenesis. He emphasized that the program originated in June 2023 through Advisory Council recommendations to the NIH Director and has since progressed through landscape analyses, listening sessions, and interagency workshops, culminating in Council of Councils action in January 2024, independent of any subsequent administrative debates about animal research.

Framing NAMs as a broad methodological transformation spanning basic, translational, and clinical science, Dr. Bharti outlined the initiative’s goals: to improve human-relevant modeling across diverse populations; to develop platforms that offer clear mechanistic insight; to validate mature NAMs for potential regulatory use (in partnership with FDA); and to strengthen biomedical research by integrating these approaches alongside established models. He described four major scientific domains within NAMs: (1) digital twins; (2) in silico models; (3) in-chemical screening; and (4) complex in vitro systems (organoids, microphysiological “organ-on-chip” models, assembled multi-tissue constructs, and 3D bioprinting).

In digital twins, Dr. Bharti traced the concept’s roots in engineering and manufacturing before its adaptation to biology and health care. He highlighted the Allen Institute’s early “digital cell” and then described recent NEI work generating the first subcellular-resolution digital twin of human RPE cells, comparing polarized and non-polarized states across multiple organelles to build an atlas spanning healthy through disease phenotypes. He noted that laboratories have already begun using the atlas to position their data along a spectrum of phenotypic severity, enabling more precise classification and targeted drug screening. He contrasted this cellular twin with a clinical digital-twin effort at the University of Pittsburgh, where advanced imaging, clinical analytics, social determinants of health, quality-of-life measures, and AI-based image analysis are integrated to construct personalized patient twins—a decision-support framework for multi-disciplinary consultation and individualized treatment planning.

Addressing in silico models, Dr. Bharti described studies that combine multi-omics and artificial intelligence to improve early disease detection, as well as a recent approach using large language models to pre-validate patient-reported outcome questionnaires for cataract surgery and intraocular lenses. He noted that such simulations can identify points of failure, strengthen psychometric robustness, and reduce logistical and ethical burdens prior to real-world deployment. He also referenced large integrated datasets (e.g., Bridge2AI) that collect multi-domain physiologic and environmental signals across thousands of participants, offering opportunities to understand systemic diseases such as type 2 diabetes and their ocular implications.

In the in-chemical domain, he described high-throughput platforms that evaluate reactivity and toxicity at molecular levels without live tissues, and in complex in vitro systems, he provided several ophthalmology-relevant examples. A Cornell/Duke “outflow-on-a-chip” model recreates Schlemm’s canal and trabecular meshwork to study steroid-induced glaucoma-like changes in aqueous humor dynamics. An assembled organoid system from Indiana demonstrates survival and connectivity of retinal ganglion cells through retinofugal pathways into thalamic and cortical targets—achieving, in a dish, neural circuit phenomena that previously required large-animal models. NEI investigators have also 3D-bioprinted an RPE– horiocapillaris construct that replicates dry AMD-like pathology, including APOE-positive drusen-like deposits, RPE degeneration, and choriocapillaris atrophy, enabling earlier-stage intervention studies. He further described body-on-a-chip configurations capable of perfusing a compound through serial organ modules to test systemic toxicity entirely in vitro.

Dr. Bharti was candid about limitations. Digital/in silico systems can lack biological fidelity; 2D cultures, while rapid for screening, lack 3D architecture; organoids and bioprinted constructs, though more physiological, are complex and not trivial to reproduce; and microphysiological chips demand specialized expertise. Conversely, animal models retain advantages for systemic physiology and certain anatomical complexities, yet often diverge from human genetics and clinical reality. NAMs therefore require validation, standardization, and comparative benchmarking against animal and human data to determine when a given approach is reliable enough to support drug development and regulatory decisions. He outlined the complementary program’s long-horizon architecture—Technology Development Centers (TDCs), a NAM Data and Resource Coordination Center, Validation and Qualification Networks, community training and engagement, and FDA collaborations—designed to build common data elements, harmonized validation frameworks, and pathways to regulatory acceptance over a decade-scale investment. In the discussion, Dr. Pradeep Ramulu asked about industry adoption and hesitations. Dr. Bharti reported that pharmaceutical companies are fully engaged, evidenced by rapid hiring and extensive collaborations with academic NAM developers; however, he underscored the need for co-development and education to overcome reproducibility  barriers and to standardize protocols and target validation in ways that satisfy industrial and regulatory requirements. Dr. Victor Perez pressed for greater visibility of the eye within broader NAM ecosystems, noting the centrality of ocular toxicity for systemic drugs. Dr.
Bharti agreed, acknowledging the eye’s complexity—which makes fully integrated, vascularized 3D ocular constructs especially challenging—but affirmed that the ophthalmic community is deeply embedded in NAM initiatives and that the FDA recognizes ocular endpoints as essential within toxicity testing paradigms. Dr. Michael Chiang thanked Dr. Bharti and emphasized the need to move from feasibility papers to real-world impact, specifically validated outcome measures, clear thresholds for “good enough” model performance, and demonstrated use of NAMs in drug development. Dr. Maria Grant advocated for workshops and systematic integration of NAMs with mature systems-biology approaches at the animal and human levels; Dr. Bharti concurred, stressing side-by-side comparative analyses, protocol standardization, and staged adoption—leveraging simpler models where appropriate and scaling complexity in tandem with validation and reproducibility. Dr. Han closed by thanking Dr. Bharti and transitioning the group into open discussion.

Open Discussion

Following the NAMs presentation, Dr. Michael Chiang reopened the floor for general discussion, emphasizing that Council members should feel free to raise any topic addressed during the meeting or any broader issues relevant to NEI’s mission. He also reassured members that the agenda did not require filling the remaining time if no additional discussion was needed.

Dr. Victor Perez began the dialogue by returning to the topic of vision-related quality of life, expressing enthusiasm for the development of a modernized patient-reported outcome measure to replace the aging NEI VFQ-25. He asked how NEI envisioned the eventual validation process among clinicians and end-users, and whether the new instrument would incorporate pediatric populations—an area he noted is historically challenging but important.

Dr. Chiang welcomed the question and elaborated on NEI’s motivations for updating quality-of-life assessment tools. He reflected on long-standing gaps in how clinicians interpret patients’ subjective experiences, noting the mismatch that can arise when objective measures (such as visual acuity) fail to reflect a patient’s functional challenges— or, conversely, when patients report functioning well despite clinician-observed deficits. He explained that the new electronic PRO initiative, led by Negin Atri and collaborators, is still in an early phase. To ensure scientific rigor and feasibility, the initial development will focus on adult populations, excluding pediatrics for now due to the complexity of developmental differences and the difficulty of distinguishing between a child’s self-report and parental interpretation. Dr. Chiang emphasized that this exclusion is temporary and pragmatic rather than philosophical, and he acknowledged the importance of returning to pediatric adaptation once the adult framework is well established.

Dr. Perez agreed with the reasoning, urging NEI not to lose sight of pediatric needs over time.

The discussion then shifted as Dr. Donald Mutti raised a question regarding recent changes in CSR’s criteria for discussing applications, noting that the threshold had moved from roughly 50% to about 30–35%. He shared concerns expressed by colleagues that this shift might limit substantive feedback for applicants. Dr. Chiang explained that NIH is actively re-examining peer-review and reporting processes, including the role of NOFO simplification and alignment with strategic plans. He emphasized that percentile scores, while necessary for triage, risk conveying “false precision,” especially when very small numerical differences guide assumptions about merit. He reiterated that NEI views application review holistically and prioritizes scientific impact, mission alignment, and balanced portfolio stewardship—not rigid payline cutoffs. Dr. Mutti supported this perspective, noting that real-world judgment by thoughtful reviewers remains the backbone of the system.

Dr. Maria Grant continued the conversation by raising concerns about the depth and quality of peer review, noting that time pressures may lead to more superficial critiques compared with earlier years. She also suggested broadening the reviewer pool to include qualified scientists outside the United States and recently retired investigators who possess deep expertise and more flexibility. Dr. Chiang acknowledged the validity of these points and shared that CSR leadership is actively exploring ways to expand reviewer participation, diversify expertise, and increase engagement from clinicians and industry scientists who can provide real-world translational context. He also noted a broader cultural shift toward a more transactional view of academic service and expressed interest in developing incentives and expectations for community contributions such as peer review.

Dr. Pradeep Ramulu affirmed this perspective, reflecting on generational changes in workload, expectations for compensation, and value placed on personal time. While acknowledging the cultural shift, he emphasized the need to find constructive ways to adapt academic incentive structures. Dr. Chiang agreed, noting ongoing discussions with journal editors-in-chief and efforts such as the Council of Vision Editors Fellowship to cultivate early-career engagement in peer review and scientific communication. As the discussion wound down, Dr. Chiang invited any final comments. Hearing none, he offered closing remarks thanking Council members for their insight, flexibility, and ongoing partnership. He noted continuing work with NIH and HHS on Council composition and expressed eagerness to reconvene in person in Bethesda as circumstances allow. He then
turned the meeting back to Dr. Han for formal adjournment.

Dr. Han thanked all participants for their contributions, noted the date of the next closed session (March 20), and formally adjourned the 173rd meeting of the National Advisory Eye Council, expressing hope to see members again soon.

ADJOURNMENT

The 173rd meeting of the National Advisory Eye Council was adjourned at 12:20 p.m. on February 13, 2026

CERTIFICATION
We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Hyo-Jung Han, PhD
Executive Secretary
National Advisory Eye Council

Meeting Minutes

The National Advisory Eye Council (NAEC) convened its 172nd meeting virtually at 10:00 a.m. on Tuesday, December 9, 2025. The meeting was publicly broadcast by the NIH videocast system. Dr. Michael F. Chiang, Director of the National Eye Institute (NEI), presided as Council Chair. Dr. Hyo-Jung (Anna) Han served as Executive Secretary. The meeting was open to the public from 10:00 a.m. to 11:47 a.m., and closed from 12:30 p.m. to 1:00 p.m. for confidential discussions, including conflict-of-interest matters, application reviews, and cooperative agreement applications.

Council Members Present:
Dr. Michael F. Chiang, Chair
Dr. Anna Han, Executive Secretary
Dr. Maria Grant
Dr. Donald Mutti
Dr. Pradeep Ramulu
Dr. Victor Perez Quinones

NIH Staff Members Present:
Neeraj Agarwal
Shawn Adolphus
Houmam Araj
Farran Briggs
Rylee Brauer
Sangeeta Bhargava
Kapil Bharti
Bronte Williams Washington
Rachel Caspi
Alysia Champagne
Nancy Chen
Emily Chew
Edwin Clayton
Karen Colbert
Roland Colbert
Tiffany Cook
Cinder Cohen
Kathryn Demott
Mala Dutta
Robert Fariss
Martha Flanders
Ashley Fortress
Ellaine Galindez-Balut
Shaojian Gao
Alexandra Gavrilovic
Susan Gillmor
Tony Gover
Nataliya Gordiyenko
Steven Henle
David Higgins
Lateefah Hill
Balendu Jha
Richard Lee
Paekgyu Lee
Renee Livshin
Natanya Malcolm
George Mckie
Elizabeth Murphy
Erika Nelson
Lisa Neuhold
Robert O'Hagan
Zixuan Peng
Amberlynn Reed
Melanie Reagan
Carissa Reilly-Weedon
Maryann Redford
Melissa Reeves
Joanna Szczepanik
Afia Sultana
Azadeh Shoaibi
Merideth Shifflett
Mobin Siddiqui
Hongman Song
Santa Tumminia
Susan Vitale
Cheryl Wiggs
Keturah Williams
Leslie West-Bushby
Charles Wright
Mina Young
Juan Yang

WELCOME AND INTRODUCTIONS
—Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang opened the meeting, acknowledged the virtual format, and thanked members for their participation. He noted a smaller-than-usual group due to pending council slate approvals. He asked each of the council members to introduce themselves.

COUNCIL PROCEDURES AND RELATED MATTERS
—Dr. Anna Han, Executive Secretary, NAEC, and Acting Director, Division of Extramural Activities (DEA)

Dr. Han introduced herself as Acting Director of the Division of Extramural Activities (DEA), opened the meeting by welcoming Council members, NEI staff, advocacy community representatives, colleagues from the Center for Scientific Review, and members of the public viewing via videocast. She noted that the October 3rd session was canceled due to a lapse in appropriations and expressed appreciation for Nathan Brown’s exceptional efforts in rescheduling and managing technical, policy, and logistical details, including expedited reposting of the Federal Register notice. Dr. Han reviewed virtual meeting etiquette, reminded Council members of restrictions on lobbying while serving as special government employees, and highlighted that future meeting dates are listed on the agenda and NEI website, with the next meeting scheduled for February 13, 2026. Approval of meeting minutes is no longer required during sessions; they are available in the Electronic Council Book for review. She concluded by asking participants to hold questions until the general discussion and then turned the floor over to Dr. Cheng for the Director’s report.

NEI DIRECTOR’S REPORT 
—Dr. Michael F. Chiang

Dr. Chiang provided updates on NIH and NEI activities, including leadership changes across NIH offices and institutes, centralization of peer review and communications functions, and notable staff retirements and departures within NEI. He acknowledged recent award recipients and reported that NEI is operating under a Continuing Appropriations Act with a flat budget of $896.5 million through January 30, 2026, while NIH overall remains at $47 billion. Further updates will follow pending congressional action.

Leadership Transitions

NIH-Wide

Office of Extramural Research (OER):
Dr. Mike Lauer retired.
Dr. Jon Lorsch (former NIGMS Director) appointed as new OER Director.
Office of Intramural Research (OIR):
Dr. Nina Shor retired after serving as OIR Director since 2022.
Dr. Roland Owens now Acting Director; long-time NIH leader with extensive experience.
Institute Directors:
NCI: Dr. Tony Latai appointed Director (formerly Harvard/Dana-Farber).
NIEHS: Dr. Kyle Walsh appointed Director (formerly Duke University).
NCCIH: Dr. Helene Langevin retired; Dr. David Shurleff (Deputy Director) serving as Acting Director. 
NIH Centralization Initiatives

Peer Review:
First-level reviews for grants, cooperative agreements, and contracts moved to the Center for Scientific Review (CSR).
NEI staff Brian and Jennifer transitioned from DEA to CSR.
Communications:
NIH consolidating communications staff and public websites (previously 700+ sites) under the Office of the Director to improve consistency and efficiency.
NEI Staff Changes

Retirements:
Karen Smith, Monique Clark, and Holly Blake retired from the Division of Extramural Activities.
Departures:
Ed Clayton (Division of Extramural Science Programs Training Programs) accepted a position at Princeton University; departure expected end of December. 
Awards

Dr. Chiang acknowledged recent NEI award recipients (details presented on slides during the meeting).

Budget Update

Continuing Appropriations Act:

Passed November 12, 2025.
NEI operating under FY25 budget through January 30, 2026.
NEI budget: $896.5 million; NIH overall budget: $47 billion (flat funding).
Monitoring developments; further updates pending congressional action.
Concept Clearance: NEI Collaborative Clinical Vision Research

Merideth Shifflett presented a concept clearance for the reissuance of a program announcement supporting NEI’s Collaborative Clinical Vision Research Program. This initiative enables extramural clinical researchers to apply for funding for complex, multicenter clinical trials and epidemiological studies involving high safety or resource risk. The program uses the UG1 Cooperative Agreement mechanism to support investigator-initiated studies addressing chronic eye and vision conditions across the lifespan, including their causes, diagnosis, prevention, treatment, and rehabilitation. These studies require specialized coordination of multiple components—such as coordinating centers and drug distribution centers—to optimize resources and expertise under NIH oversight. Council members voted to approve the concept clearance as presented.

Open Discussion

Dr. Michael Chiang opened the floor for discussion, inviting Council members to share perspectives on advancing vision research, collaborative strategies, and data integration. He explained that this session was intended to explore probing questions about data sharing, AI integration, and incentives for collaboration, and encouraged members to raise additional topics of interest.

AI and Data Integration

Dr. Donald Mutti began by asking about the integration of numeric-based datasets—such as ocular measurements and clinical outcomes—into AI systems, noting that most current efforts emphasize imaging data. He wondered whether there is equal interest in leveraging non-imaging databases for clinical decision support. Dr. Chiang agreed that numeric data such as visual acuity and intraocular pressure remain highly relevant and acknowledged the broader question: what would an ideal real-world dataset look like for AI applications? He noted that this remains an open area of research and expressed interest in seeing how these approaches evolve.

Consortia and Collaborative Models

Dr. Victor Perez emphasized the importance of consortia in driving translational research. He shared his experience with the U01 pain and sensation consortium, explaining how these mechanisms compel researchers to collaborate across basic, preclinical, and clinical domains. Perez highlighted the value of structured collaboration and suggested that similar models could benefit vision science. He also stressed the need for better visibility and advertisement of existing databases to ensure they are fully utilized. According to him, these approaches have proven effective in other fields, such as microbiome research, and could serve as a template for NEI initiatives.

Visibility and Public Awareness

Dr. Maria Grant shifted the conversation toward NEI’s visibility and public engagement. She emphasized that NEI’s accomplishments should be more widely recognized and suggested strategies to increase awareness of its role in advancing vision research. Her comments tied into earlier points about promoting data sharing and collaboration, noting that visibility can help attract partnerships and resources. Dr. Chiang acknowledged this perspective and agreed that public awareness is critical for sustaining support and fostering collaboration.

Incentives for Data Sharing

Dr. Pradeep Ramulu added that while funding and consortia provide some motivation, academic incentives often favor individual achievement over collaborative contributions. He supported Dr. Chiang’s observation that structural changes may be needed to encourage behaviors that benefit the field collectively. Dr. Chiang agreed, noting that researchers might be more willing to share datasets if doing so offered tangible benefits such as recognition or career advancement. He posed a key question to the group: how can NIH restructure its systems to incentivize data sharing and collaborative work? Dr. Chiang invited Council members to share ideas beyond the meeting and emphasized that this issue is central to advancing vision science.

Closing Remarks

The discussion underscored several themes: integrating diverse data types into AI systems, fostering collaboration through consortia, improving NEI’s visibility, and creating incentives for data sharing. Dr. Chiang thanked the Council for their insights and reiterated his commitment to exploring strategies that strengthen collaboration and accelerate progress in vision research. He encouraged members to continue providing feedback and noted that these conversations are essential for shaping NEI’s future initiatives.

Closing

Dr. Chiang expressed his appreciation to Dr. Han, Nathan Brown, and the NEI team for organizing the meeting on short notice. He extended special thanks to Council members, including Dr. Pradeep Ramulu, Dr. Victor Perez, Dr. Maria Grant, and Dr. Donald Mutti, for their ongoing collaboration and flexibility despite recent disruptions. Dr. Chiang emphasized how much he values working with the Council and looks forward to future opportunities to meet in person at Bethesda.

The open session of the meeting was adjourned at 11:47am.

CLOSED SESSION
This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS

NAEC members reviewed 590 NEI-primary applications requesting $217,033,436 (direct costs, year 01)
Another 200 applications where NEI was a secondary institute requesting $140,198,062 (direct costs, year 01).
Council concurred with Institutional Review Group recommendations on these 790 applications.
ADJOURNMENT

The 172nd meeting of the National Advisory Eye Council was adjourned at 1:00 p.m. on December 9, 2025.

CLOSED SESSION ATTENDEES

Council Members Present:

Dr. Michael F. Chiang, Chair
Dr. Anna Han, Executive Secretary
Dr. Maria Grant
Dr. Donald Mutti
Dr. Pradeep Ramulu
Dr. Victor Perez
Quinones

NIH Staff Members Present:

Shawn Adolphus
Neeraj Agarwal
Houmam Araj
Negin Atri
Sangeeta Bhargava
Rylee Brauer
Nathan Brown
Alysia Champagne
Edwin Clayton
Roland Colbert
Tiffany Cook
Donald Everett
Martha Flanders
Ashley Fortress
Shaojian Gao
Nataliya Gordiyenko
Tony Gover
Steven Henle
Stephanie Kennedy
Jimmy Le
Paekgyu Lee
Renee Livshin
Barbara Mallon
George McKie
Lisa Neuhold
Maryann Redford
Carissa Reilly-Weedon
Jennifer Schiltz
Azadeh Shoaibi
Hongman Song
Afia Sultana Kirk Thompson
Santa Tumminia
Leslie West-Bushby
Cheryl Wiggs
Charles Wright

CERTIFICATION

We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Hyo-Jung Han, PhD
Executive Secretary
National Advisory Eye Council

Meeting Minutes

The National Advisory Eye Council (NAEC) convened its 171st meeting virtually at 10:00 a.m. on Friday, June 13, 2025. The meeting was publicly broadcast by the NIH videocast system. Dr. Michael F. Chiang, Director of the National Eye Institute (NEI), presided as Council Chair. Dr. Hyo-Jung (Anna) Han served as Executive Secretary. The meeting was open to the public from 10:00 a.m. to 11:49 a.m., and closed from 12:00 p.m. to 1:00 p.m. for confidential discussions, including conflict-of-interest matters, application reviews, and cooperative agreement applications.

Council Members Present: 
Dr. Michael F. Chiang, Chair 
Dr. Anna Han, Executive Secretary
Dr. Maria Grant
Dr. Donald Mutti 
Dr. Pradeep Ramulu 
Dr. Victor Perez Quinones

NIH Staff Members Present:
Shawn Adolphus
Neeraj Agarwal
Elvira Agron
Houmam Araj
Negin Atri
Sofia Becerra
Sangeeta Bhargava
Kapil Bharti
Rylee Brauer
Nathan Brown
Gleysin Cabrera Herrera
Alysia Champagne
Wang Chenyue
Emily Chew
Edwin Clayton
Karen Colbert
Roland Colbert
Tiffany Cook
Jeffrey Cozart
Christina Curington
Subrata Debnath
Kathryn Demott
Mala Dutta
Salwa Elsaadawy
Donald Everett
Jianguo Fan
Martha Flanders
Ashley Fortress
Alexandra Fritz
Shaojian Gao
Nataliya Gordiyenko
Tony Gover
Steven Henle
David Higgins
Awilda Holland
Ji Jeong
Stephanie Kennedy
Jimmy Le
Paekgyu Lee
Richard Lee
Jennifer Lei
Renee Livshin
Barbara Mallon
Alexander Manuel
George McKie
Sheldon Miller
Mahesh Mujumdar
Elizabeth Murphy
Amelia Naik
Erika Nelson
Lisa Neuhold
Claude Ngopa
William O'Donnell
Maryann Redford
Carissa Reilly-Weedon
Jessica Ryan
Vatsala Sagar
Jennifer Schiltz
David Schneeweis
Shauna Schwartz
Grace Shen
Azadeh Shoaibi
Hongman Song
Afia Sultana
Ginger Tansey
Kirk Thompson
Santa Tumminia
Susan Vitale
Leslie West-Bushby
Cheryl Wiggs
Bronte Williams Washington
Keturah Williams
Solomon Woldeselassie
Charles Wright

WELCOME AND INTRODUCTIONS
—Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang opened the meeting, acknowledged the virtual format, and thanked members for their participation. He noted a smaller-than-usual group due to pending council slate approvals.

COUNCIL PROCEDURES AND RELATED MATTERS 
—Dr. Anna Han, Executive Secretary, 
NAEC, and Acting Director, Division of Extramural Activities (DEA)

Dr. Han introduced herself as Acting Director of the Division of Extramural Activities (DEA), following Dr. Kathy Anderson’s retirement in May. She recognized Dr. Anderson’s decades of 
service and contributions. Dr. Han also welcomed Council members, NEI staff, advocacy partners, colleagues from the Center for Scientific Review, and members of the public. She reviewed meeting etiquette, including the importance of self-identification when speaking, use of the “raise hand” feature, and limitations of the Teams chat box. She reminded Council members of their responsibilities as Special Government Employees, including restrictions on lobbying. Dr. Han announced the next Council meeting will be held Friday, October 3, 2025, ideally in person. She explained that minutes will no longer require formal approval during meetings but will continue to be circulated for review and comment.

NEI DIRECTOR’S REPORT 
—Dr. Michael F. Chiang

Dr. Chiang presented an overview of NIH and NEI updates since April 2025, emphasizing alignment with NIH priorities under new Director Dr. Jay Bhattacharya.

Leadership Transitions

NIH-Wide
Dr. Bhattacharya began as NIH’s 18th Director in April
Dr. Matt Memoli was appointed Principal Deputy Director.
NEI
Dr. Sangeeta Bhargav was appointed Director of the Division of Extramural Science Programs.
Dr. Anna Han serving as the Acting Director of DEA
Departures included:
Kathy Anderson (retired)
Maria Zacharias (retired)
Shefa Gordon (affected by NIH reduction in force)
Kerry Goetz (moved to industry)
NEI Alignment with NIH Strategic Priorities

A. Innovation
NEI initiatives exemplify innovation with broad implications across medicine:

OCT Imaging:
Revolutionized real-time, non-invasive retinal imaging; foundational in multiple fields.
Artificial Intelligence (AI):
First FDA-approved autonomous AI diagnostic was for diabetic retinopathy (Michael Abramoff).
Ongoing frontier work includes precision medicine, “oculomics,” and data privacy.
Gene and Cell Therapy:
Luxturna: First FDA-approved gene therapy emerged from NEI research.
NEI participated in Bespoke Gene Therapy Consortium and Regenerative Medicine Innovation Project.
3 of 8 trials in the bespoke program target eye diseases.
Research Highlights:
Prime editing delivery in retinal diseases (collaboration: UC Irvine, Broad Institute)
Cell-based neuroprotective therapy for MacTel2 (approved March 2025)
Laser-based cone stimulation system created “new” human color perception (“Olo”)
Microns Project: Brain-wide connectome mapping using mouse visual cortex—520 million synapses mapped
B. Chronic Disease

Multi-omics and AI:
Proteomic “aging” studies showed disease-linked molecular signatures outlasting clinical symptoms (e.g., diabetic retinopathy).
Neuroplasticity & CVI:
NEI-led working groups on neuroplasticity and extracellular vesicles (EVs)
EVs underutilized in ophthalmic research—only 9 clinical trials between 2010–2023
Bridge2AI Program:
NEI is a lead institute
Study led by Drs. Aaron and Cecilia Lee (UW) combines ocular imaging, environmental sensors, wearables, and EHR data in diabetes progression
1000 participants, 2TB data already shared
PRIMED AI (proposed):
$121M initiative under development for multimodal AI-driven precision medicine
NEI is one of 5 lead institutes
Myopia & Uveitis Studies:
BLINK2 Trial: Slowed axial elongation in older teens
ADJUST & MIRA Trials: Informed treatment withdrawal protocols and efficacy of intravitreal therapies
Cerebral Visual Impairment (CVI):
Now leading cause of pediatric visual impairment in the U.S.
Multidisciplinary collaboration with NICHD and NINDS
National registry launching
Simultaneous publications in Ophthalmology, Pediatrics, and Annals of Neurology 
C. Reproducibility

Dr. Chiang stressed the need to shift research culture:

Data Sharing:
Concern: Data sharing compliance is often performative
Academic incentives need to align with collaborative and reproducible science
S-Index Challenge: $1M prize competition to design metrics that reward impactful data sharing. 44 full submissions received.
Federated Vision Research Network:
Four winning teams selected to build interoperable clinical research models:
Harvard, Oregon, Columbia, Stanford
Focus on common data models, harmonization, and pediatric ophthalmology
Interoperability & Standards:
Strong push to adopt DICOM standards in ophthalmic imaging
NEI, FDA, and AAO guidance now discourages use of non-standard compliant imaging in NIH-funded research
Ongoing work with NIBIB and FDA to develop image calibration “phantoms”
All of Us Initiative – “Eyes on Health”:
Pilot study underway to integrate OCT, OCT-A, and fundus imaging into the NIH All of Us program
Goal: Deep phenotype linkage between retinal health and systemic disease
Policy & Funding Updates

NIH is under a Continuing Resolution (CR) through September 30, 2025; NEI funding remains at FY24 levels.
New HHS grant termination tracking system available to the public.
Policy changes:
PEDPs, diversity plans, and other supplemental documentation no longer required in some FOAs.
Funding opportunities being revised; applicants should review notices carefully.
Workforce Development & Outreach

NEI celebrated poster award winners from NIH Postbac Poster Day.
High School Video Contest winners honored in three categories.
Council of Vision Editors Fellowship launched second cohort across major journals.
NEI supports meta-science research through the NIH Science of Science Scholars pilot.
Katz Early-Stage Investigator Awards continue to support research without preliminary data. 
DISCUSSION
Dr. Donald Mutti Question:
Dr. Donald Mutti praised NEI’s accomplishments and asked how consolidation proposals (reducing 27 NIH Institutes to 8, placing NEI under a proposed Neuroscience Institute) might affect NEI’s ability to fulfill its mission. He inquired whether any analysis has been conducted on the implications of such restructuring.

Dr. Chiang’s Response:
Chiang noted that as a federal official, he cannot comment on pending legislation, but emphasized NEI’s historical independence and its unique record of supporting major vision research breakthroughs, especially that almost every breakthrough in preventing blindness in the past 50 years was NEI-supported.

Dr. Mutti followed up, asking whether anyone had undertaken a pros-and-cons analysis of consolidation. Dr. Chiang responded he was not aware of any such analysis and noted it would be difficult to create a counterfactual or randomized comparison of organizational models.

The meeting took a 15-minute break beginning at 11:30am. Upon returning at 11:45am, Dr. Chiang introduced Council Member Pradeep Ramulu who joined the meeting. Dr. Ramulu indicated that he was from Johns Hopkins as a Glaucoma Specialist and was proud to participate in their 100th year celebration.

NEI Triannual Inclusion Report

Dr. Song provided a summary of NEI’s compliance with the NIH Inclusion Policy, which mandates the inclusion and reporting of demographic characteristics—sex, race, and ethnicity—in NIH-supported human subject’s research.

Key Responsibilities & Strategies for Compliance:

NEI is federally required to present this report every three years.
The NIH policy is:
Posted on NEI’s website
Explicit in all Funding Opportunity Announcements (FOAs)
Compliance is ensured through:
Education of peer review members
Training for NIH staff
Use of tracking systems
Ongoing program director oversight, especially for Phase III clinical trials
Data Summary (Past Three Years)

General Enrollment Data:

NEI supported approximately 300 individual research studies (IRs) with active enrollment each year.
Most studies are U.S.-based.
Very few single-sex studies; the vast majority include both male and female participants.
Demographic Representation:

Sex (Domestic Studies):
~54% of participants were female, which closely matches the general U.S. population.
Race:
NEI-supported studies included participants from nearly all racial categories as per U.S. Census categories.
The racial distribution of participants generally mirrored the U.S. population.
Ethnicity:
Over 15% of participants identified as Hispanic, demonstrating significant inclusion across ethnic lines.
Phase III Clinical Trials:

Sex representation remains balanced between males and females.
Racial composition again aligned well with national benchmarks.
Hispanic participation in Phase III trials was around 13%.
Council Discussion 
Dr. Donald Mutti praised the report’s encouraging inclusion data. Suggested that the term “generalizability” could serve as a scientific synonym for “diversity, equity, and inclusion (DEI)”, which has become politically charged. “Generalizability” is neutral, values-based, and fundamental to sound scientific research, making it a useful term to retain core DEI principles without political implications.

Dr. Maria Grant commended Dr. Chiang’s broader director’s report (presented earlier in the meeting) as “vast and incredibly” representative of NEI's reach and excellence. Expressed a desire for more public visibility and awareness of NEI’s value and independence as a specialized institute.

Dr. Chiang reiterated that while he cannot comment on pending legislation (e.g., NIH consolidation proposals), his role is to focus on NEI's mission and strategic plan. Dr. Chiang reiterated NEI’s mission-driven approach, collaborative research ecosystem, and balance between being a small, cohesive community and a nationally impactful institute.

Dr. Chiang also emphasized the importance of fostering a research ecosystem where “the whole is greater than the sum of its parts.” He acknowledged NEI’s unique balance:

Small enough to be cohesive and collaborative
Important enough (vision health) to make a national impact
Dr. Donald Mutti (Follow-Up)

Echoed Dr. Grant’s sentiments, underscoring that vision science is “special” and should remain distinct. “What was true in 1968 is still true today—vision is a uniquely prized sense.”
Closing

Dr. Chiang closed the session by thanking all contributors and reaffirming NEI’s commitment to its strategic goals. Dr. Han expressed her appreciation for participants’  engagement and invited suggestions for future agendas, including the October meeting. As the meeting was ahead of schedule, she transitioned directly into the closed session. Before adjourning, Dr. Chiang recognized the behind-the-scenes efforts of Nathan Brown and commended Dr. Han’s leadership in managing her first Council meeting.

The open session of the meeting was adjourned at 11:49am.

CLOSED SESSION
This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS

NAEC members reviewed 655 NEI-primary applications requesting $225,283,564 (direct costs, year 01)
Another 205 application where NEI was a secondary institute requesting $115,787,778 (direct costs, year 01).
Council concurred with Institutional Review Group recommendations on these 860 applications.
ADJOURNMENT
The 171st meeting of the National Advisory Eye Council was adjourned at 1:00 p.m. on June 13, 2025.

CLOSED SESSION ATTENDEES

Council Members Present:
Dr. Michael F. Chiang, Chair 
Dr. Anna Han, Executive Secretary
Dr. Maria Grant
Dr. Donald Mutti 
Dr. Pradeep Ramulu 
Dr. Victor Perez Quinones

NIH Staff Members Present:

Shawn Adolphus
Neeraj Agarwal
Houmam Araj
Negin Atri
Sangeeta Bhargava
Rylee Brauer
Nathan Brown
Alysia Champagne
Edwin Clayton
Roland Colbert
Tiffany Cook
Donald Everett
Martha Flanders
Ashley Fortress
Shaojian Gao
Nataliya Gordiyenko
Tony Gover
Steven Henle
Stephanie Kennedy
Jimmy Le
Paekgyu Lee 
Renee Livshin
Barbara Mallon
George McKie
Lisa Neuhold
Maryann Redford
Carissa Reilly-Weedon
Jennifer Schiltz
Azadeh Shoaibi
Hongman Song
Afia Sultana
Kirk Thompson
Santa Tumminia
Leslie West-Bushby
Cheryl Wiggs
Charles Wright

CERTIFICATION
We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Hyo-Jung Han, PhD
Executive Secretary
National Advisory Eye Council

Meeting Minutes

The National Advisory Eye Council (NAEC) convened at 10:00 a.m. on Monday, April 21, 2025. All participants attended virtually. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was closed to the public for the review of grant and cooperative agreement applications.

Closed Session
The meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

Review of Applications
NAEC members considered 610 grant and cooperative agreement applications on which NEI was the primary Institute; these applications requested a total of $223,774,797 (direct costs year 01). The Council also considered 371 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $172,771,568 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 981 applications.

Adjournment 
The meeting of the National Advisory Eye Council was adjourned at 11:49 a.m. on April 21, 2025.

Closed Session Attendees
Council Members Present:
Dr. Michael F. Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Maria B. Grant
Janice Lehrer-Stein
Dr. Maureen Maguire
Dr. Tirin Moore
Dr. Donald Mutti
Dr. Victor Perez Quinones
Dr. Pradeep Ramulu

NIH Staff Members Present:
Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Negin Atri
Dr. Sangeeta Bhargava
Rylee Brauer
Nathan Brown
Dr. Ed Clayton
Jay Colbert
Dr. Tiffany Cook
Don Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. Shaojian Gao
Dr. Nataliya Gordiyenko
Dr. Tony Gover
Dr. Maria Grant
Dr. Hyo-Jung Han
Dr. Steven Henle
Lateefah Hill
Dr. Hongman Song
Dr. Brian Hoshaw
Dr. Jeanette Hosseini
Dr. Jimmy Le
Dr. Paek Lee
Renee Livshin
Dr. Barbara Mallon
Dr. George McKie
Dr. Lisa Neuhold
Dr. Robert O’Hagan
Melanie Reagan
Dr. Maryann Redford
Carissa Reilly-Weedon
Dr. Jennifer Schiltz
Dr. Merideth Shifflett
Dr. Azadeh Shoaibi
Dr. Afia Sultana
Dr. Joanna Szczepanik
Dr. Kirk Thompson
Dr. Santa Tumminia
Leslie West-Bushby
Dr. Cheryl Wiggs
Bronte Williams-Washington
Keturah Williams
Dr. Charles Wright

CERTIFICATION
We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 169th meeting at 8:30 a.m. on Friday, October 11, 2024. The meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended either virtually or in-person. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 8:30 a.m. until 2:30 p.m. The meeting was closed to the public from 2:40 p.m. until 5:00 p.m. for the review of grant and cooperative agreement applications.

Council Members Present:
Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary
(in-person)
Dr. Reza Dana (in-person)
Dr. Maria B. Grant (in-person)
Dr. Maureen Maguire (in-person)
Dr. Tirin Moore (in-person)
Dr. Donald Mutti (in-person)
Dr. Victor Perez Quinones (in-person)
Dr. Pradeep Ramulu (in-person)

NIH Staff Members Present:
Shawn Adolphus (virtual)
Dr. Neeraj Agarwal (in-person)
Dr. Dheeraj Agrohia (virtual)
Lisa Applewhite (in-person)
Mike Arango (virtual)
Dr. Houmam Araj (in-person)
Dr. Sangeeta Bhargava (in-person)
Dr. Kapil Bharti (in-person))
Holly Blake (virtual)
Nathan Brown (in-person)
Dr. Irina Bunea (virtual)
Dr. Rachel Caspi (virtual)
Dr. Emily Chew (in-person)
Faith Chen (virtual)
Dr. Ed Clayton (in-person)
Karen Colbert (in-person)
Wanda Coleman (virtual)
Dr. Mary Francis Cotch (virtual)
Kathryn DeMott in-person)
Britt Dennis (virtual)
Dr. Mela Dutta (virtual)
Dr. Jordan Dworkin (in-person)
Donald Everett (in-person)
Dr. Martha Flanders (in-person)
Dr. Ashley Fortress (in-person)
Ellaine Galindez-Balut (virtual)
Dr. James Gao (in-person)
Alexandra Gavrilovic (in-person)
Dr. Susan Gillmor (virtual)
Kerry Goetz (in-person)
Dr. Nataliya Gordiyenko (in-person)
Dr. Shefa Gordon (virtual)
Dr. Tony Gover (in-person)
Charles Gushue (virtual)
Dr. Anna Han (in-person)
Syed Haqqani (in-person)
Dr. Himide Hardy-Pointer (virtual)
Dustin Hayes (virtual)
Judith Hill (in-person)
Lateefah Hill (in-person)
Dr. Fang Hua, (virtual)
Dan Ignaszewski (in-person)
Dr. Shekhar Jha (virtual)
Dr. Marco Ji (virtual)
Alicia Kerr (in-person)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (in-person)
Dr. Richard Lee (in-person)
Dr. Jung Wha Lee (virtual)
Renee Livshin (virtual)
Rashid Mahdi (virtual)
Natanya Malcolm (virtual)
Alex Manuel (virtual)
Dr. George McKie (in-person)
Dr. Sheldon Miller (virtual)
Mike Moore (virtual)
Erika Nelson (virtual)
Dr. Lisa Neuhold (virtual)
William O’Donnell (virtual)
Dr. Bob O’Hagan (virtual)
Dr. Angelica Ortiz (virtual)
Barbara Payne (virtual)
Melanie Reagan (in-person)
Dr. Mary Ann Redford (virtual)
Amber Reed (virtual)
Holly Russo (virtual)
Dr. Jennifer Schiltz (in-person)
Dr. David Schneeweis (in-person)
Shokrai Wendy (virtual)
Dr. Grace Shen (in-person)
Dr. Azadeh Shoaibi (in-person)
Karen Robinson Smith (in-person)
Dr. Hongman Song (in-person)
Dr. Carolyn Stein (in-person)
Dr. Afia Sultana (virtual)
Dr. Joanna Szczepanik (virtual)
Ginger Tansey (virtual)
Dr. Santa Tumminia (in-person)
Dr. Ehsan Ullah (virtual)
Fausto Vela (virtual)
Dr. Kati Veres (virtual)
Dr. Chenyue Wang (virtual)
Leslie West-Bushby (virtual)
Dr. Cheri Wiggs (in-person)
Bronte Washington-Williams (in-person)
Keturah Williams (virtual)
Dr. Charles Wright (in-person)
Juan Yang (virtual)
Maria Zacharias (virtual)

WELCOME AND INTRODUCTIONS
—Dr. Michael F. Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang called the 169th NAEC meeting to order. He introduced two guest speakers, Dr. Carolyn Stein of the University of California, Berkeley, and Dr. Jordan Dworkin of the Federation of American Scientists. Council members briefly introduced themselves.

COUNCIL PROCEDURES AND RELATED MATTERS 
—Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA)

Dr. Anderson welcomed the NEI research and advocacy community, colleagues from the Center for Scientific Review, invited speakers, and members of the public who were in attendance virtually, and thanked staff members who organized the meeting and provided technical support.

She also extended thanks to Dr. Tirin Moore and Dr. Maureen Maguire for agreeing to extend their terms for another meeting as new council members wait to be approved. She thanked Dr. Reza for his service on council for the past three years. She then reviewed best practices for a hybrid meeting.

She noted that future NAEC meetings are listed on the agenda and on the NEI website. The next in-person NAEC meeting will be held on Friday, February 21, 2025. Minutes of the June 2024 NAEC meeting were made available in the electronic council book (ECB) prior to the meeting. A motion to accept the June meeting minutes was made, seconded, and approved unanimously.

Going forward, draft council minutes will be emailed to Council members for approval in advance of the meeting as under a new requirement to have final meeting minutes certified 120 days after the meeting.

NEI DIRECTOR’S REPORT
NEI DIRECTOR’S REPORT —Dr. Michael F. Chiang

Dr. Chiang began by noting the value of social media in disseminating news about scientific and research activities taking place at NIH and NEI. He encouraged attendees to follow NEI’s social media accounts, @NEIDirector and @NatEyeInstitute, on X/Twitter, as well as his LinkedIn account, ChiangMF. Dr. Chiang announced that Drs. Reza Dana, Maureen Maguire, and Tirin Moore would be rotating off the council and thanked them for their service. He noted that several new members will be joining the next meeting.

NIH and NEI and Leadership and Staff Updates

Dr. Chiang noted that Dr. Carolyn Hunter has been named the Director of the Office of Strategic Coordination, which manages the NIH Common Fund. NEI has been doing a lot of activities with the Common Fund, reflecting the cross-disciplinary impact of research in vision.

At NEI, Dr. Chiang introduced two new members of the Division of Extramural Science Programs. Dr. Steven Henley, an AAAS Fellow, will serve as a Program Officer for the glaucoma portfolio, and Dr. Ashley Fortress will serve as a Program Officer for regenerative medicine portfolio.

Dr. Chiang also noted that Dr. Grace Shen, a Program Officer for the retina portfolio, will be retiring in October 2024 after 21 years of service at NEI.

Awards and Recognition

Dr. Chiang congratulated the winners of the Kavli Prize in Neuroscience: Dr. Nancy Kanwisher of the Massachusetts Institute of Technology, Dr. Doris Ying Tsao of the University of California, Berkeley, and Dr. Winrich Freiwald of the Rockefeller University. The trio of NEI-funded researchers were awarded the prize for the discovery of “face areas” in the brain – research conducted over three decades.

Dr. Chiang also congratulated Dr. Rachel O. Wong of the University of Washington, for receiving the 2024 Joram Piatigorsky Basic Science Award for her work on the development and repair of circuits in the vertebrate retina and for giving the lecture at this year’s event.

Awards and Recognition (2)

Dr. Chiang celebrated the achievements of three researchers in the vision research community who were named 2024 Clarivate Citation Laureates: NEI intramural researcher Okihide Hikosaka; Ann M. Graybiel of the Massachusetts Institute of Technology; and Wolfram Schultz of the University of Cambridge. This designation is made by the Institute for Scientific Information to researchers whose work has had a major impact in their field and is regarded as a barometer of predicting who might win a Nobel Prize or a Lasker Award. These researchers were recognized for physiological studies of the basal ganglia, central to motor control and behavior, including learning.

Dr. Chiang also lauded NEI intramural investigator Dr. Hendrikje Nienborg, who was recently awarded tenure.

NEI-funded Highlight: Gene therapy for Leber Congenital Amaurosis

Dr. Chiang noted a recent study published in the September 2024 issue of The Lancet in which 15 patients received a subretinal injection of a gene therapy for a form of Leber congenital amaurosis (LCA1) caused by mutations in the guanylyl cyclase 2D gene. The therapy was developed by a drug company called Atsena Therapeutics, and in the trial, patients experienced a 100-1000-fold improvement in their vision with no adverse events. Although the trial was funded by Atsena, it built upon a large foundation of NEI supported research.

NEI-funded Highlight (2): Dry Age-Related Macular Degeneration

Dr. Chiang highlighted a project that identified the gene AKT2 as a potential, new therapeutic target for dry Age-Related Macular Degeneration (AMD). This work was led by Dr. Debasish Sinha at the University of Pittsburgh, along with Dr. Jim Handa at Johns Hopkins University and Dr. Kapil Bharti and Dr. Ruchi Sharma at NEI. Using both a mouse stem cell model as well as an induced pluripotent stem cell-derived retinal pigment epithelium model, they showed that the overexpression of AKT2 leads to lysosome dysfunction and dry AMD. The paper was published in July in Nature Communications.

NEI-funded Highlight (3): Slowing geographic atrophy in AMD

Dr. Chiang also highlighted another study on dry AMD conducted by a team of intramural NEI researchers: Dr. Emily Chew, Dr. Tiaernán Keenan, and Dr. Elvira Agrόn. They re-analyzed retinal images in the Age-Related Eye Disease Studies (AREDS/AREDS2) datasets. The original studies did not account for foveal sparing in the late stages of dry AMD, so in their re-analysis, the team discovered a previously hidden treatment effect in patients taking antioxidant and lutein/zeaxanthin AREDS 2 supplements. In patients taking these supplements the expansion of geographic atrophy toward the central fovea slowed by 55% over three years, helping them preserve their central vision. The study, published online in Ophthalmology in July, supports the continued use of these supplements as a highly effective and cost-effective treatment in patients with late-stage dry AMD.

NIH: Communities Advancing Research Equity (CARE) for Health

Communities Advancing Research Equity (CARE) for Health is an NIH initiative launched this summer that aims to establish a primary care focused research network that integrates research into routine care. The goals of the initiative are to create sustained engagement with communities that are underrepresented in clinical research and to build trust in science among patients as well as primary care clinicians. Dr. Chiang said that CARE for Health recently announced three pilot projects matched to ongoing treatment studies on chronic back pain, drug and alcohol addiction, and gout prevention and treatment. Noting that he serves on the Oversight Committee for the initiative, Dr. Chiang asked how primary care could benefit from more collaboration with the vision community and whether there are studies that could be considered that could bring eye care to the community.

Discussion

Dr. Mutti noted the need for fixing the fragmented state of pediatric vision care, an issue highlighted in a recent National Academies report. Vision screening currently takes place in schools, but there is variation in how states do it, and there is a gap between detection in a school-based environment and the actual delivery of care. How to close this gap and have treatment covered could benefit from further study, he said.

Dr. Maguire pointed out that diabetes is another major public health problem that is very amenable to screening and treatment, particularly with new methods emerging for detecting early disease.

Dr. Ramulu said the suggestions by Dr. Mutti and Dr. Maguire offer direct benefit to participants, but also that the eye has a great capacity to detect systemic disease in ways that may not yet be fully understood. Ongoing research is exploring the link between the eye and conditions involving cognition and neurodegeneration, for example, but it is important to consider the balance between studies that bring direct patient or participant benefit and those that benefit to research, and how to effectively meld the two.

Dr Chiang agreed, adding that primary care in the US is stretched increasingly thinner, so motivating that community to get involved in research may pose some challenges.

Dr. Ramulu noted that two examples to emulate might be a clinical trial currently running in India focusing on improving vision with regard to cognitive outcomes, and a similar effort with a hearing intervention that is embedded within a community-based cohort of primary care deliverers.

NIH Simplified Review Framework

The NIH Simplified Review Framework, a planned change to the grant review process presented to the Council in October 2023, will be going into effect on January 25, 2025, Dr. Chiang said. Currently, grants are evaluated on five review criteria – significance, innovation, approach, investigator, and environment. Changes to the current system aim to focus more on the scientific and technical merit of a proposal and mitigate the effect of reputational bias on the review process. Under this new framework, these five criteria are collapsed into three factors. The first, the importance of research, integrates significance and innovation and addresses whether the project should be done. The second, rigor and feasibility, corresponds to the current third criterion, approach, and addresses whether the project can be done. These two factors will be scored on a 1-9 scale. The third factor is focused on expertise and resources, corresponding to investigator and environment in the current criteria. It will not receive an individual score but is considered when assigning the overall impact score. Dr. Chiang directed questions or comments to Dr. Brian Hoshaw, who chaired the implementation of this effort, and to Dr. Kathleen Anderson. Dr. Anderson noted that the application process will remain unchanged, and that only the review process will undergo these changes.

NIH Updates: Scientific Management Review Board

Dr. Chiang noted that the Scientific Management Review Board, a body within the NIH that has been dormant since 2015, will be meeting on November 14, 2024. The Board consists of nine NIH institute directors and eight community members, most of whom are people in leadership positions at universities. Dr. Chiang will be one of the nine institute directors in attendance.

Dr. Chiang briefly described the history and revival of the SMRB. It was formed as part of the NIH Reform Act, passed in 2006. Its purpose is to advise the Department of Health and Human Services and to advise the NIH on using organizational authorities to establish or abolish institutes within the NIH, to reorganize offices within institutes, and to reorganize within and across institutes at the NIH. Dr. Francis Collins, who served as NIH Director from 2009-2021, felt that the NIH Advisory Committee to the Director could do these tasks more efficiently, so the board has not convened since 2015. Recent Congressional reports (to which Dr. Chiang provided QR codes) have highlighted the need to reform the NIH and improve operations to better support research. Revival of the SMRB was one of the recommendations to this end.

NIH Updates: Statement on Asian Scientists

Dr. Chiang highlighted a statement put out by NIH Director Monica Bertagnolli expressing the agency’s support for Asian Americans, Asian immigrants, and Asian research colleagues.

Driving Innovation: Quantum Sensing and Software

Dr. Chiang described three new Notices of Special Interest (NOFOs). One NOFO, which is due October 24, 2024, and is spearheaded by Dr. Tony Gover, is for small businesses developing quantum sensing technologies for imaging and signal detection in biomedical applications. It is especially aimed at supporting the development of low-cost, portable user-friendly devices that could help stimulate more equitable biomedical data collection The two other NOFOs, due November 4, 2024, and spearheaded by Dr. James Gao, are geared towards creating software for science. Often, software is written for a specific project by a researcher who lacks the time and resources to turn it into a production-quality product, and these NOFOs aim to close that gap. One, called Building Sustainable Software Tools for Science, is an R03 mechanism that supports collaborations between researchers and software engineers to create tools that accord with best practices and design principles. The other, called the NIH Research Software Engineer Award, is an R50 mechanism that provides protected time for software engineers to develop software in the context of existing NIH-funded projects.

Neuroscience: Connectomics, Blueprint

In recent work funded by the BRAIN Initiative, researchers characterized the entire set of 140,000 interconnected neurons and 50 million synapses – the connectome – of the fruit fly. These findings were published in Nature in October in a series of nine papers. Of these, Dr. Chiang said, three papers were directly tied to the visual system, revealing how much impact the visual system has had on neuroscience research overall. Dr. Chiang acknowledged NEI program officers and researchers who work with the BRAIN Initiative.

Dr. Chiang also highlighted the Blueprint Neurotherapeutics Network. This initiative includes two components – one that focuses on biologics (such as gene therapy and antibody or protein therapy) and one that focuses on small molecules. He noted that these programs support several ongoing projects on visual diseases.

Rare Genetic Eye Disease

Dr. Chiang provided an update on the National Ophthalmic Disease Genotyping and Phenotyping Network, also known as eyeGENE. The project was originally developed in 2006 by Dr. Santa Tumminia at NEI and Phase 3 of the project launched last year. Phase 3 launch will include a new accrual protocol that focuses on patient accessibility and involves developing innovative electronic consent forms and mail-in saliva kits for DNA collection.

Dr. Chiang also noted that the National Organization for Albinism and Hypopigmentation for the first time welcomed researchers to its annual conference, held in July 2024. This is traditionally a patient and family meeting, but a group of NEI researchers worked with Verily to enroll patients into eyeGENE. Verily recently developed a new retinal camera for capturing retinal photos. In collaboration with NEI, this camera was used at the meeting to capture retinal photos for the eyeGENE dataset.

Novel Human Biology Models: Complement-ARIE Program

A Common Fund initiative called Complement Animal Research In Experimentation or Complement-ARIE aims to develop, standardize, and validate human-based laboratory or computer approaches for modeling human biology. These New Approach Methodologies (NAMs) include the use of organoids, digital twins, artificial intelligence, and other approaches. NEI’s involvement in this effort has been led by Dr. Martha Flanders. Dr. Chiang noted that three major initiatives are planned: One is an $18 million per year project for establishing NAMs technology development centers; another is a NAMs data hub and coordination center; and the third is a validation and qualification network. Considering that a lot of work in the vision community relies on techniques such as organoids, Dr. Chiang noted there may be ways that vision researchers can take advantage of these opportunities.

Oculomics Common Fund Venture Initiative

Last year, the NIH Common Fund created a Venture Initiative Program to fund 3-year, $15- million projects – smaller in scale than its usual projects. NIH institutes were asked to nominate projects for this program, and Dr. Tony Gover worked with other program officers to develop an initiative called “Oculomics,” which was selected for funding.

Dr. Chiang described the three projects that will be funded under this initiative. One, led by Dr. Amani Fawzu at Northwestern University and Dr. Stephen Burns at Indiana University, aims to develop technology to monitor systemic health by looking at vascular oculomics at a cellular level. Another, led by Dr. Vivek Jay Srinivasan and Dr. Laura Balcer at New York University, will develop next generation optical coherence tomography tools to detect biomarkers of neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease. A third, led by Dr. Jinahua Wang, Dr. Liang Liang at the University of Miami, and Dr. Yuhua Zhang at the Doheny Eye Institute, aims to develop novel methods to measure blood flow in retinal capillaries to detect cerebral small vessel disease, which contributes to dementia.

Dr. Chiang asked members of the Council for their thoughts on how to better stimulate clinical adoption of new technologies such as OCT-based diagnosis.

Discussion

Dr. Dana noted that as OCT and other technologies evolve, few are getting validated. Even if they are validated scientifically, they may not be validated by the FDA as endpoints in clinical trials. That means it is difficult to adopt metrics based on these technologies into translational research, except at best as secondary endpoints. Therefore, he said, it is important to develop crosstalk and education for regulators about the validation of new technologies.

Dr. Grant said that although the eye-brain connection is very strong, NEI should perhaps also drive connections to a wider range of diseases such as cardiovascular disease, pulmonary disease, diabetes, and sickle cell disease. These diseases are more applicable to a wider base of patients, so she suggested broadening the research program to explore the use of these technologies in identifying biomarkers for systemic diseases. Additionally, Dr. Grant noted that time is an enormous issue in determining whether a tool will make the move from research to clinical practice. For adoption into community clinical practice, the tool’s use must save time rather than take time.

Dr. Perez agreed, noting that in addition to introducing the technology itself, it is crucial to consider recruiting patients, educating clinicians, and expanding to other specialties for which looking at the eye is not second nature. Additionally, he said, the machines themselves are large and expensive. Research initiatives that can develop smaller and less expensive versions of the technology will also be important.

Dr. Ramulu said that he could think of only one success story where OCT was adopted into clinical care – and that is in multiple sclerosis, where OCT has been used as an endpoint in multiple randomized trials. For the technology to be used in areas such as stroke or primary care, it has to move beyond the domain of the ophthalmologist so experts can use it independently, he said.

Dr. Mutti added that if new imaging technologies could be incorporated into existing technologies and be multimodal, that would make time less of a factor for clinicians using them. Also, he noted that validation is key because without it, insurers will not cover these tools. Dr. Maguire concurred with Dr. Mutti’s point that creating multimodal technologies will make it easier for clinical practices in the community to adopt them. The dream would be for a patient to spend 5 minutes in front of a machine that could diagnostically capture markers in the brain, heart, lungs, and eyes.

Dr. Chiang noted that the theme he was taking from the discussion was the need to think beyond the eye and beyond eye doctors using these technologies.

Foster Collaboration: Data Harmonization, Image Privacy

Data harmonization is a major issue in conducting collaborative clinical research. Different electronic health records systems around the country often do not talk to each other because they use different data models. As part of the OHDSI Initiative, NEI researchers set out to develop a common data model to address this problem, running some pilot projects that have enabled pooling data from millions of patients. However, it generally requires an engineer to convert an existing system into that common model, and academic centers often do not have the resources to make it happen. Dr. Chiang described a $1 million challenge launched in September 2024 to fund projects that create a federated vision research network that will enable collaborative research. An ODHSI seminar on health databases will take place on October 30, 2024, Dr. Chiang said.

Privacy is another health data issue. According to health privacy law, removing roughly 20 identifiers such as name, social security number and date of birth de-identifies a medical record. This is a big issue with retinal images because on one hand clinicians seek access to this data for research, but on the other hand there is a risk of people being re-identified based on those images. There is no consensus on whether retinal images are considered protected health information or de-identified.

Dr. Kerry Goetz and Dr. Amber Reed at NEI hosted a panel on August 12, 2024, discussing where the correct operating point should be with the help of multiple thought leaders in the field. Among the conclusions of the meeting was that NEI and the American Academy of Ophthalmology should work together to develop educational initiatives to build trust and clarify some of these misconceptions about retinal image sharing. The American Academy of Ophthalmology Board of Trustees also recently published a statement that said: “A very small risk of re-identifying individuals from de-identified retinal images exists, but the data set has very high value for advancing scientific knowledge.” Dr. Chiang noted that he was concerned that different medical centers may not have the same opinions about these issues, and that leadership from NEI and NIH may be necessary. He invited council members to share thoughts about what they think is needed for NEI/NIH leadership in this area.

Discussion

Dr. Ramulu agreed that NIH and NEI leadership would be very helpful. Another group that should have a seat at the table is institutional review boards, he said. A white paper offering a coherent vision on these issues would ideally lead to some harmonization across different IRBs and institutions, though many would look at things differently, even based on that same recommendation and the same facts, he said.

Dr. Grant noted that one big thing universities pay attention to is funding. Limiting their funding if they do not cooperate could be effective, she said. Dr. Dana said he disagrees because a system that is operationalized by force will not work because people who do not want to collaborate simply will not. Collaboration needs to be organic.

Dr. Chiang noted that his reading of the American Academy of Ophthalmology article was that random 10-digit numbers do not mean much but if those numbers happen to be peoples’ phone numbers they can suddenly be linked with individual identifiers. The paper argued, however, that at the moment retinal images cannot currently be linked with individual identifiers because no database containing that information exists, he said. Also, he added, it argued that people often do not understand the differences between irises and retinas. Iris imaging is easier and is considered PII.

NEI-NIBIB: Enhance All of Us with Ocular Imaging

Dr. Chiang announced a collaboration between NEI, the National Institute of Biomedical Imaging and Bioengineering, and the All of Us project that will conduct an ancillary study that involves collecting retinal images from 5000 people. Photos and OCTs will be collected at four All of Us sites – two in California, one in New Haven, and one in Chicago. The project is exciting from a research perspective because it aims to identify image-based risk factors and integrate them into All of Us, Dr. Chiang said. But it will also be methodologically important because All of Us does not currently have images in its data set. The study will help establish what we can learn from getting these images into the data set and will also enable the development of best practices for how to store and analyze such data in the cloud, how to standardize image data and metadata, and how to share information back with diverse patient cohorts.

Myopia: NASEM Study Report (Released 9/17/2024)

In September, the National Academies of Science, Engineering and Medicine released its 2024 report on myopia, Dr, Chiang said. The 400-page report was co-sponsored by NEI and a number of other organizations, several of which are in the optometric community. The NEI staff member who led this effort was Dr. Cheri Wiggs, and Dr. Mutti served on the expert panel.

The report made a number of recommendations, Dr. Chiang said. One is to classify myopia as a disease. Another is to recommend 1-2 hours of daily outdoor time for kids because outdoor time stimulates the eye with brighter and more varied light and requires different eye movements and focus compared with indoors. Another recommendation was to develop an integrated national data surveillance system on vision screening, referrals, and demographics. Recommendations specific to NEI include developing a repository for myopia-related data; supporting research in genetic and environmental mechanisms of disease; and supporting research on new treatment strategies and understanding treatment mechanisms.

Dr. Chiang said that NEI is planning a workshop for spring 2025 that follows up on the report. He asked whether Dr. Mutti had anything to add.

Dr. Mutti said the report’s conclusions underscored the prevalence of the disease. The last National Academy report on myopia was more than 30 years ago and it concluded that myopia was very stable over the 20th century, but the environment is very different now. He noted that the consensus opinion explaining the steep rise was the lack of outdoor time in the modern visual diet. There is now an urgent need to better understand basic mechanisms that drive eye growth to develop better treatment strategies. Also, he added, national surveillance efforts in the US are lacking, so what is happening in elementary school children here is unknown.

Dr. Grant asked whether there was enough existing data on light therapy and the need for UV light for proper eye growth to push for recommendations that children have more outside recess time at school.

Dr. Mutti replied that this would be an inexpensive intervention that would receive full-throated support from the committee. He noted that it would be helpful to understand what the biological benefit of outdoor time is. One mechanism identified so far is that brighter light stimulates dopamine release from the retina. However, he noted that the world has moved toward a more indoor environment for particular reasons, and that indoors is a lot more fun than it ever used to be. If the mechanisms were better understood, it could bring them indoors.

Cerebral/Cortical Visual Impairment (CVI)

Dr. Chiang noted several developments in research on CVI. At a recent ARVO Special Interest Group meeting in June 2024, researchers discussed the promise of eye tracking for developing predictive models for who is likely to develop CVI, moving prediction from a qualitative to a quantitative level. NEI is also in the process of building a CVI registry, and an Expert Panel meeting held in June 2024 discussed important details for the registry. Also, a publication forthcoming in December 2024 in Ophthalmology along with an accompanying NEI editorial will establish a working definition of CVI. In parallel, the American Academy of Pediatrics will publish a clinical report in Pediatrics about screening and building awareness for CVI.

Dr. Chiang noted that one of the challenges of CVI is that it is on the border of the eye and the brain, and clinicians of these different specialties often refer patients back and forth between them. Given that there are a lot of medical issues at the eye-brain interface, Dr. Chiang asked the Council whether the vision community should take more ownership of the condition.

Discussion

Dr. Ramulu said they should. At the end of the day, he said, the role of the vision community is in overseeing and optimizing people's vision, and not all problems with vision stem from the eyeball. He noted that issues that affect the brain and muscles and other factors that feed into vision are still more in the domain of vision experts than of other experts.

Collaborate and Educate: Artificial Intelligence

Work integrating AI into precision medicine and multimodal analysis is in process, Dr. Chiang said. Dr Sangeeta Bhargava is spearheading an NEI-led Common Fund program called Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI). The goal is to launch that program in 2026-2027. Also, the Common Fund recently published a Request for Information on this topic. Responses were due in September.

Dr. Kerry Goetz and Dr. Mike Arrango were recently invited to the White House through the Office of Science and Technology Policy for an AI event to give a presentation on the transformational potential of ocular imaging to predict overall health and wellness and increase healthcare access, Dr. Chiang said.

Educate: Seminar Series and Resources

Dr. Chiang provided QR codes to numerous NEI resources: the NEI Intramural Research Seminar Series, the NEI Data Science and Health Informatics Seminar Series; the NEI Grants website, and the NEI Extramural Research Newsletter.

“Recruit Talented and Diverse Individuals”

NEI has created a mentoring program for junior editorial board members who are early career KGrant awardees. The idea is for these junior editors to be mentored by associate editors to help them learn to be better reviewers, Dr. Chiang said, and hopefully to eventually become editorial board members themselves.

Dr. Chiang also gave an update on this year’s Diversity in Vision Research & Ophthalmology summer internships. The program, run by Dr. Cesar Perez-Gonzalez, is designed for students from backgrounds traditionally under-represented in research. Seven students participated this summer. Dr. Chiang provided a QR code to an article NEI put out about the program, which featured DIVRO alum Luke Nelson.

Finally, Dr. Chiang noted that the third annual Eye on the Future video contest for high school students had a great response this year. The students visited the NIH for a lab tour and networking in July and attended a presentation by a panel of researchers from the vision community.

All these initiatives are efforts to bring young people into the field, Dr. Chiang said.

NAEC Budget Update —Ms. Karen Colbert, NEI Budget Officer

Ms. Colbert recapped the current fiscal year and shared her expectations for the new 2025 fiscal year, which began October 1, 2024.

A continuing resolution allows NIH to continue operations through December 20, 2024, and the hope is that once Congress returns after the elections and the Veterans Day holiday, there will be some movement towards establishing appropriations for the year, she said. Until then, funding is held at last fiscal year's level and funds are doled out based on the number of days in the continuing resolution bill. The outcome of the 2024 elections and the subsequent makeup of the next Congress will play a large role in how things look in FY2025, she said.

Ms. Colbert reviewed budget proposals from both the House and the Senate. The House bill leaves NIH funding flat with fiscal year 2024. It reduces ARPA-H funding from $1.5 billion to $500 million. Total 21st Century Cures Act funding is reduced by $280 million from $407 million to $127 million in FY 2025. However, that reduction follows the plan from the original Cures authorization. The $1.28 billion that is freed up from ARPA-H and Cures is repurposed within the NIH budget.

The bill does not give budget levels for Institutes and Centers because it appropriates funding according to an NIH restructuring plan proposed by the House Energy and Commerce Committee. In that plan, only the National Cancer Institute, National Institute of Mental Health, and the new National Institute on Dementia correspond to existing Institutes and Centers. The National Institute of Allergy and Infectious Diseases would be split into two, and the other Institutes and Centers, along with ARPA-H and the NIH Common Fund, would be merged into seven super-institutes, Ms. Colbert explained.

Meanwhile, the Senate bill proposes $50.224 billion in base discretionary funding for NIH, an increase of $2.05 billion over fiscal year 2024. It also includes $127 million in Cures Act funding for a total of $50.351 billion for NIH. The Senate bill sustains ARPA-H funding at $1.5 billion and restores the All of Us Research Program, the Brain Initiative, and Cancer Moonshot to FY2023 funding levels after being cut in fiscal year 2024.

The House and Senate will come together to reconcile differences in the bills that have passed both chambers, although it is unknown how far they will get before the current continuing resolution expires on December 20. It is likely that there will be additional continuing resolutions until Congress settles on an omnibus or multiple minibus bills to fund the government for the balance of the fiscal year.

Discussion

Dr. Maguire asked how the House Energy and Commerce Committee recommendation mesh with recommendations with respect to reorganizing NIH. Ms. Colbert replied that so far that bill is a recommendation, and that NIH has not yet moved towards implementing it. When the House and Senate come together in conference, they will decide what between the two bills will move forward and what will be tabled until later.

Team Science—Dr. Carolyn Stein, UC Berkeley; Dr. Jordan Dworkin, Federation of American Scientists; Amber Reed, NEI; Dr. Kapil Bharti, NEI

Promoting Team Science for Social Benefit—Dr. Carolyn Stein, UC Berkeley

Dr. Stein discussed incentives in science and how they shape scientists’ behavior, as well as what incentive challenges exist for team science. Dr. Stein studies the economics of science and innovation, and she noted that although economists often see profit as a key motivator in innovation, that is probably not the right way to think about basic research. Much of her work explores what key motivators are at work for research.

Dr. Stein described a 2004 study that addressed this question in postdocs and found that postdocs are willing to accept a 20% cut in salary in exchange for more scientific freedom, suggesting that the enjoyment people get from free inquiry is one powerful motivator. Funding, of course, is another incentive, and a study published in 2020 reported that Requests for Applications (RFAs) put out by the NIH do seem to shift scientists away from what they are currently working on to the topic of the RFA. However, the cost of making this shift is high, so researchers do it when they expect their likelihood of getting funded is high. Finally, Dr. Stein said that in her opinion, the most important incentive in science is credit. She quoted Darwin saying, “My love of natural science has been steady and ardent. This pure love has, however, been much aided by the ambition to be esteemed by my fellow naturalists.” In other words, once a discovery is published, it enters the public domain and is no longer the property of the person who discovered it—and credit for the discovery is the compensation for publication.

The importance of credit generates intense competition. Dr. Stein described her own research addressing credit, competition, and the cost of being scooped. She and colleagues examined the citations of publications associated with proteins deposited in the Protein Data Bank, an open repository of structural information for large molecules such as proteins and nucleic acids. Given two structures of very similar proteins, the one deposited first garners 20% more citations. However, when asked, researchers believe that the “citation penalty” for coming in second is much larger—and that coming in second will lead to 60% fewer citations. The perception probably matters more for behavior than the reality, she said.

That perceived penalty means that researchers prioritize being first, often over the quality of a project. Dr. Stein studied the effect this competition has on science – again, using structural biology as an example, because of the clear and objective measures on quality in this specialty. She and her colleagues found strong evidence that scientists who are working in very competitive areas of structural biology are finishing their projects more quickly, but that their results appear to be of lower quality. Furthermore, it is the more important or higher stakes projects where this effect is strongest. That is not because such projects are more difficult, but because competition prioritizes speed.

Dr. Stein then discussed some challenges around incentives that arise in team science – specifically, how credit is assigned in scientific projects done by large groups. The European Organization for Nuclear Projects (CERN), for example, has rules around authorship and the order of names on a publication. Often, the list is simply alphabetical. That makes sense in the kind of physics conducted at the institution, because papers often have hundreds or even thousands of authors. Such systems make it very difficult to recognize individual contributions, and they leave room for inference about who did what, which allows bias to creep in. One study published in 2021 explored how tenure decisions of men versus women were affected by whether they worked on team projects. The study found that men seem to get tenure at the same rate, whether they work alone or in teams. Women, however, are less likely to get tenure if they work in teams, although that gap closes if most of their work is done alone. The authors surmise that people on a tenure committee implicitly assume that when women work with other people, they are not the main contributors. When they work alone, the committee members do not have to make that inference.

To address this problem, a credit taxonomy developed in 2012 that many journals are adopting enables academics to specify at the end of a paper what each team member contributed. Dr. Stein noted however, that companies seem to have less issue with attributing credit on team projects. She proposed that this is because in research, external credit matters most, but within a company, internal credit suffices because rewards such as promotion and recognition are issued internally. Finding a way to use internal rewards within large research collaborations could help mitigate some of the incentive challenges in team research, she said.

Discussion

Dr. Dana noted that one thing absent from Dr. Stein’s talk was the mention of self-esteem, and he asked whether there are efforts to better understand this dimension of team science. Dr. Stein agreed that this is an important dimension but was unaware of any efforts to measure it.

Dr. Maguire noted that she thought the credit taxonomy was very important, and she wondered how widely it was being used. She also wondered whether the responsibilities listed out in the taxonomy are incorporated in the PubMed listing. Dr. Stein said that some journals have made it mandatory, but others do not require it. She noted that there is some research using data from this credit taxonomy that she will investigate that might address the question.

Dr. Dworkin noted that new research is now looking at self-promotion in how people write about their own research, which relates to the self-esteem element. He appreciated the comparison to firms and internal rewards and asked whether anyone has looked at university or department level awards and honors and how those function for careers compared to external awards and recognition. Dr. Stein agreed that these awards likely function more like inside incentives. Dr. Chiang noted that self-esteem seems to be somehow tied to the metrics we create for determining what is a good researcher.

Mapping the Landscape of Team Science Reforms—Dr. Jordan Dworkin, Federation of American Scientists

Dr. Dworkin’s talk explored how different researchers are proposing ways of rethinking incentives in science as the importance of team science grows. He cited a study from 2007 that showed the rapid growth of team science between 1955 and 2000. Not only were such teams becoming more prevalent and larger, but they also seem to produce a larger share of more impactful papers, patents, and innovations, he said. And some evidence suggests that not only are teams more common, but they are coming to fill a different niche in the scientific ecosystem. That idea is reflected in a 2019 paper, which suggests that smaller teams tend to be more disruptive, whereas larger teams are producing more impactful but also more consolidatory work. Other work points to the career implications of these different niches. A 2024 paper found that in fields where larger teams tend to be more prevalent, junior scientists face some negative career outcomes on average, such as being less likely to secure funding or obtain tenure and are slightly more likely to leave their scientific field, or even science altogether. What is more, these relationships tend to be slightly more pronounced among scientists who are underrepresented – in this case, women and foreign-born scientists.

These results raise the question of how to incentivize and reward the type of collaborative contributions that are necessary to do the kind of science that is best done in teams, Dr. Dworkin said. That might involve making teams more “legible” – that is, making individual contributions more visible and easier to assess. It might also involve creating incentives that are aligned with those contributions. Essentially, he said, the question is how to foster an ecosystem that can efficiently and effectively support a variety of career paths that fill different collaborative roles. Physics publications, for example, can have thousands of authors, but even for papers with a dozen authors, it is important for the rules of authorship to reflect the authors’ different roles. Defining baseline standards for authorship, allowing co-first authorship, and crediting data sources are all ways for adapting norms and incentives to team science. Currently, the H-index is still the most predictive of promotions in science, but new metrics that, for example, decompose individual contribution from the whole team’s contribution on a paper may provide more nuance.

Dr. Dworkin also noted contribution taxonomies as another approach to standardize individual contributions to team projects. Elements like writing, reviewing, and editing are common contributions listed, while software or funding acquisition are more niche contributions to the team. Wider adoption of such an approach could help recognize, value, and make legible the different roles that authors are playing.

Dr. Dworkin noted, however, that even if you make a team legible, it does not mean that people are going to reward the contributions that are important for a team to function. Efforts to address reward structures such as tenure and promotion are also emerging. Two such efforts are the San Francisco Declaration on Research Assessment (DORA) and the Coalition for Advancing Research Assessment (coARA). These are flexible, open ended commitments that institutions make to realign their incentive structures with different models and different priorities. The University of California, Irvine, for example, states that it is strongly committed to creating an academic climate that facilitates and rewards faculty contributions to collaborative scholarship. They define multiple categories of contributions that cover contributing ideas, bringing specific expertise, obtaining funding, or providing project administration.

Dr. Dworkin highlighted the need for efforts to develop accessible and meaningful new metrics beyond the traditional H-index, such as the S-index effort led by NEI (more on that in the next talk). It would also be helpful to find new ways of seeing and valuing mentorship and software creation. Institutional and cultural change will also be crucial for driving adoption of new metrics. The Office of Research Quality at the National Institute of Neurological Disorders and Stroke has a new program called Sustainable Transformation of Institutional Research Rigor that funds the university or department level initiatives to enhance research rigor and reproducibility.

Dr. Dworkin noted that there are ways to support career paths that have collaborative incentives built into them – for example, with roles like career scientist or research specialist, which involve hands-on science without the administrative and managerial components of running a lab. These kinds of roles could help keep people in academic research, increase institutional knowledge, and facilitate dedicated technical expertise. The National Cancer Institute, for example, has a research specialist award (R50) that provides salary support and autonomy for non-independent investigator scientists to hold stable research careers where they contribute to a team, lab, or department. More broadly, the NIH has such positions for research software engineers and statisticians. Dr. Dworkin noted that there is growing recognition that creating and maintaining software is vital for many scientific projects and that such technical positions increasingly serve foundational roles in team science, especially in the biomedical space. He noted that the United States Research Software Engineer Association has pointed to the value of a core model. That might involve a co-funding model between federal and institutional money that provides an onramp for the position.

Finally, Dr. Dworkin mentioned several new, ambitious, collaborative institutional designs that are emerging and that sit either outside of or in parallel with academic institutions. These designs aim to facilitate a type of coordinated team effort that is difficult in traditional academic career paths and institutions. They vary in how well they scale, but they can raise the profile of collaborative projects and they allow for experimentation within the industry.

Discussion

Dr. Grant asked whether Dr. Dworkin knew of any studies that have looked at the percentage of uploaded data that is actually used by another investigator. Dr. Dworkin said he did not know the answer, but his gut feeling was that it was a low number. Dr. Stein said she had also not heard of such data, but she pointed out that it would be helpful for there to be a way to specifically cite the use of data from other researchers’ work. This could be something indicating, “not only did I use the conclusions of this paper, but I actually used the data they created.”

Dr. Dana noted that during the pandemic, many reporters were mining uploaded data on cohorts of patients receiving varying treatments, though some stories that emerged from this effort were later debunked. Dr. Grant said that in her understanding, even if the data is uploaded and is available, researchers often have to contact the Investigator in order to glean the nuances needed to actually interrogate the data set. The beneficial outcome of uploading all this data was therefore unclear, she said.

Dr. Chiang noted that this question segues nicely to the next talk. He added, however, that if researchers are given the right incentives for presenting a data set that somebody else can use and do something useful with, then they are going to figure out how to do it effectively.

Incentivizing Team Science – The S-Index Challenge— Amber Reed, NEI

Ms. Reed gave her presentation online because her travel was precluded by extreme weather. She began by explaining the notion of challenges, also called prize competitions, as one mechanism, alongside grants, cooperative agreements, contracts, and other types of awards, for stimulating innovation used by the NIH. Challenges offer monetary and sometimes nonmonetary awards to challenge participants, and they enable the public to solve problems presented by federal agencies and to receive awards for the best solutions. She enumerated several reasons for using challenges, including that they stimulate creative and unanticipated solutions to vexing scientific problems, open the search for solutions to people beyond the usual suspects, and bring a diversity of perspectives to a problem. She noted that NIH launched 22 challenges in fiscal year 2024, and two of these were from NEI.

Ms. Reed explained that the S-Index challenge is a $1 million, trans-NIH initiative led by NEI and supported by 16 institutes, centers and offices, and that it aims to incentivize and reward high quality data sharing practices. The idea behind the S-index is inspired by the H-index, a metric used to gauge researchers’ productivity based on their number of publications and the number of times their publications have been cited. The S-index instead focuses on data contributions and reflects the increasing need for open, accessible data to advance research across disciplines. The S-index aims to provide a simple yet measurable way to track and reward effective data sharing.

The challenge is open to the public and has three categories of registration: Individuals; teams consisting of a group of individuals competing on behalf of themselves; and entities, which consist of a group of people competing on behalf of a legally established organization, institution, or corporation. Team captains must be US citizens and entities must be US-based. She noted that interested parties must register their intent to participate by March 3, 2025.

Discussion

Dr. Dana asked how this index is measured, and how H-index is translated to this index. Dr. Reed invited Dr. Chiang, who came up with the idea, to address the question. She noted, though, that finalists in the challenge would be invited to test their proposal against a dataset that would be provided.

Dr. Chiang explained that the S-index does not yet exist, and its parameters will be defined by participants in the challenge. The similarity to the H-index is simply that it is a metric associated with an individual researcher. S-index will reflect data sharing in a parallel way to how the Hindex reflects citations, he said. The more data that you share that is useful for other people to produce results, the higher your S index, However, it remains for participants in the challenge to define how to measure sharing, “good” data, and the way it gets used.

Dr. Mutti asked Ms. Reed to clarify the aim of the S-Index Challenge. Ms. Reed explained that the aim was to incentivize people to come up with an effective metric for data sharing and to spur innovation in how people think about this issue. Dr. Chiang added that a paper published about 15 years ago described the H-index, and the hope is that the challenge will stimulate a similarly detailed definition of an S-index.

Dr. Kerry Goetz said that the S-index is meant to model not a data set’s value, but a researcher’s contribution toward making that data set useful. She added that the people often charged with doing the hard work of sharing the data from a project are not the people who are first and last authors, so it is important to create incentives as well as avenues for recognition and citation for them.

Translating Human Retinal Epithelium (RPE) Biology into Disease Treatments using induced Pluripotent Stem Cells (iPSCs)—Dr. Kapil Bharti, NEI

Dr. Bharti described a translational team science project in his laboratory that involved developing an RPE patch for patients with late stage dry age-related macular degeneration (AMD). Scientists in his lab and collaborators conducted the work over the course of a decade, and it involved expertise across multiple scientific disciplines and types of expertise, from cell biology and bioengineering to GMP manufacturing and regulatory science. When Dr. Bharti’s team began the project, the idea of using RPE cells to treat dry AMD was not new, and several similar stem cell efforts had been attempted in the clinic. This project differed in that it aimed to use iPSCs that were autologous – that is, made from a specific patient’s own cells – and that the iPSCs would be made using a slightly different protocol and transplanted in a biodegradable scaffold. These differences were intended to make the cells integrate better and faster into the eye.

The catalyzing event for the project was a $10 million, four-year grant that required milestones to be achieved each year. Dr. Bharti said that as Dr. Stein and Dr. Dworkin had discussed in their talks, the scientists who worked on the project – mostly postdoctoral fellows, as well as some students and technical staff – had different incentives for participating, including a big publication, career advancement, or even a springboard to a different career path. The project began with a few scientists thinking about developmental biology and making stem cells into RPEs but blossomed into many components. Clinical colleagues developed a protocol and recruited patients, and different groups of scientists created and optimized the RPE scaffold, developed an animal model to test the system, and regulatory experts oversaw the submission of the work to the FDA to enable a clinical trial, which is currently ongoing.

Dr. Bharti said that the work, which was led to a large extent by Dr. Ruchi Sharma, was enabled by a key discovery about how transcription factors regulate the differentiation of the RPE. The RPE stem cell protocol, which was developed by multiple scientists in the lab along with Dr. Sharma, has been reproduced hundreds of times in the lab and beyond. Currently, over two dozen labs across the world and half a dozen companies are using it, Dr. Bharti said. Dr. Sharma coauthored the publication describing the protocol with scientists from Johns Hopkins as well as the University of Pittsburgh, underscoring the fact that the project has enabled many collaborations. It took almost a year to pin down how to grow RPE on the scaffold – a process that also involved the expertise of multiple scientists in the lab.

The bioengineering component of the work spurred scientists in the lab to apply for an NIH Director’s Innovation Award, which was used to robotize the process. Two other scientists on the team developed a method of characterizing RPE cells to determine whether they were mature enough to go into patients by using an artificial intelligence-based matrix to quantify images of RPE cells. Transforming the lab protocol into a GMP protocol was also a major task, as was the regulatory science aspect and the animal model development, Dr. Bharti said. As lab members and collaborators leaned into the work, they gained expertise that often substantially changed the trajectory of their careers. Dr. Bharti also noted that many people worked behind the scenes to make the project happen. Administrative staff members provided invaluable support in purchasing equipment and materials and in helping produce and update the 12,410-page-long investigational new drug (IND) application for the FDA for the Phase I/IIa clinical trial. Tech transfer officers also helped navigate relationships with industry. Dr. Bharti described the contributions of many people who were instrumental in catalyzing the project, as well as a larger list of people who contributed to the IND submission.

Discussion

Dr. Maguire asked Dr. Bharti about his role as the leader and how he went about assembling the team. She also asked what motivated people to stay with the team even though they might not be getting publications, large salaries, or external recognition.

Dr. Bharti replied that his role was primarily to listen to the people he had brought on and to trust their expertise—and to embrace the fact that everyone was extremely dedicated and was doing their best even when things were not working. He recalled a period when they were having difficulty with the GMP protocol, and how one late Friday evening after a period of frustration he sent the team home, telling them they would all return to the problem on Monday. But on Saturday morning his lab members emailed him because they had come in to troubleshoot the problem and had identified the solution. “I think the motivation for them was that they saw that there was something big here, they saw that they could change the world,” he said.

General Team Science Discussion

Dr. Chiang began the discussion by noting that when he began his first assistant professor job, he was told his job was to write papers and get tenure, and he now questions whether having lots of individual scientists engaged in writing papers and getting tenure was the way to enable groundbreaking innovations in science.

As an institute director at the NIH, he feels fortunate to be in a position of trying to effect cultural change in enabling more of a team science approach, and NEI has taken something of a leadership role in this effort, he said.

Dr. Mutti noted that for team science to be successful, external credit and internal motivation are important, but there are also practical considerations such as jobs, promotion, and salary. He asked Dr. Bharti whether there was some form of recognition or support structure that enabled people on his team to land on their feet after the project ended.

Dr. Bharti said that most of his team consisted of early career scientists, and that when they started this project in 2014 or 2015, there was nothing in place – just the hope that that work would yield papers, which it did. He noted that he made sure to acknowledge authorship in ways everyone agreed to, often with multiple first authors on a paper. Team members were able to take advantage of opportunities to take their careers in new and unexpected directions. Now, however, the lab is trying to put more formal processes around team science in place. The biggest challenge, he added, was in building incentives for technical staff, since citations do not necessarily help them advance their careers. So, they are less motivated by the promise of credit for the work and more motivated by salary, which is often significantly higher in industry.

Dr. Mutti suggested that a sports team offers an analogy to doing team science. Academia expects everybody to eventually be a team captain that leads projects, he said. But team participation may be difficult in academia, unless it is okay to be recognized as a really great team member, and perhaps not necessarily a team captain. Dr. Chiang asked whether Dr. Stein and Dr. Dworkin had thoughts about how best to shift the culture toward incentivizing discovery, rather than incentivizing being the captain.

Dr. Dworkin referred to a study he mentioned briefly in his talk, which tried to create an impact measure that disentangled into individual contributions from broader team contributions. But he noted that as long as citations are being measured, the team’s impact will be attributed to the more senior scientists on the team because on average the papers they are on will be more highly cited. Another approach may be to track careers – where members of a particular team end up, how they function, and how they felt on the team. There are mechanisms in place for following people who end up in academia, and that may bias our understanding of how teams function towards team members who are predisposed to end up as PIs, he said. Compiling more robust data sets within government may show more variability. Better understanding how scientists grow in their career within their performance on an individual team may be insightful, he said.

Dr. Stein noted that basketball has a team metric called “adjusted plus-minus” that tracks how a team scores points when a given player is in or out of the game. It may be possible to come up with a similar metric for labs, based on authorship, she said. However, a challenging aspect of science is that there is a high degree of randomness regarding whether or not a project is successful, and it is important that such a metric not encourage people to preferentially work on less risky projects. Another avenue to explore, she said, may be making more use of soft information about a person’s performance as a team player by codifying things like systematic performance reviews and making sure people are recognized and rewarded for excelling in this realm.

Dr. Ramulu said he appreciated Dr. Stein’s comment in her talk about decreasing the importance of external credit, and it gets to Dr. Dana’s earlier comment on self-esteem and success. He cautioned that there was potentially some backwards logic in the notion of quantifying discovery.

Dr. Dana noted that an established PI probably already knows who their best team players are – and the equations and numbers proving it may not be necessary. He noted that there is currently so much available data and analysis that there is perhaps a misguided idea that doing more analysis will yield something closer to the truth. There is something to be said for holistic evaluations, he said – though the question is how to incorporate them into research methodology. He cautioned that for the output of any metric to be worthwhile, it was crucial to carefully define things like quality, importance, or impact.

Dr. Moore noted that the sports analogy is not very appropriate because the team is the frontfacing entity and the primary energy within sports, whereas in science it is the PI. He also noted that the H-index already does to some extent incentivize teamwork.

Dr. Grant asked for clarification about whether R50 grants were open to people throughout NIH or just within NCI. She noted her support for a mechanism for supporting scientists that were not PIs, but that were making major contributions to a team of scientists and giving them an incentive to stay in science rather than moving to industry or leaving entirely.

Dr. Dworkin replied that that these grants are indeed a great model, but to his knowledge only the NCI uses them to support a senior scientist who has an open-ended contribution to the team. Other institutes use them as a research software engineer award. Regardless, these types of mechanisms allow team players a path forward in a lab. Dr. Chiang said he first heard about the award in a talk at a university. Faculty were discussing the lack of a pathway for staff scientists at their institution, and the NCI R50 was mentioned. He noted that NEI has looked into it and plans to discuss it further. Dr. Maguire noted that the closest NEI has is the core grants to support positions like machine shop staff, statisticians, or imagers – whatever needs can support the vision research community.

Dr. Mutti asked how to handle the intellectual property and whether it was an impediment to innovative team science. Dr. Bharti replied that his approach has been to be as inclusive as possible. Often a person comes up with an idea based on a discussion held by multiple team members, so he believes that whoever is on the team should be a part of the intellectual property, and the lawyers can figure it out later if need be.

Dr. Perez noted that social media is very powerful, and it can help provide exposure to research. He noted that Dr. Chiang was particularly adept at its use and asked for thoughts about wielding it effectively. Dr. Stein noted that she had to take herself off Twitter because she found it stressful, though she sees other people use it effectively to disseminate and promote their work.

Concept Clearance: NEI Product Assistance Center—Dr. Tony Gover, NEI

The goal of this concept is to create a product assistance center that would support NEI investigators, either from industry or academia, to develop regulated medical products that diagnose and treat diseases and disorders of the visual system, Dr. Gover said. The center would provide in-kind consultant services for product development activities prior to or during NEIfunded translational research efforts. It would be created through a contract directly through the NIH.

Dr. Gover laid out the need for such support for the vision research community. Although NEI receives hundreds of applied research grants each year, very few are for translational research. The applications for translational research that do come in tend to do poorly at study section. Proposed translational projects fail for multiple reasons. They often have weak regulatory and commercialization strategies or do not fully address Chemistry Manufacturing and Controls requirements. They often raise concerns over identifying appropriate contract research organizations and manufacturers. They are also often weak on intellectual property (IP), either due to a lack of freedom to operate, a lack of IP in general, or poorly defined pathways to commercialization. That is why it is critical for NEI to support investigators early in the product development pipeline by providing in-kind services to address these product development issues, Dr. Gover said.

The proposed NEI Product Assistance Center contractor will provide in-kind consultant services including support for any product development activity that would be required for a successful transitional research effort, Dr. Gover said. He noted that providing this service should increase the number and quality of translational research applications NEI receives, and ultimately, it will increase the number of products that enter the marketplace and impact the lives of patients.

Discussion

The assigned discussants for this concept clearance were Dr. Mutti and Dr. Maguire.

Dr. Reza commended NEI, Dr. Chiang, and Dr. Gover for championing translational research, and asked how researchers could obtain the support from the proposed center. Dr. Gover said that researchers would submit a letter requesting assistance to the NEI, upon which NEI program officers would vet the project. To be eligible it would have to meet the mission of NEI and the priorities of one of NEI’s portfolios. The team’s technology would have to be at the right readiness level, and the intent of the work would have to be translation, he said. For successfully vetted submissions, access to the center would be on a first come first served basis, Dr. Gover said.

Dr. Mutti said he sees a tremendous need for this type of support as a way of getting more products to commercialization. He also noted that universities are not always as helpful as they could be with tech transfer issues. Dr. Maguire agreed with the need for this program and asked whether other institutes have similar programs, and if so, what their experience with them has been. Dr. Gover replied that NEI is a part of the NIH Blueprint for Neuroscience Research, and that within that program, researchers who are funded receive such in-kind services. So far that includes one or two NEI projects, but the aim is to provide this support more broadly. Additionally, Dr. Gover said that other institutes and centers and other parts of the federal government often use this type of mechanism for product development efforts, and it generally works well.

Dr. Maguire noted that the types of services this program provides would also be useful for projects at the clinical trials stage, and she asked whether these were eligible. Dr. Gover said they were. Dr. Maguire also asked why the language states that the contractor work cannot be used to develop federal government applications. Dr. Gover explained that the PI must own the application and is totally responsible for it. The consultant would not be writing the application for the PI, but would, for example, help the PI develop a clinical trial protocol for their submission.

Dr. Mutti asked how this service could help PIs navigate intellectual property issues. Dr. Gover said that applicants often do a poor job thinking through those issues, so consultants would help them determine whether they have freedom to operate or secure their IP, for example, and generally help them navigate the IP landscape.

Dr. Perez also commended Dr. Gover on his work on translational medicine. He asked how early in the application process researchers should reach out. He also asked whether the center would provide assistance in developing the infrastructure for a startup, for example in terms of contracts or license agreements. Dr. Gover said the best time to reach out is as early as possible in an applied research project. The center would act as a general contractor and would connect the researcher with specific expertise (e.g. legal or IP) as needed. But he noted that the service provided would be consultation – so the contractors could only provide advice and opinion on things like licensing agreements because the IP would be owned by the university.

Dr. Anderson asked for a motion to approve this concept, which passed unanimously.

BRAIN Multi-Council Working Group Update—Dr. Tirin Moore, NEI

Dr. Moore, NEI’s representative on the BRAIN Multi-Council Working Group, summarized the group’s council meeting held on August 22, 2024. BRAIN director Dr. John Ngai began the meeting by acknowledging staff members and contributors at different institutes, as well as outgoing and new council members. He then highlighted some recent news from BRAIN investigators, including the Kavli Prize in Neuroscience. As mentioned in Dr. Chiang’s Director’s Report, all three awardees have long been supported by the NEI.

Dr. Moore recounted that Dr. Ngai also noted a series of articles that highlight a decade of work by the BRAIN initiative and resulted in a full map of the neural connections of the fruit fly, which will advance understanding of brain processing in larger animals. He also noted that the 10th annual BRAIN Initiative conference was held this summer and that it included networking opportunities for trainees as well as a panel discussion including former NIH director Francis Collins and early architects of the BRAIN Initiative. Dr. Ngai also briefly discussed the BRAIN Initiative’s budget, which was decreased by $280 million in FY2024.

The BRAIN director then highlighted efforts to enhance community engagement, including a briefing in front of the Congressional Neuroscience Caucus in April and a lecture series in May at Oregon Health Sciences University to celebrate the contributions of Earl Blumenauer, who was the co-chair and founder of the Congressional Neuroscience Caucus. BRAIN recently signed on to the NIH Blueprint’s ENDURE program, an R25 that seeks to bring undergraduate students into neuroscience. He also noted an upcoming Funding Opportunity aimed at promoting equity by disseminating novel neuroscience tools to underserved labs and universities. The director then summarized some recent highlights in BRAIN Initiative-funded science. This included work related to a project called the Armamentarium for Precise Brain Cell Access, which aims to leverage emerging information about cell types, their molecular or circuit properties, and other features to pin down how those cells interact to give rise to behavior. It also included a project in which high density single neuron recordings in interoperative human patients aimed to map language comprehension in the brain in real time. Finally, the leader of the Neuroethics Working Group gave an update on the group’s work. They highlighted a recent meeting at which participants discussed how the intersection of AI neuroscience and ethics raises potential issues relating to informed consent, privacy, confidentiality, and equity of care.

The BRAIN Multi-council Workgroup meeting was recorded and can be viewed here.

Retiring Council Member Remarks

Dr. Reza Dana gave a brief statement about his time on Council to mark the end of his tenure. He thanked his colleagues for the honor and privilege of working with them and for the opportunity to see how NEI operates from the program side. He offered one cautionary note to the Council – that blindness as a public health issue is very complex, with biological, social and economic components that cannot always be solved. It is important to acknowledge, he said, that it is impossible to do everything, especially in a time of limited resources. Rather, he said, it is crucial to be extremely selective in thinking about how to allocate those resources. He lauded Dr. Chaing’s leadership and his capacity to engage with people and issues and to question things. Dr. Chiang responded that working with Dr. Dana on the Council has been a great experience and that he greatly appreciated the perspective that Dr. Dana added. Dr. Chiang noted that he was especially grateful for his candor in council meetings, conveying what he thought the council needed to hear rather than what they wanted to hear.

General Discussion

Dr. Mutti kicked off the general discussion with thoughts about changing attitudes to team science. He noted that he does not remember many experiences in school where group work was encouraged, but today it seems much more prevalent in education. He wondered whether this may be a generational change that is partly responsible for driving the growth of team science.

Dr. Stein responded that even since she was in graduate school she has observed a large jump in how commonly people in her field, economics, collaborate. Previously, it was common for graduate students to author a solo paper and take it on the job market, but now graduate students often write joint papers. That could be because of childhood conditioning, she said, but it could also be because science is getting more specialized, making it more valuable and necessary to work in teams to bridge different areas of expertise.

Dr. Maguire brought up the prospect of making motivational interviews available that would convey the benefits of working in research. She noted that there is much talk about the negative side of doing science – the difficulty of getting grants and landing positions, the lack of funding, and the demands of committee meetings. However, she said, there is not enough emphasis on the benefits of working with wonderful colleagues, and the excitement of bouncing ideas off smart and insightful people with expertise that is different but relevant to your own. The positives need to be more strongly conveyed to demonstrate the value to young people of choosing scientific research as a profession.

Returning to the topic of how much things have changed, Dr. Dana noted that the pandemic has created new dynamics in how we engage with technology and with each other. His lab had a very robust weekly lab meeting that was disrupted by the pandemic and has only now returned to normal; people seem much less willing to engage in person, he said. On one hand, technology is enabling connection at an unprecedented level, and on the other, it has created an enormous amount of noise, he said, and finding the sweet spot is a challenge.

Dr. Moore asked why it might be that young scientists are more open to collaborating. Dr. Stein speculated that the urge to work together may be a natural response to training times getting longer. People used to do their PhDs in 4 years and emerge on the job market with a publication, but now that time is stretching to 5 or 6 years or more. It is so difficult to have all the tools now for one person to produce a paper on the cutting edge of the field, that trainees are realizing that working together and pooling talents improves their research, she said.

Dr. Perez changed the topic of the discussion, noting that negativity and worries were swirling around pending legislation on NIH reform, but added that he was glad Dr. Chiang was on committees addressing the issue. He asked what he and his colleagues on the Council could tell extramural researchers who asked about the process. He also asked how Council members might help Dr. Chiang.

Dr. Chiang explained that he was not able to offer any opinions about pending legislation and he could not tell people what to say. However, he said, he can encourage Council members to talk about the impacts of the work at NEI and to share their opinions.

One reason that enthusiasm for academic science careers is flagging among young trainees may be that they are spending less time than past generations traveling to scientific meetings and engaging with colleagues about research, Dr. Grant said. She reflected on the fact that these days, the amount of travel that scientists can do has greatly diminished due to economic factors. Researchers might instead attend one large meeting per year, but conferences like ARVO can be overwhelming for students and early career scientists. She wondered whether NEI might be able to provide resources for smaller, niche meetings on specific topics, where researchers at different stages of their careers can engage in a more intimate and inspiring setting.

Dr. Chiang noted that the issue of negativity towards science and medicine had surfaced multiple times over the course of the day. That salary is one reason for current levels of disillusionment, and various types of uncompensated work is another. He agreed that for the field to thrive, it is crucial to counter that negativity.

Early in his career, he said, he often brought his kids to work with him so they could see how much he loved his job. Recently, he said, a mid-career scientist told him that when they saw their mentors expressing annoyance and complaining about so many aspects of their professional life, they felt disincentivized to follow in these mentors’ footsteps. Maybe we need to focus on that positivity and identify spokespeople who can speak about research in an inspiring way, he said.

He noted that the NIH creates educational YouTube videos, and that many get perhaps 50 views, but occasionally one gets 500,000 views because the speaker is so motivational, interesting, and fun to listen to. He wondered how to find these 500,000-view people in the vision community, and how to bring people together in a way that is useful for scientists and inspirational for younger people.

Dr. Chiang then invited NEI’s Dr. Houmam Araj to speak on the R13 conference grant mechanism. Dr. Araj explained that NEI has a very active R13 conference mechanism, and he noted that leadership has been supportive of using this mechanism for supporting conferences relevant to the mission of the NEI. He encouraged anyone with ideas for conferences that could receive R13 funding to reach out to him.

Dr. Anderson added that NEI cannot support all the costs associated with conferences but prioritizes supporting travel costs for trainees to attend conferences.

Next, Dr. Chiang asked Dr. Stein to describe the Journal of Economic Perspectives, which she had mentioned during lunch. Dr. Stein said that the journal was started by the American Economic Association, the governing body of the field of economics. It is an unusual journal in that the articles are not peer-reviewed, she explained. The journal looks for growing areas of interest and solicits the leaders of those research areas to produce an article that is not quite a review article, but a synthesis of the literature written almost like excellent lecture notes for an upper-level undergraduate class. Dr. Stein said she considers these articles a gift to the field and seeks them out when she is exploring a new topic.

Dr. Chiang said one reason he was interested in hearing about this publication is that NEI has been thinking about how best to publicize what the agency does to a general audience.

Dr. Ramulu noted that NEI is the engine that makes a lot of research run. Other organizations benefit from that and publicize the work they do through the NEI. He asked Dr. Chiang to what extent he feels NEI needs to advertise what it does, and to what extent he feels it does not need that level of external validation. He also asked what NEI gains by people recognizing that it is funding the work it funds.

Dr. Chaing responded that this is a multi-pronged issue. One reason is to motivate the best people to get into the field, he said – specifically, young researchers mapping their career paths. Many of the problems and questions in vision research would benefit from a multidisciplinary approach, and lots of people working in eye departments are not vision researchers, per se, but cell biologists, bioengineers, or computational scientists, for example. He added that the agency gets attention by showing they do important work that matters to the American public, so it is important to communicate this.

Asked to weigh in, Dr. Tumminia added that one of NEI’s roles is to educate the American public, and given the lack of trust in science, it is crucial to do a better job explaining what problems NEI researchers are addressing. She noted that scientists are good at talking about their work to other experts but fall short in speaking with the nonscientists in their lives.

Dr. Ramulu noted he appreciates the context this discussion added to the idea of the videos Dr. Chiang mentioned – which sometimes get 50 views but occasionally get 50,000. Dr. Ramulu returned to Dr. Chiang’s question earlier in the meeting about whether the vision community should be more involved in CVI and conditions that may be generated in the brain rather than the eye. He said he had looked back at NEI’s mission, which includes improving people’s quality of life and eliminating vision loss. People with CVI do have vision loss so it is very appropriate, in his opinion, for NEI to take it on, he said.

Dr. Perez noted that the Department of Defense has done a great job with traumatic brain injury, in particular. These patients do present with quality-of-life issues including ocular symptoms and pain so it is something that NEI should be involved with and should continue to expand.

As the discussion wrapped up, Dr. Anderson and Dr. Chiang asked attendees to get in touch with any ideas they might have about topics that could be addressed at future meetings. Dr. Chiang expressed appreciation toward the speakers who had addressed team science, and he noted that NEI was in a position to do something about this topic. He adjourned the meeting and said that the closed portion would continue after a 10-minute break.

The open session of the meeting was adjourned at 2:25 pm.

CLOSED SESSION

This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS

NAEC members considered 541 grant and cooperative agreement applications on which NEI was the primary Institute; these applications requested a total of $300,135,919 (direct costs year 01). The Council also considered 214 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $164,132,559 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 755 applications.

ADJOURNMENT

The 169th meeting of the National Advisory Eye Council was adjourned at 5:00 p.m. on October 11, 2024.

CLOSED SESSION ATTENDEES

Council Members Present:

Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary (in-person)
Dr. Reza Dana (in-person)
Dr. Maria B. Grant (in-person)
Dr. Maureen Maguire (virtual)
Dr. Tirin Moore (in-person)
Dr. Donald Mutti (in-person)
Dr. Victor Perez Quinones (in-person)
Dr. Pradeep Ramulu (in-person)
 

NIH Staff Members Present:

Shawn Adolphus (virtual)
Dr. Neeraj Agarwal (in-person)
Lisa Applewhite (in-person)
Dr. Houmam Araj (in-person)
Nathan Brown (in-person)
Dr. Sangeeta Bhargava (in-person)
Nathan Brown (in-person)
Dr. Ed Clayton (in-person)
Donald Everett (in-person)
Dr. Martha Flanders (in-person)
Dr. Ashley Fortress (in-person)
Dr. James Gao (in-person)
Alexandra Gavrilovic (in-person)
Dr. Nataliya Gordiyenko (in-person)
Dr. Shefa Gordon (virtual)
Dr. Tony Gover (in-person)
Dr. Steve Henle (in-person)
Lateefah Hill (in-person)
Dr. Brian Hoshaw (virtual)
Alicia Kerr (in-person)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (in-person)
Dr. Barbara Mallon (virtual)
Dr. George McKie (in-person)
Dr. Mary Ann Redford (virtual)
Dr. Jennifer Schiltz (in-person)
Dr. Grace Shen (in-person)
Karen Robinson Smith (in-person)
Dr. Hongman Song (in-person)
Dr. Afia Sultana (virtual)
Dr. Joanna Szczepanik (virtual)
Dr. Santa Tumminia (in-person)
Dr. Cheri Wiggs (in-person)
Bronte Williams-Washington (in-person)
Keturah Williams (in-person)
Dr. Charles Wright (in-person)
 

CERTIFICATION
These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 168th meeting at 8:30 a.m. on Friday, June 7, 2024. The meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended either virtually or in-person. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 8:30 a.m. until 2:15 p.m. The meeting was closed to the public from 2:30 p.m. until 5:00 p.m. for the review of grant and cooperative agreement applications and the Board of Scientific Counselors Report.

Council Members Present:
Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary (in-person)
Dr. Reza Dana (in-person)
Dr. Maria B. Grant (in-person)
Ms. Janice Lehrer-Stein (in-person)
Dr. Maureen Maguire (virtual)
Dr. Tirin Moore (in-person)
Dr. Donald Mutti (in-person)
Dr. Victor Perez Quinones (in-person)
Dr. Pradeep Ramulu (in-person)

NIH Staff Members Present:
Shawn Adolphus (in-person)
Dr. Neeraj Agarwal (in-person)
Dr. Afrouz Anderson (in-person)
Lisa Applewhite (in-person)
Dr. Houmam Araj (in-person)
Dr. Sangeeta Bhargava (in-person)
Dr. Kapil Bharti (virtual)
Holly Blake (in-person)
Dr. Christopher Bradley (virtual)
Nathan Brown (in-person)
Dr. Emily Chew (virtual)
Dr. Ed Clayton (in-person)
Jay Colbert (virtual)
Karen Colbert (in-person)
Claudia Costabile (virtual)
Dr. Mary Francis Cotch (virtual)
Kevin Chu (virtual)
Kathryn DeMott (virtual)
Britt Dennis (virtual)
Donald Everett (in-person)
Dr. Martha Flanders (in-person)
Dr. Ashley Fortress (in-person)
Dr. James Gao (in-person)
Alexandra Gavrilovic (virtual)
Kerry Goetz (in-person)
Dr. Nataliya Gordiyenko (in-person)
Dr. Shefa Gordon (in-person)
Dr. Tony Gover (in-person)
Dr. Anna Han (in-person)
Dustin Hayes (in-person)
Lateefah Hill (virtual)
Dr. Brian Hoshaw (in-person)
Dan Ignaszewski (in-person)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (in-person)
Dr. Richard Lee (in-person)
Renee Livshin (virtual)
Natanya Malcolm (virtual)
Dr. George McKie (in-person)
Dr. Lisa Neuhold (in-person)
Bobby Nonato (virtual)
William O’Donnell (virtual)
Dr. Bob O’Hagan (virtual)
Barbara Payne (virtual)
Dr. Mary Ann Redford (in-person)
Carissa Reilly-Weedon (virtual)
Holly Russo (virtual)
Dr. Jennifer Schiltz (in-person)
Dr. David Schneeweis (in-person)
Shauna Schwartz (virtual)
Dr. Grace Shen (in-person)
Dr. Azadeh Shoaibi (in-person)
Karen Robinson Smith (in-person)
Dr. Hongman Song (in-person)
Dr. Santa Tumminia (in-person)
Terry Vance (virtual)
Fausto Vela (virtual)
Leslie West-Bushby (virtual)
Dr. Cheri Wiggs (in-person)
Bronte Washington-Williams (in-person)
Keturah Williams (virtual)
Dr. Charles Wright (in-person)
Maria Zacharias (virtual)

WELCOME AND INTRODUCTIONS
—Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang called the 168th NAEC meeting to order. He introduced two guest speakers, Dr. Vinit Mahajan of Stanford University and Dr. Afrouz Anderson of the National Institute of Biomedical Imaging and Bioengineering. All Council members briefly introduced themselves.

COUNCIL PROCEDURES AND RELATED MATTERS
—Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA)

Dr. Anderson welcomed the NEI research and advocacy community, colleagues from the Center for Scientific Review, invited speakers, and members of the public who were in attendance virtually and in person, and staff members who organized the meeting and provided technical support. She also made some logistical announcements regarding participation in the hybrid meeting.

She noted that future NAEC meetings are listed on the agenda and on the NEI website. The next in-person NAEC meeting will be held on Friday, October 11, 2024. Minutes of the February 2024 NAEC meeting were made available in the electronic council book (ECB) prior to the meeting. A motion to accept the February meeting minutes was made, seconded, and approved unanimously. Going forward, draft council minutes will be emailed to Council members for 3 168th National Advisory Eye Council Meeting, June 7, 2024 approval in advance of the meeting as under a new requirement to have final meeting minutes certified 120 days after the meeting.

NEI DIRECTOR’S REPORT
NEI DIRECTOR’S REPORT —Dr. Michael F. Chiang
Dr. Chiang began by noting the value of social media in disseminating news about scientific and research activities taking place at NIH and NEI. He encouraged attendees to follow NEI’s social media accounts, @NEIDirector and @NatEyeInstitute.

NIH and NEI Leadership and Staff Updates
Dr. Chiang announced that Dr. Kathleen M. Neuzil has been named director of the Fogarty International Center. He noted that Dr. Neuzil is an infectious disease specialist and a global health expert, and that she served as a vaccine policy advisor to both the World Health Organization and the US Centers for Disease Control and Prevention. He also noted that NEI has many touchpoints with the Fogarty Center though its global health focus.

Dr. Chiang also announced the departure of Dr. Joshua Gordon, Director of the National Institute of Mental Health, after serving during an especially important time for mental health in the US.

At NEI, Dr. Chiang welcomed Bronte Williams-Washington, who will serve as the new Operations Coordinator for the Division of Extramural Activities and the Division of Extramural Science Programs.

Awards and Recognition
Dr. Chiang congratulated Dr. Larissa Huryn, a pediatric ophthalmologist at NEI who received the 2024 Outstanding Emerging Leader Award from the American Association for Pediatric Ophthalmology and Strabismus (AAPOS). He also lauded Dr. Emily Chew for receiving the Proctor Medal and Dr. Anand Swaroop for receiving the Friedenwald Award from the Association for Research in Vision and Ophthalmology (ARVO).

Dr. Chiang also congratulated Dr. Carlos Ramon Ponce of Harvard Medical School for being one of 20 winners of the NIH Common Fund challenge competition for Complement Animal Research in Experimentation (Complement-ARIE). Dr. Ponce’s project investigates how neural networks use visual information processing for image recognition.

NEI-funded Highlight –Dr. Chiang highlighted a research project funded by NEI and led by Drs. Jayshree Advani and Anand Swaroop. Their project investigated genotype, RNA expression, DNA structure and DNA methylation in 160 human donor retinas to identify genes involved in adult macular degeneration disease progression and pathology.

Highlights of Innovative Research –Dr. Chiang noted that an element of NEI’s mission statement is to drive innovative research. He highlighted several innovative research projects in which NEI is involved.

One such project was a workshop on extracellular vesicles organized by Dr. Alissa Weaver of Vanderbilt University and Dr. Ali Djalilian of the University of Illinois. The workshop outlined opportunities for research on extracellular vesicles in the visual system. A white paper from the workshop summarizing these opportunities is forthcoming.

Another effort Dr. Chiang noted was the NIH Regenerative Medicine Innovation Project (RMIP), one of four innovative projects created through the 21st Century Cures Act. Of the 20 funded RMIP projects, five are related to vision. NEI Deputy Director, Dr. Santa Tumminia, is now working with her counterpart Dr. Robert Carter at the National Institute of Arthritis and Musculoskeletal and Skin Diseases to establish the next steps for RMIP – including creating public private partnerships for developing cell-based therapies. After a workshop hosted in November 2023, they expect to produce a research plan this year.

Highlights of Innovative Research (2) –Another innovative project that Dr. Chiang described was Stage 3 of EyeGENE, a long-running effort to study rare inherited eye diseases. Stage 3 aims to collect large genomic datasets to target diagnoses that are currently underrepresented in the program, including Aniridia, Best disease, Blue-cone monochromacy, and corneal dystrophy. The project is now re-opening enrollment with a new data collection protocol in place. Efforts are underway to pilot the use of electronic consent forms and mailed DNA collection kits.

Highlights of Innovative Research (3) –Another innovative project that Dr. Chiang described was Stage 3 of EyeGENE, a long-running effort to study rare inherited eye diseases. Stage 3 aims to collect large genomic datasets to target diagnoses that are currently underrepresented in the program, including Aniridia, Best disease, Blue-cone monochromacy, and corneal dystrophy. The project is now re-opening enrollment with a new data collection protocol in place. Efforts are underway to pilot the use of electronic consent forms and mailed DNA collection kits.

Discussion
Dr. Maria Grant suggested tapping into departmental or university-wide announcements to post this opportunity. Dr. Reza Dana suggested ways to disseminate the tools that emerge from such research efforts – for example, taking a mass marketing approach, or in a more focused manner, working with nonprofit organizations that serve affected communities, or through professional organizations such as the American Academy of Ophthalmology. Dr. Pradeep Ramulu said that there was already strong interest in this topic within the low vision community and that he has talked to many researchers who plan to submit an application. Because the deadline is short, he suggested that the effort needs a longer launchpad to bring new people into the field. That could help lure experts such as engineers, behavioral change architects, interventional specialists and others who are not necessarily low vision specialists.

Dr. Chiang agreed on the importance of tapping into expertise beyond the vision research community. He noted that a recent World Health Organization report on accessibility noted the wheelchair and the hearing aid as key accessibility tools. He wondered what the low vision community’s equivalent of that would be—whether it might be glasses, or a white cane, or something that has not yet been invented. Dr. Janice Lehrer-Stein noted that her own version of a low-vision accessibility tool was a service dog, but that he has no thumbs, cannot drive, and is not great with smart phones and the internet. She said there is a huge interest in improvements to tools for navigating in physical space but also for accessing documents, handling currency, and other daily activities. Most rehabilitative work is done by nonprofits, she said, though companies like Microsoft are creating some powerful products. She suggested public-private partnerships as well as challenges or hackathons to engage engineers.

Highlights of Innovative Research (4) –Dr. Chiang described an initiative on Oculomics and imaging supported by the Common Fund at the NIH. Launched last year, it aims to develop novel non-invasive ocular imaging technologies as well as machine algorithms to build better tools for identifying biomarkers for systemic diseases. A Research Opportunity Announcement (ROA) for $1.6 million total costs per year for up to three years was announced in March, with a deadline in late May. Applications are currently being reviewed.

Another ongoing Common Fund project called Bridge2AI funded a team from the University of Washington headed by Drs. Aaron Lee and Cecilia Lee. That work gathered data from 4000 people with diabetes at different disease stages and used artificial intelligence (AI) to examine saludogenesis – progression from disease to health. The researchers have now released the first dataset from this project, with data from 204 participants, and it can be accessed at https://aireadi.org.

A third Common Fund project that Dr. Chiang described has been a signature initiative of NIH Director Monica Bertagnolli, and was just announced yesterday in a press release and an editorial in Science magazine. It addresses the overall decline in health among the US population, particularly in underserved populations, and its goal is to establish primary care focused networks that integrate research into routine clinical care. The budget will be $5 million for FY24 and will ramp up in future years. Dr. Chiang asked Council members for their thoughts on how to better connect eye care to primary care.

Discussion
Dr. Victor Perez noted that many physicians are afraid of addressing eye issues and prefer leaving that to specialists. Education and outreach to primary care providers can enable them to integrate elements of eye care into common disease treatment such as diabetes and hypertension, he said, and maybe this can serve as a platform to demonstrate that they can integrate the use of imaging and other tools for eye care in a user-friendly manner.

Dr. Dana agreed and noted that few medical schools have a required ophthalmology curriculum. He also said that it will be important to look beyond diabetic retinopathy into aspects of eye care that may be less familiar to primary care physicians. Invited speaker Dr. Vinit Mahajan noted that some practices across northern California have been making imaging widely accessible by deploying cameras and combining AI and humans to screen patients. Originally, ophthalmologists feared that adding these tools to primary care would cause specialists to lose patients, but the increased screening enabled primary care practices to correctly refer patients to ophthalmologists.

Dr. Ramulu noted that the aim of the proposal is not to get primary care doctors more involved in ophthalmology, but to create a research connection between the two. Algorithms for ophthalmological imaging that can improve screening for diseases such as hypertension or diabetic retinopathy should help do that. Dr. Mutti said that one factor limiting efforts to improve services to the underserved was the fact that young trainees were hesitant to move to underserved areas. Incentivizing a public service career might move the needle, he added.

Dr. Grant noted that even within academic communities, experts like pulmonologists, cardiologists and hematologists do not appreciate how important the eye can be for diagnosing other diseases. Making data that shows this more mainstream may help convince clinicians, she said. Also, she suggested tapping into state-wide efforts on earlier disease diagnosis by educating patients. Dr. Chiang summarized the discussion by noting that both technology and policy are at play in this issue.

Highlights of Collaborative Research (1) –Dr. Chiang described several ongoing projects that relate to another element of NEI’s mission statement, to foster collaboration. He mentioned that Amber Reed and Kerry Goetz in the NEI Office of Data Science and Health Informatics have been working on a resource that can generate synthetic patient data. The tool they developed is called Synthea and it is freely accessible and available at https://synthetichealth.github.io. One of the applications for this is people trying to test the interoperability of new electronic health record systems.

There are also efforts to standardize ocular imaging, and NEI has been pushing the adoption of standards by commercial devices. On May 3, 2024, NEI published a new guide notice strongly encouraging the use of common formats like DICOM, both for clinical and nonclinical imaging. Researchers whose grants score highly may not be prioritized for funding if they are not using devices that produce data in these common formats.

Discussion
Dr. Ramulu asked Dr. Chiang how synthetic data might be useful for research capacity. Dr. Chiang responded that retinal images are one example of how synthetic data could be used. There are a lot of concerns about privacy and whether or not retinal images are deidentified, with different institutions having different policies. Accessing them through synthetic EHR data could offer a solution.

Dr. Goetz added that Synthea does not just include eye-related information but also diabetic and primary care information, so it could be used to study the relationship between the three areas. But she and her colleagues still have to validate the system further before it can be useful for research, she says. But she noted that in addition to synthetic clinical information, the program aims to generate synthetic images and is trying to create a use case for research and development of tools that bridge the imaging to electronic health record link.

Fostering Collaborations and Improving Quality of Life –Dr. Chiang next spoke about an effort to quantify vision-related quality of life. A questionnaire called the Visual Function Questionnaire 25, developed in the 1990s, is the most common instrument for doing this, but it has some limitations and is somewhat outdated. On September 29, 2023, NEI hosted a workshop with the FDA and the Patient Centered Outcomes Research Institute (PCORI) to develop a new generation of tools for measuring quality of life. Participants are preparing a white paper from the workshop. One key idea was the creation of a disease agnostic tool that tests multiple domains and that uses a database managed by NEI.

In honor of May being Healthy Vision Month, Dr. Chiang discussed components of another effort to address vision-related quality of life, the National Eye Help Education Program (NEHEP). One social media campaign called Reframe your Vision, focuses on the relationship between vision and mental health.

Highlights of Collaborative Research (2) –Dr. Chiang gave an update on the NASEM Myopia Study, a study group cosponsored by NEI and chaired by Dr. Kevin Frick at Johns Hopkins University and Dr. Terry Young at the University of Wisconsin. The group is conducting a consensus study to assess the mechanistic understanding of myopia and propose a research agenda. Participants will produce a final report by the end of the year. In the meantime, Dr. Chiang said, a symposium held at ARVO’s annual meeting in May aimed to build a group of people interested in myopia.

Highlights of Collaborative Research (3) –Collaboration is also building on the small business front, Dr. Chiang said. NEI has a Small Business Innovation Research (SBIR) cooperative agreement for early-stage trials with greater than minimal risk. Researchers conducting early-stage commercialization-oriented trials can apply for three years of funding, with budget requests at $1 million per year and total costs of up to $2 million. Another opportunity is the Small Business Transition Grant for New Entrepreneurs, which is meant to support early career scientists transitioning to entrepreneurship. This grant will have a training component. A Pre-Application Technical Assistance Webinar was held on Tuesday June 11.

Highlights of Collaborative Research (4) —Dr. Chiang described a collaboration with the NIH Center for Alzheimer’s and Related Dementias (CARD). NEI will share space in the CARD clinic and conduct testing on its patients including deep retina phenotyping and central visual pathway testing and will also generate induced pluripotent stem cells from CARD patients. The aim is to develop tools for risk assessment and determining diagnosis and prognosis of dementias, and to learn how the pathophysiology of the eye and brain are related to each other.

Highlights of Collaborative Research (5) —Dr. Chiang discussed efforts to develop ways that NEI can collaborate with NIBIB and the All of Us study. After a workshop held last year, efforts are now in the concept development stage and NEI representatives will give a presentation in July to All of Us leadership.

Recruit, Inspire, Train: Career Development—Dr. Chiang described a funding opportunity that NEI recently joined, Stimulating Access to Research in Residency (StARR) R38 award. NEI is one of four NIH institutes participating in this initiative which aims to attract ophthalmology residents to research. Dr. Chiang also noted an effort called the Council for Vision Editors, which launched in April with an initial cohort and aims to provide editorial opportunities for 14 early faculty members. In this program, the cohort meets a few times per year with Dr. Chiang and Editors-in-Chief of some of the major vision journals to discuss how to advance the field. Young faculty members are matched with journals and mentored as junior editorial board members, creating career development experiences.

Recruit, Inspire, Train: Workforce Diversity—Dr. Chiang described a trio of efforts to provide mentorship to trainees at multiple levels. An ongoing program in the Office of the Chief Officer for Scientific Workforce Diversity (COSWD) offers mentorship supplement awards for investigators who are outstanding mentors in the area of Diversity, Equity, Inclusion and Accessibility (DEIA). NEI’s Diversity in Vision Research and Ophthalmology summer program brought in 7 students (5 college, 1 medical school, 1 veterinary school) from underrepresented backgrounds in 2024. Finally, a high school video contest, which has run for the past three years, has students submit videos about vision science and/or projects they have developed. The winners receive $2000 and are brought to the NIH campus in Bethesda for a day to tour NEI labs and attend networking events. This year, NIH Principal Deputy Director Larry Tabak will be speaking with the students.

ARVO 2024: NEI and Research to Prevent Blindness (RPB) Career Development Symposium—A symposium held at ARVO this year brought together early career researchers who have received NEI mentored career grants and/or RBP career development awards. The symposium included keynote talks, roundtable symposia, and panel discussions on career development issues. Dr. Chiang noted that this event has not happened since 2005, the year Dr. Chiang had attended and found it extremely valuable.

Education Resources— Dr. Chiang provided QR codes for educational resources. These included a link to information about a seminar series hosted by the NEI Office of Data Science and Health Informatics, and to the NEI extramural research newsletter (Subscribe here) which provides updates on funding opportunities, policies, and events.

NAEC Budget Update —Ms. Karen Colbert, NEI Budget Officer, recapped the current fiscal year and shared her expectations for the new 2025 fiscal year, which begins October 1, 2024.

The FY2024 NIH budget remained flat with FY2023 enacted levels, which is effectively a budget cut because of increased costs and inflation. During periods of flat or reduced budgets, the agency reviews commitments in all areas and prioritizes training and support for early career investigators. NEI proposed spending for the year invests $742 million, or 83% of the total budget, into extramural research; $111 million or 12% of the budget into intramural research, and $43 million, or 5% of the budget into research support.

How the NIH budget will change in FY2025 is still unknown. This is an election year, which always has an impact on the budget process. It is unlikely that Congress will pass appropriations before FY2025 begins in October, and instead the NIH will likely start the year under a continuing resolution. Continuing resolutions avoid costly and difficult government shutdowns but can also delay some funding decisions. The president’s budget request for FY2025 is $898.8 million, which is $2.3 million above the current year.

In recent House and Senate activity, Kay Granger (R-Texas) announced in March she was stepping down as chair of the House Full Appropriations Committee, and the chair is now Tom Cole (R-Oklahoma). Tom Cole has historically been supportive of NIH so there is hope that this is a good sign for the budget process. He released his markup schedule for FY2025 appropriations bills; there is currently no expectation for a House Appropriations Subcommittee hearing for NIH. However, the Senate held their hearings in March, during which several areas were raised as funding priorities. These include continued investment in better diagnostics, precision care for mental health patients, targeted investments for research on women’s health, reducing the cancer death rate, data science and data sharing, Alzheimer’s Disease, Diabetes, and other areas.

Discussion
Dr. Dana asked how much variance there generally is in the relative intramural to extramural expenditures. Ms. Colbert said the number has been consistent, with the intramural program representing approximately 12% of the total NEI budget. Dr. Dana also asked about the number of laboratories or PIs supported by the intramural and extramural funding. Dr. Chiang said the number of intramural investigators was smaller, with 26 laboratories and six core facilities.

Translational Opportunities for Multi-Omic Research Approaches— Dr. Vinit Mahajan, Stanford University; Dr. Afrouz Anderson, NIBIB

TEMPO: A multi-omic approach to identifying disease mechanisms in living humans— Dr. Vinit Mahajan, Stanford University

Dr. Mahajan directs the Molecular Surgery Program at Stanford, and he noted that ophthalmologists and vision scientists can deliver any molecule anywhere in and around the eye – and that they can essentially operate on cells. For example, the first FDA-approved gene therapy involves injecting a needle just below the retina to deliver a gene therapy vector that treats retinal pigment epithelial cells to prevent vision loss. But he added that they do not take advantage of this procedure to remove fluid from the eye. Cataract surgery, the most common surgery in the world, involves removing fluid from the eye, but this fluid is thrown away. He and his colleagues instead save and freeze it, and then use it to develop molecular diagnostic technologies, including a method called TEMPO, which stands for “Tracing the Expression of Multiple Protein Origins” and was described in a recent publication in the journal Cell.

For TEMPO, they extract 50 microliters of eye fluid and use DNA array technology to measure about 6,000 proteins. They then traced protein signatures to specific types of cells, such as different types of immune cells, retinal cells, or blood vessel cells. These signatures were robust, containing more than 50 proteins each. TEMPO also reveals protein signatures of disease. Eye fluid samples taken from people with retinitis pigmentosa were missing the signature from rod cells, as the disease’s pathology would predict. Diabetic retinopathy also showed a distinctive molecular signature that changed over the course of disease progression. TEMPO could also identify and reveal molecular insights about Parkinson’s disease.

Dr. Mahajan and his colleagues also applied AI modeling to groups of proteins identified with TEMPO to identify a molecular signature of aging overall, predicting study participants’ birthdays with some accuracy. They also used the approach to identify molecular signatures of aging for multiple eye-related diseases, identifying which cell types contributed most strongly. These signatures could reveal signs of advanced aging even when a patient’s disease was controlled, suggesting aging may be a separate biological pathway.

Dr. Mahajan also described studies using TEMPO to investigate eye cancer, identifying protein profiles that help classify a tumor without a biopsy. The technique identified characteristics in patients’ samples that suggest whether specific cancer therapies are likely to be effective. That is especially powerful in uveal melanoma, a rare but deadly cancer. Testing patients’ cells in this way can be used to identify whether they carry a particular drug target and therefore whether they would be candidates for a specific therapy or clinical trial.

Dr. Mahajan summarized his talk by underscoring the power of combining proteomics with single cell sequencing, as TEMPO does, and noting that some of his colleagues are also applying the technique to samples taken outside the eye to look at conditions such as inflammatory bowel disease, neurological diseases and other cancers, as well as aging and menopause. He is currently trying to encourage industry to include such eye samples as they enroll patients in studies of molecular therapies. He also suggested that NEI support a multicenter fluid collection effort to power further studies.

Discussion
Dr. Dana noted with interest that TEMPO pinpointed macrophages as players in in diabetic retinopathy, saying that this aligns with his observations of macrophages as the chief source of pro-angiogenic molecules in several of the disorders presented. He noted he will send a paper that captures what macrophages do in regard to the expression of both ligands and receptors to drive that process.

Dr. Grant asked whether Dr. Mahajan’s team had compared the aging profiles observed in eye fluid with blood samples. She also asked what he makes of the presence of B cells in the fluid samples. Dr. Mahajan replied that he expects eye fluid to be strongly enriched for relevant proteins because it is local and close, and because blood is generally less important for eye disease markers because proteins get diluted out of it and may not be reflected in blood. As for the B cells, he noted that there was substantial subclinical inflammation in the eye, and that although it is an immune privileged area, it is not “immune zero.” These different cells may have contributions that have not been clinically characterized, he added.

Dr. Perez asked whether the work had characterized pediatric aqueous fluid, and Dr. Mahajan said that they had collected some samples from pediatric uveitis but that it was more complicated to characterize and there was no comparative control.

Integrating biomedical imaging with multi-omics analysis for diagnosis of ocular and systemic diseases— Dr. Afrouz Anderson, NIBIB

Dr. Anderson focused on the intersection of imaging and Artificial Intelligence (AI), noting that efforts to enable imaging technologies through AI have grown by 3.7 times ($1.1B) at NIH over the past five years, along with an enormous market growth in the use of AI and machine learning in imaging technologies. NIBIB is disease agnostic and does a lot of work in the early stages of tool development. The aim of these tools is to optimize the information that can be obtained from the imaging data and to be able to explain its clinical relevance.

Preparing data for AI analysis requires intensive work including curation, quality control, annotation, and harmonization, she noted. It is also crucial to understand bias and diversity in the data, she added. A major actor in data resources for AI and imaging is a multi-institutional collaboration called the MIDRC – Medical Imaging and Data Resource Center. Its goal is to create an open discovery data common for creating patient data sets and using machine learning for creating clinically relevant tools. MIDRC contains sequestered data that is still being validated in collaboration with the FDA, as well as public facing data.

Due to a 2023 executive order to build a national research infrastructure for AI, NIH has participated in NAIRR, the National AI Research Resource pilot program to deploy these resources to early users. MIDRC is also part of the ARPA-H Biomedical Data Fabric Toolbox. This is a national infrastructure for industrial data curation and discovery and visualization of AI in healthcare, Dr. Anderson said.

Dr. Anderson described some examples of NIBIB’s AI imaging portfolio. What is most exciting, said Dr. Anderson, is the growing overall capability in noninvasive optical imaging technology. This growing suite of tools can image at all scales, from macro to nano and both structurally and functionally. Multimodal imaging can reveal multiple biomarkers for ocular and systemic disease. Longitudinal data can be captured in all these different ways. These multidimensional capabilities enable scientists to study more complex diseases and disease processes, and partnerships have been crucial for these advances.

Harnessing AI for ocular imaging, both for research and for point of care use, is an exciting prospect, though it comes with challenges, she said. These include access to large usable datasets, developing the best algorithms, addressing bias, and creating trustworthy and explainable AI that yields standardized outcome measures, as well as challenges in regulatory clearance and clinical adaptation. But the solution lies in building engineering and medical partnerships and using the type of data repository and federated networks that MIDRC has created, she said. Building on these models and working together across different societies and stakeholders can help push these tools’ utility beyond a single disease.

Discussion
Dr. Mahajan asked whether ophthalmology led the way in terms of AI imaging. Dr. Anderson said it did, and she described the power of multidimensional data in ophthalmology. Dr. Chiang also noted that ophthalmology is often said to have the first FDA approved autonomous AI system, but in terms of FDA-approved AI imaging systems currently available, radiology leads the way. He asked what that field is doing that the vision field is not doing. Dr. Anderson stressed that connection with different societies, and a true community driven approach, is crucial. Vision researchers are poorly connected to physicians and other medical practitioners and do not necessarily understand their needs, she said. She added that the establishment of an imaging standard is crucial, but something the field is still working on.

Dr. Dana noted that any AI system relies on access to large amounts of reliable, normative data. That is a challenge because there is so much variation even within the “normal” population. Efforts to develop AI tools will have to deal with the fact that ophthalmologists, in particular, tend to image clear-cut disease states, whereas many other fields have a lot more information on control populations, he said.

Dr. Maguire referred to a discussion earlier in the day about the challenges of getting eye care into primary care. She asked how far off we might be from a primary care physician ordering a lipid panel to also be able to order a battery of tests on a single machine that would offer wide-ranging information on systemic conditions. Dr. Anderson replied that although regulatory issues can extend the timeline, technologically such a scenario is perhaps five years away. She added another five for clinical approval – so, optimistically, she estimated a total of 10. Already, point of care diagnostics can detect biomarkers from both an imaging and a molecular perspective. She said partnerships between people who understand the needs for applications and those who have technological expertise will be key.

BRAIN Multi-Council Working Group Update—Dr. Tirin Moore, Stanford University

At the May 2024 meeting, Dr. Moore reported, the BRAIN Director summarized the status of the BRAIN Initiative’s budget. Since its launch in 2014, the BRAIN Initiative has enjoyed robust funding, with a peak in its total budget for Fiscal Year 2023 due to a large but temporary increase in funds derived from the Cures Act. That temporary increase was reduced to previous years’ levels for the current year, resulting in a $280 million reduction in funding. Nevertheless, the Director stressed that the initiative planned to be a good steward of the funds allocated to the BRAIN initiative, and to fund the best science. It is hoped that some funds will be restored in future years. The BRAIN initiative is still committed to funding ongoing commitments with some slight adjustments to out-year costs for projects. The reduction also means the BRAIN initiative may need to reduce the number of awards made this year and likely next year and cancel some initiatives.

The BRAIN Director also announced recent honors and awards received by investigators involved in BRAIN Initiative projects, including Dr. Larry Abbot of Columbia University, Terry Sejnowski at the Salk Institute for Biological Studies, and Haim Sompolinsky at Harvard University, who won the 2024 BRAIN Prize. He also summarized recent BRAIN Initiative events, including requests to participating ICs on the impact of the BRAIN the ICs initiatives. There have been several articles published on these perspectives, which have been inspiring and encouraging about the impact the BRAIN has had on the mission of the ICs. The BRAIN recently held a workshop on “Advancing Human Neuroscience Through Neurostimulation and Recording” at the end of May. He also mentioned the10th Annual Brain Initiative conference, held on June 16, 2024, provides a forum for discussing new developments and bringing BRAIN investigators together. The BRAIN Director provided some updates on recent awards, including the distribution of BRAIN funded investigators across the United States (36 states have BRAIN awards), as well as challenges in diversifying the pool of BRAIN-funded investigators and scholars.

Another major source of discussion was how the initiative plans to handle the substantial decrease in budget and which priorities, under the circumstances, should be emphasized, Dr. Moore said. The BRAIN Multi-council Workgroup meeting was recorded and can be viewed here.

Concept Clearance: NEI New Innovator Award— Dr. Sangeeta Bhargava, NEI

The goal of this concept is to support postdoctoral researchers and other early-stage investigators who show exceptional creativity, propose especially novel or insightful work, and address important issues in vision research. The concept is driven by two observations. First is that NEI’s F32 postdoctoral program, has seen a dramatic drop in applications of more than 50% in the last five years. Other institutes across the NIH have observed a similar trend. The second observation is that an NIH advisory committee established in 2022 to re-envision postdoctoral training provided recommendations to address this decline. These recommendations included increased pay and benefits, create and expand mechanisms to support postdoctoral scholars to transition into independent careers, support safe and diverse perspectives, and promote training and development.

This new concept aims to incorporate all of these recommendations. It would be open to both US citizens and noncitizens based at US institutions who have either a research or a clinical doctorate. The concept is both research and person focused. Applicants are encouraged to emphasize innovation and creativity. The review process will emphasize the individual’s creativity, innovation of the research proposal, and the impact on the mission of NEI. Ultimately the goal is to support promising early-stage researchers to move into independent positions.

Discussion
The assigned discussants for this concept clearance were Drs. Dana and Moore. Dr. Dana noted that the drop in postdoctoral scholars is alarming but not surprising, with many moving into industry given limitations in federal funds. Any measure with a meaningful impact on the decline should be supported, but if there are not enough people being funded then the award will become a prize but will not change the trend. Dr. Dana would prefer more awards given for less money, but overall, he thinks this is a good idea. He asked, though, whether other institutes have similar mechanisms, and how many awards NEI hopes to disburse.

Dr. Bhargava responded that the NIH Common Fund has a similar program started in 2014. NIAID launched a similar program in 2019 that has succeeded in getting postdoctoral fellows into more independent positions and supporting early-stage-investigators who have then gone on to get R01 grants. The number of NEI awards depends on the budget, but the aim is to support as many meritorious applications as possible.

Dr. Moore said the drop in postdoctoral applications is striking and asked whether the reason for it was known. Dr. Bhargava said both salary issues and the Covid epidemic likely played a role. Salary drives postdocs into industry instead of academia. Other factors were mentioned in the report. Dr. Moore said he believed the concept was a good idea and especially liked that it is open to non-US citizens. Dr. Anderson noted that NEI is not limited on how many awards can be made under this program. If many meritorious applications come in NEI will prioritize them with other projects from early-stage investigators.

Dr. Maguire said she likes the recommendations for improving the overall postdoc experience. She asked if the decrease in postdocs was leading to a shortage causing independent jobs not to be filled, or if there were simply too many postdocs before. Dr. Bhargava replied that the number of graduate students had increased while the number of postdocs decreased – seemingly because they chose a different path. Dr. Dana noted a third option – that because investigators’ budgets have been kept constant, and at many institutions, postdoctoral salaries have increased, the number of postdocs that could be funded has decreased.

Dr. Perez said he thinks the concept would be a great program and asked how the review process would differ from other awards. Dr. Bhargava said that rather than focusing on data and publications, this award would focus on how creative or innovative the proposal was and whether it brings something new to the field. The review will also emphasize the potential of the person to make novel scientific contributions.

Dr. Moore noted that it will be difficult to evaluate newly independent investigators from postdoctoral applications during the review.

Dr. Dana suggested that the name of this award – NEI Innovator – sounds very high level. He suggested changing the name to something like NEI Early Investigator, or NEI Early Career Innovator Award, to prevent people from being misled by the title.

Dr. Anderson asked for a motion to approve this concept, which passed unanimously.

Concept Clearance: A Community Driven Research Approach to Achieving Vision Health Equity—Dr. Jimmy Le, NEI

This concept clearance emerged for the NEI Strategic Plan and from a workshop held last year with the National Institute on Minority Health and Health Disparities, on vision and health equity, Dr. Le said. The goal of this concept is to advance vision health equity by supporting community engaged research on multi-level interventions that simultaneously address vision health conditions and social determinants of health – which include nonmedical factors shaping daily life, such as housing, education, employment, and transportation. The concept aims to support research that prioritize populations with health disparities, focuses on multi-level interventions, demonstrates meaningful engagement with community partners to ensure that the interventions under investigation are responsive to the needs of the community and can achieve sustainable improvements once the research ends.

Dr. Le laid out the concept’s rationale: Vision health equity research is an important strategic priority for NEI. The Covid pandemic and other current events, laid bare the impact of inequities in the prevention, treatment, and management of diseases among health disparity populations, he said. Vision health disparities are addressable, best driven by the community, and the vision field is ready to lead large-scale projects addressing health equities, he added. Community engaged science is a gap in NEI’s current research portfolio. For example, refractive error and vision screening sounds like an obvious solution, Dr. Le said, but what happens after to address issues identified through screening matters a lot, and there need to be interventions at multiple levels, engaging many different types of community partners. Another example would be how mobile health might increase access to vision health services in rural settings. In what ways could collaboration with faith-based organizations or other businesses or services could expand the delivery of vision health interventions? How could culturally informed health promotion strategies improve vision health literacy? How might peer support programs and navigators connect patients to resources and other vision services? In what ways could AI enhance detection and referral processes in low resource settings? He ended by recapping the objectives and scope of this initiative which include:

Catalyze, develop, and evaluate community-engaged, multilevel interventions that address health disparities to advance vision health equity.
Evidence of meaningful community engagement include but are not limited to community partners holding roles as key personnel on research projects.
Transdisciplinary collaborations with researchers outside the vision field such as health services, health disparities, education, behavioral science, and social science.
He then thanked his collaborators at NEI and NIMHD asked for council feedback on this concept.

General Discussion

Dr. Grant opened the discussion by asking for clarification about the R38 grant mechanism. Dr. Chiang explained that is this program funds departments to support clinical residents to do research during their residency years. The R38 funds the years that are devoted to research. He noted that three other institutes besides NEI also participate in this program. Dr. Anderson clarified that the R38 is an institutional award, while the F32 is an individual fellowship award.

Dr. Grant noted that a common problem in ophthalmology is that students who want to get into the field but do not get accepted into a residency program end up taking a gap year. This is a great time to introduce physicians to science, Dr. Grant said. She suggested some hybrid version of the R38 could help enable that. Dr. Chiang agreed, and noted another common scenario, in which a medical student who wants to take time off to do research but cannot access a funding mechanism to do that. NEI would like to inspire people to get into research and he sees this as one way to do this. He asked what else can the vision community be doing to inspire someone to go into research?

Dr. Dana noted that many candidates are not that interested in research, but they want to get into a good residency and research experience helps them to do this. It is not possible to identify in advance who will choose to follow which path (academia or private practice), Dr. Dana said. He did say that it is our job to create opportunities for them, even if you cannot control their career choice. Dr. Perez noted that it will be up to individuals to push themselves into research opportunities in ophthalmology and vision and take advantage of these types of mechanisms.

Dr. Ramulu noted that they recruit faculty who have already been through this type of program which inspired his institution to apply for this program.

Dr. Maguire said that in finding ways to deliver eye care to underserved populations, a common consideration is manpower, and one option raised earlier in the day was training programs sponsored by journals that help awardees be good reviewers and get them involved in the editorial process. Dr. Maguire noted that it would be good to extend this effort to biostatisticians, considering there is a severe shortage of them.

Dr. Mutti asked for a clarification on what to call the Early-Stage Innovator Award. He also sought clarification on how applicants should think through whether to apply for it as a sort of pre-R01, or to cast their lot as a new investigator with an R01. Dr. Bhargava explained that if the researcher does not have a lot of data but perhaps a clever paradigm shifting idea, then you could go for the Innovator program. If you have multiple ideas and supporting data, a new investigator could apply for both, as the NIH does permit applicants to submit two distinct applications at the same time.

Dr. Mutti asked whether Dr. Bhargava had some feedback on encouraging early-stage investigators who do not have the reputation of a senior person. Dr. Brian Hoshaw, Chief of the Review Branch at NEI, addressed this question. He explained that all NEI R01s are reviewed at the Center for Scientific Review (CSR) and all early-stage investigator applications are clustered together during the review meeting – separate from applications from more senior investigators. Dr. Anderson added that institutes are encouraged to prioritize early-stage investigators and these applications might get a (virtual) 5% bump to their application scores. NEI prioritizes applications from early stage and new investigators when developing funding recommendations.

Dr. Ramulu said that what all these concept proposals illustrate is that science done at the NEI is changing. So young investigators who are developing proposals on topics relating to AI or big data or health equity often ask what study sections they should be submitting them beyond the typical ones that review NEI R01s. It is definitely creating anxiety in people working in these new areas, Dr. Ramulu said. It is not clear how to message that people who submit grant proposals on such topics are going to get a fair review, he said.

Dr. Chiang said that these are all great questions and noted that one big job of NEI is to stimulate the science that is best going to position us to achieve our mission moving forward. In the face of that, the field will have to evolve, he added. It may be challenging to find the most appropriate reviewers in a world that is changing rapidly. Dr. Anderson noted that submitted applications to an NEI RFA or initiative do not get reviewed by CSR review but are reviewed by NEI review staff who put together a panel with reviewers with the appropriate expertise for those specific applications. She also noted that CSR updates the make-up of and can create new study sections as science changes. They have a very established process for doing this. Dr. Hoshaw added that for CSR reviews, applicants can use tools that will match their application with the appropriate study section. Applicants should also get in touch with program officers to discuss their research as they can give advice about appropriate review panels based on their experiences. Dr. Bhargava added that for applications that are going to be reviewed in CSR, applicants can describe the expertise needed for the application in their cover letter. It is also possible to see the full membership of CSR standing study sections to ensure that the panel has the appropriate expertise and ask for additional expertise that is not represented on the panel.

Dr. Chiang thanked the council members for their engagement and feedback during the open session and noted that staff take their comments and recommendations very seriously and use them to develop new ideas. He adjourned the meeting and said that the closed portion would continue after a 15-minute break.

CLOSED SESSION

This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS

NAEC members considered 597 grant and cooperative agreement applications on which NEI was the primary Institute; these applications requested a total of $198,463,603 (direct costs year 01). The Council also considered 360 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $224,829,511 (direct costs year 21 168th National Advisory Eye Council Meeting, June 7, 2024 01). The Council concurred with the Institutional Review Group recommendations on these 957 applications.

ADJOURNMENT
The 168th meeting of the National Advisory Eye Council was adjourned at 5:00 p.m. on June 7, 2024.

CLOSED SESSION ATTENDEES

Council Members Present:
Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary (in-person)
Dr. Reza Dana (in-person)
Dr. Maria B. Grant (in-person)
Ms. Janice Lehrer-Stein (in-person)
Dr. Maureen Maguire (virtual)
Dr. Tirin Moore (in-person)
Dr. Donald Mutti (in-person)
Dr. Victor Perez Quinones (in-person)
Dr. Pradeep Ramulu (in-person)

NIH Staff Members Present:

Shawn Adolphus (in-person)
Dr. Neeraj Agarwal (in-person)
Lisa Applewhite (in-person)
Dr. Houmam Araj (in-person)
Holly Blake (in-person)
Nathan Brown (in-person)
Dr. Sangeeta Bhargava (in-person)
Dr. Kapil Bharti (virtual)
Nathan Brown (in-person)
Dr. Ed Clayton (in-person)
Jay Colbert (virtual)
Karen Colbert (virtual)
Donald Everett (in-person)
Dr. Martha Flanders (in-person)
Dr. Ashley Fortress (in-person)
Dr. James Gao (in-person)
Alexandra Gavrilovic (virtual)
Dr. Nataliya Gordiyenko (in-person)
Dr. Shefa Gordon (in-person)
Dr. Tony Gover (in-person)
Dr. Brian Hoshaw (in-person)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (in-person)
Dr. Barbara Mallon (virtual)
Dr. George McKie (in-person)
Dr. Lisa Neuhold (in-person)
Dr. Bob O’Hagan (virtual)
Dr. Mary Ann Redford (in-person)
Dr. Jennifer Schiltz (in-person)
Dr. Grace Shen (in-person)
Dr. Azadeh Shoaibi (in-person)
Karen Robinson Smith (in-person)
Dr. Hongman Song (in-person)
Dr. Afia Sultana (virtual)
Dr. Santa Tumminia (in-person)
Dr. Cheri Wiggs (in-person)
Bronte Williams-Washington (in-person)
Keturah Williams (virtual)
Dr. Charles Wright (in-person)

CERTIFICATION
These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

NIH VideoCast

167th Meeting of the National Advisory Eye Council
6700B Rockledge Drive, 1st Floor Conference Room

Open Session: 8:30 am - 2:45 pm

8:30-8:45 a.m.

Welcome and Introductions
Michael F. Chiang, MD
Kathleen C. Anderson, PhD

8:45 - 10:15 a.m.

NEI Director's Report
Michael F. Chiang, MD

Discussion
Council Members

10:15 - 10:30 a.m.

BREAK

10:30 - 11:30 a.m.

The intersection of technology, study design, and quality of life: Best practices for inclusion of participant perspectives in research
John-Ross (“JR”) Rizzo, MD, NYU

Discussion
Council Members

11:30 - 11:45 a.m.

BRAIN Multi-Council Workgroup Update
Tirin Moore, PhD

11:45-12:00 p.m.

Concept Clearances

Post-baccalaureate Opportunities in Visual Science
Ed Clayton, PhD, NEI
12:00 - 12:45 p.m.

LUNCH BREAK — 6700B, 3rd floor

12:45 - 1:45 pm

ARPA-H Overview and NEI Partnerships
Amy Jenkins, PhD, ARPA-H
Cal Roberts, MD, ARPA-H

Discussion
Council Members

1:45 - 2:15 pm

Retiring Council Member Remarks
Dr. Teresa Borras
Dr. James Coughlan
Dr. Thomas Gardner
Dr. Renu Kowluru

2:15 - 2:45 pm

General Discussion
Council Members

Closed Session: 3:00 - 5:00 pm

Confidentiality and Conflict of Interest
Kathleen C. Anderson, PhD

Review of Grant and Cooperative Agreements
Kathleen C. Anderson, PhD

Adjourn

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 166th meeting at 8:30 a.m. on Friday, October 13, 2023. The meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended either virtually or in-person. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 8:30 a.m. until 3:00 p.m. The meeting was closed to the public from 3:30 p.m. until 5:00 p.m. for the review of grant and cooperative agreement applications.

Council Members Present:
Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary (in-person)
Dr. Terete Borrás (in-person)
Dr. James Coughlan (in-person)
Dr. Reza Dana (in-person)
Dr. Thomas Gardner (virtual)
Dr. Maria B. Grant (in-person)
Dr. Renu Kowluru (in-person)
Ms. Janice Lehrer-Stein (in-person)
Dr. Maureen Maguire (in-person)
Dr. Tirin Moore (in-person)
Dr. Donald Mutti (in-person)
Dr. Victor Perez Quinones (in-person)
Dr. Pradeep Ramulu (in-person)

NIH Staff Members Present:
Shawn Adolphus (virtual)
Dr. Neeraj Agarwal (in-person)
Lisa Applewhite (in-person)
Dr. Houmam Araj (in-person)
Dr. Kapil Bharti (in-person)
Dr. S. Patricia Becerra (virtual)
Dr. Sangeeta Bhargava (in-person)
Holly Blake (virtual)
Nathan Brown (in-person)
Leslie West-Bushby (virtual)
Alysia Champagne (virtual)
Faith Chen (virtual)
Dr. Emily Chew (virtual)
Monique Clark (virtual)
Dr. Ed Clayton (in-person)
Jay Colbert (virtual)
Karen Colbert (virtual)
Dr. Mary Frances Cotch (virtual)
Kathryn DeMott (virtual)
Britt Dennis (virtual)
Joshua Denny (in-person)
Mala Dutta (virtual)
Donald Everett (in-person)
Dr. Martha Flanders (in-person)
Dr. Ashley Fortress (in-person)
Dr. James Gao (in-person)
Dr. Susan Gillmor (virtual)
Dr. Kerry Goetz (in-person)
Dr. Nataliya Gordiyenko (in-person)
Dr. Shefa Gordon (in-person)
Dr. Tony Gover (in-person)
Dr. Thomas Greenwell (in-person)
Lateefah Hill (in-person)
Dr. Brian Hoshaw (in-person)
Dr. Michelle Hribar (in-person)
Koray Dogan Kaya (virtual)
Dr. Alicia Kerr (virtual)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (in-person)
Renee Livshin (virtual)
Dr. Barbara Mallon (virtual)
Dr. George McKie (in-person)
Dr. Sheldon Miller (virtual)
Archana Mohale (virtual)
Dr. Lisa Neuhold (in-person)
William “Russ” O’Donnell (virtual)
Shaun Patton (in-person)
Barbara Payne (virtual)
Dr. Zepeng Qu (virtual)
Dr. Mary Ann Redford (in-person)
Melissa Reeves (virtual)
Carissa Reilly-Weedon (virtual)
Holly Russo (virtual)
Dr. Delia Olufokunbi Sam (virtual)
Dr. Jennifer Schiltz (in-person)
Dr. David Schneeweis (virtual)
Dr. Shauna Schwartz (virtual)
Dr. Grace Shen (in-person)
Dr. Azadeh Shoaibi (in-person)
Rugie Sillah (virtual)
Karen Robinson Smith (virtual)
Dr. Hongman Song (in-person)
Dr. Afia Sultana (virtual)
Dr. Xun Sun (virtual)
Dr. Ginger Tansey (virtual)
Dr. Santa Tumminia (in-person)
Fausto Vela (virtual)
Dr. Cheri Wiggs (in-person)
Mary Wiles (virtual)
Keturah Williams (virtual)
Dr. Charles Wright (in-person)

Others Present Virtually:
Dr. Monica Hooper (virtual), Guest Speaker
Dr. Stephen McLeod (virtual), Guest Speaker
Television Operations

NOTE: Due to the open videocast format of this meeting, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.

WELCOME AND INTRODUCTIONS
—Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang called the 166th NAEC meeting to order. He welcomed invited speakers, Ms. Kerry Goetz, Associate Director of the NEI Office of Data Science and Health Informatics and Dr. Michelle Hribar, an NIH Data Scholar at NEI. All Council members briefly introduced themselves.

COUNCIL PROCEDURES AND RELATED MATTERS
—Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA)

Dr. Anderson welcomed the NEI research and advocacy community, NEI and NIH staff, invited speakers, and members of the public who were in attendance virtually and in person, and staff members who organized and provided technical support. She also thanked Drs. Coughlan, Gardner, Kowluru, and Borrás who agreed to extend their terms through the February 2024 3 166th National Advisory Eye Council Meeting, October 13, 2023 meeting. She also made some logistical announcements regarding participation in the hybrid meeting.

She noted that future NAEC meetings are listed on the open agenda and on the NEI website. The next in-person NAEC meeting will be held on Friday, February 16, 2024. Minutes of the June 2023 NAEC meeting were made available in electronic council book (ECB) prior to the meeting. A motion to accept the June meeting minutes was made, seconded, and approved unanimously.

NEI DIRECTOR’S REPORT
NEI DIRECTOR’S REPORT —Dr. Michael F. Chiang
Dr. Chiang began by noting the value of social media in disseminating news about scientific and research activities taking place at NIH and NEI. He encouraged attendees to follow NEI’s social media accounts.

NIH and NEI Leadership Updates
In NEI’s intramural research program, Dr. Richard Lee has come onboard as NEI’s Clinical Director. In the Office of the Director, Jessica Ryan was promoted to Deputy Executive Officer. In the extramural science programs division, Dr. Ed Clayton was hired to work with Dr. Neeraj Agrawal to run the NEI research training portfolio, and Dr. Azadeh Shoaibi was hired as a program officer in the collaborative clinical research group. Dr. Ellen Liberman, who served as the glaucoma program director, retired in July 2023. Linda Dingle has returned to her position as a grant specialist in the grants management branch. Recruitment is ongoing for the position of Director of Extramural Science Programs.

NEI Updates –Dr. Chiang congratulated several NEI investigators who received major awards.

Dr. Gordon Legge of the University of Minnesota received the APS James McKeen Cattell Fellow Award for his foundational research on low vision.

Within Health and Human Services (HHS), Dr. Mary Ann Redford, received the HHS Career Achievement Award for the multidisciplinary research she conducted and supported over the course of her career, spanning multiple topics including vision, dental, HIV, and women’s health. Dr. Cynthia Jaworski received the 50 Year Length of Service Award for her work in the Laboratory of Retinal Cell and Molecular Biology.

The 2023 Lasker-DeBakey Clinical Medical Research Award went to a trio of researchers from the vision community. Dr. David Huang from Oregon Health & Science University, and Drs. James Fujimoto and Eric Swanson from the Massachusetts Institute of Technology received the award for inventing optical coherence tomography, a retinal imaging technology that has revolutionized patient care.

Another notable awardee was Dr. Shiela Angeles-Han from Cincinnati Children’s Hospital Medical Center. Dr. Angles-Han received a Team Science Leadership Scholars Program award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the Office of Research on Women’s Health for her project, “Towards personalized use of methotrexate for the treatment of juvenile idiopathic arthritis-associated uveitis.”

The National Academy of Medicine announced its newly elected members, which included four people from the vision research community. Dr. Justin Hanes, at Johns Hopkins University, was honored for his discoveries and inventions of drug delivery technology targeting the mucosal ocular nervous system. Dr. Hongkui Zeng, from the Allen Institute for Brain Science, was honored for her investigations of cell types and connections in the mammalian brain. Dr. Eric D. Green, the director of National Human Genome Research Institute (NHGRI), was honored for his work on incorporating genomics into clinical car. Finally, Dr. Chiang himself was also elected to the Academy for his research on retinopathy of prematurity.

Highlights of Collaborative Research—Dr. Chiang noted that an element of NEI’s mission statement is fostering collaboration. He highlighted two collaborative projects in which NEI is involved.

NEI’s strategic plan identified plasticity as a topic for which scientific exploration can advance therapies for diseases such as amblyopia, traumatic brain injury or stroke. To foster collaborations between vision research and neuroscience, an open virtual workshop to explore gaps in knowledge about visual neuroplasticity will be held on January 10, 2024. The meeting will focus on four scientific areas: cortical cellular mechanisms, functional reorganization, subcortical mechanisms, and retinal remodeling.

Another collaborative project is a trans-NIH project on regenerative medicine that includes NEI and NIAMS. A recent AMP (Accelerated Medicines Partnership) public-private partnership project involving gene therapies, awarded three out of eight clinical trials for vision-related diseases. A workshop in November 2023 funded by Food and Drug Administration (FDA) and Foundation for the National Institutes of Health (FNIH) will explore the possibility of establishing an AMP initiative for cell-based therapies. NEI Deputy Director Dr. Santa Tumminia, who has been spearheading this effort, said that if this project goes forward, the vision community is poised to do well.

Highlights of Innovative Research—Dr. Chiang noted that driving innovative research is another pillar of NEI’s mission statement

NEI has focused on developing novel quantum technology imaging systems and quantum computer algorithms for disease diagnosis. That work aligns closely with NIH efforts, exemplified by a Notice of Special Interest (NOSI) published in September 2023 for using quantum sensing in biomedical applications. NEI is also actively supporting translational research, with applications for two types of awards – R61 (exploratory) and R33 (developmental) due in February 2024.

Highlights of Innovative Research, Health Disparities (1)—Dr. Chiang highlighted two efforts addressing health disparities research, which has been a key focus for NEI.

Dr. Chiang described one Notice of Funding Opportunity (NOFO) called Understanding and Mitigating Health Disparities experienced by People with Disabilities caused by Ableism, for which applications are due November 29, 2023. This NOFO aims to understand the impact and mechanisms of ableism on health outcomes, and to look at interventions at the system and community levels.

Dr. Chiang also noted that NIH is seeking public comments to a change in its use of the word “disability” in its mission statement. The current mission as stated, is “to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life and reduce illness and disability.” The proposed revision, on which comments are open until November 24, 2023, would change the last clause so that it says “… to apply that knowledge to optimize health and prevent or reduce illness for all people.”

Dr. Chiang then asked council members and attendees for their thoughts on this proposed change.

Discussion
Council member, Jenny Lehrer-Stein, thanked Dr. Chiang for noting this change. She noted the enormous diversity encompassed by the term disability and said that many in the disability community consider the term to be descriptive, and not negative. She added that the proposed change helps advance this concept.

Highlights of Innovative Research, Health Disparities (2)—Dr. Chiang highlighted several other efforts addressing health disparities research.

A predoctoral training program called ADVANCE aims to train pre-doctoral students from diverse backgrounds to conduct health disparities and health equity research and to develop, implement and evaluate preventative interventions.

A NOFO called Health and Healthcare Disparities among Persons Living with Disabilities aims to fund research on novel and innovative applications and interventions that address the intersecting impact of disability, race, ethnicity and socioeconomic status on healthcare access and health outcomes. First applications for the program are due on February 5, 2024.

Dr. Chiang asked council members and attendees whether they knew of projects that would benefit from this opportunity or have thoughts about how to encourage investigators to apply for such a program.

Discussion
Dr. Dana asked when the new program announced, noting that something so new, that differs from the usual investigator-initiated research, requires time to be planned, and if the application process is rushed the NIH may feel compelled to grant applications at a level that may not normally be competitive.

Dr. Anderson replied that the health and health care disparities among persons living with disabilities Funding Opportunity Announcement was published a couple of weeks ago, but the program is going to be active for three years, through October 2026, leaving plenty of time to develop and revise projects and pull together collaborative teams.

Dr. Grant noted sickle cell retinopathy as a possible area of research under this funding program. Patients often cycle through repeated trips to the emergency room while in great pain, and clinicians often crack down on medications. Changes in vision can be an early predictor of a severe sickle cell episode, so studying the ocular component of the disease might be a way to investigate the intersection of ethnicity, race, disability, socio economic issues, and eye disease.

Ms. Lehrer-Stein noted that President Biden has discussed the designation of disability as a health disparity, and the disability community and others have noted the lack of available data that impacts quality of life. It is also an area of tremendous uncertainty with respect to women's rights. Abortion bans in 21 states affect more than 35 million women, 3 million of whom are women with disabilities. Furthermore, 35 states presume that a person like her – a mother of three and grandmother of one – is unfit to parent because of a disability. The question, she said, is how to match the scientific and the lay community on this topic.

Dr. Coughlin underscored the need to push for collecting more data that tracks how different factors like race and socioeconomic status impact disability.

Dr. Ramulu noted that to truly conduct interventional work that can improve healthcare access and outcomes, it will be crucial to collaborate with researchers who have experience going into the community and who have connections with groups that experience health disparities. That is especially true for people with visual disabilities, who may have difficulty accessing other healthcare services because of those disabilities.

Dr. Chiang noted that the concept of the eye being a window to the body is especially true today because of advances in ocular imaging technologies – work which received a Lasker Award. It is an exciting time to be exploring these issues, he said.

Dr. Dana suggested reaching out for collaborators to schools of public health, where these topics have arguably gained more traction than in most medical schools.

Fostering Collaborations: Data Sharing Challenge—Dr. Chiang noted that data sharing requirements have caused some angst and frustration in the community. Metaphorically speaking, he said the White House Guidance and NIH requirements to come up with a data sharing plan are essentially sticks, but the community also needs carrots. A validated quantitative data sharing index could serve as a carrot.

The goal is to develop and validate such an index, which is being called an S-index (paralleling the H index) to identify and reward exemplar data sharers. This mechanism could be used to identify and sustain quality data sets. Tthe idea would be to conduct a challenge, judged by a collaborative group, essentially as a carrot to incentivize self-directed change. This could be done in collaboration with universities, publishers, or data indexers, and it would propel cultural change by creating good datasets as stand-alone products of studies. NEI staff presented this idea to the leadership at NIH, and currently a group of partners including National Institute of Neurological Disorders and Stroke (NINDS), National Library of Medicine, NCBI (The National Center for Biotechnology Information) BRAIN Initiative, Office of Data Science, and others are on board. The first step, ongoing now, is to do a landscape analysis, then conduct some workshops for interested people and the general public to design the challenge and flesh out the judging criteria, with the aim of launching the challenge in 2024.

Dr. Goetz said she would be extremely interested in hearing input or feedback about the proposed index, what the hurdles to doing this might be, and considerations on how make this a more equitable measure.

Foster Collaboration: Cortical Visual Impairment—Dr. Chiang described a workshop on cortical visual impairment (CVI) that will take place in December 2023. CVI emerged as an interest for NEI in its strategic planning process because there are so many unanswered questions and fundamental unknowns about it. CVI is now the leading cause of childhood blindness in the US, and pediatricians, neurologists and eye doctors tend to pass patients back and forth between them. The two-day workshop, which has been a year and a half in the making, will bring together experts from many disciplines with the goal of drafting definitions and determining criteria for diagnosis, as well as moving toward building a registry for CVI.

Foster Collaboration: Quality of Life (1)—Dr. Chiang described another workshop, held in September 2023, on patient reported outcomes and vision related quality of life questionnaires. Instruments for measuring vision-related quality of life need to be improved, so the intent of this workshop was to highlight the importance of patient perspectives and patient reported outcomes, and to think about opportunities and challenges for creating new instruments.

Discussion
Dr. Perez said that one of the challenges is to have a consensus about which measurements are needed. For the ocular surface, the problem is to understand what to look for and how to put it in a way that is cohesive and easy to communicate. Also, he congratulated the workshop organizers for involving the US Food and Drug Administration to underscore to that agency how important quality of life endpoints are.

Dr. Ramulu said it was a great workshop, and he noted that it is challenging to pin down which measures to select, and whether an array of different measures or one integrated measure would be most useful. Additionally, there are difficulties with measurement science, such as reproducibility and accuracy, speed, ability to adapt the measurements to people with vision or hearing deficits. He expressed hope that the summary of the workshop would lead to calls for proposals that move the science forward.

Dr. Maguire noted that this area is very complicated, and one important thing noted during the workshop was the importance of asking the patient, “What are you having difficulty with?” and “What is important to you?” — thereby personalizing the measure to the patient.

Dr. Dana concurred with the importance of demonstrating the importance of quality-of-life measures to the FDA in ophthalmic research. There are many examples in ophthalmology where patients’ quality of life and quality of vision can be improved without impacting vision in a direct way.

Foster Collaboration: Quality of Life (2) —Dr. Chiang described an NEI-funded project called Project Prakash, based in India, that aims to understand brain plasticity in children with congenital blindness. The project has been funded for 15 years and is based at Dr. Schroff’s Charity Eye Hospital, which provides surgeries for children with cataracts and other reversible forms of blindness. A long-held assumption has been that past a certain critical period, the brain lacks plasticity and intervention would not be effective. But more recent data reveals that sight recovery surgery induces significant white matter plasticity, suggesting that treatment for children past the critical period may be effective. It also suggested the need to rethink how we think about critical periods. Dr. Chiang traveled to India to see this project in action.

Foster Collaboration: Complement-ARIE Concept Prize Competition —Dr. Chiang called attention to a Common Fund research program for the development, standardization, validation, and use of methods that complement, make more efficient, or in some cases replace traditional animal models. These methods can be in vitro methodologies, in silico or some type of artificial intelligence system or organoid model. The planning for this program has been ongoing for some time, and the Challenge announcement was published in November 2023. The submission deadline is January 11, 2024.

“Recruit talented and diverse individuals” —Dr. Chiang highlighted two recruitment programs. He said that NEI has officially signed on to the StARR program – Stimulating Access to Research and Residency – which aims to facilitate a path for clinician scientists by supporting institutional programs in research during their residency. For residents interested in research, Dr. Chiang hopes to make people know that the vision field is very welcoming to physician scientists. Another program he described was the NIH administrative supplements to promote diversity in health-related research funding opportunity. This funding opportunity is applicable for PIs of active grants to support and provide research training to candidates from high school students through faculty researchers.

Another example of diversity-related recruitment efforts is an NEI video contest called Eye on the Future. The purpose is to identify high school students from around the United States and get them interested in health care and vision. There were 60+ submissions in the contest’s second year, and the 13 winners came to Bethesda for a day to engage with NEI scientists and networked with scientists and clinicians.

Educate about vision research advances: OCT —Dr. Chiang described a White House educational event scheduled for November 2023 that will showcase advances in nature, energy, national security, IT, AI, industries of the future and health that improve the lives of Americans. NEI was selected to demo an Optical Coherence Tomography (OCT) device. This was timely as developers of this technology were honored with a Lasker award in 2023.

NAEC Budget Update —Ms. Karen Colbert, NEI Budget Officer, summarized the budget for the last fiscal year, 2023, and shared what’s currently known about the budget for the current fiscal year, which began on October 1, 2023.

NEI’s 2023 budget was $896.1 million, which was a 3.8% increase over NEI’s 2022 budget. Official spending totals for 2023 are not yet available. In fiscal year 2022, NEI spent 83% of its budget on extramural research, 12% on intramural research and 5% on research support – figures that closely align with historical trends.

A couple weeks before the NAEC October 2023 meeting, the government avoided a shutdown by Congress passing and the President signing a continuing resolution that allowed the government to operate for 48 days, from October 1 to November 17. Funding during this period is determined by calculating a daily budget based on last year’s appropriation – approximately $2.5 million per day – and multiplying that by the 48 days for which the resolution holds. These funds cover most nuts and bolts of operation, with grant awards making up the largest percentage of costs. An NIH Guide notice was released in early October and gave NIH institutes and centers the discretion to reduce certain awards, providing a temporary mechanism for spending flexibility.

Ms. Colbert predicted that in the best outcome, NEI’s FY2024 budget will be same as FY2023, though a budget cut was still possible. A budget with no increase is essentially a funding cut because the cost of doing business increases each year, she noted, but NEI staff are confident in their abilities to manage within the resources they are afforded.

The budget picture for NIH overall is a bit different, Ms. Colbert said. The House bill reduces the total NIH funding by $3.7 billion, which would mean targeted cuts while most institutes and centers are held flat. The House bill also reduces the Cures Act funding, without replacing it with non-Cures money. The Senate bill, meanwhile, backfills the Cures Act funding and proposes a net increase to NIH of $265 million. Ms. Colbert speculated that there would be one more continuing resolution before the FY2024 budget was finalized.

NEI-All of Us Collaboration on Vision Health —Dr. Joshua Denny, CEO of All of Us, NIH; Kerry Goetz, NEI; Dr. Michelle Hribar, NEI and Oregon Health Sciences University

All of Us Program Overview —Dr. Joshua Denny, MD, MS, CEO of All of Us

Dr. Denny broadly described the aims and approach of All of Us, a study announced in 2015 by then-President Barack Obama and launched nationally in 2018. The study aims to enroll at least 1 million participants and to assemble a massive dataset that will accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for a broad population representative of the diversity of the US.

All of Us has recruited more than 700,000 participants so far, hailing from all 50 states. Of these, close to 5000 have completed all the initial surveys, donated DNA, and agreed to share their electronic health records. More than 80% of participants are underrepresented in biomedical research. The study collects five basic types of data – electronic health records, participant surveys, physical measurements, biosamples, and wearables data – though people choose not to submit some of these data types.

Returning value to participants is a big part of the program. In a survey asking people why they might join, the prospect of accessing their genetic information was the biggest draw. Another was simply altruism – the ability to make a difference in the future health of their communities. In terms of the genomics, participants can receive information about their hereditary disease risk, based on whether they carry a disease-causing variant in 59 genes associated with serious health conditions; their bodies’ ability to metabolize medicines, based on 7 genes; and their genetic ancestry. People who have been found to have an elevated genetic risk for diseases can meet with a genetic counselor to discuss their results.

All of Us data is longitudinal, with some information from electronic health records dating back to the 1980s. Researchers can access these data at different tiers. Basic summary statistics and aggregate counts are available publicly, to anyone, and beyond that, access works on a passport data model, meaning that once individual researchers receive approval, they can create workspaces for their projects. The data is available to academic and not-for-profit organizations, and institutions can sign a master agreement that enables access for their researchers. Dr. Denny noted that he and his team have tried to focus on diversity in the institutions and researchers that use the data; currently, 40 Historically Black Colleges and Universities (HBCUs), 57 Hispanic Serving Institutions are using AoU data, and outreach is ongoing to other minority-serving institutions, including tribal colleges and universities.

The first paper to come out of All of Us, published in 2021, showed that multisite All of Us data fed into an artificial intelligence algorithm can accurately predict who needs glaucoma surgery based on electronic health records variables. All of Us aims to build a large set of core data including DNA sequencing, electronic health records and surveys that researchers can use, Dr. Denny said, but there are lots of opportunities for ancillary studies, too. He mentioned a few that are ongoing, including one about serology relating to COVID, one investigating quantitative cognitive behavioral trait modules, and one looking at nutrition for precision health.

Discussion
Dr. Maria Grant asked Dr. Denny to elaborate on the nutritional questionnaires used in the nutrition precision health study, and specifically how researchers were capturing accurate diet information considering that about 25% of the population is low income. Dr. Denny responded that this study includes a subset of the All of Us population and uses a couple different types of questionnaires. A subset of the study group will receive take-home diets to measure biomarkers before and after intake, and a subset of that smaller group will do a feeding study at a clinical research center. The aim will be to adopt some of the questionnaires into the larger All of Us cohort and to enable participants to submit photos of their food as well.

Dr. Dana asked what the formal definition of the term “underrepresented” was in relation to All of Us. Dr. Denny responded that the participants of All of Us do not constitute a representative population because the study specifically sought to over-enroll people who are underrepresented in biomedical research. This is defined based on groups that are absent or unexplored in most existing studies. For example, it’s not known whether sexual or gender minorities are underrepresented in research because often, no questions are asked that would identify them. Meanwhile, with genetics, 95% of all GWAS (genome-wide association studies) focus on people of European ancestry, so All of Us seeks to enroll others. Dr. Denny noted that a paper exists that explains the definition used in the study.

NEI-All of Us Workshop Highlights —Kerry Goetz, Associate Director of NEI Office of Data Science and Health Informatics

Dr. Goetz discussed how NEI’s strategic plan, which says the agency must invest in resources to pursue technological advancements, positions NEI to work with All of Us to create a data source for clinical research using ocular imaging, genomics, and biospecimens. Ocular imaging is now common in eye care. And what’s more, data analysis and image processing tools have advanced to allow artificial intelligence, machine learning and deep learning methods to be applied to research and clinical decision support tools, and to lay the groundwork in a new area of science called oculomics. This new field might include things like the study of risk factors for systemic disease or investigations into social or biomedical causes for disease disparity, but its development has been hampered by a lack of publicly available, disease agnostic cohorts and by limitations in data quality and standardization.

At a workshop held in April 2023, NEI, National Institute of Biomedical Imaging and Bioengineering (NIBIB) and All of Us researchers met to discuss these issues. Attendees were subject matter experts in AI and vision science, ophthalmology, diagnostics, retinal imaging technologies, analysis platforms, public health, biomarkers. privacy, data security, and health disparities, and they explored the current state of science and opportunities to expand research with large retinal imaging cohorts. The workshop summary, called Opportunities for Ophthalmology Research in Large Research Cohorts, was posted in November 2023, and as of this meeting had already been downloaded more than 200 times.

Dr. Goetz noted that the eye is often called the window into the soul, as well to overall health. If the metadata associated with ocular images can be captured in a fast, cost-effective way, she said, the dataset of disease agnostic images such as those in All of Us coupled to biometric, clinical, genomic, and survey data from a large, diverse population could push forward research on ocular health, as well as research on neurodegenerative and cardiovascular health, aging and inherited conditions. She described an NEI proposal for a pilot study that would place four high quality, low cost easy to use devices in four existing All of Us locations. Participants could consent to ocular imaging, and these images would then be linked with their other All of Us data. Participants would also have access to these data, potentially contributing to the early detection of disease. An ancillary study proposal describing the pilot study has been submitted to All of Us for review.

Discussion
Dr. Grant asked whether blood samples of these patients would be available to investigators. Dr. Goetz said that the ocular imaging samples will become part of the All of Us research project and investigators will be approved to access data based on their permission level.

Dr. Teresa Borrás noted the need to promote the All of Us data within the research community, and Dr. Goetz noted that All of Us communicates widely with the public and that NEI will make sure to promote any vision-specific datasets.

Dr. Victor Perez asked whether there were plans to collect functional data, like vision, and whether there is the worry of collecting tests for which experts have no agreed-upon interpretation. Dr. Goetz said that according to the proposal, the data to be collected will be clearly labeled for research, to limit issues with interpretation.

Dr. Donald Mutti asked whether other eye-specific measurements are also made during the assessment. Dr. Goertz said that the project also hopes to capture standard Snellen visual acuity, and possibly other measures such as intraocular pressure. Across the board, eye measures are inconsistent, she said.

Common Data Models for Ophthalmology Research Collaboration —Dr. Michelle Hribar, NEI and Oregon Health Sciences University

Dr. Hribar, who is in her second year as a NIH data scholar at NEI, talked about the importance of common data models – otherwise called data standardization. One key to a rich, diverse dataset is sourcing it from multiple locations. But data that originates in electronic health records tends to be siloed because different institutions use different systems for electronic health records and implement them in different ways. That’s where data standardization comes in, she said.

One approach for standardizing data is to pull it into a single registry. Having everything available at a single site is a big benefit, but this approach can require extensive legal, privacy and security agreements. It also may have limits in scalability because each site must do a lot of work to contribute data into the shared repository. A second, newer approach involves each site keeping their own data. Here, researchers use various bioinformatics tools to share their code and their models between sites. This approach is much more scalable, and it means large data components such as imaging do not have to be pulled out and send to a different location. It does, however, require data standardization and harmonization up front, and partners need to be available at each site to run models at researchers’ request.

One widely used data model is the OMOP (which stands for observable outcomes data partnership) common data model, which All of Us datasets use. This data model was originally developed with the aim of using observational health data to do surveillance of treatments and products. It is simply a standardized scheme for organizing and naming data and compiling it into a database. Ophthalmic functional and imaging data is currently not officially part of OMOP. Imaging data can be especially tricky to share. The OHDSI (Observational Health Data Sciences and Informatics) Eye Care and Vision Research Workgroup, a multidisciplinary group of researchers in eye care and vision research co-led by Dr. Goetz, Dr. Hribar, and Dr. Sally Baxter, is working to harmonize ophthalmic data and add it to OMOP.

The resulting OHDSI Ophthalmic Data Network would consist of data distributed across multiple institutions that could be accessed through a data coordinating center. One way of using this data might be to look beyond a clinical trial to investigate longer timeframes or broader patient cohorts for an intervention, said Dr. Hribar. Another opportunity would be validating artificial intelligence models on additional data besides that on which the models were trained.

Discussion
Dr. Maguire asked how the American Academy of Ophthalmology’s IRIS Registry might interface with this system. Dr. Hribar replied that her team has been speaking with IRIS and it would be wonderful if IRIS could essentially be a node on this ophthalmic data network, if the data were standardized the same way.

Dr. Dana noted that this work will require lots of resources and attention over many years, a difficult thing to maintain in academia, and asked whether there exists a centralized superstructure at the NIH for allocating these resources. Dr. Hribar noted that the OHDSI community has been in existence for over a decade and that a significant number of people within it were from pharma.

Dr. Grant said that billing codes in electronic medical records can often paint an incomplete or inaccurate picture of patients’ medical condition, so she worried about the accuracy of this database. Dr. Hribar agreed that billing codes are not necessarily accurate, and that data experts working on this dataset have instead been using natural language processing to identify clinical information from progress notes.

Dr. Ramulu asked whether IRBs (institutional review boards) handled access to information stored at their institution in different ways, and whether standards were emerging for this. Dr. Hribar said that there were individual institutional review board protocols that had to go through approval, but there was some sharing between different sites in this respect. She speculated that in some cases, an umbrella institutional review board approval would be needed, while for others separate approvals for each study would be required.

Discussion
Ms. Lehrer-Stein encouraged Dr. Wiggs and her colleagues to explore current pending legislation called the Websites and Software Application Accessibility Act, which highlights universal design as accessibility devices are increasingly keyed to the internet. She also relayed her recent travel experience when a tour guide in Bologna, Italy had purchased statues of monuments to allow her to experience them tactilely.

Dr. Coughlan underscored the importance of universal design. In the past, assistive technology was stigmatized and treated as something to be used as a last resort, he said. It is important to normalize these types of tools, and it is possible to create them to be broadly useful and pleasing. Dr. Coughlan also asked whether grants for the research Dr. Wiggs proposed might be devised to specifically incentivize scientists with vision impairments to apply. Dr. Wiggs thanked him for the suggestion and agreed that writing this into the description of the funding opportunity was important.

Dr. Ramulu said that in designing accessibility technology it is important to place the focus on systems-based change. Instead of people with visual disabilities shouldering the burden, businesses, hospitals, and other institutions should have tools that enable them serve people with a variety of needs – from those with visual impairment to those who simply forgot their glasses.

Dr. Mutti said that as the design of these tools gets increasingly high-tech it is important to avoid creating disparities in who can afford to access them. Dr. Wiggs agreed, noting that the cost of 3D printing has gone down considerably and that a similar decrease in price point would hopefully increase access to other technologies.

Kerry Goetz noted that accessing current assistive technologies often requires visiting a low vision specialist, and because there are so few such providers, patients experience a long wait. She highlighted the importance of adding capacity to provide access more widely to assistive technology.

Dr. Anderson asked for a motion to approve this concept for potential development into a future funding opportunity, which passed unanimously.

NEI-India Collaborative Research Program Renewal—Dr. Charles Wright, NEI

Dr. Wright described this collaborative research program, which was launched in 2005 with the goal of ending the burden of blinding disease for citizens of India and the United States. There are many touchstones for collaboration. For example, diabetes prevalence has risen dramatically in both countries and is the primary risk factor for diabetic retinopathy. Climate change is also increasing the disease burden in both countries. The program has long had a board scope from basic to translational research, and this will continue with the program’s renewal. Some of the health topics to be explored include the link between climate change-related pollutants and ocular disease risks and outcomes, as well as genetic markers that predict the risk or impact of eye disease.

Dr. Wright highlighted two projects that were funded since this program was last re-issued. The first is a basic science project that uses cryoEM to resolve the structures of protein complexes spanning the first visual synapse that are implicated in conditional stationary night blindness. The second is more translational – it involves sequencing the genome of patients with microphthalmia, anophthalmia and coloboma and identifying variants in vitamin A metabolism genes.

Discussion
Dr. Dana asked how many grants had been funded so far, to which Dr. Wright replied four.

Dr. Maguire asked whether those grants could have been funded through other mechanisms. Dr. Wright said they could have, but the advantage of this program is that it does not involve transfer of funds to India so projects can start as soon as a grant is awarded.

In response to a question from Dr. Perez, Dr. Wright described the process of grant evaluation. The US-based collaborator applies to the NIH at the same time as the Indian collaborator applies to the Indian equivalent of the NIH. Both need to score favorably for the project to be funded. Dr. Wright said that estimated that 17 or 18 grants have been submitted.

Dr. Ramulu asked why clinical trials were not allowed as part of this program. Dr. Wright said that is how the project was originally conceived. Dr. Anderson added that NEI’s clinical trials portfolio does have clinical trials sites in India, so such trials can occur. They are just done in a different way that gives a little more oversight and budget flexibility.

Dr. Mutti noted that many of the health topics Dr. Wright had mentioned referred to environmental pollution and climate change, and asked whether he envisioned increased interest in these areas. Dr. Wright explained that at a section on global health at ARVO, there seemed to be an increase in interest among the community to move in this direction. He added that this an area NEI is looking to grow.

Dr. Ramulu suggested including rare diseases as a point of focus as well.

Dr. Anderson asked for a motion to approve this concept for reissue, which passed unanimously.

NEI Loan Repayment Program Update —Dr. Neeraj Agrawal, NEI
Dr. Agrawal gave an annual update on NEI’s participation in the NIH loan repayment program, which aims to attract health professionals to a career in research by paying their educational debt.

The program is open to US citizens and residents and re-pays up to $50,000 plus accrued US taxes. Participants must spend 50% of their time on research, which must be overseen by a mentor. The grant is renewable multiple times and NIH grant support is not required. NIH intramural program researchers are also eligible to apply. NEI participates in five different types of research programs; one added this year is Diversity (L34), which is open to anyone from an underrepresented minority or other diverse group. This year NEI received 13 renewals and 13 new applications. They renewed 10 out of the 13 and funded 6 out of the 13 new applications. NEI’s success rate for new applications is slightly lower than in previous years because of changes in funding rules.

Discussion

Dr. Gardner noted that the people he knows who have successfully applied have found the program very helpful. He asked whether the number of applications was optimal, and Dr. Agrawal said that although the numbers have dropped a bit, they are currently stable at about 30 applications per year.

Dr. Dana asked for clarification about whether the program supports basic research, as Dr. Agrawal had not mentioned basic research in the list of supported research programs. Dr. Agrawal said it does, but specific basic research projects get classified as part the other programs – for example, any research that uses human tissue falls under the category of clinical research.

Dr. Ramulu asked whether the program pays up to the full amount of somebody’s loans. Dr. Agrawal said the program pays the full percent, including undergraduate studies, and that people often reapply until all their loans are paid off.

Dr. Perez lauded the program, saying that it helps clinician scientists stay in the vision field.

NIH Simplifying Review Framework Initiative and Center for Scientific Review Updates —Dr. Noni Byrnes, Director of CSR

Dr. Burns began with an overview of CSR activities and then described multiple initiatives to strengthen peer review. In fulfilling its mission to conduct fair, independent, expert, and timely review for NIH grant applications, CSR reviews about 60,000 applications annually. The Center’s work is conducted with the assistance of about 275 scientific review officers and 19,000 reviewers in over 1200 meetings every year. CSR maintains a large number of standing study sections and also reviews many special initiatives. CSR works under a 3-domain framework for optimizing peer review. One domain focuses on fine-tuning study sections; another on training, evaluating and diversifying reviewers; and a third on establishing a solid process for things like criteria, scoring system and mechanisms for transparency.

Dr. Byrnes described ENQUIRE– which is a tortured acronym for Evaluating Panel Quality in Review. This is a systematic, data driven 12–18-month process for evaluating study sections. Each year 20% of all study sections undergo the process, with the aim of ensuring that every study section gets an external look every five years. For example, late-stage preclinical drug discovery was seen as a gap area, so CSR created a study section. The Center also took research on social determinants of health out of a single study section and distributed it into multiple study sections related to specific research areas.

CSR has also overhauled how it evaluates NIH research project grant applications. The aim for simplifying this process was to remove some administrative burden to allow reviewers to focus on science. Another concern was mitigating reputational bias in grant proposal evaluation of the project. One major change is to swap out the current five review criteria for three review factors – importance of the research, rigor and feasibility, and expertise and resources – that contribute to the overall score. Starting in January 2020, CSR sought and received a tremendous amount of input from the research community through avenues such as informal comments on blog posts as well as working groups. Between July 2021 and September 2022, NIH internally examined and approved the new framework. Public comment, solicited through a Request for Information open from December 2022 and March 2023, was largely supportive, Dr. Byrne said. The aim is to implement the changes beginning with applications received in January 2025. Between then and now, CSR will be holding webinars for the public and for staff describing the changes, refining grant application instructions, conducting trainings and doing outreach to socialize the change for reviewers, applicants, and others.

A third focus was improving the review of fellowship applications, with the goal of ensuring that peer review is identifying the most promising researchers of the next generation. A frequently voiced concern was that an over representative number of awards was going to trainees at elite institutions and with well-known sponsors. An analysis of 6000 applications confirmed this anecdotal worry, showing that a large number of awards went to a small number of institutions.

Input from working groups yielded two recommendations. The first was to change the review criteria to allow the application to present themselves, their research and their specific training needs rather than more boilerplate material. The second was to revise the application to better map on to the new review criteria – for example, eliminate undergraduate grades, which do not predict future success but can sway reviewers. After community input and internal review process similar to the one conducted for the review of criteria grant applications, an RFI has now been published and implementation will begin with applications received in January 2025.

Dr. Byrne also described other initiatives to promote fairness in review. CSR developed an online orientation for study section chairs focused on how to foster a strong study section culture. They also developed targeted bias awareness training for reviewers, which has been well received – people refer to the training when they find themselves having to intervene with colleagues. To date, 24,000 CSR reviewers have taken the training, which will be required beginning with May 2024 council review meetings. There is also a training module for review integrity, which has been completed by 17,000 CSR reviewers since its launch in Fall 2022, and it will be required beginning with February/March 2024 review meetings. CSR has a direct bias reporting mechanism, included in every email from any CSR staff member. The contact for that, Dr. Gabriel Fosu, CSR’s chief diversity officer, will ensure that all reports get investigated.

Finally, Dr. Byrne discussed efforts to diversify review panels. CSR has created a reviewer finder tool to identify lesser-known qualified reviewers. and one category is funded but underutilized investigators. Agencies and societies can recommend reviewers through the portal. The goal is to broaden the pool of potential reviewers but achieving it will require active culture change. CSR has focused on emphasizing the importance of reviewer diversity from above and is also committed to moving beyond demographic and geographic diversity to also capture a spread of topic, laboratories, and career stages. CSR’s data shows that interventions made over the past few years have significantly increased the number of women and underrepresented minorities of its reviewers.

Discussion

Dr. Dana said that as research gets more specialized, reviewers often do not have the depth needed to evaluate a body of grants. Vision related R01 grant applications generally go to two study sections which are designed to cover the same body of work, he said, and so reviewers have breadth but not necessarily depth. Dr. Byrnes replied that depth of expertise is subjective. Achieving the level of depth that Dr. Dana was seeking was likely impossible, she said, and for a five-year project breadth is also very important.

Dr. Borrás noted her frustration with the grant applications that do not get scored. These applications often have conflicting comments from reviewers, and although reviewers are supposed to discuss these differences and distill them into useful feedback, that rarely happens. She wondered whether it was possible to put some kind of number on non-scored submissions to help applicants figure out what to change. Another issue she raised is that many study sessions do not have standing members, so resubmitting a grant yields a whole new set of critiques. Dr. Byrnes noted that scoring is not an exact science and disagreed that adding a score to unscored applications would be useful. The summary statement is intended to provide the feedback Dr. Borrás is seeking, and researchers can discuss this with their program officers to gain clarity about the weaknesses in the proposal.

Dr. Borrás also noted that science has changed a lot: previously, to be funded, grants had to be hypothesis driven but that is not the case anymore. Today’s work is instead data driven. And yet reviewers still often make the comment that the work is not sufficiently hypothesis driven. Dr. Byrnes said that should not be happening – and if this comment is coming up, it should be brought to someone’s attention.

Dr. Perez asked Dr. Byrnes to explain how CSR determines what level of diversity of experience the review panels should contain. Dr. Byrnes said that there are no specific benchmarks. Currently about 45% are full professors, 45% are associate professors, and 10% are assistant professors, which she thinks is a good mix.

Dr. Anderson also noted that CSR has an early career reviewer program on which NEI modeled a very similar program that aims to introduce early career researchers to the review process. NEI’s program allows early career researchers to dip their toes into reviewing by having them serve as secondary or tertiary reviewers. Seeing the review process up close also helps them develop their own grant-writing skills.

Dr. Kowluru noted that she especially appreciates CSR’s changes to the review process because they allow researchers to focus on deepening existing science rather than just chasing innovation.

Dr. Chiang said that several clinicians have told him that they have noticed the number of clinicians on study sections has been decreasing. However, he said, they have a unique role to play in addressing the question of whether the study should be done. He expressed concern that if just one or two clinicians are present, their perspectives are too easily diluted or drowned out. Dr. Byrne said this was an interesting notion. She noted that CSR does monitor the participation of clinicians on committees, and she encouraged societies and similar organizations to submit names of clinicians targeted to different panels.

General Discussion
Dr. Grant asked if there might be an opportunity to centralize IRB submissions. Her experience is that we spend a tremendous amount of time getting relatively simple protocols approved – often due to back and forth between the main and the supplemental institution. She stated, sometimes we are inundated with a lot of stuff that is not important in getting the science done – and we should try to make that better for everyone as a community.

Dr. Redford said she agrees – and that NIH thinks that in concept, the single IRB framework is meant to facilitate review and approval. Still, she said, even though there is a single IRB of record, individual institutions require their own review and approval – that is problematic. But those are institutional issues that need to be dealt with.

Dr. Mutti said that this is an important issue, and that institutions have not caught up with the idea of a single IRB, and that very few groups can perform the single IRB review, and it is exorbitantly expensive in terms of cost and investigator time.

Dr. Everett echoed these concerns, noting the cost is becoming a huge problem. Many institutions seek approval from private IRBs, which charge for every modification. Dr. Mutti noted that just recently, he saw IRB costs go from $2000 to over $15,000 with the majority of resources going to get the study approved, not do the work.

Dr. Maguire noted that this also affects study design. Once an investigator gets a clinical trial through multiple IRBs there is great resistance to any change, even if it would be better for the patients and for the trial.

Dr. Coughlan asked about the S index challenge, which he found very interesting. In the context of the H index for publications, a publication must pass some bar. He wondered whether there was some bar like that for the S index – whether anyone has reviewed the the data is sensible or the metadata is needed – and what kinds of ideas there are to ensure the quality of data.

Dr. Goetz noted that she and her colleagues are just starting to lead this effort and that they are currently reaching out to a broad swathe of individuals who have experience with this. Some have mentioned that they have created metrics that pull in components of quality or other factors that aren’t just linked to publication. There are many approaches, a workshop discussing this issue will hopefully emerge in the late summer or early fall of 2024.

Dr. Chiang noted that one of the themes from earlier in the day is that what’s discussed in Bethesda needs to be disseminated – through social media, or through news. Council members are primary gateways to the real world, so whatever they can do to speak about these conversations to the community. Dr. Tumminia underscored this point, noting that council members are NEI’s conduit to the community and they represent a variety of different stakeholder groups, so their efforts to get the message out would be of great benefit to NEI.

Dr. Chiang officially adjourned the open session.

CLOSED SESSION

This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as amended (5, USC Appendix 2). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS
NAEC members considered 473 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $154,189,301 (direct costs year 01). The Council also considered 234 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $210,966,817 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 707 applications.

ADJOURNMENT
The 166th meeting of the National Advisory Eye Council was adjourned at 5:00 p.m. on October 13, 2023.

CLOSED SESSION ATTENDEES

Council Members Present:
Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary (in-person)
Dr. Terete Borrás (in-person)
Dr. James Coughlan (in-person)
Dr. Reza Dana (in-person)
Dr. Maria B. Grant (in-person)

Dr. Renu Kowluru (in-person)
Ms. Janice Lehrer-Stein (in-person)
Dr. Maureen Maguire (in-person)
Dr. Tirin Moore (in-person)
Dr. Donald Mutti (in-person)
Dr. Victor Perez Quinones (in-person)
Dr. Pradeep Ramulu (in-person)

NIH Staff Members Present:

Dr. Neeraj Agarwal (in-person)
Lisa Applewhite (in-person)
Dr. Houmam Araj (in-person)
Dr. Sangeeta Bhargava (in-person)
Nathan Brown (in-person)
Dr. Ed Clayton (in-person)
Donald Everett (in-person)
Lateefah Hill (in-person)
Dr. Brian Hoshaw (in-person)
Dr. Alicia Kerr (virtual)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (in-person)
Dr. Barbara Mallon (virtual)
Dr. George McKie (in-person)
Dr. Lisa Neuhold (in-person)
Dr. Mary Ann Redford (in-person)
Dr. Jennifer Schiltz (in-person)
Dr. Martha Flanders (in-person)
Dr. Ashley Fortress (in-person)
Dr. James Gao (in-person)
Dr. Nataliya Gordiyenko (in-person)
Dr. Shefa Gordon (in-person)
Dr. Tony Gover (in-person)
Dr. Thomas Greenwell (in-person)
Dr. David Schneeweis (virtual)
Dr. Grace Shen (in-person)
Dr. Azadeh Shoaibi (in-person)
Karen Robinson Smith (virtual)
Dr. Hongman Song (in-person)
Dr. Afia Sultana (virtual)
Dr. Santa Tumminia (in-person)
Dr. Cheri Wiggs (in-person)
Keturah Williams (virtual)
Dr. Charles Wright (in-person)

CERTIFICATION
These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 165th meeting at 9:00 a.m. on Friday, June 16, 2023. The hybrid meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended either virtually or in-person. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 9:00 a.m. until 2:30 p.m. The meeting was closed to the public from 2:45 p.m. until 5:00 p.m. for the review of grant and cooperative agreement applications.

Council Members Present:
Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary (in-person)
Dr. Terete Borrás (in-person)
Dr. James Coughlan (in-person)
Dr. Reza Dana (virtual)
Dr. Thomas Gardner (in-person)
Dr. Maria B. Grant (in-person)
Dr. Renu Kowluru (in-person)
Dr. Maureen Maguire (in-person)
Dr. Donald Mutti (in-person)
Dr. Pradeep Ramulu (in-person

NIH Staff Members Present:
Dr. Neeraj Agarwal (in-person)
Lisa Applewhite (in-person)
Dr. Houmam Araj (virtual)
Chelsea Bender (virtual)
Dr. Sangeeta Bhargava (in-person)
Nathan Brown (in-person)
Dr. Rachel Caspi (virtual)
Dr. Emily Chew (virtual)
Karen Colbert (virtual)
Dr. Ximena Corso-Diaz (virtual)
Dr. Mary Frances Cotch (virtual)
Kathryn DeMott (virtual)
Donald Everett (in-person)
Dr. Edmond Fitzgibbon (virtual)
Dr. Martha Flanders (virtual)
Dr. Ashley Fortress (virtual)
Ellaine Galindez-Balut (virtual)
Dr. James Gao (virtual)
Alexandra Gavrilovic (virtual)
Dr. Shefa Gordon (in-person)
Dr. Tony Gover (in-person)
Dustin Hays (in-person)
Lateefah Hill (in-person)
Dr. Brian Hoshaw (in-person)
Dr. Koray Dogan Kaya (virtual)
Stephanie Kennedy (virtual)
Dr. Alicia Kerr (virtual)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (in-person)
Dr. Huirong Li (virtual)
Dr. Ellen Liberman (in-person)
Renee Livshin (virtual)
Nikitha Maan (virtual)
Dr. George McKie (in-person)
Dr. Sheldon Miller (virtual)
Erika Nelson (virtual)
Dr. Lisa Neuhold (in-person)
William “Russ” O’Donnell (virtual)
Michael Phan (in-person)
Dr. Mary Ann Redford (virtual)
Dr. Michael Redmond (virtual)
Melissa Reeves (virtual)
Carissa Reilly-Weedon (virtual)
Dr. David Schneeweis (in-person)
Dr. Jennifer Schiltz (in-person)
Dr. Grace Shen (in-person)
Karen Robinson Smith (virtual)
Dr. Hongman Song (virtual)
Dr. Afia Sultana (virtual)
Dr. Santa Tumminia (in-person)
Dr. Cheri Wiggs (in-person)
Dr. Biying Xu (virtual)
Dr. Cheng-Rong Wu (virtual)
Maria Zacharias (in-person)

Others Present Virtually:
Dr. Monica Hooper (virtual), Guest Speaker
Dr. Stephen McLeod (virtual), Guest Speaker
Television Operations

NOTE: Due to the open videocast format of this meeting, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.

WELCOME AND INTRODUCTIONS
—Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang called the 165th NAEC meeting to order. He welcomed new council members, Drs. Maria B. Grant, Donald O. Mutti, and Pradeep Ramulu, to the meeting. Dr. Grant is an ophthalmologist studying the use of stem cells for vascular repair in retinal diseases at the University of Alabama at Birmingham. Dr. Mutti is an optometrist at Ohio State University investigating myopia. Dr. Ramulu is a glaucoma specialist and ophthalmologist at Johns Hopkins University. All Council members briefly introduced themselves and Dr. Chiang thanked the organizers for enduring the challenges of setting it up as a hybrid event.

COUNCIL PROCEDURES AND RELATED MATTERS
—Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA)

Dr. Anderson welcomed NEI staff, members of the public who were in attendance virtually and in person, Center for Scientific Review staff, and staff members who organized and provided technical support. She also made some logistical announcements regarding participation in a hybrid meeting.

She noted that future NAEC meetings are listed on the open agenda and on the NEI website. The next in-person NAEC meeting will be held on Friday, October 13, 2023. In addition, she noted that there were applications submitted to late funding announcements issued by other NIH institutes that needed to be considered for funding before the end of the fiscal year. Those applications will be made available for evaluation by council members via the electronic council book (ECB) in August.

Minutes of the October 2022 NAEC meeting were made available in the Electronic Council Book (ECB) prior to the meeting. A motion to accept the October meeting was made, seconded, and approved unanimously.

Each year in January, the Committee is asked to review the NEI Advisory Council Operating Procedures. The updated procedures were posted in the ECB for review and no substantive changes were made. A motion to accept the 2023 Operating Procedures was made, seconded, and approved unanimously.

NEI DIRECTOR’S REPORT
NEI DIRECTOR’S REPORT —Dr. Michael F. Chiang
Dr. Chiang began by noting the value of social media in disseminating news about research, clinical care, and policy, as well as keeping the vision research community aware of funding opportunities. He asked committee members to consider following NEI’s social media accounts and to encourage their institutions to do the same.

NIH and NEI Leadership Updates—In May, President Biden nominated Dr. Monica
Bertagnolli as the 17th Director of the National Institutes of Health. Dr. Bertagnolli currently serves as Director of the National Cancer Institute. She will take up the position of NIH Director pending Senate confirmation. Additionally, Kapil Bharti, PhD, has was hired as the new Scientific Director for NEI.

NEI Updates –Dr. Chiang congratulated several NEI investigators who received major awards.

The 2023 Helen Keller Prize for Vision Research was awarded to six scientists who conducted research on the genetic basis of vision loss. This work ultimately led to the development of Luxterna, a gene therapy treatment for inherited retinal disease and the first FDA-approved gene therapy. The development began with research conducted in NEI’s Intramural Program cloning the RPE65 gene, which makes a protein required for vision.

Two NEI senior investigators will receive major awards at ARVO’s 2024 Annual Meeting.
Emily Chew will receive the Proctor Medal and Anand Swaroop will receive the Friedenwald Award. NEI staff scientist Dr. Ruchi Sharma will receive the Knights Templar Eye Foundation Award for her work on developing a technique for growing retinal pigment epithelium cells from stem cells.

Six NEI-funded scientists were elected to the National Academy of Sciences. They are Dr. David Brainard from the University of Pennsylvania who studies color constancy, Dr. Jennifer Elisseeff from Johns Hopkins who studies biosynthetic corneal implants, Dr. Marla Feller from the University of California, Berkley, who studies retinal development, Dr. Duojia Pan from the University of Texas Southwestern who studies retinal development, Dr. Michael Shadlen from Columbia University who studies visual perception, and Dr. Hongkui Zeng at the Allen Institute whose work addresses connectomics, open science, and big data in vision.

Additional NEI Grantee Highlights—Dr. Chiang also highlighted the work of several other NEI-supported researchers. Dr. Maya Koronyo-Hamaoui at Cedars-Sinai studies retinal vascular tight junctions as a pathway for amyloid beta protein deposition in the retina and identified biomarkers indicating deficiencies in the blood-retinal barrier that may be useful for Alzheimer disease screening and monitoring. Krzysztof Palczewski at the University of California, Irvine, studies how stress perturbs cellular and tissue homeostasis and has identified a class of small molecules that can potentially treat stress-associated retinal diseases.

Highlights of New Developments and Innovative Research—Dr. Chiang noted that driving innovative research is one pillar of NEI’s mission statement. He highlighted recent developments in several research projects.

One effort he described is a $97 million public-private partnership called the AMP Bespoke Gene Therapy Consortium, which aims to develop standards to speed the development of gene therapies for rare diseases. Recently the effort announced that eight diseases, three of which are eye-related, have been selected for gene therapy research and clinical trials. These diseases are NPHP5 retinal degeneration (led by Dr. Tomas Aleman at the University of Pennsylvania), congenital hereditary endothelial dystrophy (led by Dr. Anthony Aldave at the University of California, Los Angeles), and retinitis pigmentosa 45 (led by Dr. Stephen Tsang at Columbia University.). Dr. Chiang acknowledged NEI staff members Dr. Santa Tumminia, Dr. Hongman Song, Dr. Mary Ann Redford, and Dr. Wei Li for their work on this project.

Another innovative research effort is a project at the intersection of neuroscience and
regeneration, launched in 2014 as the NEI Audacious Goals Initiative (AGI). This $80 million project has developed tools for visualizing the eye and optic nerve at unprecedented detail and has focused on collaboration, team science, and data sharing. NEI is planning a symposium, AGI at Age 10, that aims to define next steps for translating research into new therapies. Additionally, two upcoming workshops are planned: a workshop on the role extracellular vesicles in vision on September 14, 2023, and a workshop on visual neuroplasticity on January 10, 2024. Both workshops will be held virtually. NEI staff members leading these workshops include Drs. Tom Greenwell, Ashely Fortress, Hongman Song, Martha Flanders, and. Alicia Kerr.

Highlights of Collaborative Research—Dr. Chiang noted that another element of NEI’s
mission statement is fostering collaboration. He highlighted several collaborative projects in which NEI is involved.

One collaboration focuses on cortical visual impairment (CVI). Dr. Cheri Wiggs and Don Everett at NEI are working with colleagues at NICHD and NINDS as well as other stakeholders to organize a workshop on CVI co-chaired by Dr. Melinda Chang at the University of Southern California and Dr. Lofti Merabet at Harvard University. A key aim is to create a CVI registry to be hosted by NEI that will support research studies. Another collaborative project addresses myopia and aims to identify a research agenda to better understand its pathogenesis and rising incidence. The study committee, co-chaired by Dr. Kevin Fricks at Johns Hopkins University and Dr. Terri Young at the University of Wisconsin-Madison, will hold a public meeting on July 18, 2023.

Dr. Chiang also highlighted three collaborative data science projects. One of these is All of Us, a landmark project that aims to gather a vast trove of health data from 1 million people from diverse backgrounds over several years. Efforts to get more eye data, specifically Optical Coherence Tomography (OCT) imaging, into the data set are ongoing and include a recent workshop led by Dr. Kerry Goetz at NEI. Another collaborative data project is Bridge2AI, which aims to build data sets and which held its first annual in-person meeting on April 17, 2023. One of four funded components of the project is led by ophthalmologists Drs. Aaron Lee and Cecilia Lee at the University of Washington, with the help of NEI program officer Dr. James Gao. They will be launching a pilot study on salutogenesis and diabetes. A third data collaboration project is called AIM-AHEAD, which intends to use AI and machine learning to address health disparities by detecting bias in the medical record. Ophthalmic imaging data is easy to obtain, quick and objective, and could be used as a clear measure to help anchor observations that are subject to bias.

NEI has an active Notice of Special Interest (NOSI) on the Development of Innovative
Informatics & Data Science Technologies, Tools, and Methods for Vision Research. A NOSI
does not have set-aside funding but indicates an area of interest for the institute. Researchers can find NOSIs by searching for “current funding opportunities” on the NEI website or search for “Notice of Special Interest” in the NIH Guide. In responding to a NOSI, researchers should be
sure to enter the NOSI’s number into the Agency Routing Identifier field (box 4B) of the SF424 application form.

Dr. Chiang also called out a collaboration with the Department of Defense (DoD), which has a vision research program. NEI has worked with the DoD on this project since 2018. Dr. Tian Wang is the DoD program officer and Dr. Tony Gover is the NEI program officer for this
program. The DoD is particularly interested in eye injury or visual dysfunction related to military exposure. Over $ 4 million dollars of projects have been funded through this collaboration.
Applications are due by November 8, 2023.

Educating Stakeholders about Visual Impairment—Dr. Chiang noted that another element of NEI’s mission statement is to educate stakeholders on NEI’s activities and why they are
important. He highlighted the work of the National Eye Health Education Partnership (NEHEP) on patient communication. At the 2023 NEHEP partnership summit in April 2023, the chef, Christin Hàwho has neuromyelitis optica, presented a talk on adapting to vision loss. Dr. Chiang also noted that Texas Congressman Pete Sessions, who launched the NEI Retinal Organoid Challenge in 2017, visited the NIH in late March 2023 and held some discussions with NEI staffers. NEI is working on identifying partner organizations who engage with vision care and research on a planned campaign to increase awareness of vision loss, the impact of vision research, and steps for maintaining eye health. Dr. Chiang then asked council members to offer feedback on what key messages should be included and what audiences should be targeted for such a campaign.

Discussion
In response to Dr. Chiang’s question, Dr. Dana suggested defining the primary purpose of such messaging. He noted that most people fear vision loss and therefore agree that eye health is important but suggested more messaging around the economic impact of vision loss, which is generally associated with aging but affects many populations beyond the elderly. With the rise in obesity and type 2 diabetes, conditions broadly associated with low socioeconomic status, increased attention on the link between diabetes and vision loss is needed. Dr. Dana also suggested that descriptions of major advances to counteract vision loss in national media could help raise public awareness.

Dr. Grant noted messaging needs to go beyond social media, which some populations, such as
the elderly, do not access as much as other groups. She said that even in 2023, a large number of people with eye disease do not see an ophthalmologist until the very late stages of their disease and that more gains are needed in raising awareness of vision loss and increasing access to treatments of eye disease among economically disadvantaged people or people who otherwise have less contact with the medical system. During and after the Covid-19 pandemic, virtual medicine has become more common and in-person eye care visits have become even more challenging for some patients. Mobile services or technologies such as cell phone apps that could perform basic imaging, as well as messaging on the importance of eye health, could help, she said.

One way to target communities who are less reachable through media is through institutions such as churches or libraries, Dr. Borrás added. Providing access to coaches or other people who can convey basic information could help bring awareness to medically underserved communities.

Dr. Ramulu noted the power of stories, explaining that providing information is often less effective than conveying personal narratives in which people relate their experience with eye disease and treatment. Dr. Maguire added that stories of people expressing regret about not
seeking care for vision loss or overlooking health practices such as controlling blood sugar could be especially powerful.

Dr. Chiang noted that bringing messages around vision health into communities is squarely within the scope of NEI’s mission, and that better storytelling and messaging could help convey what NEI does and why it matters.

Recruiting the Next Generation of Vision Researchers—Dr. Chiang noted that training a diverse workforce of ophthalmologists was a core mission for NEI, but that Hispanic, Black, and Native American practitioners remain underrepresented in the field. Women and underrepresented groups also receive significantly fewer major grant awards, although their
success when they do is very similar to that of white male grantees. He added that more could be done to increase diversity in the pipeline of researchers applying for these grants. Many mechanisms exist to support diversity among young trainees, and it is important to make sure people know about these opportunities. Dr. Chiang posted two QR codes and a twitter handle that link to NEI extramural funding opportunities. He also noted additional outreach efforts including a very well attended symposium on grants at the 2023 ARVO meeting. He asked committee members to discuss how to ensure vision scientists or potential vision scientists learn about available opportunities.

Discussion
Dr. Coughlan noted that he knows he can reach out to NEI staff if he has questions about funding opportunities, but early career researchers might be intimidated to do so. He wondered whether it might be possible to create a chatbot that can help scientists narrow down the vast list of opportunities on the NIH website based on their specific goals.

Dr. Ramulu suggested reaching out directly to early career groups such as the Minority Ophthalmology Mentoring Program and giving presentations about available opportunities. Dr. Kowluru added that NEI staff could consider visiting and giving presentations about research opportunities at smaller institutions with especially high numbers of students from underrepresented groups, such as her institution, Wayne State University in Detroit, Michigan.

Dr. Dana noted that medical students often view ophthalmology as an elitist field, and therefore it is not attractive to trainees who seek specialties that will enable them to have a big impact on their communities. More work could be done to engage medical students and provide early exposure to ophthalmology to counter this myth and make clear that vision can be at the heart of primary care medicine.

Dr. Grant agreed that ophthalmology does not integrate well into other specialties and has not been adapted well to a primary care setting. It may be helpful to provide an introduction to the field early in students’ education, either in medical school or in graduate school. She also noted that NEI could consider holding additional, in-depth symposia on grant opportunities, beyond ones held at major meetings such as ARVO.

Dr. Mutti said that his profession, optometry, should do more to recruit at the undergraduate level, which is when talented students from underrepresented groups are often settling on career choices. Students often see medicine and dentistry as more attractive options, but optometry offers a lot of career satisfaction, he said, and experts in the field should actively encourage promising students from diverse backgrounds to consider it.

Another way to make the vision fields more attractive to young trainees is for NEI to increase its focus on funding research that addresses health disparities in communities that have been historically neglected, noted Dr. Ramulu.

Dr. Chiang thanked the committee for its valuable input and noted that NEI staff is working to offer a more intensive grants symposium before rather than during ARVO. He also wondered
whether imaging methods that make it possible to visualize the eye more simply could help draw more people into the field.

NAEC Budget Update —Ms. Karen Colbert, NEI Budget Officer, discussed the FY2023 and FY2024 budget outlook and explained how the debt ceiling may affect NEI funding. NEI funding falls into three major buckets: Extramural research, intramural research, and research support. Estimated spending for FY2023, which aligns with funding trends over several years, suggests that 83% of NEI’s budget will go to extramural research, 12% to intramural research, and 5% to research support. In FY2023, NEI received a 3.8% increase ($32.6 million) over the previous fiscal year – the largest percentage increase in the past 5 years.

Currently, the NEI budget office anticipates a flat budget over the next two years, but a budget cut is also possible. The FY2024 President’s Budget Request for NEI is $896.1 million, unchanged from FY2023. Congress can approve, modify, or disapprove portions of the President’s Budget Request. The House Appropriations Committee has stated its intentions of curbing the federal budget and has proposed cutting the FY2024 budget to FY2022 levels. The Senate’s proposal remains to be determined.

Ms. Colbert explained that the debt ceiling is the total amount that the US government is authorized to borrow to meet its fiscal obligations. The Fiscal Responsibility Act of 2023 suspends the nation's $31.4 trillion debt limit through January 1, 2025. As part of the Act, some supplemental appropriations received by NIH institutes in response to the Covid-19 epidemic are being rescinded and the loss of those appropriations may affect NIH funding. Based on these and other factors, it is expected that budgets will be lean for at least the next couple years.

Advancing Health Equity and Disparities Research in Vision—Dr. Monica Hooper, NIMHD; Dr. Stephen McLeod, University of California, San Francisco; Drs. Jimmy Le and Cheri Wiggs, NEI

Dr. Chiang introduced the session and its speakers, noting that it stemmed from a workshop that occurred in April 2023, organized by several NEI staff members with their counterparts at the National Institute on Minority Health and Health Disparities (NIMHD). This session is a direct follow-up to that workshop, addressing the question “Where do we go from here?”.

Vision-related Health Disparities and Diversity in the Ophthalmology and Optometry Workforce—Dr. Monica Webb Hooper

Dr. Webb Hooper, the Deputy Director of NIMHD, began by defining the concept of health disparities, noting that they are preventable, avoidable, and rooted in disadvantage. They are also modifiable. They often intersect with race, ethnicity, and socioeconomic status, as well as with gender, sexual orientation, and other characteristics. She defined social determinants of health as the structural forces in society – for example, social, economic, and legal forces – that determine opportunities such as access to high quality jobs, education, and other factors. These things in turn impact factors such as where we live, what we eat, and how we access healthcare. Social determinants of health can be positive, but adverse ones drive health disparities.

Dr. Webb Hooper defined health equity as a guiding principle and a continuing process for centering fairness, opportunity, equality, and social justice—an ongoing effort to ensure that optimal opportunities exist for everyone to attain the best possible health. Science plays a key role in efforts to build health equity because it generates the evidence needed to inform change on a societal and an individual level.

Studies have documented notable racial and ethnic disparities in vision and eye care, with African American, Black, and Latino or Hispanic people having a higher prevalence of vision impairment than white people. Socioeconomic disparities are also present. Diabetic retinopathy, the leading cause of legal blindness in adults, has a higher prevalence in Black or African American and Mexican American populations than White populations, and its prevalence is as high as 45% in American Indian and Alaskan Native people. Disparities also exist in disease severity, screening rates, and prescriptions for vision-correcting glasses and outpatient visits for ophthalmology. Several barriers might explain disparities in access to care.

Dr. Webb Hooper described NIMHD’s research framework for health disparities and measuring demographics and health determinants. She noted that most medical research has focused on individual-level biological mechanisms, but such research overlooks many complexities that help explain poor health outcomes in people from minoritized groups. Thinking more broadly and holistically, and exploring other domains, such as the physical and built environment, sociocultural environment, and health care system effects, is critical. The NIMHD centers racism and discrimination as notable factors that affect all these issues across the sociocultural environment.

Measuring the causes and effects of health disparities in a standardized way is crucial, Dr. Webb Hooper noted. NIMHD’s toolkit for doing so, called PhenX, was launched in May 2020 and has since been expanded with additional protocols aimed at standardizing data collection. It exists as a resource that NEI researchers can incorporate in their work. Overall, the vision and eye care field is still relatively early in the process of incorporating health disparities into patient care, she said. In a survey of the literature, she found most studies to be squarely in the first generation of such work – understanding what disparities exist and documenting their prevalence. A few studies have entered the second generation – investigating contributing factors and the mechanisms underlying risk. Very little work enters the third generation or fourth generation realm – developing and testing interventions and implementing them at a population level.

Discussion

Dr. Dana noted that although it is widely appreciated that racial background in the United States is misaligned with health outcomes, and that race is not a biological determinant, but a social construct, race and ethnicity data are collected in a very binary way. Yet, socioeconomic status plays a very important role in health disparities too, regardless of skin color, but collecting such data is more complex and multifaceted. He asked how researchers could do a better job collecting data on socioeconomic status, which might inform us about providing equity and opportunity regardless of race.

Dr. Webb Hooper responded that racial categories are important because they reflect how people present in the world, which in turn affects how they are treated and assessed and how they behave. Very little data is available about people who identify as multi-racial or multi-ethnic because until recently there was not the option for people to indicate multiple heritages on medical forms and assessments. NIMHD’s PhenX tool kit includes standard categories for race and ethnicity – and measuring these self-identified features continues to be important because they affect health outcomes. Indeed, one way researchers will know when health equity is assured is that these categories will no longer be associated with health disparities. Dr. Webb Hooper noted that although socioeconomic status is a more complex variable to assess, there are common ways of doing so. For example, researchers often use individual or household income, educational attainment, occupation, whether someone is above or below the poverty line, or neighborhood characteristics as indicators of socioeconomic status. Measuring these variables in a standardized way is important so that assessments can be made over time and progress can be tracked.

Dr. Borrás asked whether data collection in studies focusing on the Latino population tracks peoples’ immigration status. People who are undocumented are often afraid to fill out health forms, so there may be less information about this vulnerable group. Dr. Webb Hooper responded that most studies do not make this distinction, though some studies funded by NIMHD focus specifically on immigrant health. She noted that she is not aware of any such studies on vision or eye care, but that the institute hopes researchers will explore those nuanced distinctions to explore how legal status affects health disparities.

Dr. Maguire referred to the four generations of health disparities research that Dr. Webb Hooper described in her talk, and noted her assessment that the eye disease field is still mainly in the first generation, of documenting and describing the barriers to health care. She asked how the field could move into later stages, of exploring interventions, and asked whether other areas of medicine that are further ahead could serve as models. Dr. Webb Hooper agreed that the prospects for doing so can seem overwhelming but noted that there appears to be enough information on documented disparities to move more actively into studies exploring why such disparities exist and thinking about interventions. She pointed to a program in Baltimore and other cities focused on creating interventions in school settings, and said it was one example that could be explored in the vision and eye care space. She said that before joining NIMHD, she had studied tobacco-related disparities, which have moved into third or fourth generation research. This involves creating culturally appropriate interventions that can work on a population level, and also ones aimed at policy, such as banning menthol in cigarettes.

Dr. Chiang noted that one limitation he sees in research on disparities is that it often does not integrate different underlying causes of disparities into a holistic approach. Dr. Webb Hooper agreed, noting that an important aspect of NIMHD’s framework is to encourage researchers to move beyond their silo and instead take a more whole-person approach. She and her colleagues at the institute hope that over time, more projects will encompass multiple domains. For example, looking at how interventions targeting individual level behavior change play out at the community level, or how to effect change within the health system itself.

Vision, Health Disparities, and Health Equity at the Intersection—Dr. Stephen McLeod
Dr. McLeod, who is the Chief Executive Officer of the American Academy of Ophthalmology, described perspectives on health disparities from the care delivery community and the American Academy of Ophthalmology. A framework for health inequity that resonates with the Academy is one proposed by health equity researcher Paula Braverman at the University of California, San Francisco: “A systematic, potentially avoidable difference in health between groups of people of different relative positions, and so, hierarchies according to wealth, power and prestige.”

Dr. McLeod noted that health equity requires a continual process of examining opportunity and care delivery systems. He also discussed the role of race in health disparities, noting that it conflates three different epidemiologic features. One is that it serves as a proxy to a lot of other issues, for example, education, built environment, poverty, or insurance access. Another is that even though race is a social construct, there are some messy underlying genetic components.

Finally, there is also the issue of racism itself. Teasing out how all these issues affect health disparities in a more granular way would be helpful.

The Academy convened a task force on health disparities that culminated in a series of publications that came out last year. The goal was to examine the extant literature, examine where we are right now and try to identify knowledge gaps and to create a roadmap for moving the field forward into studies on interventions. Although disparities do exist, he said, the gap seems to be narrowing. In addition to drivers like low income, unemployment, lower education, and lack of health insurance, there were also geographic factors, with a much more elevated incidence of blindness and visual impairment in the South. Dr. McLeod also noted one study that looked at how the Affordable Care Act affected utilization of diabetic retina exams. In areas where access to care became easier through the ACA, researchers observed an initial increase in adherence to diabetic screening guidelines, but it soon tapered. The study indicated that a lot of structures must be put in place besides simply insurance access to achieve health goals.

Recognizing the gaps that exist, the Academy feels that much more extensive data will need to be gathered to better understand the risks underlying health disparities and to design appropriate interventions. The Academy aims to expand the social determinants captured in its IRIS Registry, the nation’s first comprehensive eye disease clinical registry, and other data sets will also help, including NIH’s All of Us. It turns out that ophthalmology and optometry is one of the most common ways that of people enter the healthcare system, so the vision field is actually helping to recruit a lot of All of Us participants.

Dr. McLeod ended by underscoring the Academy’s commitment to addressing health equity in vision and eye care. He noted that this will require extensive documentation of inequalities with good data, understanding the mediators of health disparities, and identifying how they can be modified. An additional critical component is educating the care delivery community about health disparities.

Discussion

Dr. Chiang noted that he appreciated Dr. McLeod’s comment on how often the optometrist or ophthalmologist is a person’s first contact with the health system.

Dr. Coughlin asked how disability and conditions such as depression and anxiety might play into health disparities. Dr. McLeod noted that this was an important point, and that data should be collected as broadly as possible. He noted that finding clinics that can provide consistent eye care for adults with disabilities such as Down Syndrome is very challenging.

Dr. Kowluru noted that access to health care and health insurance issues are big challenges that are discussed a lot, and asked how clinicians and researchers might address them. Dr. McLeod said that one of the responsibilities of the profession is to play a part in the entire continuum, from supporting science directed toward public health outcomes to serving as advocates at the state and federal level for making changes in the care delivery system.

Dr. Grant asked why the vision and eye care community, as a whole, has seemed reluctant to go into the community – in the way that mobile blood banks do. The absence of community involvement is especially surprising given that this field of healthcare targets visually impaired patients who often have trouble getting transportation. Dr. McLeod noted that outside of the pediatric population, routine screening is not well established. There are some mobile programs out there but it’s not clear how effective they are. A problem in integrating vision care into the primary care environment is that the equipment takes up a lot of room and can’t be used for anything else, so it’s expensive in terms of needed infrastructure. Also, people who get their medical care in the community – say, at federally-funded government clinics— tend to be the most vulnerable patients who are living well below the poverty line, for whom English is a second language. Very few of those clinics offer vision care. It’s crucial to understand these hurdles to do a better job of delivering care in the primary space, particularly to the most vulnerable patients.

Advancing Health Equity and Disparities Research in Vision—Drs. Jimmy Le and Cheri Wiggs

Dr. Le noted that health disparities are preventable, and that working to eliminate them is the right thing to do. In 2021, under Dr. Chiang’s leadership, NEI published its vision for the future, which for the first time outlined a strategic plan in which addressing health disparities is a core area of emphasis. NEI continues to recognize that eliminating vision loss and improving quality of life involves conducting research that probes the cause of health disparities and identifies ways to promote health equity.

Between 2018 and 2022, NEI has supported several projects that seek to document and better understand health disparities. Dr. Le described a handful of illustrative examples and noted that NEI has set out to shift its research on health disparities from documenting pervasiveness to a more inclusive, multidisciplinary approach that is centered on removing barriers and promoting equity. He also presented a Notice of Funding Opportunity to support vision research focused on promoting equity.

Dr. Wiggs then described the roots of NEI’s workshop on health disparities, noting that they set out to understand challenges in understanding vision health disparities and to learn about strategies that have been successful in integrating social determinants of health in different research areas and how such strategies could be integrated into vision research. The workshop, held in April 2023, consisted of 23 participants, addressed two main discussion topics. The first of these involved pinning down the etiology of health disparities in vision and understanding what is currently known, what new types of data need to be collected, and how to promote research collaborations that would fill in the blanks.

A key challenge that participants brought up was the real-world complexity of health disparities. There are multiple drivers of health disparities and many of them are interconnected, making it challenging to differentiate them. Participants also noted the challenge of navigating misconceptions about the subject and an overemphasis on biological research. Participants also noted that studies often use inconsistent criteria and terminology, and that certain communities were not fully described by the data. However, since vision health is a part of overall health, participants agreed that datasets and approaches from other health related realms, particularly cancer, could inform how studies relating to vision are designed.

The second main topic of the workshop discussion was examining interventions that could advance health equity. In six presentations and a discussion, the group sought insights on what types of interventions have succeeded, how to develop new ones, and what strategies could be used to successfully implement them. Here, too, a major challenge is that there are multiple levels of causes underlying health disparities, but many existing efforts have defaulted to an individual level of intervention, which does not address the real-life complexity of the problem. Another issue is that interventions are often tested without clearly defining outcome measures, so evaluating their effects is difficult. Another difficulty is that communities experiencing high levels of health disparities often lack trust in medical research, and there is an overall waning trust in public health institutions, which impacts efforts to cultivate community engagement.

Participants noted that efforts to test interventions should move beyond typical randomized controlled clinical trials and should embrace community based participatory research. Using well-defined patient-centric outcome measures, including quality of life reporting, was also deemed crucial. Adding eye health to the mainstream public health agenda may also be extremely important. Although there is a lack of strong evidence that vision screening is useful in eye health, that could be because screening quality is poor or because it so infrequently leads to follow-up care. Ensuring access to eye care – through new technologies, telemedicine or helping people navigate the healthcare system – should also be a focus.

Discussion

Dr. Dana asked Dr. McLeod whether the association is working with the American Academy of Optometry on health equity efforts. He also asked what specific fields of healthcare have been successful in identifying and addressing health disparities. Dr. McLeod confirmed an ongoing partnership with the American Academy of Optometry. He also noted that exploring best practices in other fields of medicine had been a focus of the NEI workshop. Cancer care, in particular has wrestled with these issues productively, he said, but vision and eye care has much to learn from other fields as well.

Dr. Grant spoke to a point Dr. McLeod made earlier, about the fact that the equipment needed for eye care was cumbersome and space-intensive, making it not generally cost effective for primary care practices to offer vision care. She noted that today, tools for basic eye care can be integrated into a cell phone app, and posited instead that ophthalmology is reluctant to yield control over eye care to primary care specialists. Dr. McLeod contested her point, saying that ophthalmologists would love to have the primary care community play a larger role in eye care but that doing so has been a major struggle. He noted that efforts to incorporate ophthalmology into the medical school curriculum, to include it in family practice training or making emergency room physicians more comfortable with providing eye care have faced an uphill battle. He added, though, that miniaturization of technology does provide an opportunity, and that ophthalmology as a field needs to figure out how to harness these advances in closing the eye care gap.

Dr. Gardner noted that while the discussions around health disparities in eye care seem valuable, there appeared to be a lack of achievable quantifiable objectives or discrete milestones that would indicate progress. Dr. McLeod responded that in order to see quantifiable improvements, health equity had to be a programmatic imperative. He noted that the American Academy of Ophthalmology had been working closely with Federally Qualified Health Centers (FQHC), a set of nonprofit clinics established in medically underserved areas, because an aim of the FQHC project is to identify metrics for measuring success. Establishing such tangible measures is something that the vision care community will have to do in order to come up with a roadmap of interventions that can be rolled out to large communities and demonstrate impact. Dr. Le added a point that Dr. Webb Cooper made in her talk – that health equity is not an outcome but is a continuum. He noted that simply measuring disparities risks neglecting their root causes.

Dr. Mutti said that visual screening seemed like a concrete measure, and that he was surprised by the comment that it is not considered effective. He asked why that might be. Dr. Wiggs replied that many possibilities were discussed at the workshop. One reason is that screenings are only as good as the follow-ups to them, yet getting follow-up care for vision and eye health is often extremely challenging. Dr. McLeod raised another concern - that primary care physicians are not always comfortable with conducting such screenings and so the results can be very noisy. Also, while a screening can point to a concern, it does not actually diagnose a problem. Many more steps are needed for diagnosis and treatment to occur, so making the connection between screening and a positive health outcome can be challenging.

Dr. Grant noted that in the past, the number of patients that were seen pro bono in university settings seemed much higher. She wondered whether more patients were now being turned away from pro bono care and asked whether the economics of taking care of underserved patients had changed. Dr. McLeod said that academic health centers across the country are indeed now feeling more of a squeeze and there is increasing stress in terms of providers willing to see Medicaid patients.

Concept Clearances

NEI SBIR Clinical Trial Cooperative Agreement—Dr. Paek Lee

Dr. Lee presented a concept for “NEI Small Business Innovation Research (SBIR) Clinical Trial Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk.”

The initiative aims to support early-stage, investigator-initiated clinical trials with a risk level greater than the magnitude of harm or discomfort that people ordinarily encounter in the course of daily life or routine physical or psychological tests. Currently NEI only accepts applications for minimal risk clinical trials under SBIR and STTR (Small Business Technology Transfer) funding opportunities. Trials with greater than minimal risk are supported by U01 and UG1 cooperative agreement mechanisms. But those funding opportunities are not designed to support expedited and commercialization-oriented trials.

This initiative will fill that gap by supporting 2-3 year trials that investigate the safety and/or efficacy of screening, diagnostic, preventative or therapeutic interventions. It is intended for early-stage trials with strong preliminary or preclinical data. Examples include invasive ocular implants, invasive surgical or diagnostic instruments, or early-stage therapeutic drugs, biologics, or devices.

Discussion

Dr. Grant asked Dr. Lee to define the size of the company. He says the eligibility requirements state the company must have 500 employees or fewer.

Dr. Maguire appreciated the spirit of the proposal of expediting and moving things along quickly and she expressed hope that this attitude could be moved to the non-SBIR side of the aisle as well.

A motion to approve this concept for potential development was made, seconded, and approved unanimously.

Stimulating Access to Research in Residency (StARR)—Dr. Neeraj Agrawal

Dr. Agrawal said the StARR program is an existing funding opportunity from the Heart, Lung and Blood Institute – RFA-HL-23-006. He explained that this is not technically a concept clearance because NEI is requesting council approval to join this funding announcement.

StARR is an institutional research training program for residents, analogous to the NEI K12 program. The funding program is used by several other institutes. It supports institutional, mentor training programs that engage residents in research. It provides salary support and expenses for 1 to 2 years of research for resident-investigators. The overall aim is to increase the numbers of trained clinician scientists engaged in vision research and to promote their career development.

This funding opportunity aims to solicit applications from institutions to provide outstanding and immersive mentored research opportunities for ophthalmology residents who wish to conduct research, and to foster institutions’ ability to transition resident-investigators to individual career development research awards.

This funding opportunity provides support for a variety of supplemental research and professional development activities, including technical support, participation in short-term courses or workshops on research skills, training on oral and written research communication, and travel to scientific conferences and NIH-sponsored workshops.

The program has been very successful for the current participating institutes. Since ophthalmology is a smaller field, NEI expects to support two residents per year and anticipates that about 10 institutions will apply.

Discussion

Dr. Dana said the opportunity sounded very interesting, but many details remain to be worked out. He confirmed that the current K12 program supports 2-4 residents per year per institution. More than 95% of ophthalmology residents say they want to be physician scientists, but not more than half actually go on to do research. This mechanism could permit applicants to claim how interested they are. He noted though, that because it is a small field, some years there might not be any participants in the program.

Dr. Grant asked whether the research could occur during a gap year or two between residency and fellowship. Dr. Agrawal said that this will occur during residency.

Dr. Mutti asked Dr. Agrawal to confirm whether the program would also open to optometry residents, and Dr. Agrawal confirmed that it would.

Dr. Ramulu asked what the vision for the clinical training would be. Dr. Agrawal said it would be up to the program and the candidate.

Dr. Gardner said this program would be a fantastic bridge to allow people to start their research training. He made a plea for the execution to be as flexible as possible. Dr. Agrawal agreed.

Dr. Grant noted that it would be great for people coming into ophthalmology research after finishing their residency training in other fields. Dr. Agrawal said that this would be open to any medical residency who wanted to engage in vision research.

Dr. Maguire asked whether the applicant programs would be required to have an educational component in place, offering courses and workshops for career development. Dr. Agrawal said that institutions would have to show this component in their application.

Dr. Anderson noted that this training was to allow people who may have never been in a lab to gain that experience. She noted that council members suggested that NEI should consider allowing residents to do this program before or after their clinical training, and not just during their residency. She also noted that council members suggested that NEI consider opening the program to residents in other fields interested in conducting vision-related clinical research.

A motion to approve that NEI participate in this funding opportunity was made, seconded, and approved unanimously.

General Discussion

Dr. Maguire asked whether Notices of Special Interest (NOSIs) are given any special
consideration in any study sections. Dr. Anderson replied that because NOSIs are not RFAs, they are reviewed in study sections and reviewers are not given any special instructions for evaluating them. If prospective grantees include a NOSI’s number on the grant application, NEI program staff can flag those grants and give them priority.

Dr. Dana wanted to return to the topic of stem cell and regenerative therapies. He reminded the council that the first successful allotransplant was a cornea as a restorative transplant. Also, the first successful stem cell application clinically, anywhere in any tissue was also ocular, in 1988. The first topical biologic for regeneration was also ocular – recombinant NGF for the cornea and ocular surface. A therapy approved in March 2023 in Japan is the first allogenic cell therapy to treat corneal endothelial disease. He noted that it is important to consider that there is more to regenerative therapy in the eye than retinal ganglion cells. New delivery mechanisms, as well as therapies that restore the microenvironment, are also important areas to explore. He noted that currently there is inadequate attention to these areas of regenerative therapy, and industry has picked up on that.

Dr. Chiang responded that NEI agrees that cellular therapy is not limited to the retina. He noted that NEI also has an anterior segment initiative and consortia looking at neural pathways at the ocular surface. He underscored the importance of the microenvironment, and the immune response to the success of regenerative therapies.

Dr. Kowluru asked about the collaboration between NEI and DoD. Dr. Chiang noted that the entry point to these grants is through DoD. Dr. Gover said that the funding mechanism is not reciprocal – that NEI is allowed to pick up grants submitted through this collaboration, but if a grant comes in through NEI there is no mechanism for the DoD to pick it up.

Dr. Grant asked about opportunities for mid-career and senior investigators to do career development – for example, acquiring training on new techniques that could expand an investigator’s career in a new direction. Dr. Agrawal replied that NEI used to participate in the K24 program, which enables such training, but does not anymore. Dr. Anderson said that in the past, institutions had more mid-career mentored awards, but institutions have moved away from this because they want to devote more resources to early career investigators.

Dr. Ramulu said that it was interesting to hear Dr. Chiang lay out NEI’s accomplishments and that many of them (say, traumatic brain injury) do not have to do with eyes. He asked Dr. Chiang whether the NEI is doing a good enough job messaging the idea that it is not just an eye institute but actually a vision institute. Dr Chiang noted that “eye institutes” often get siloed, but that scientists thrive when they work within the larger milieu of science and medicine. He agreed that it was important to make this message clear and asked committee members for their advice on how to do so.

Dr. Grant raised the topic of grant projects and an idea Dr. Chiang mentioned, of potentially enhancing team science by bringing together a team of researchers around a disease rather than having them each working under disparate grants. Dr. Chiang noted that he did not have specific research mechanisms in mind but believed that overall, the vision science community will thrive if researchers build connections between related topics linked by a common goal.

Dr. Anderson adjourned the open session meeting at 2:30pm.

CLOSED SESSION

This portion of the meeting was closed to the public in accordance with the determination that
this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as
amended (5, USC Appendix 2). Members absented themselves from the meeting during
discussion of and voting on applications from their own institutions or other applications in
which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS
NAEC members considered 539 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $185,144,084 (direct costs year 01). The
Council also considered 306 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $228,975,536 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 845
applications.

ADJOURNMENT
The 165th meeting of the National Advisory Eye Council was adjourned at 4:30 p.m. on June 16, 2023.

CLOSED SESSION ATTENDEES

Council Members Present:
Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary (in-person)
Dr. Terete Borrás (in-person)
Dr. James Coughlan (in-person)
Dr. Reza Dana (in-person)

Dr. Thomas Gardner (in-person)
Dr. Maria B. Grant (in-person)
Dr. Renu Kowluru (in-person)
Dr. Maureen Maguire (in-person)
Dr. Donald Mutti (in-person)
Dr. Pradeep Ramulu (in-person)

NIH Staff Members Present:

Dr. Neeraj Agarwal (in-person)
Lisa Applewhite (in-person)
Dr. Houmam Araj (virtual))
Dr. Sangeeta Bhargava (in-person)
Nathan Brown (in-person)
Donald Everett (in-person)
Dr. Martha Flanders (virtual)
Dr. Ashley Fortress (virtual)
Dr. James Gao (virtual)
Dr. Shefa Gordon (in-person)
Dr. Tony Gover (in-person)
Lateefah Hill (in-person)
Dr. Brian Hoshaw (in-person)
Dr. Alicia Kerr (virtual)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (in-person)
Dr. Ellen Liberman (in-person)
Dr. George McKie (in-person)
Dr. Lisa Neuhold (in-person)
Dr. Mary Ann Redford (virtual)
Dr. David Schneeweis (in-person)
Dr. Jennifer Schiltz (in-person)
Dr. Grace Shen (in-person)
Karen Robinson Smith (virtual)
Dr. Hongman Song (virtual)
Dr. Afia Sultana (virtual)
Dr. Santa Tumminia (in-person)
Dr. Cheri Wiggs (in-person)

CERTIFICATION
These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 164th meeting at 9:00 a.m. on Friday, February 3, 2023. The hybrid meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended either virtually or in-person. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 9:00 a.m. until 2:00 p.m. The meeting was closed to the public from 2:15 p.m. until 4:00 p.m. for the review of grant and cooperative agreement applications.

Council Members Present:
Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary (in-person)
Dr. Terete Borrás (in-person)
Dr. James Coughlan (in-person)
Dr. Reza Dana (virtual)
Dr. Katia Del Rio-Tsonis (in-person)
Dr. Thomas Gardner (in-person)
Dr. Mary Elizabeth Hartnett (in-person)
Dr. Renu Kowluru (in-person)
Ms. Janice Lehrer-Stein (in-person)
Dr. Maureen Maguire (in-person)
Dr. Victor Quinones Perez (in-person)
Dr. Benjamin Teller (in-person)

NIH Staff Members Present:
Mr. Shawn Adolphus (virtual)
Dr. Neeraj Agarwal (in-person)
Ms. Lisa Applewhite (virtual)
Dr. Houmam Araj (in-person)
Dr. Sangeeta Bhargava (in-person)
Ms. Holly Blake (virtual)
Mr. Nathan Brown (in-person)
Ms. Shon Carroll (virtual)
Ms. Monique Clark (virtual)
Mr. Jay Colbert (virtual)
Ms. Karen Colbert (virtual)
Ms. Claudia Costabile (virtual)
Dr. Mary Frances Cotch (virtual)
Dr. Kevin Czaplinski (virtual)
Mr. Don Everett (in-person)
Ms. Devina Fan (virtual)
Dr. Martha Flanders (virtual)
Dr. Ashley Fortress (virtual)
Dr. James Gao (virtual)
Ms. Alexandra Gavrilovic (virtual)
Dr. Nataliya Gordiyenko (virtual)
Dr. Shefa Gordon (in-person)
Dr. Tony Gover (in-person)
Dr. Tom Greenwell (virtual)
Ms. Himide Hardy-Pointer (virtual)
Mr. Dustin Hays (virtual)
Ms. Lateefah Hill (in-person)
Dr. Brian Hoshaw (in-person)
Dr. Jeanette Hosseini (virtual)
Ms. Stephanie Kennedy (virtual)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (virtual)
Dr. Ellen Liberman (in-person)
Ms. Renee Livshin (virtual)
Dr. George McKie (in-person)
Ms. Archana Mohale (virtual)
Dr. Lisa Neuhold (in-person)
Ms. Jill Payne (virtual)
Mr. Michael Phan (in-person)
Ms. Melanie Reagan (virtual)
Ms. Amber Reed (virtual)
Ms. Carissa Reilly-Weedon (virtual)
Dr. David Schneeweis (in-person)
Dr. Jennifer Schiltz (virtual)
Dr. Grace Shen (in-person)
Ms. Rugie Sillah (virtual)
Ms. Karen Smith (virtual)
Dr. Hongman Song (virtual)
Dr. Cibu Thomas (virtual)
Dr. Santa Tumminia (in-person)
Ms. Leslie West-Bushby (virtual)
Dr. Cheri Wiggs (in-person)
Dr. Charles Wright (virtual)
Ms. Maria Zacharias (in-person)

Others Present Virtually:
Dr. Anne Coleman (in-person), Guest Speaker
Dr. Douglas Rhee (in-person), Guest Speaker

NOTE: Due to the open videocast format of this meeting, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.

Welcome and Introductions
—Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang called the 164th NAEC meeting to order and thanked the organizers for enduring the challenges of producing a hybrid event. He then welcomed guest speakers, Drs. Douglas Rhee and Anne Coleman to the meeting. Dr. Rhee, a glaucoma specialist, is professor and chair of ophthalmology and visual sciences at Case Western University School of Medicine, and the current president of the American Society of Cataract and Refractive Surgery. Dr. Coleman is a glaucoma specialist and epidemiologist working at the interface of ophthalmology and population health, and the director of the Stein Eye Institute at the University of California, Los Angeles.

Dr. Chiang also welcomed two new Council members, Ms. Janice Lehrer-Stein and Dr. Victor Perez Quinones. Ms. Lehrer-Stein is a retired attorney and disability rights activist who serves on the Board of Trustees of the American Foundation for the Blind, and the Foundation Fighting Blindness. Dr. Perez Quinones is a professor of ophthalmology at Duke University and an expert on ocular immunology; he also works to introduce students from disadvantaged backgrounds to science and medicine.

All Council members briefly introduced themselves.

Council Operating Procedures
—Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA)

Dr. Anderson welcomed NEI staff, members of the NEI research and advocacy community, and staff from the NIH Center for Scientific Review, and then made some logistical announcements regarding the coordination of the hybrid meeting.

She noted that future NAEC meetings are listed on the open agenda and on the NEI website. The next NAEC meeting will be held on June 16, and the October 2024 NAEC meeting has been rescheduled to October 11 due to a conflict.

Minutes of the October 2022 NAEC meeting were made available in the Electronic Council Book (ECB) prior to the meeting. A motion to accept the October meeting was made, seconded, and approved unanimously.

Each year in January, the Committee is asked to review the NEI Advisory Council Operating Procedures. The updated procedures were posted in the ECB for review and no substantive changes were made. A motion to accept the 2023 Operating Procedures was made, seconded, and approved unanimously.

NEI Director's Report
—Dr. Michael Chiang

Dr. Chiang discussed efforts to get information about NEI opportunities onto social media and made note of two relevant X handles — @NEIDirector and @NatEyeInstitute. He once again officially welcomed Ms. Lehrer-Stein and Dr. Perez Quinones to the Council. Dr. Chiang also outlined procedures for accessible meeting practices. He noted that one current member of the Council has a visual disability, making adherence to these practices especially relevant, but that accessible meeting practices make meetings clearer for all attendees, regardless of their disability status.

Dr. Chiang commented on the challenge of disseminating NEI’s activities to the community. NEI currently communicates information, such as vision community news and grant opportunities, via social media platforms, including X and Instagram. He encouraged attendees to follow all NEI’s social media accounts.

NAEC Updates – Appreciation— Dr. Chiang gave nods of appreciation to three retiring Council members who were attending their last Council meeting: Drs. Katia Del Rio-Tsonis, Mary E. Hartnett, and Benjamin Teller. Dr. Chiang recalled how the three members were serving on Council when he first began as the Director of NEI, and he has greatly appreciated their efforts to serve during the difficult times of the Covid-19 pandemic.

NEI Staff Updates— Ms. Melanie Reagan has been appointed Deputy Director for Management and Executive Officer after serving as Acting Deputy Director for Management for the past 1.5 years. Dr. Rich Krauzlis was recently appointed Chief of the NEI Laboratory of Sensorimotor Research after serving as the Acting Chief of the laboratory for two years. Dr. Benjamin Solomon has been named Acting NEI Clinical Director. Dr. Maryann Redford recently retired from her position as Program Officer with the Collaborative Clinical Research group. She oversaw many grants in the clinical research area and will be working part time as a contractor while her replacement is recruited. Dr. Hongman Song was recently promoted from Program Analyst to Program Officer. She manages a portfolio largely related to glaucoma.

Active NEI Leadership Searches—Searches continue for a Scientific Director and a Clinical Director. The Scientific Director search is nearing its conclusion, and an announcement about the position is imminent.

NIH Leadership Updates —Dr. Hugh Auchincloss has been appointed Acting Director of the National Institute of Allergy and Infectious Disease after Dr. Anthony Fauci’s retirement last year. Dr. Nina Schor has been appointed NIH Deputy Director of Intramural Research, overseeing intramural programs at all NIH Institutes. Dr. Monica Bertagnolli has been appointed Director of the National Cancer Institute. Dr. Joni Rutter has been named Director of the National Center for Advancing Translational Sciences. Dr. Roger Glass recently retired as Director of the Fogarty International Center, and Dr. Peter Kilmarx is currently serving as Acting Director. Dr. John Gallin is retiring in March 2023 from his position as Associate Director for Clinical Research and Chief Scientific Officer at the NIH Clinical Center.

National Academy of Sciences Awardees—Dr. Chiang congratulated two NEI grantees who received National Academy of Sciences Awards. Dr. Hongkui Zeng, director of the Allen Institute for Brain Science, received the 2023 Pradel Research Award for mid-career researchers for her work on connectomics and open science. Dr. Tim Buschman from Princeton University received the 2023 Troland Research Award, for investigators age 45 or younger, for his work on neuronal mechanisms of cognitive control, attention, and working memory.

Additional NEI Grantee Highlights—Dr. Chiang also highlighted the work of several other NEI-supported researchers. Dr. Vaithilingaraja Arumagaswami from UCLA conducted studies on the Zika virus, highlighting a pathway with virus-fighting effects. His most recent work identifies the role of the same pathway in SARS-CoV-2 infection and shows that targeting this pathway with verteporfin blocks the replication of SARS-CoV-2. Dr. Kapil Bharti, a researcher in the NEI intramural program, and Dr. Marc Ferrer, head of the National Center for Advancing Translational Sciences 3¬-D Tissue Bioprinting Laboratory, developed 3-D bio-printed eye tissue models of disease. They created the models by combining three choroidal cell types into a hydrogel and printing the tissue onto a biodegradable scaffold. This could potentially be a model for studying disease pathogenesis.

Two organoid projects were also mentioned by Dr. Chiang. The first project, led by Dr. David Gamm at the University of Wisconsin, grew retinal organoids and found they formed connections with other retinal cell types. The second organoid project, led by Dr. Duygu Kuzum at the University of California, San Diego implanted human organoids into mouse brain and found that the implanted tissue reacted to visual stimuli and formed active connections with neurons in the native tissue.

Dr. Chiang highlighted a funding announcement, Engineering Next Generation Human Nervous System Microphysiological Systems, that supports research efforts to create human cells derived from microphysiological systems such as organoids or tissue chips. The aim is for these systems to represent organ function and replicate complex central nervous system diseases. The program, which will be active for the next three years, uses the R21 mechanism that supports high-risk, high-reward projects. Applications do not require preliminary data.

The BRAIN Initiative —New Fiscal Year 2022 (FY22) awards for this program totaled $315 million. Of that funding, 18 % went to vision research and 26 % went to NEI grantees conducting non-vision research. That means 44% of BRAIN initiative funding in FY22 was either directly or indirectly related to the NEI portfolio, underscoring that vision research is a big part of neuroscience research overall.

Anterior Segment Initiative —NEI recently funded a consortium of eight multidisciplinary projects investigating the neural circuitry of the anterior segment and its role in ocular pain and dry eye. NEI has committed more than $50 million to this five-year initiative.

Implementation Research —At the October 2022 NAEC meeting, Drs. Rinad Beidas and Jennifer Sun discussed various aspects of dissemination and implementation of research findings related to vision research. In follow-up to that session and council discussion, NEI signed on to a funding opportunity, Dissemination and Implementation Research in Health, and seeks applications on strategies to promote implementation of evidence-based interventions and practices in preventing and managing vision-related conditions. The program, which will be active for the next few years, includes topics such as telehealth and artificial intelligence, as well as social determinants of health and community-based research.

Discussion
Dr. Chiang asked Council members to offer advice on evidence-based clinical interventions and practices that might be ideal for implementation research projects.

Dr. Maguire said that successful treatment strategies for eye diseases exist, but large segments of the population do not take advantage of them. She advised it would be worthwhile to compare different approaches for how to get more people into treatment and care.

Dr. Harnett noted that many public health interventions have value, such as exercise and diet, but people may have barriers in their everyday lives to implementing those interventions. Understanding those barriers may lead to a path for implementing good health practices.

Dr. Kowluru noted that this topic relates to health disparities.

Next Generation of Vision Researchers —Dr. Chiang described a new funding opportunity called the Trailblazer Award for New and Early-Stage Investigators which supports research projects that integrate engineering and physical sciences with life and/or biomedical sciences. NEI, The National Institute of Aging, and the National Institute of Biomedical Imaging and Bioengineering participate in this funding opportunity.

Discussion
Council members then discussed how NEI can better promote funding opportunities to new and early-career investigators, as well as how NEI might broaden outreach about such opportunities to researchers in other fields.

Dr. Del Rio-Tsonis suggested promoting workshops sponsored by NEI and inviting engineers and experts in optics. Dr. Borrás seconded this idea, noting that the Glaucoma Foundation has held highly productive workshops to which organizers invited speakers who were completely outside the field. Dr. Kowluru proposed including some non-vision-related research at large vision conferences such as ARVO.

Dr. Perez Quinones suggested proactively identifying engineering or physical sciences meetings where vision researchers could present work and network. Dr. Dana seconded that idea, noting that some of the best investigators work outside the fields of vision and ophthalmology. Scientific meetings such as Keystone Symposia or Gordon Research Conferences are excellent venues for early-stage investigators to engage with experts in different fields and explore new technologies and disciplines. Dr. Dana noted that many junior faculty or postdocs could benefit from attending such conferences but are stymied by a dearth of funding. He suggested launching an NEI program that supports young investigators’ attendance at non-NEI sponsored and perhaps even non-NIH-sponsored conferences to seed such interactions. He also suggested that NEI work with conferences such as Keystone or Gordon Research Conferences to have a small sliver of their programs dedicated to vision.

Dr. Maguire endorsed these ideas and additionally proposed sending out information to leaders of core grants supported by NEI or to institutions with large vision research communities. This outreach could include a list of available funding mechanisms and could show examples of exciting projects that synergize research across scientific disciplines. Dr. Hartnett added that many universities have grant writing centers and mentorship networks that help with grant writing and that outreach to these groups could help spread the word.

Dr. Chiang asked whether NEI could create a crash course in vision science for researchers with expertise in different methodologies, suggesting that such a course could entice scientists to the field. Dr. Hartnett noted that the Ryan Institute for Macular Research often brings in speakers who describe new techniques. Dr. Del Rio-Tsonis added that NEI could use the platform of the nonprofit Prevent Blindness America to reach out to other fields.

ACD Working Group on Diversity —The first Subgroup on Individuals with Disabilities Report found that although 27 % of US adults have a disability and that people with a disability are profoundly underrepresented in the biomedical and behavioral research workforce, and even more so among recipients of NIH funding. The report also identified nine recommendations for building disability inclusion and dismantling ableism within the NIH. The full report was made available to council members prior to the meeting.

Discussion
Council members then discussed what NEI should be doing to address ableism. Ms. Lehrer-Stein noted that current diversity, equity, and inclusion efforts have so far made only minimal gains on disabilities – less than 4% of all DEI organized inquiries included disabilities as one of the diversity factors. She praised NIH’s efforts but noted that elevating data collection on people with disabilities to the top of the list of recommendations is crucial for achieving equity. She also called on NEI specifically – which is composed of scientists who seek treatments and cures for visual diseases that cause disability – to be the standard bearer in terms of understanding that diversity must include people with disabilities. Publicizing NIH’s efforts to academic institutions could offer an opportunity to collaborate and create some open-source resources on disabilities.

Dr. Coughlan encouraged NEI to do more to highlight and promote the diversity supplement program. To date, only a tiny percentage of funding through the supplement goes to people with disabilities. He noted that the program is a powerful recruiting tool that is underappreciated. When asked for advice on getting more researchers interested in research on tools to help people with disabilities navigate the world, Dr. Coughlan noted that just 15 years ago the field was obscure, but that is no longer the case. Today, younger people are expecting accessibility in circumstances and settings where they never used to, which makes it easier to promote this type of research. There are no easy answers, he said, but scientists should have the patience to look far and wide when hiring.

Office of Data Science and Health Informatics Update —The All of Us project at NIH aims to recruit 1 million participants from diverse backgrounds and characterize them both longitudinally and deeply across many data types. Currently, the project is capturing very little ocular data, but access to retinal imaging, especially if linked with electronic health record data, could greatly expand the breadth of studies this dataset could enable. Even despite the relative lack of ocular data in All of Us, Dr. Chiang noted that the first study to be published from the dataset was led by an ophthalmologist. NEI and All of Us are discussing a proposal to place retinal cameras and Ocular Coherence Tomography imaging devices in some regional centers with the goal of recruiting approximately 50,000 people and capturing retinal images longitudinally. A workshop planned by NEI, All of Us, and NIBIB to discuss this proposal and explore the scientific opportunities presented by the inclusion of ocular data is scheduled for April 20, 2023.

Public Health and Disparities Research —Vision health equity is a major priority for NEI. For example, Covid tests are not accessible for people with low vision. NEI staff members Drs. Sangeeta Bhargava and Cheri Wiggs worked with NIBIB’sRADx program to develop a set of best practices for accessible design of in vitro diagnostics. Additionally, NEI and the National Institute of Minority Health and Disparities are organizing a workshop on vision health equity, scheduled for April 11, 2023. The aim is to identify areas of research to reduce health disparities in vision research and care.

NAEC Budget Update —Ms. Karen Colbert, NEI Budget Officer, first outlined the three main phases of the federal budget process, explaining that over the decades its timing has become quite unpredictable. After the release of the President’s budget in February, Congress begins work to develop and report budget estimates, complete budget resolutions, consider annual appropriations bills, complete reconciliation, and pass appropriations. The goal is to complete the process before the start of the new fiscal year on October 1. While this is a normal process, Ms. Colbert noted that Congress has only provided NIH with a budget prior to October 1 once in the last two decades.
In the FY 2023 budget, NEI received a funding increase of 3.8 % above the FY 2022 appropriation ($896,549,000). In 2022 the increase for NEI was 3.4 % above FY21 appropriation ($863,918,000), and in 2021 it was 1.4 % above the FY 2020 appropriation ($835,714,000). In the FY 2023 budget, NIH received an overall funding increase of 5.6 % ($47.5 billion), with the difference due to funds targeted by Congress to specific programs at NIH. Alzheimer’s disease and cancer research continued to receive the most significant increases from Congress. The FY 2024 budget process is delayed, with the release of the President’s budget not expected before March 2023. Ms. Colbert noted that the House Appropriations Committee has expressed interest in curbing spending and passing conservative appropriations bills. She also noted that it is unclear what this will mean for NIH and NEI budgets.
Opportunities to Advance Basic and Clinical Research on the Lens —Dr. Houmam Araj, Program Officer, Lens and Cataract Program, NEI, Dr. Douglas Rhee, Case Western University School of Medicine, and Dr. Anne Coleman, University of California, Los Angeles

Dr. Chiang introduced this session by noting that although the Lens and Cataract Program is one of the smallest at NEI, for eye doctors it is a bread-and-butter issue, with most people likely to experience a cataract or refractive problem at some point in their lives. This session therefore aimed to explore the possibility of growing this portfolio and defining what focus a potential expansion should take.

Lens and Cataract Program – Consilience —Dr. Houmam Araj
Dr. Araj opened his talk by asserting that a barrier exists between basic science and patient care, and that consilience is needed to overcome it. The divide between basic research and clinical care is especially evident in the eye, which is a highly complex structure. Indeed, this complexity led Darwin’s wife Emma to question whether the existence of the eye could be explained by her husband’s slightly wacky theory of natural selection.

Indeed, Dr Araj said, the eye is both extremely simple and inordinately complex. The lens is one of its simpler components, consisting of just two cell types and lacking nerves, blood vessels and even nuclei in most cells. Yet cataracts, which form in the lens, have left some 20 million people around the world blind, and millions of surgeries to correct cataracts are performed each year at considerable public cost. Cataracts have a high public health significance – as does another condition, called presbyopia, caused by a hardening of the lens.

NEI has a long-standing program for lens and cataract research, and most supported projects involve basic research to address lens development, homeostatic dysregulation, and oxidative damage, with the goal of developing clinical applications. In 2015, two high-profile studies emerged showing that metabolite molecules called oxysterols could reverse cataracts in vivo. The studies were heralded as opening a path to a new future for treating cataracts. The research community got excited, especially because the proposed mechanism was biologically plausible.

Yet shortly thereafter, at least two negative reports were published, casting doubt on oxysterol’s cataract-melting potential. And after that, four other papers supported positive effects, though in slightly different models, furthering confusion in the field. These contradictory reports are a significant barrier in moving from research to clinical application – and the contradictions are evident in many more scenarios, such as whether oxidative damage can cause cataracts or other conditions. Many other examples can be found in the “phytochemical zoo” of different molecules, each with different efficacies and many discrepant findings.

Dr. Araj affirmed that such fragmentation of research is preventing the progression of basic research to clinical applications but noted that it also offers an opportunity. He called on the concept of “consilience” as defined by the evolutionary biologist Edward O. Wilson in his 1998 book of the same name. The term postulates a process of “linking together of knowledge from different disciplines to create a common groundwork of explanation.” This is very different from hypothesis-driven research. Instead, it enables people to apply enhanced rigor and observation to different models to resolve these differences and break down silos in different applications, thereby producing a unity of knowledge. Dr Araj concluded his presentation by stating “recent work has pointed to the possibility of individualized chemotherapy for treating congenital cataracts – but clearly, consilience is needed in that area of research too – as cataracts continue to be the menace they have long been.”

Discussion
Dr. Borrás noted that the first scientific director of NEI built the strongest lens program that NEI ever had. Dr. Del Rio-Tsonis said the themes of the presentation demonstrate that it is worth increasing the NEI program for intramural and extramural research.

Dr. Dana noted that Council members appreciate the burden of cataracts, but the issue that many physicians have about lens disease is that there is a cure – the relatively simple procedure of cataract surgery. The cost of the procedure has dropped significantly over the years. The question is not only a scientific one but also a socioeconomic one. Dr. Dana explained that even if there was a “magic drug” that could stop the progression of lens disease, the cost would have to be much less than the existing cost of cataract surgery. In contrast, degenerative disease has a much different economic calculus and impact.

Bridging Basic and Clinical Research — Dr. Douglas Rhee
Dr. Rhee began his talk by noting that cataract surgery is one of the most successful and safest procedures in medicine and is considered one of the most impactful innovations in modern history. But cataract treatment still has some unmet clinical needs. These include reducing complications of surgery, addressing access and health care disparities, and enhancing sustainability. One area where these three factors overlap is reducing infection, or endophthalmitis.

In addition to economic sustainability, environmental sustainability is also a major issue in medicine. In 2013, the US health care sector was responsible for about 10% of greenhouse gas emission in the US. Cataract surgery is the most common surgery performed in the US – 4.2 million were performed here in 2019 – and the procedure generates a significant amount of waste. According to a study done in England, the majority of greenhouse gasses – 53.8% – produced by cataract surgery come from procurement (i.e., disposables), which include unused medication that by law must be disposed of, as well as single use disposables such as tubing and instruments. For each cataract surgery, $148 in medication is disposed of which, when multiplied by 4.2 million surgeries, is $620 million in wasted medications annually.

The US spends $6.8 billion annually - 12% of Medicare’s budget – on cataract surgery. Much of that money is spent on single use medication and disposables in an effort to reduce infection, but this practice is not evidence-based, Dr. Rhee said. For example, a recent study in a premier hospital in India that turned to single use practices during the Covid-19 pandemic found no difference in endophthalmitis rates after making the change.

Dr. Rhee then turned to health disparities, noting that they are driven by insufficient insurance coverage, healthcare staffing shortages, stigma and bias within the medical community, transportation and work-related barriers, and patient language barriers. The first and the fourth of these are key barriers, and there are differences in cataract blindness between Americans of different races and ethnicities, as well as between those in rural versus urban settings. Cost is one of the top barriers to care.

Dr. Rhee then returned to the question of reducing endophthalmitis. In a retrospective registry study of 2 million surgeries between 2011 and 2018, the introduction of intracameral moxifloxacin reduced the incidence of endophthalmitis from about 0.7 to 0.2%. Another study found the endophthalmitis rate to be about 0.4%. The cost of treating endophthalmitis, and the consequences for patients who did not recover fully from it, are significant.

In the US, use of intracameral moxifloxacin is extremely low, even though 15 years of research suggests it is beneficial. In surveys, 80% of clinicians said they do not use it because there are no commercially available products, and they are concerned about liability and safety issues stemming from compounded products used off-label. In a 2014 survey, 84% of clinicians said they would use moxifloxacin if it were available. Yet roughly 48% of clinicians are not convinced of its need because there is no positive scientific study to point to. That figure means the field is well-positioned for equipoise if such a study could be conducted.

Dr. Rhee stated that studies comparing single-use versus multi-use pharmaceuticals and equipment before and after surgery could decrease the cost of cataract surgery and equalize health care disparities. A prospective randomized controlled trial would provide support for the use of moxifloxacin in preventing endophthalmitis. Dr. Rhee and colleagues have designed such a study, called TIME, but dauntingly, it would require 74,000 patients. That means the scope and cost of the project have been prohibitive for a single institution or company to complete. The group therefore collaborated with the Cooperative Studies Program at the H. John Heinz III Department of Veterans Affairs Medical center in Pittsburgh to design such a study. That study did not pass final review, because at the time there was no pharmaceutical partner, and the cost burden was deemed too high. Both of those concerns have now been resolved.

Dr. Rhee concluded that despite the efficacy of cataract surgery, there remains a significant unmet need to address access to the surgery, health disparities, sustainability, and reduce endophthalmitis. NEI can partner with key stakeholders to address that need.

Discussion
Dr. Hartnett asked what is required to change the recommendations if a trial were to show intracameral moxifloxacin to be superior. Dr. Rhee replied that once the evidence exists, it is matter of engaging regulatory agencies and updating educational standards.

Dr. Perez Quinones asked how liability, a major issue in the US, might affect prospects for conducting surgeries with muti-use instruments and medication. Dr. Rhee responded that determination of liability generally rests on whether or not a clinician followed the standard of care. Demonstrating that the multi-use approach is safe would support its use as a standard of care.

Dr. Dana followed up on the issue of industry involvement, explaining that commonly performed procedures are what is called “bundled payments,” where the calculated cost, paid for by Medicare or other insurance carriers, includes everything required for the surgery. That bundle means that the margins companies can make are limited. Therefore, a study would have to show a significant advantage to their hypothesis, in terms of lower complication rates and cost implications, to motivate a change. The large study Dr. Rhee described may be helpful in moving the needle if it can create a new standard of care.

Dr Chiang noted that the discussion highlights the importance of thinking about this work within a broader societal context that considers factors such as sustainability.

Population Health and Cataracts – Dr. Anne Coleman
Dr. Coleman opened her talk by noting that cataracts are the most common cause of age-related vision loss and more than half of all Americans older than 80 are living with cataracts. The prevalence of cataracts ranges anywhere from 2.8% to 27.1% in population-based studies. Cataract surgery is highly effective, but policies often limit surgery to one eye, despite the fact that intervening in both eyes has major benefits on quality-of-life measures and safety concerns such as falls and car crashes. Although cataract burden is often described as an issue in the developing world, it is also very much present in the US, she said.

According to population-based studies conducted in the early 1990s, cataract prevalence in the Black population was 15.9 per 1000, compared to 9.1 per 1000 in the White population. Similarly, Black participants were 4 times more likely to have cortical cataracts than White participants, and White participants were 2.8 times more likely to have had cataract surgery than Black participants. Similar levels of disparity continue today, according to more recent population-based studies. Disparities are also found in the Latino population, among Chinese Americans, and based on income. Dr. Coleman noted, however, that population-based studies are costly and pose logistical challenges, and that they may not capture everyone in an intended population (for example, the housing-insecure which are present in all communities).

Comparing data from National Health and Nutrition Examination Survey (NHANES) across time also reveals that racial disparities in access to cataract surgery continued over time. Dr. Coleman highlighted the opportunity for NEI to synergize research on disparities with NHANES, which has a robust infrastructure for sampling and exams. The study also surveys social determinants of health and oversamples medically underserved populations. It offers the potential for new discoveries as well as validating findings in a nationally representative sample.

NIH’s All of Us study, intended to be one of the most diverse health databases in history, also includes data that can fill some scientific gaps. One drawback of this data set is that it is a “convenience sample,” including only those who volunteer for it. Electronic health records, which are now beginning to capture social determinants of health (albeit inconsistently), offer another data source. One challenge with electronic medical records data is that many different diagnostic codes are used, often inconsistently, to indicate cataracts. Reliability of coding and possible selection bias are also potential issues.

A relatively new tool for epidemiological studies on cataracts is a smartphone-based application with an ophthalmic camera system. A study of residents in a skilled nursing facility in San Francisco conducted such mobile screening for cataracts and found cataracts in 51% of participants. Teleophthalmology is also a potentially powerful approach that clinicians and researchers have become more comfortable with during the pandemic. A study in rural Nepal combined these two approaches, using a mobile device camera and remote image interpretation by an ophthalmologist. Using teleophthalmology improved diagnosis and referral, suggesting the approach is feasible and scalable. For example, it is being used in Cameroon, where there are only 3.6 ophthalmologists per one million people.

Cataract surgery shows the same types of social and economic disparities that cataracts do, with lower surgery rates observed among Black and Latino populations, low-income rural residents, and those with lower educational attainment. Additionally, travel distance can decrease likelihood of getting cataract surgery, pointing to barriers in the rural community. Complex cataract surgery showed its own set of disparities, being more likely in Black, Asian, and Hispanic participants compared to non-Hispanic White people; in men compared to women; and in people older than 84 compared to those age 65-69.

Many factors interact to drive health disparities. Dr Coleman explained that researchers in epidemiology and public health are starting to use an approach called a conceptual model, which can take into account and control for a variety of interacting factors. Studying racial and ethnic disparities at an epidemiological level can be challenging because although racial and ethnic disparities certainly exist, race and ethnicity are not changeable factors, so it is not clear how to address these disparities unless we solve the bigger problem of racism in this country. A causal mediation analysis allows researchers to identify downstream mediators that are responsible for part of the exposure effect and to home in on modifiable targets, such as socioeconomic disparities.

In terms of interventions, Dr. Coleman said, clinical trials are not a silver bullet. Randomized clinical trials can be prohibitively expensive, unethical, and/or take too long. And you cannot randomize patients to not receive cataract surgery to determine the surgery’s effect on falls or dementia risk. A new type of trial, called Target Trial Emulation, allows researchers to use observational data and the study design principles of randomized trials to estimate an intervention’s causal effect while avoiding biases. Another important epidemiological approach is called Lifecourse Epidemiology, which allows researchers to follow how environmental exposures at different periods in the lifespan can affect the development of cataracts.

Whether epidemiologists use traditional or newer methods to study health disparities relating to cataracts, Dr. Coleman cautioned, capturing hidden populations is a major challenge. Hidden populations consist of people who do not come into contact with the health care system—for example, people facing housing instability and seasonal or migrant farm workers. Yet these individuals potentially have an especially high burden and an increased risk of cataracts, for example due to exposure to ultraviolet radiation or ambient air pollution. Improving access to care is thus crucial for addressing disparities.

Discussion
Dr. Kowluru commented that environmental factors and radiation increase the incidence of cataracts but can also create epigenetic changes, so these factors leave a legacy for future generations. Dr. Coleman responded that this makes efforts to increase access to care especially important. She also noted that insurance reimbursements for cataract surgery are decreasing, but that an important question for policy makers is whether reimbursements have gotten too low. Clinicians are often incentivized to utilize fancy techniques over more routine but effective ones because such procedures offer higher reimbursements. Yet these newer techniques are failing to stem the rising burden of cataracts in the US, she said, even while most people do not realize the US has a cataract burden at all.

Dr. Hartnett, who is a pediatric retina specialist, asked about disparities in access to treatments for eye diseases in children and infants. Dr. Coleman responded that California, where Dr. Hartnett practices, has special insurance for children that families can access. She noted, however, that some families may not know about this resource and that knowledge of such resources is often fragmented, with segments of the population who need assistance often unfamiliar with resources that are available to them.

Kicking off a more open discussion, Dr. Chiang noted that cataracts fall on a spectrum of severity and asked whether a quantitative test exists to determine whether a person’s cataract is severe enough to require intervention. Dr. Coleman explained that previously, clinicians used a classification system in which a specially designed reader assessed lens photographs to grade a given cataracts. Today, the classification has become much more subjective to the clinician, which affects how the condition is recorded in electronic medical records. Dr. Rhee agreed that the lack of standardization definition is problematic.

Dr. Dana added that Dr. Leo Chylack at Brigham and Women’s Hospital, now retired, developed a grading system called LOCS that was previously widely used for cataract research. He also said he was surprised that the total cost of cataract surgeries to the US medical system was only $6.8 billion. Yet the cost of glaucoma treatment surpasses $15 billion and more than $12 billion for anti-VGEF therapy. He further noted that cataracts occur much more widely in the population. The lower amount spent on cataracts reflects society’s failure to comprehensively address cataracts and indicates that extending services is a public health issue. Yet nonsurgical approaches being developed for cataracts will have to fit today’s pharmacoeconomic model, in which the cost of the therapy justifies its commercial development.

Dr. Del Rio-Tsonis noted that most available data on prevalence and disparities relies on information from people with Medicare or private insurance and asked how Dr. Coleman and her colleagues reach out to people outside that population. Dr. Coleman said that for the rural community, a master’s student on her team, whose mother is a migrant farm worker, is building ties with community groups in Bakersfield, California, that support this population. Through this contact, public health experts have been able to work with these groups to conduct screenings. Community engagement is equally crucial in engaging with housing insecure communities, she added. Population based studies are often based on census tracts, which provides a strong denominator, but that approach does not work with hidden populations, she said. For example, it is unknown how many migrant farm workers there are, and many are undocumented. For these groups public health researchers must use statistical assumptions and methods to estimate the denominator.

Dr. Teller asked how far in development are nonsurgical interventions for cataracts, such as the eye drops described in Dr. Araj’s presentation. That is impossible to predict, Dr. Araj said, due to the wide spectrum of reports in the literature. Dr. Araj added that this spectrum indicates a dire need for experts working in this and other areas to come together and build cohesion and consilience into their research programs.

Dr. Chiang closed the discussion by noting that the talks highlighted many opportunities for collaboration – for example, with the National Institute of Environmental Health Sciences, where researchers are working on understanding the exposome. He then thanked all the speakers for their interest in this topic and for participating in this session.

Concept Clearances

Translational Research Program —Dr. Tony Glover
Dr. Grover described a concept for an NEI translational research program for therapeutics, which would utilize the phased R61/R33 mechanism. The program’s goal is to provide a funding mechanism to advance the development of biological, pharmaceutical, medical device, and/or combination therapies for any disease or disorder of the visual system. The R61 phase would support exploratory research on specific products backed by preliminary data, but not advanced enough for clinical trials – for example, optimization of lead compounds or refinement of device design. Projects that meet R61 milestones will be eligible to transition to the R33 phase which would focus on research that would support submission of an Investigational New Drug or an Investigational Device Exemption application to the US Food and Drug Administration.

This program would complement existing translational research programs, such as the NEI Small Business Research Program and several NIH Blueprint programs which NEI participates in, including the Blueprint MedTech program, the Blueprint Neurotherapeutics Network for biologic drug discovery and the Blueprint Neurotherapeutics Network for small molecule drug discovery. This funding opportunity would advance the development of devices and/or therapies specifically for vision related diseases.

Discussion
Dr. Kowluru said she is very enthusiastic about these programs but raised the concern that the amount of preliminary data required excludes young scientists who may have new ideas. Dr. Gover responded that other mechanisms, such as the R21 and R01, are open to new investigators, but for this funding the institute is targeting more mature research to de-risk the development of new interventions.

Dr. Perez Quinones asked whether this funding mechanism applies to new assays and how NEI would handle new intellectual property. Dr. Gover said any projects related to product and lead optimization would be eligible and explained that as with all other funding mechanisms the intellectual property stays with the sponsor.

Dr. Dana expressed enthusiasm for the program but asked for details on how study sections would be composed, noting that basic scientists often are not qualified to assess translational research. He also requested more clarification about how this program relates to the more classic existing small business initiatives. Dr. Grover said the review of applications will be conducted by the NEI review branch and that NEI will be able to recruit appropriate external regulatory experts, clinicians, and scientists for the review. He also said that there are several options for continuing development of products supported through this program. Investigators can either apply for funding to conduct clinical trials, or they can seek support from venture capital or established pharmaceutical or device companies.

In response to a question from Dr. Borrás, Dr. Gover said that scientists do not already have to have intellectual property rights to apply to the program.

Dr. Anderson called a vote on the concept, and the motion to approve it passed unanimously.

Renewal of the NEI Institutional Mentored Physician Scientist Award— Dr. Neeraj Agarwal
Dr. Agrawal presented a concept to renew the NEI K12 Institutional Mentored Physician Scientist program. The goal of this program is to encourage institutions to provide opportunities for clinicians to pursue training in vision research. The award must complement but be distinct from other research training programs at the institution. It also enables scholars to propose a separate ancillary study to an existing trial or to gain research experience in a clinical study led by another investigator. NEI currently supports K12 programs at 10 different institutions Across these institutions, a high percentage of awardees are successful in competing for subsequent independent research grants.

Discussion
Dr. Borrás noted that she has long worked with K12 awardees and appreciates the program. She asked what percentage of K12 grantees eventually receive an R01 grant. Dr. Agrawal replied that most of the data he presented today reflects subsequent success of trainees in receiving K08 and K23 grants. He estimated that about 50-55% of those awardees are successful in competing for an R21 or R01 grant.

Dr. Gardner strongly endorsed the program, noting that it provides a unique opportunity for young physicians who may have developed an interest in research late in their clinical training. He added that this program complements K08 and K23 awards and is the seeding ground for subsequent R01s.

Dr. Dana noted that at Harvard, K12 funding has transformed careers and has had a strong impact on the Department of Ophthalmology. He noted that funding for the program has contracted somewhat, funding fewer students for fewer years.

Dr. Perez Quinones also praised the program, while noting that Dr. Agrawal’s data suggested that some universities are more successful than others in the percentage of young researchers who convert to independent funding. Dr. Agrawal replied that he believes K12 programs at all 10 institutions have been successful. Dr. Gardner noted that Dr. Agrawal has greatly contributed to the K12 mechanism’s success through his work with principal investigators and the scholars themselves.

Dr. Borrás added that the program helps not only the clinician-awardees, but also the PhD investigators with whom they work and who benefit from having a clinical expert on the team.

Dr. Anderson called a vote on the concept, and the motion to approve it passed unanimously.

Retiring Council Member Remarks

Dr. Anderson extended her thanks to Drs. Teller, Hartnett, and Del Rio-Tsonis for their work on Council and encouraged them to offer some remarks about their experience.

Dr. Del Rio-Tsonis said that it has been an honor to participate in the Council’s work. She noted that she sees the Council as being in the middle of a transformation, spurred by broader changes happening at NEI. She commended the Council – along with ongoing efforts at NEI – for embracing diversity and inclusion, both in terms of the Council’s composition and the initiatives it has championed. She expressed hope that those efforts continue. Dr. Del Rio-Tsonis said she had especially appreciated the opportunity to participate in NEI’s strategic planning process. In that work, she appreciated the creation of the Office of Regenerative Medicine. She noted that she was sad to see that Office go and expressed hope that its termination was temporary.

Dr. Hartnett said she had been happy to be invited to serve on the Council because she saw it as an opportunity to participate in a group charged with communicating the importance of science and advising NEI on the pursuit of its mission. Ultimately, she said, her Council position turned out to be a much more enriching experience than she had expected, and she was grateful for the leadership and collegiality of her colleagues. She added that she has especially learned a lot about the extramural and intramural program through interactions with program officers. She expressed the hope that NEI will continue to support not only emerging areas of science powered by big data, but also investigator-initiated science.

Dr. Teller said he has learned a great deal during his tenure on the Council and is looking forward to spreading that knowledge. He recalled that when he was initially invited to participate, he was hardly aware of the Council’s existence. Although he was concerned about keeping up with his clinical practice while serving on the council, he said, he is very glad he stuck with it. In response to a request for suggestions from Dr. Anderson, he proposed assigning new Council members a mentor.

Dr. Anderson adjourned the open session at 2:00 pm.

CLOSED SESSION

This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., and Section 1009(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. §§ 1001-1014). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS
NAEC members considered 540 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $200,645,906 (direct costs year 01). The Council also considered 266 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $259,117,086 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 806 applications.

ADJOURNMENT
The 164th meeting of the National Advisory Eye Council was adjourned at 4:05 p.m. on February 3, 2023.

CLOSED SESSION ATTENDEES

Council Members Present:

Dr. Michael F. Chiang, Chair (in-person)
Dr. Kathleen Anderson, Executive Secretary (in-person)
Dr. Terete Borrás (in-person)
Dr. James Coughlan (in-person)
Dr. Reza Dana (virtual)
Dr. Katia Del Rio-Tsonis (in-person)
Dr. Thomas Gardner (in-person)
Dr. Mary Elizabeth Hartnett (in-person)
Dr. Renu Kowluru (in-person)
Ms. Janice Lehrer-Stein (in-person)
Dr. Maureen Maguire (in-person)
Dr. Victor Quinones Perez (in-person)
Dr. Benjamin Teller (in-person)

NIH Staff Members Present:

Dr. Neeraj Agarwal (in-person)
Dr. Houmam Araj (in-person)
Dr. Sangeeta Bhargava (in-person)
Mr. Nathan Brown (in-person)

Mr. Donald Everett (in-person)
Dr. Martha Flanders (virtual)
Dr. Ashley Fortress (virtual)
Dr. James Gao (virtual)
Ms. Alexandra Gavrilovic (virtual)
Dr. Nataliya Gordiyenko (virtual)
Dr. Shefa Gordon (in-person)
Dr. Tony Gover (in-person)
Dr. Tom Greenwell (virtual)
Ms. Lateefah Hill (in-person)
Dr. Brian Hoshaw (in-person)
Dr. Jeanette Hosseini (virtual)
Dr. Alicia Kerr (virtual)
Dr. Jimmy Le (in-person)
Dr. Paek Lee (virtual)
Dr. Ellen Liberman (in-person)
Ms. Renee Livshin (virtual)
Dr. Kristine Mackin (virtual)
Dr. Barbara Mallon (virtual)
Dr. George Mckie (in-person)
Dr. Lisa Neuhold (in-person)
Mr. Michael Phan (in-person)
Dr. Jennifer Schiltz (virtual)
Dr. Grace Shen (in-person)
Ms. Karen Smith (virtual)
Dr. Hongman Song (virtual)
Dr. Cibu Thomas (virtual)
Dr. Santa Tumminia (in-person)
Dr. Afia Sultana (virtual)
Dr. Cheri Wiggs (in-person)
Dr. Charles Wright (virtual)

CERTIFICATION
These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 163rd meeting at 10:00 a.m. on Friday, October 14, 2022. The entire meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended virtually. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 10:00 a.m. until 2:30 p.m. The meeting was closed to the public from 2:30 p.m. until 4:00 p.m. for the review of grant and cooperative agreement applications.

Council Members Present:
Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Terete Borrás
Dr. James Coughlan
Dr. Reza Dana
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Maureen Maguire
Dr. Benjamin Teller

Ad-Hoc Members Present:
Ms. Janni Lehrer-Stein
Dr. Victor Perez-Quinones

NIH Staff Members Present:
Mr. Shawn Adolphus
Dr. Neeraj Agarwal
Ms. Lisa Applewhite
Dr. Houmam Araj
Dr. Sangeeta Bhargava
Ms. Stephanie Blackford
Mr. Nathan Brown
Ms. Alysia Champagne
Dr. Emily Chew
Mr. Jay Colbert
Ms. Karen Colbert
Dr. Mary Frances Cotch
Dr. Kevin Czaplinski
Ms. Ashley Dash
Ms. Joy Jackson Farrar
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Dr. Mohita Gaur
Ms. Alexandra Gavrilovic
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Jimmy Le
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Renee Livshin
Dr. George McKie
Dr. Sheldon Miller
Dr. Lisa Neuhold
Ms. Jill Payne
Ms. Melanie Reagan
Dr. Maryann Redford
Ms. Carissa Reilly-Weedon
Dr. Jennifer Schiltz
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Afia Sultana
Ms. Sharon Taylor
Dr. Santa Tumminia
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Dr. Charles Wright
Ms. Maria Zacharias

Others Present Virtually:
Dr. Rinad Beidas, Guest Speaker
Dr. Fernanda Ruiz, Science Writer
Dr. Jennifer K. Sun, Guest Speaker

NOTE: Due to the open videocast format of this meeting, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.

Welcome and Introductions
—Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang called the 163rd NAEC meeting to order and welcomed Council members, members of the NEI research and advocacy community, NEI and NIH staff, and guest speakers. Council members introduced themselves and gave a brief overview of their research areas. Dr. Chiang introduced and welcomed two new Council members Ms. Janni Lehrer-Stein and Dr. Victor Perez-Quinones. Ms. Lehrer-Stein is a retired attorney, disability rights activist, and advocate who has worked with the National Council on Disability and served as policy advisor for presidential, gubernatorial, and state election campaigns. Dr. Perez-Quinones is a Professor of Ophthalmology at Duke University with expertise in ocular inflammation, graft vs host disease, and clinical trials.

Council Procedures and Related Matters
—Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA)

Dr. Anderson reviewed Council procedures and etiquette for the Zoom meeting and Council conflict of interest and confidentiality rules. The open session of the meeting was videocast and will be available on the NIH videocast website.

Dates for future Council meetings are listed on the NEI website. The next NAEC meeting will be hybrid, virtual and held in person, in Bethesda, Maryland on February 3, 2023. Due to a conflict, the meeting planned for October 13, 2023, will be rescheduled.

Minutes of the June and August 2022 NAEC meetings were provided in the Electronic Council Book prior to the meeting. A motion to accept the minutes was made, seconded, and approved unanimously by Council members. The approved minutes will be posted on the NEI website.

Director's Report
—Dr. Michael Chiang

Dr. Chiang commented on the challenge of disseminating NEI’s activities to the community. NEI currently communicates information, such as vision community news and grant opportunities, via social media platforms, including X and Instagram. He encouraged attendees to follow all NEI’s social media accounts.

NEI Staff Updates— Dr. Michael Steinmetz, Director of the NEI Division of Extramural Science Programs (DESP) passed away in July 2022. Dr. Steinmetz joined NEI in 2007 and was involved in several efforts, including the Audacious Goals Initiative (AGI), and played a role in bringing NEI into the NIH Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative. During his 15-year NEI career, Dr. Steinmetz’s influence expanded well beyond the Institute. His legacy made a difference in vision and neuroscience programs throughout the National Institutes of Health.

Dr. Kathleen Anderson, Director of the NEI DEA, will also serve as Acting Director of DESP until a replacement is found. Dr. Sangeeta Bhargava will serve as Acting Deputy Director of DESP. Monique Clark, Grants Specialist, was promoted to Team Lead in the NEI Grants Management Branch.

NIH and NEI Leadership—In December 2022, Dr. Anthony S. Fauci will be stepping down as Director of the National Institute of Allergy and Infectious Diseases (NIAID), Chief of the NIAID Laboratory of Immunoregulation, and Chief Medical Advisor to President Biden. The search for the NEI Clinical Director is in progress and follow-up interviews for the NEI Scientific Director are underway. The search for the NEI Executive Officer/Deputy Director for Management is in the final stages and an announcement will be made soon.

NEI Intramural Research Program—The first U.S. patient received autologous stem cell therapy (biodegradable patch) to treat dry age-related macular degeneration as part of a phase I/IIa clinical trial. The NEI Ocular and Stem Cell Translational Research Section developed the patch by converting the patient’s blood cells to induced pluripotent stem cells (iPSCs), programmed the iPSCs to retinal pigment epithelium (RPE) cells, and grew them as a monolayer on the patch. This effort was the culmination of 15 years of research and development.

Regenerative Medicine—Dr. Chiang congratulated the three teams who developed different physiologically competent retinal organoid systems and won the final phase of the 3D Retinal Organoid Challenge (3-D ROC). The winners included Drs. Maria Valeria Canto-Soler (University of Colorado Anschultz Medical Campus), Maria Natalia Vergara (University of Colorado Anschultz Medical Campus), and Wei Liu (Einstein College of Medicine, New York City).

AGI Transplant Immunology Workshop—The AGI Transplant Immunology Workshop was held on July 29, 2022. The purpose of the workshop was to delineate the state of science, define gaps in knowledge, and articulate barriers and opportunities in transplant immunology that may advance retinal and eye transplantation. Dr. Chiang thanked Drs. Kia Washington and Victor Perez Quinones for co-chairing the workshop and expressed excitement for the new initiatives that will emerge.

Neuroscience, Immunology, and Regenerative Medicine Initiatives— Projects in the Ocular Surface Innervation from Cell Types to Circuit Functions Initiative aim to delineate ocular surface innervation from corneal sensation to pain circuits and tearing reflexes. Eight cooperative agreements were awarded. The consortium kickoff meeting is scheduled for October 28, 2022.

A Community Research Resource: Characterization of the Resident Ocular Microbiome is a funding opportunity that aims to develop a community-based resource of microbial data associated with the resident ocular microbiome of healthy individuals. Applications will be reviewed in November and presented to the NEI Council at the February 2023 meeting.

The AMD Integrative Biology Initiative: Discovery of AMD Pathobiology using Patient-Derived Induced Pluripotent Stem Cell (iPSC)-derived Retinal Pigment Epithelium (RPE) was established to determine if patient-derived iPSCs can be used to discover the underlying pathophysiology of age-related macular degeneration (AMD). Four cooperative agreement awards were made.

Neuroscience: Cerebral Visual Impairment—Through the strategic planning process, NEI has become interested in cerebral visual impairment (CVI), which is now the leading cause of untreatable childhood blindness in the U.S. and is associated with prematurity, perinatal brain damage, and oxygen deprivation. NEI recognizes the need for better understanding of the neural basis, as well as tools and guidelines for diagnosis, classification, and management, of this condition. It is important to gain a better understanding of the rehabilitation needs of brain-based versus ocular impairment. This effort will require an interdisciplinary approach that includes neuroscience and structural and functional imaging experts, educators, ophthalmologists, optometrists, and occupational/physical therapists.

Dr. Chiang shared that he and others at NEI attended two meetings with the CVI community in summer 2022. He announced at the meetings that NEI will build a CVI registry to allow researchers to track and better understand conditions, develop treatments, and facilitate recruitment to studies of new treatments and rehabilitation strategies. NEI is working with the CVI community to determine the data points that will be most helpful.

Genes, Environment, Epidemiology: Myopia—Implementation groups established within NEI have identified myopia as an area of interest due to its increasing prevalence. About 33–40 percent of American adults suffer from this condition. It is estimated that by 2050 about 4.8 billion people in the world will suffer from myopia. The ongoing research (genetics, animal models, epidemiology) is limited by self-reporting of clinical and environmental data, which are difficult to quantify. The National Academies of Sciences, Engineering, and Medicine is launching an NEI-sponsored consensus study of myopia with broad basic science to health disparities objectives that will address epidemic drivers of the rapid increase in myopia prevalence. Dr. Cheri Wiggs and Mr. Donald Everett are participating in this effort. A large public meeting is planned for 2023.

Public Health and Disparities Research—To address the difficulty of COVID test use for people with visual impairment, NEI is collaborating with the NIH Rapid Acceleration of Diagnostics (RADx®) initiative on plans to make COVID tests more accessible to people with vision loss. The White House launched an initiative via the Administration for Community Living (ACL) on increasing the accessibility of COVID tests. Dr. Chiang highlighted the fact that NEI aims to develop a larger footprint in health equity relating to eye and vision care and is in early-phase discussions with the National Institute on Minority Health and Health Disparities (NIMHD) on planning a workshop that will focus on approaches to address health disparities in vision care involving unoperated cataracts and uncorrected refractive error as well as scientific approaches toward understanding the underlying basis for health disparities in vision care.

Data Science—On May 10, 2022, NEI, the U.S. Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC) hosted a Joint Workshop on Promoting Adoption of Ocular Imaging Standards to identify barriers and approaches to widespread adoption of standards for interoperability. As follow-up to this meeting, the American Academy of Ophthalmology and the Association for Research in Vision and Ophthalmology (ARVO) published an editorial endorsing this effort. Ms. Kerry Goetz at the Office of Data Science and Health Informatics (ODSHI) and her group are working with a planning committee on follow-up steps.

Dr. Michelle Hribar, NIH Data and Technology Advancement (DATA) Scholar was hired to develop a common data model for eye care and vision research in collaboration with the Observational Health Data Sciences and Informatics Program.

The White House’s Office of Science and Technology Policy (OSTP) has published a public access memo about access to federally funded research that applies to all federal agencies. This memo states that all publications resulting from federally funded research are to be made freely and publicly accessible in repositories without embargo and the scientific data should be made accessible upon publication. OSTP and NIH are working to ensure that policies are consistent. Further announcements on this topic will be made in the future.

Bridge to AI: OT2 Data Generation Projects—Dr. Chiang provided an overview of the Data Generation Projects for the NIH Bridge to Artificial Intelligence (Bridge2AI) program (OT2). This is an NIH Common Fund project that aims to accelerate use of AI in biomedical and behavioral research. One goal is to generate flagship diverse datasets about human health that can be used by scientists across domains of medicine. This effort integrates an ethics component to reduce bias. This is a collaborative effort which involves the National Center for Complementary and Integrative Health (NCCIH), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Library of Medicine (NLM), and National Human Genome Research Institute (NHGRI). Four awards were given for data generation projects and three awards were given for a Bridge Center to conduct integration and evaluation activities.

One of the data generation projects that received an award is the Multimodal Atlas of Disease of Artificial Intelligence: Generating Datasets for Pseudotime Mainfolds of Health Trajectories (MAD-AI) project from the University of Washington. Led by Drs. Cecilia Lee and Aaron Lee, this study will collect data from a diverse population (4,000 participants) with varying stages of type 2 diabetes to understand chronic disease progression and recovery. The study aims to harness AI’s power to learn to recognize disease from great volumes of data and generate an AI-friendly hypothesis-agnostic dataset.

Eye on the Future Video Contest—In an effort to increase the interest of underrepresented minority (URM) high school students in science, Ms. Devina Fan and Ms. Maria Zacharias organized the Eye on the Future Video Contest. NEI received over forty submissions and ten high-school teen contest winners visited the NIH campus for a tour and was able to meet performing the duties of the Director of NIH, Dr. Lawrence Tabak and Chief Officer for Scientific Workforce Diversity, Dr. Marie Bernard. Dr. Chiang expressed excitement at organizing this event again in 2023.

Dr. Hartnett asked how will the Eye on the Future Video Contest be advertised in the future to reach interested students. Dr. Chiang confirmed that NEI will aggressively promote the contest throughout social media, meetings, and websites.

NAEC Budget Update—Ms. Karen Colbert, NEI Budget Officer, reported on the estimated spending for Fiscal Year (FY) 2022 and outlined the NIH and NEI budgets for FY 2023. Estimated NEI spending for FY 2022 is as follows: extramural research (including all grant activities and research and development contracts), 83 percent; intramural research, 12 percent; and research support, 5 percent. These funding levels are typical and have remained consistent over time.

Currently in FY 2023, NEI is operating under a Continuing Resolution (CR) effective through December 16, 2022. More information about the FY 2023 budget will be available once the mid-term elections conclude in November 2022. There is no expectation of continuing to operate under the CR for the full year however, once the current CR expires, it is likely that short-term CRs will be put in place as Congress completes the budget process. It is expected that Congress will provide an omnibus bill to fund NEI through FY 2023.

Ms. Colbert presented a comparison of NEI funding levels for FY 2021 through FY 2023. The President’s Budget request ($853,355,000) for FY 2023 is significantly lower than the House ($891,186,000) and Senate ($890,700,000) proposed FY 2023 levels. The House and Senate have proposed 3 percent increases for NEI. The President’s Budget is a planning document and does not establish appropriation. The FY 2024 President’s Budget request also is being developed without having a current appropriation in place.

The House has proposed a $2.5 billion increase for NIH excluding the Advanced Research Projects Agency for Health (ARPA-H), whereas the Senate has proposed a $2 billion increase for NIH including ARPA-H at same level as FY 2022 ($1 billion). The Senate bill also includes a minimum 3.1 percent increase for most NIH Institutes and Centers with targeted increases for priorities such as pain/opioids, health disparities, and environmental health.

Dr. Teller asked if NIH has lobbyists working on behalf of NIH to request more funds. Dr. Gordon responded that federal employees are not allowed to lobby, but various groups lobby on behalf of NIH, including the Ad Hoc Group for Medical Research, which lobbies on behalf of all NIH Institutes. The National Alliance for Eye and Vision Research and the Alliance for Eye and Vision Research (NAEVR/AEVR) educate Congress members on NEI efforts and lobby for additional NEI funding.

PROMOTING IMPLEMENTATION AND DISSEMINATION OF CLINICAL RESEARCH
—Dr. Rinad Beidas, Chair, and Ralph Seal Paffenbarger, Professor of Medical Social Sciences, Feinberg School of Medicine at Northwestern University and Dr. Jennifer Sun, Associate Professor, Harvard Department of Ophthalmology

Dr. Chiang noted the implementation and dissemination of clinical research is a great challenge. He reminded Council members that during the last NAEC Council meeting, a question emerged about the gap in dissemination of clinical research. In response to this challenge, NEI Council workgroups will be formed. To kick off this effort, NEI invited special guests Drs. Rinad Beidas and Jennifer K. Sun.

Harnessing Implementation Science to Transform Health and Healthcare — Dr. Beidas is an investigator who conducts implementation science and behavioral economics research and helps organizations use best practices to improve clinical care quality and equity of care and health outcomes.

Dr. Beidas described how her identity as a Middle Eastern immigrant, mother, and community member influenced her perspective on implementation science and how she uses it to advocate for and amplify the needs of communities in pursuit of achieving population health and social justice. Implementation science in conjunction with behavioral economics has given her better insights to help staff, clinicians, leaders, and organizations use best practices with the end goal of improving the quality and equity of care and enhancing health outcomes.

She first became interested in implementation science after finding that young people were not receiving evidence-based practices in the community. This issue reflected a broader field-wide issue, and she believes implementation science can allow the community to move the needle, achieve the promise of scientific discovery, and transform health and healthcare equitably. She encouraged attendees to consider how this discipline might advance NEI’s mission to eliminate vision loss and improve quality of life through vision research.

Dr. Beidas defined implementation science as making sure all people obtain the procedures, approaches, and interventions that work best in their community while ensuring health equity. NIH defines it as the study of methods to promote the adoption and integration of evidence-based practices, interventions, and policies into routine healthcare and public health settings to improve population health. The assumptions and foci of implementation science include conducting the work in partnership with communities, considering clinician behavior within organizational constraints, understanding context and how it relates to success or failure, implementing an evidence-based “thing,” and using specific frameworks, methods, and strategies. It is helpful to distinguish between the evidence-based “thing” that is being deployed and the strategies that are used to deploy it.

The implementation science subway is a heuristic tool developed by Dr. Meghan Lane-Fall and collaborators to help investigators integrate implementation studies. Investigators identify the practice of interest (POI) they would like to implement and determine whether the POI has shown efficacy and effectiveness. In this process, investigators identify which types of studies must be done (e.g., efficacy research, effectiveness studies, mixed-methods studies, design implementation strategies, testing of implementation strategies).

Dr. Beidas provided an overview of the foundational concepts of implementation science by describing various crucial components of implementation science grant proposals, including conceptual models, implementation strategies (i.e., interventions), and measurement and analysis.

urrent implementation science conceptual models were described based on the theoretical approaches used in an implementation science framework developed by Nilsen et al. (2015). This framework places theoretical approaches into three categories: approaches describing and/or guiding the process of translating research into practice (i.e., process models), approaches for understanding and/or explaining what influences implementation outcomes (e.g., determinant frameworks, classic theories, implementation theories), and approaches for evaluation of implementation (e.g., evaluation frameworks). Dr. Beidas related intervention and implementation strategies to outcomes using the framework defined in Proctor et al. (2009). Intervention strategies (evidence-based practice) are different than implementation strategies (e.g., organizational strategies, group/learning strategies). Outcomes include implementation outcomes (e.g., feasibility, acceptability, health equity), process outcomes (efficiency, safety, effectiveness), and health outcomes (e.g., function, symptoms, quality of life). Implementation outcomes are usually the focus of implementation trials.

The Expert Recommendations for Implementing Change (ERIC) project compiled more than 73 discrete implementation strategies, which are the “how” of implementation and can be placed in the following categories: planning (e.g., assessing context before implementation), education (e.g., training), restructuring (e.g., creating new teams), quality management (e.g., audit and feedback), finance (e.g., altering incentives), and policy (e.g., changing liability laws). There are multiple approaches (e.g., concept mapping) to selecting implementation strategies, and they require conducting a needs assessment, consolidating inputs into a working logic model that guides strategy selection, and specifying theory of change and operationalizing strategies. Dr. Beidas noted that prioritizing equity in testing implementation strategies is critical and is achievable by testing the differential effectiveness of implementation strategies in minoritized and marginalized populations, adding additional strategies, and understanding partner perspectives on approaches.

Dr. Beidas reiterated that implementation and health outcomes are distinct and encouraged attendees to look at equity across implementation outcomes and conduct post hoc analysis to identify new inequities that may emerge during the implementation process. Qualitative and mixed methods are foundational and offer nuance and depth in the characterization of implementation outcomes.

One example of Dr. Beidas’ studies is the Adolescent and child Suicide Prevention and Routine clinical Encounters (ASPIRE) trial. The ASPIRE trial focused on understanding quantitatively the current use of an evidence-based firearm safety practice, S.A.F.E Firearm (POI), and attitudes of clinicians and leaders in two large health systems toward this program (mixed-methods study). Dr. Beidas and her group conducted implementation mapping to design implementation strategies and currently are conducting a hybrid/effectiveness implementation trial to ask whether the less costly and scalable electronic health record (EHR)-based “nudge” is powerful enough to change clinician behavior or whether more intensive and expensive facilitation is needed to overcome implementation barriers.

Dr. Beidas described applications of implementation science in NEI-funded work. One example is the Implementation of Teleophthalmology in Rural Health Systems Study (I-TRUST) by Dr. Liu (University of Wisconsin) in which the POI is teleophthalmology for diabetic retinopathy. Mixed-methods studies were done to study barriers to implementation of teleophthalmology, and implementation strategies (Implementation for Sustained Impact in Teleophthalmology [I-SITE]) were designed. Currently, an implementation trial is underway to assess the effectiveness of I-SITE vs usual care teleophthalmology for increasing diabetic eye screening rates among eight rural health systems across five states; understand key factors and core implementation components that distinguish high- and low-use rural health systems affect I-SITE implementation; and determine implementation costs.

Other emerging opportunities in vision research and implementation science include using the intersection of data science, AI, and registries to better ascertain implementation outcomes and identify care gaps; leveraging practice-based research networks such as the Diabetic Retinopathy Clinical Research (DRCR) Retina Network; partnering with implementation scientists to produce meaningful team science from bench to bedside; and prioritizing hybrid trials and reporting strategies used earlier on in clinical research.

Dr. Beidas said she is hopeful that the information she shared will generate ideas about how this discipline might advance the mission of NEI to eliminate vision loss and improve quality of life through vision research.

Discussion
Dr. Maguire asked if there were basic implementation strategies, that could be applied universally across different medical disciplines, for disseminating and adopting information. Dr. Beidas responded that a universal playbook for implementation doesn’t exist but the process she presented consisting of identifying barriers and facilitators, designing strategies, and deploying those implementation strategies is a ubiquitous process across content areas. She advised prioritizing individual-level strategies and using principles from behavioral science or behavioral economics to restructure the environment and to easily facilitate behavioral changes in clinicians and patients. For high-priority points of interest, Dr. Beidas warned that basic implementation isn’t enough because you must also utilize audit and feedback, and organization-level strategies to signal to an organization that the new implementation matters, and adherence is expected.

Dr. Hartnett shared she would like to learn more about implementation science. Dr. Beidas recommended the textbook, Dissemination and Implementation Research in Health: Translating Science to Practice by authors Brownson, Colditz and Proctor and she recommended the journals, Implementation Science and Implementation Science Communications. She shared that NIH and Academy Health are cohosting the 15th Annual Conference on the Science of Dissemination and Implementation in Health, which will be held in December 2022. She advised investigators to partner with implementation scientists.

Dr. Del Rio-Tsonis highlighted the disconnect between basic researchers and clinical researchers to share information and the need for programs to foster collaborative efforts. Dr. Beidas agreed that more needs to be done to bridge the gap between researchers and added that training should be incorporated to build capacity for collaborating. She acknowledged there is a need for more implementation scientists to meet the demand.

Development, Determination, and Dissemination of Evidence-Based Practices—Dr. Chiang briefly introduced special speaker Dr. Sun, who directs clinical eye research at the Joslin Diabetes Center. She chairs diabetes initiatives at the DRCR Retina Network, which is an NEI-funded collaborative research network, and is Co-Scientific Director for the Mary Tyler Moore Vision Initiative.

Dr. Sun provided an overview of evidence-based practices in ophthalmology—within the context of retinal disease—including how to develop new practices, determine which practices will benefit patients, disseminate information about evidence-based practices, and determine whether these practices are being successfully implemented.

Dr. Sun outlined the Early Treatment Diabetic Retinopathy Study staging system was developed in 1991 to grade retinopathy severity based on retinovascular lesions, as well as the early efforts of the Mary Tyler Moore Vision Initiative. She described efforts in dystrophia retina pigmentosa (DRD) through studies from the DRCR Retina Network, a collaborative network of diverse clinical sites dedicated to scientifically rigorous, impactful clinical research of retinal diseases. Since its conception, the network has conducted 38 multicenter studies with 117 publications, and in 2017, the network’s scope expanded to all retinal diseases. This collaborative network was formed by NEI and includes network chairs, a coordinating center, and clinical sites (389 active investigators, 139 active sites in 29 states and 2 provinces in Canada). Dr. Sun provided an overview of completed network protocols and highlighted the studies performed covering a wide breadth of complications within diabetic eye disease and various severity stages of diabetic retinopathy.

The DRCR develops new practices that can be evaluated for use in clinical care by conducting clinical studies using a multistep protocol development process that begins when the network invites internal or external submitters to present their ideas to the applicable Steering Committee for review. The designated ideas are presented to network investigators, a Steering Committee, as well as an Executive Committee (EC) that prioritizes them based on network resources and public health importance. A Protocol Development Committee is formed, and protocol drafts are reviewed by network investigators and collaborators, designated EC members, the NEI external Protocol Review Committee, and the Data Safety Monitoring Committee (DSMC).

The most recently completed study, Protocol AC, is the first phase III study of step therapy for diabetic macular edema and showed that using bevacizumab first and switching to the more expensive aflibercept if vision remains suboptimal is as effective at improving vision as aflibercept monotherapy. This study has substantial implications for public health cost savings and outlines a standardized retreatment regimen and switching criteria that can be used in clinical care. The Protocol Development Committee developed the AC switch criteria (i.e., detailed flowchart with integrated decision algorithms) that were presented for implementation by the retina community in August 2022 with the hope that the simplified message is easier for clinicians to retain and use. Dr. Sun noted that development of usable practices is strengthened by diverse input and multilayered review, and new treatment algorithms should be rooted in current clinical practice; easily remembered and implemented by clinicians; readily explainable to patients and a lay audience; and translatable across the spectrum of low- to high-resource settings.

To evaluate whether new practices benefit patients, investigators consider evidence in clinical research (e.g., case series and reports, cohort studies, randomized controlled trials). Dr. Sun provided an overview of the current care of diabetic macular edema and diabetic retinopathy and noted that the common approaches to management of patients in this field have been directed by DRCR Network clinical studies and valuable systematic reviews and meta-analyses from organizations such as the Cochrane organization.

The ophthalmology community learns about evidence-based practices via scientific meetings, publications, systematic reviews, society practice guidelines, throwaway publications, press releases, continuing medical education meetings, podcasts, websites, webinars, and social media. The DRCR Retina Network easily tracks scientific meeting presentations, publications, systematic reviews and meta-analyses, and society practice guidelines. It is more challenging to understand how information is disseminated by the other dissemination avenues (e.g., websites, podcasts) that wield large influence on clinical practice and disseminate information of widely varying quality.

To determine whether evidence-based practices are being implemented, investigators rely on surveys, electronic health record databases, medical claims databases, and public health surveillance reporting systems. Personal experience, word of mouth, and web searches have been useful in observing that DRCR Retina Network results are being implemented in clinical practice. DRCR Network results and treatment algorithms are reflected in multiple practice guidelines for diabetic eye care from different organizations (e.g., American Academy of Ophthalmology, American Diabetes Association). DRCR Retina Network studies also have influenced recommended practice guidelines for multiple international societies and are referenced by international groups.

There is a need for standardized approaches to understand how clinical research impacts clinical care because understanding implementation patterns will help define gaps in care that could be addressed to improve visual outcomes and knowing the current practices will help design future clinical studies and trials to further improve care. Consideration should be given to new approaches to determine adoption and uptake of evidence-based practices. One potential approach is NEI’s distribution of a Request for Applications (RFA) to create infrastructure to understand implementation of evidence-based practices in DRD. This effort would involve a collaborative network formed by different stakeholders (e.g., clinical researchers, patients with diabetes) and a pipeline of implementation studies that would inform ongoing trial development in DRD. In time, this effort could be expanded to all areas of ophthalmology.

Dr. Sun commented on the high prevalence of vision loss around the world and noted that efforts such as understanding implementation of best practices to improve practices and clinical care could lead to optimization of vision outcome for all patients. She outlined multiple organizations that have contributed to efforts in DRD and indicated that she is hopeful that additional efforts in implementation science, which will need strong collaborations, will benefit from existing partnerships.

Discussion
Dr. Hartnett commented that organizations such as the DRCR Retina Network are of great value to public health and demonstrate the importance of science (e.g., conducting clinical trials, identifying long-term outcomes, having comparison groups) to academics as well as private practitioners who may largely be influenced by anecdotal evidence but may not know the long-term benefits. Dr. Sun agreed and added that one of the first initiatives of the DRCR Retina Network was to involve community practitioners in addition to academicians. Community practitioners are essential in clinical trials because they enroll the patients needed for the trials. In addition, community practitioners’ participation in clinical research has allowed them to gain an understanding of the importance of standardization and a better understanding of the data. Dr. Sun noted that the integration of discussions about implementation and discussions with community practitioners about clinical trial data would be a good learning opportunity.

Dr. Maguire pointed out that in addition to emphasizing implementation in terms of educating and changing clinicians’ behavior, investigators should also emphasize to clinicians the need to educate patients about taking advantage of and continuing very effective treatments. Dr. Maguire supported her assertion with data she gathered from Medicare that 25% of AMD (Age-related macular degeneration) patients stop treatment after the first injection and 50-60% stop treatment within five years. Dr. Sun agreed and added that loss of patients’ follow-up is an enormous challenge in clinical practice.

Dr. Dana commented that while science is important to optimizing standards for care, there’s still a barrier between determining those standards and implementing them in the real-world where you must also contend with financial and social barriers that affect optimal healthcare to the patients. Dr. Dana used the example of how physicians must often delay patient therapy while trying to convince or waiting for insurance companies to accept coverage for necessary procedures, necessary preventions, or approved drugs. Dr. Sun agreed and noted that the social determinants affecting which patients get care and help are all critical in evidenced based practices.

Dr. Teller asked Dr. Sun how soon in the future will telehealth and telemedicine Artificial Intelligence (AI) be implemented for early detection of diabetic retinopathy. Dr. Sun answered the FDA has approved several AI systems for diabetic retinopathy that are currently in use now and she’s certain they will continue to approve and expand efforts. She noted that many tele-medicine screening initiatives, made scalable by the integration of AI evaluation, are in partnership with health services and they are currently out in the communities performing retinal screenings. She believes five to ten years is a very achievable goal for this approach to be implemented on a global scale. She warned that the challenge may be attaining collaboration across stakeholders and countries to address inequities in healthcare and reach the underserved populations that need this care the most.

PORTFOLIO OVERVIEW: Collaborative Clinical Research Program
—Dr. Maryann Redford, Program Director, Collaborative Clinical Research Program, NEI

Dr. Redford provided an overview of the Collaborative Clinical Research (CCR) Program, which supports NEI-funded clinical trials. Dr. Redford, Dr. Sangeeta Bhargava, Mr. Donald Everett, and Dr. Jimmy Le manage the CCR portfolio, which comprises phase III clinical trials, gene and cellular therapy/regenerative medicine trials, research networks, multisite epidemiologic studies, international research projects, and Cochrane systematic reviews.

CCR grant support mechanisms are highly skewed toward Cooperative Agreements (U mechanism), which are utilized by NIH when substantial staff involvement is required. CCR Program Directors regularly participate in multiple activities (e.g., study design, oversight committee meetings) that allow them to monitor studies and provide stewardship. Monitoring committees, including the Data and Safety Monitoring Committee and the Data and Monitoring Committee are outside experts that, in addition to assisting NEI and study leadership in protecting the interest of research participants, monitor study quality, timeliness, and integrity.

The CCR cooperative agreement funding opportunity announcements (FOAs) for collaborative clinical vision research (PAR-21-041, PAR-21-042), early-stage clinical trials involving greater than minimal risks (PAR-22-149), and epidemiology studies (PAR-21-204) solicit applications on design and implementation. Applications are reviewed by an in-house special emphasis panel convened by NEI. NEI Scientific Review Officers (SROs) ensure rigorous review. NEI also offers secondary data analysis (PAR-22-141), clinical research study planning (PAR-22-128, PAR-22-135), and parent (R01s, R21s) funding opportunities to the clinical research community.

NEI supports testing of cutting-edge treatments such as visuomotor prosthetic and stem cell and gene therapy interventions. Two NEI-funded stem cell studies are being supported by the Regenerative Medicine Innovation Project (RMIP). NEI also supports several multicenter clinical trials across the U.S. that private industry does not support (e.g., Endothelial Thickness Comparison Trial, Diabetes Endothelial Keratoplasty Study, Myopia Progression and Soft Contact Lens Myopia Control). Most NEI-funded clinical studies use both academic and private practice-based enrollment centers and, increasingly, international sites, which enhances enrollment and accelerates the translation of research to practice. NEI funds studies that address vision issues across the lifespan (e.g., AMD in elderly patients, uveitis in juveniles, spectacle correction in children) and public health issues at the international scale in Ethiopia, Nepal, and Niger.

NEI also supports two research networks: the Pediatric Eye Disease Investigative Group (PEDIG) and the DRCR Retina Network. Both PEDIG and the DRCR Retina Network are open collaborative networks. PEDIG studies involve 300 pediatric ophthalmologists and optometrists and have influenced clinical pediatric care worldwide. Dr. Redford highlighted the DRCR Retina Network’s rigorous protocol development process, the large teams supporting all 398 practitioners involved in studies, and the support garnered from 17 industry and foundation partners. She also emphasized the influence the DRCR Retina Network studies have had on clinical practice.

NEI-supported epidemiologic studies and systematic reviews include the Study of Latinos Ojos (SOL Ojos) and Cochrane Eye and Vision (CEV). SOL Ojos is an ancillary eye study to the National Heart, Lung, and Blood Institute (NHLBI)-supported Hispanic Community Health Study/Study of Latinos (HCHS/SOL) that will leverage prospective phenotypic and genotypic parent study data for Latino participants of diverse origins and presents an opportunity to examine relations among eye conditions and novel cardiovascular disease, biomedical, and sociocultural risk factors.

Dr. Redford concluded by praising the Ocular Hypertension Treatment Study for having three articles ranked as the top three with significant impact on clinical glaucoma care by the American Glaucoma Society.

Discussion
Noting her experience as both a clinical investigator and a past member of the DSMC, Dr. Maguire expressed that the collaborative studies operate on high-levels due to the involvement of the best investigators from different disciplines. She pointed out Dr. Redford’s presentation which showed the number of publications and influences produced from the collaborative studies demonstrate their value. She also praised the DSMC for its diversity by including members who are separate from the collaborative studies to provide expert advice and oversight.

Dr. Dana thanked NEI for their efforts to fill an important niche by supporting clinical research studies that are typically overlooked by private industries for investments due to their lengthy research time. Dr. Redford commended Dr. Dana for overcoming the challenges of conducting a limbal stem cell deficiency study by leveraging the NHLBI-funded program Production Assistance for Cellular Therapies (PACT) to conduct preliminary pre-clinical work.

Dr. Del Rio-Tsonis asked how the SOL Ojos study connects with difficult-to-reach populations and how will the data be implemented to improve the vision of the community. Dr. Redford explained that NEI leverages extensive work already done by NHLBI to recruit diverse populations of Latinos. NEI will assess the conditions gathered from comprehensive exams and determine how they correlate with systemic and genetic data already available. NEI will assess implementation if significant conditions and disparities are found.

Dr. Borras highlighted the importance of the Ocular Hypertension Treatment Study as a resource that was of tremendous help to the glaucoma field. Dr. Redford thanked Dr. Borras and pointed out that publications from other NEI-supported glaucoma studies also placed in the top 10 publications with significant impact on clinical glaucoma care ranked by the American Glaucoma Society.

PORTFOLIO OVERVIEW: Research Training and Workforce Development
—Dr. Neeraj Agarwal, Program Director, NEI

Dr. Agarwal presented an overview of the current NEI training portfolio comprising 257 total active grants, including individual fellowships (F30, F32, F32), mentored career development grants (K08, K23, K99/R00), and institutional training grants (T32, T35, K12).

Dr. Agarwal presented a comparison of NEI’s fellowship and research grants portfolios through the 2012–2022 period, organized into the six cores of the NEI research program: retina; cornea; lens; glaucoma; strabismus, amblyopia, and visual processing (SAVP); and low vision. The percentage of SAVP NEI fellowships (43%) is larger than that of SAVP NEI research grants (23%), whereas the percentages of retina NEI fellowships (43%) and research grants (44%) are similar. The other programs (cornea, lens, glaucoma, low vision) constitute 10 percent of the NEI fellowship portfolio.

Dr. Agarwal outlined the fellowship success rate for FY 2017–2022 as calculated by dividing the number of awarded fellowships by the number of submitted applications. The success rate of F30s is higher than that of F31s and F32s throughout this period. It will be important to determine how many F30 awardees (MD/PhD candidates) enter ophthalmology residency programs. FY 2015 and FY 2016 data show that 50 percent of F30 awardees entered ophthalmology residency programs. The R01 success rate by F32 (postdoctoral fellowship) awardees for FY 2012–2022 is 40 percent (12 F32 awardees with funded R01s of 30 applicants). K99 awardees are not factored into this calculation. For this period, 16 F32 awardees obtained K99 awards. The success rates of FY 2022 active institutional training grants are as follows: 100 percent for K12; 63 percent for T32; and 100 percent for T35. Currently, the total number of active institutional training grants are 10 K12s, 30 T32s, and 11 T32s.

The percentages of K career development grants awarded by NEI’s and the research grants portfolios through the FY 2012–2022 period (organized into the six cores of the NEI research program) are similar except for the glaucoma program. An overview of success rates of K awardees (K08, K23, K99) for FY 2017–2022 shows the success rate for these awards is higher than NIH rates. The R01 success rates of K awardees for FY 2012–2022 are 49 percent for K08; 55 percent for K23; and 59 percent for K99.

Other trans-NIH training initiatives include the following:

Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) - National Institute of General Medical Sciences (NIGMS) K99/R00
Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative Diversity K99/R00
NIH Blueprint Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award (F99/K00)
Jointly Sponsored Institutional Predoctoral Training Program (JSPTPN)-Trans-NIH Blueprint Initiative for Predoc Institutional Training Program
The NEI Loan Repayment Program (LRP) aims to attract health professionals to careers in research by paying investigators’ educational debt and provides up to $50,000 for debt payback and accrued IRS taxes. NIH grant support is not required, and applicants must be U.S. citizens or U.S. permanent residents and can apply multiple times. The deadline for the LRP is November 17, 2022. LRP has four categories of loan repayment (e.g., pediatric research, clinical research, health disparity, Research in Emerging Areas Critical to Human Health). The funding rate for the NEI LRP for FY 2022 is higher (87%) than the NIH LRP funding rate (59%). The total award amount for FY 2022 is $1.3 million. The LRP analysis by degree for FY 2017–2021 (140 total funded applications) shows 41 percent were MD: MD/PhD; 31 percent were Doctor of Optometry (OD): OD/PhD; and 28 percent were PhD.

Discussion
Dr. Coughlan asked Dr. Agarwal’s thoughts on young investigators preferring to apply for R21 grant mechanisms rather than R01 grant mechanisms because they believe R21s are easier to get since there’s no requirement for pilot data but pointed out statistics show that R21s are more competitive and harder to get than R01s. Dr. Agarwal agreed with Dr. Coughlan and shared that many young investigators often contact him with the belief that R21s are easier to acquire than R01s but he confirmed that is not necessarily the case. At NEI. success rates for R01 applicants are higher than for R21 applicants. Dr. Agarwal noted the following benefits of R01s: investigators have the advantage of an Early-Stage Investigator (ESI) status; their R01s are reviewed with other applications from ESIs; less emphasis is placed on preliminary data; and they have up to five years of funding with an R01 versus only 2 years with a R21.

Dr. Anderson highlighted that NEI has one of the highest success rates for ESIs applying for R01s and added that ESIs are also eligible to apply for the Stephen I. Katz Early-Stage Investigator Research Project Grant .

Dr. Del Rio-Tsonis thanked Dr. Agarwal specifically, for providing information about the trans NIH initiative, Blueprint Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) award in a prior Council meeting. She shared that her graduate student applied and successfully received the grant, but she expressed her concern that her student only learned about the grant because the Council member was privileged to the information through the Council presentation. She asked how NEI promotes funding opportunities to potential candidates. Dr. Agarwal responded he and others at NEI promote these funding opportunities at different meetings and on the NIH and NEI web. He also encourages potential candidates to contact him with questions.

Dr. Chiang thanked Dr. Del Rio-Tsonis for pointing out the challenge of effectively promoting training opportunities. NEI has been using social media for promotion of such opportunities. Dr. Chiang encouraged Council members to share ideas on how to reach potential candidates and to promote funding opportunities with their community. Potential approaches include recruiting awardees to share the information with potential candidates who may not utilize social media. Career development award information will be shared during a possible future K Award Symposium. Dr. Kowluru suggested that social media may be the best way to promote the opportunities.

CONCEPT CLEARANCE
NEI Center Core Grant for Vision Research (P30) Renewal
—Dr. Ellen Liberman, Program Director, DESP, NEI

Dr. Liberman presented a concept clearance for the renewal of the NEI P30 Center Core Grant for Vision Research (PAR-20-051). The goal of these institutional Center Core Grants is to build research infrastructure within an institution for the purpose of providing technical support to groups of NEI R01-funded investigators. The Core grant supports the cost of shared resources rather than individual R01 grants, creating an economy of scale for institutions that have intensive vision research. In addition, institutions benefit from promotion of a collaborative environment and cost-effectiveness. Grants are required to have an administrative core and three or more resource and/or service cores. Applicant institutions must have a minimum of eight active R01s to be eligible. Any researcher at the institute can use the core facilities.

Discussion

Discussants Drs. Borrás and Moore expressed strong support for the renewal, noting the importance of providing instruments and resources that are beyond the reach of individual R01 grant budgets. A suggestion was made to consider supporting a smaller core center grant for institutions that have less than eight R01s. Council members also recommended updating the examples of the cores provided in the rationale as the need for machine shops has diminished with the advent of 3D printing. Dr. Liberman agreed that the language in the funding opportunity should be updated to reflect new technologies available and resources needed to support those.

A motion to approve the concept was made, seconded, and approved unanimously.

PORTFOLIO OVERVIEW: Research Training and Workforce Development
—Dr. Neeraj Agarwal, Program Director, NEI

Dr. Agarwal presented an overview of the current NEI training portfolio comprising 257 total active grants, including individual fellowships (F30, F32, F32), mentored career development grants (K08, K23, K99/R00), and institutional training grants (T32, T35, K12).

Dr. Agarwal presented a comparison of NEI’s fellowship and research grants portfolios through the 2012–2022 period, organized into the six cores of the NEI research program: retina; cornea; lens; glaucoma; strabismus, amblyopia, and visual processing (SAVP); and low vision. The percentage of SAVP NEI fellowships (43%) is larger than that of SAVP NEI research grants (23%), whereas the percentages of retina NEI fellowships (43%) and research grants (44%) are similar. The other programs (cornea, lens, glaucoma, low vision) constitute 10 percent of the NEI fellowship portfolio.

Dr. Agarwal outlined the fellowship success rate for FY 2017–2022 as calculated by dividing the number of awarded fellowships by the number of submitted applications. The success rate of F30s is higher than that of F31s and F32s throughout this period. It will be important to determine how many F30 awardees (MD/PhD candidates) enter ophthalmology residency programs. FY 2015 and FY 2016 data show that 50 percent of F30 awardees entered ophthalmology residency programs. The R01 success rate by F32 (postdoctoral fellowship) awardees for FY 2012­­–2022 is 40 percent (12 F32 awardees with funded R01s of 30 applicants). K99 awardees are not factored into this calculation. For this period, 16 F32 awardees obtained K99 awards. The success rates of FY 2022 active institutional training grants are as follows: 100 percent for K12; 63 percent for T32; and 100 percent for T35. Currently, the total number of active institutional training grants are 10 K12s, 30 T32s, and 11 T32s.

The percentages of K career development grants awarded by NEI’s and the research grants portfolios through the FY 2012–2022 period (organized into the six cores of the NEI research program) are similar except for the glaucoma program. An overview of success rates of K awardees (K08, K23, K99) for FY 2017–2022 shows the success rate for these awards is higher than NIH rates. The R01 success rates of K awardees for FY 2012­–2022 are 49 percent for K08; 55 percent for K23; and 59 percent for K99.

Other trans-NIH training initiatives include the following:

Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) - National Institute of General Medical Sciences (NIGMS) K99/R00
Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative Diversity K99/R00
NIH Blueprint Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award (F99/K00)
Jointly Sponsored Institutional Predoctoral Training Program (JSPTPN)-Trans-NIH Blueprint Initiative for Predoc Institutional Training Program
The NEI Loan Repayment Program (LRP) aims to attract health professionals to careers in research by paying investigators’ educational debt and provides up to $50,000 for debt payback and accrued IRS taxes. NIH grant support is not required, and applicants must be U.S. citizens or U.S. permanent residents and can apply multiple times. The deadline for the LRP is November 17, 2022. LRP has four categories of loan repayment (e.g., pediatric research, clinical research, health disparity, Research in Emerging Areas Critical to Human Health). The funding rate for the NEI LRP for FY 2022 is higher (87%) than the NIH LRP funding rate (59%). The total award amount for FY 2022 is $1.3 million. The LRP analysis by degree for FY 2017–2021 (140 total funded applications) shows 41 percent were MD: MD/PhD; 31 percent were Doctor of Optometry (OD): OD/PhD; and 28 percent were PhD.

Discussion
Dr. Coughlan asked Dr. Agarwal’s thoughts on young investigators preferring to apply for R21 grant mechanisms rather than R01 grant mechanisms because they believe R21s are easier to get since there’s no requirement for pilot data but pointed out statistics show that R21s are more competitive and harder to get than R01s. Dr. Agarwal agreed with Dr. Coughlan and shared that many young investigators often contact him with the belief that R21s are easier to acquire than R01s but he confirmed that is not necessarily the case. At NEI. success rates for R01 applicants are higher than for R21 applicants. Dr. Agarwal noted the following benefits of R01s: investigators have the advantage of an Early-Stage Investigator (ESI) status; their R01s are reviewed with other applications from ESIs; less emphasis is placed on preliminary data; and they have up to five years of funding with an R01 versus only 2 years with a R21.

Dr. Anderson highlighted that NEI has one of the highest success rates for ESIs applying for R01s and added that ESIs are also eligible to apply for the Stephen I. Katz Early-Stage Investigator Research Project Grant .

Dr. Del Rio-Tsonis thanked Dr. Agarwal specifically, for providing information about the trans NIH initiative, Blueprint Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) award in a prior Council meeting. She shared that her graduate student applied and successfully received the grant, but she expressed her concern that her student only learned about the grant because the Council member was privileged to the information through the Council presentation. She asked how NEI promotes funding opportunities to potential candidates. Dr. Agarwal responded he and others at NEI promote these funding opportunities at different meetings and on the NIH and NEI web. He also encourages potential candidates to contact him with questions.

Dr. Chiang thanked Dr. Del Rio-Tsonis for pointing out the challenge of effectively promoting training opportunities. NEI has been using social media for promotion of such opportunities. Dr. Chiang encouraged Council members to share ideas on how to reach potential candidates and to promote funding opportunities with their community. Potential approaches include recruiting awardees to share the information with potential candidates who may not utilize social media. Career development award information will be shared during a possible future K Award Symposium. Dr. Kowluru suggested that social media may be the best way to promote the opportunities.

GENERAL COUNCIL DISCUSSION
Dr. Anderson opened the floor for general discussion by Council members.

Dr. Del Rio-Tsonis shared her concerns about Data Management and Sharing specifically, the risk of shared data being scooped prior to publication. She asked whether the shared data could have an embargo placed on it until it is published. Dr. Chiang noted her concern is a common one heard by NEI, and he will circulate resources on the Data Management and Sharing Policy provided by Dr. Mike Lauer, during the 161st NAEC meeting in June 2022, which contains detailed information to help address many concerns.

Dr. Chiang expressed that the question of when to release data is a common one. He believes the research community is at a crossroads. Scientifically, the culture is that the output of a research project is the publication. He believes that both the publication and the data are equally important outputs. This issue will be solved as the data are viewed as being as important an output as the publication. To truly value data sharing and team science, the research community will have to recognize the current unequal value of data and publications.

Dr. Hartnett expressed concern for the lack of clarity in the Data Management and Sharing Policy of what data needs to be shared. Dr. Chiang clarified that not all data needs to be shared according to the official NIH policy but one of the goals of Data Management and Sharing is to get away from the statement, “data will be shared upon request” or similar statements. He advised her to speak to Program Officers and he assured her that resources will be circulated amongst the community discussing the issue in detail.

Dr. Coughlan commented he has gained an interest in data sharing licenses and would like to learn more about them. He views adding data sharing licenses to data as a benefit because they legally mandate users of the data to attribute the investigators, plus there are various levels of the license that can impose other stricter requirements. Dr. Coughlan questioned how restrictive of a data license can investigators choose for data funded by NIH, and he used the example of licenses that prohibit the commercialization of data. Dr. Chiang responded that NEI has received similar questions in the past about Creative-Common versus Apache licenses. With prior queries, they were unable to find any guidance about this issue, but he will follow up to see if there are new developments. He shared that NEI worked with Dr. Marco Zarbin (Editor-in-Chief of Translational Vision Science and Technology) on creating a publication type that represents datasets or software libraries to get credit after datasets or code are published. Emily Chu also has implemented this concept within ophthalmology science. Dr. Chiang noted that these conversations originated from discussions with Editor-in-Chiefs of major vision journals, and he hopes we all can create a culture within the vision community that focuses on the benefits of data sharing.

Dr. Borras inquired, since experiments are continuous and produces data that is continuous, at what point do you share the data; do you share it in the middle of research or wait, for example, another 2-3 years until the end. Dr. Chiang provided Dr. Borras with the link to the best guideline in the Data Management and Sharing Policy that addresses her issue.

Dr. Del Rio-Tsonis asked whether there is a plan to include a budget for implementation of the Data Management and Sharing Plan in mechanisms that have a strict budget cap (e.g., R15, R21). Dr. Anderson indicated that she would seek advice on this issue. She added that investigators do not have to submit a modular budget with their funding applications (e.g., R01) to be competitive. Investigators should request the needed funding, including the funding needed to share data. Dr. Del Rio-Tsonis asked whether the data repositories will be curated or managed in a manner that would align with the Data Management and Sharing Policy. Dr. Chiang pointed out that investigators must ensure that collected data are interpretable by others so that they are useful. He hopes the Data Management and Sharing Policy stimulates conversations about this effort in the community. Examples of appropriate data repositories include generalist repositories that are publicly available (e.g., figshare). Information on these repositories will be circulated to the group. Templates of data sharing management plans for different types of data will be provided in the future.

Drs. Anderson and Chiang thanked attendees and Ms. Lehrer-Stein and Dr. Perez-Quinones for their participation. Dr. Chiang concluded that he looks forward to future discussions on implementation and dissemination of clinical research findings.

OPEN SESSION ADJOURNMENT
Dr. Anderson adjourned the open session of the Council meeting at 2:30 PM.

CLOSED SESSION
This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as amended (5, USC Appendix 2). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS
NAEC members considered 514 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $185,625,500 (direct costs year 01). The Council also considered 111 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $127,504,212 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 625 applications.

ADJOURNMENT
The 163rd meeting of the National Advisory Eye Council was adjourned at 4:05 p.m. on October 14, 2022.

CLOSED SESSION ATTENDEES
Council Members Present:
Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Terete Borrás
Dr. James Coughlan
Dr. Reza Dana
Dr. Katia Del Rio-Tsonis
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Tirin Moore
Dr. Benjamin Teller

NIH Staff Members Present:
Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Dr. Kevin Czaplinski
Mr. Donald Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Dr. Nataliya Gavrilovic
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Alicia Kerr
Dr. Paek Lee
Dr. Kristine Mackin
Dr. Barbara Mallon
Dr. George Mckie
Dr. Lisa Neuhold
Dr. Maryann Redford
Dr. Jennifer Schiltz
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Santa Tumminia
Dr. Afia Sultana
Dr. Cheri Wiggs
Ms. Keturah Williams
Dr. Charles Wright

CERTIFICATION
These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 161st meeting at 10:00 a.m. on Friday, June 17, 2022. The entire meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended virtually. Michael Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen Anderson, PhD, served as Executive Secretary. The meeting was open to the public from 10:00 a.m. until 2:07 p.m. The meeting was closed to the public from 2:35 p.m. until 4:34 p.m. for the review of grant and cooperative agreement applications.

Council Members Present:
Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Terete Borras
Dr. James Coughlan
Dr. Reza Dana
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Maureen Maguire
Dr. Tirin Moore
Dr. Benjamin Teller

NIH Staff Members Present:
Mr. Shawn Adolphus
Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. John Ball
Dr. Sangeeta Bhargava
Ms. Stephanie Blackford
Ms. Holly Blake
Mr. Nathan Brown
Mr. Juan Castillo
Ms. Alysia Champagne
Dr. Emily Chew
Ms. Monique Clark
Mr. Jay Colbert
Ms. Claudia Costabile
Dr. Mary Frances Cotch
Ms. Ashley Dash
Mr. Walter Davis
Ms. Kyla Delaine
Mr. Britt Dennis
Dr. Chairlie Drinnan
Mr. Donald Everett
Ms. Diana Fisher
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Dr. Mohita Gaur
Ms. Alexandra Gavrilovic
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Dr. Bin Guan
Mr. Syed Haqqani
Ms. Natalie Haynes
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Jeanette Hosseini
Dr. Koray Dogan Kaya
Dr. Michael Lauer
Dr. Jimmy Le
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Renee Livshin
Mr. Alex Manuel
Dr. George McKie
Dr. Sheldon Miller
Ms. Archana Mohale
Mr. Daniel Molina
Dr. Lisa Neuhold
Mr. Russ O'Donnell
Ms. Scarleth Perez
Mr. Trevor Peterson
Dr. Zepeng Qu
Dr. Maryann Redford
Ms. Melissa Reeves
Ms. Carissa Reilly-Weedon
Ms. Holly Russo
Ms. Jessica Ryan
Dr. Jennifer Schiltz
Dr. David Schneeweis
Dr. Trupti Shetty
Ms. Rugie Sillah
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Xun Sun
Dr. Anand Swaroop
Dr. Santa Tumminia
Dr. Chenyue Wang
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Dr. Angelina Williams
Mr. Michael Wright
Ms. Maria Zacharias

Others Present Virtually:
Ms. Kim Cook, NIH Events Management
Ms. Kathy Sedgwick, Science Writer

NOTE: Due to the open videocast format of this meeting, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.

Welcome and Introductions
—Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang called the 161st NAEC meeting to order and welcomed Council members, members of the NEI research and advocacy community, NEI and NIH staff, and guest speakers. Council members introduced themselves and gave a brief overview of their research areas.

Council Procedures and Related Matters
—Dr. Kathleen Anderson, Executive Secretary, NAEC

Dr. Anderson reviewed Council procedures and etiquette for the Zoom meeting. The open session of the meeting was videocast and will be available on the NIH videocast website. Dates for future Council meetings are listed on the NEI website. An additional closed Council meeting will be held on August 9, 2022, to review applications submitted to two NEI-issued Requests for Applications (RFAs) to be considered for funding in Fiscal Year 2022. The next open Council meeting is planned to be held in person on Friday, October 14, 2022. Minutes of the February 2022 NAEC meeting were provided in the Electronic Council Book prior to the meeting. A motion to accept these minutes was made, seconded, and approved unanimously by Council members. The approved minutes will be posted on the NEI website.

Director's Report
—Dr. Michael Chiang

NIH and NEI Leadership Updates
In December 2021, Dr. Francis Collins stepped down as NIH Director. Dr. Lawrence Tabak has been appointed by the White House to serve as Acting Director. Dr. Tara Schwetz is Acting NIH Principal Deputy Director.

NEI is currently conducting two major recruitments: Scientific Director and Clinical Director. Dr. David Schneeweis has served as Acting Scientific Director since the retirement of Dr. Sheldon Miller in 2019. Applications for this position closed on January 31, 2022, and second-round interviews are underway. After seven years as NEI Clinical Director, Dr. Brian Brooks stepped down in January 2022 Dr. Brooks will continue to lead the Ophthalmic Genetics and Visual Function Branch. The Clinical Director search committee has been formed and an announcement of the position is pending.

Advanced Research Project Agency for Health (ARPA-H)
On May 25, 2022, Department of Health and Human Services’ Secretary Xavier Becerra announced the formal establishment of ARPA-H as an independent entity within HHS, complementary to but not duplicative of NIH programs, and focused on supporting transformative, high-risk/high-reward biomedical and health research. Adam H. Russell, D.Phil., has been appointed Acting Deputy Director and will report directly to Secretary Becerra.

Awards and Recognition
Dr. Chiang congratulated longtime NEI grantee Dr. Sheila Nirenberg who was awarded the Lighthouse Guild’s 2022 Bressler Prize for “revolutionizing the field of computational neuroscience and biomedicine to help people regain their sight.” Dr. Nirenberg is the Nanette Laitman Professor in Neurology and Neuroscience and Professor of Computational Neuroscience at the Institute for Computation Biomedicine, Weill Cornell Medical College. In addition, two members of the NEI staff recently received awards. Dr. Emily Chew, Chief of the Clinical Trials Branch and Director of the Division of Epidemiology and Clinical Applications, received the American Ophthalmological Society 2022 Medal. Dr. Mitra Farnoodian-Tedrick, a research scientist in the Ocular and Stem Cell Translational Section, received an award from the Knights Templar Eye Foundation for her work on developing a stem cell-based drug discovery platform to target lipid defects in Stargardt disease. Seven NEI-supported investigators have been named members of the National Academy of Sciences in 2022: Drs. Jean Bennett, Hollis Cline, Charles Kimmel, Roberta Klatzky, Alex Kolodkin, Stephen Lisberger, and Krzystof Palczewski.

NEI-funded Research Highlights
NEI intramural researchers Drs. Davide Ortolan and Kapil Bharti used artificial intelligence-based software to generate the first single-cell-resolution map of human retinal pigment epithelium (RPE). Results will enable study of molecular and functional RPE differences responsible for regional retinal disease and help develop precise therapies for specific degenerative eye diseases.

NEI grantees Drs. Fatima Abbas and Frans Vinberg at the University of Utah Moran Eye Center successfully revived light-sensing neuron cells in organ donor eyes and restored communication between them. These first electrophysiological recordings made from the central retina of postmortem human eyes demonstrate the value of the retina as a model for investigating neuronal death and methods for regeneration, with implications for disease treatment and reversibility of cell death.

Finally, a pair of NEI intramural researchers, Drs. John Ball and Wei Li, used a ground squirrel model to explore the optical properties of the retina. They demonstrated that light passing through bundles of mitochondria focus into a beam rather than blocking, absorbing, or scattering light. This explanation for the Stiles-Crawford effect may inform earlier detection of retinal disease that often damages mitochondria.

NEI Strategic Plan Implementation Update
Dr. Chiang provided an update on current and planned activities related to the areas of emphasis (AoE) in the NEI Strategic Plan.

Immune System and Eye Health. NEI issued an RFA (RFA-EY-22-001) inviting applications from multidisciplinary research teams to develop A Community Research Resource: Characterization of the Resident Ocular Microbiome aimed at delineating and characterizing the core ocular surface microbiome.
Regenerative Medicine. Projects in this AoE included publication of an Audacious Goals Initiative (AGI) road-mapping paper in Nature Medicine; The Association for Research in Vision and Ophthalmology (ARVO) Regenerative Medicine Town Hall, “Characterization and Standardization of Cell Sources,” that emphasized the need for harmonized regulation of validated material testing; and review of 3-D Retina Organoid Challenge (3-D ROC) entries. In addition, plans are underway for the AGI Transplant Immunology Workshop on July 29, 2022.
Data Science. On May 10, 2022, NEI, the U.S. Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC) hosted a Joint Workshop on Promoting Adoption of Ocular Imaging Standards to identify barriers and approaches toward widespread adoption of standards for interoperability. Approximately 350 researchers, clinicians, vendors, and representatives from government and professional societies participated. Several papers to promote adherence to the standard include an editorial, white paper, and workshop proceedings. Additional data science opportunities include the $500,000 DataWorks! Prize, a collaboration between NIH and the Federation of American Societies for Experimental Biology (FASEB). This annual challenge showcases the benefits of research data management, sharing, and re-use for advancement of knowledge, discovery, and human health. In February 2022, NEI signed on to the Biological Knowledgebase funding opportunity announcement (FOA) (PAR-20-097) that supports data curation that scales to the needs of the community.
Public Health and Disparities Research. NEI issued a Notice of Special Interest (NOSI): Research Addressing Eye and Vision Health Equity/Health Disparities to encourage applications that target reduction of health disparities experienced by visually impaired or blind persons. NEI collaborations with the National Institute of Minority Health and Health Disparities (NIMHD) are in the works, including a series of workshops. NEI also signed onto the trans-NIH funding opportunity, Global Brain and Nervous System Disorders Research Across the Lifespan (PAR-22-097) that encourages applications for innovative, collaborative research projects with scientists and institutions in low and middle income countries (LMIC) focused on brain and nervous system function and disorders.
NEI Training Program Updates
This year, 12 of NEI’s 20 summer interns are participating in person and 11 individuals from traditionally underrepresented groups in vision research became interns through the Diversity in Vision Research and Ophthalmology (DIVRO) program. Recruitment is ongoing for the NEI Clinician Scientist Reviewer Program to increase the pool of clinician scientists—particularly those from groups underrepresented in science and medicine—to serve as reviewers on NEI special emphasis panels.

Peer Review Bias Training
In September 2021, the NIH Center for Scientific Review (CSR) began piloting a 30-minute online training module to raise reviewer awareness of potential sources of bias in peer review and develop practical skills to mitigate them. During the January 2022 Council round of review, over 6,000 reviewers completed the training. Of those who completed an evaluation, 87 percent reported that NIH has a moderate, big, or very big problem with bias in peer review, 90 percent were extremely satisfied with the training, and 82 percent indicated they would probably or definitely take specific actions to combat bias.

Diversity, Equity, Inclusion, and Accessibility (DEIA)
The NEI Eye on the Future Campaign video contest aims to inspire teenagers to pursue careers in science, eye health, and vision research, with an emphasis on underrepresented groups in science and medicine.

The NIH Chief Officer for Scientific Workforce Diversity (COSWD) issued a notice inviting comments on the development of a prize competition for institutional excellence in DEIA (NOT-OD-22-109) that will recognize institutions that model innovative interventions for enhancing faculty and student diversity.

The 2022 Consolidated Appropriations Act (P.L. 117-103) included a provision requiring NIH grantee institutions to report cases of sexual harassment to NIH within 30 days of removal or disciplinary action. The provision aims to make NIH-funded projects welcoming for all grantees, staff, and trainees, and goes into effect on July 8, 2022.

On March 24, 2022, the Rapid Acceleration of Diagnostics (RADx®) Tech program held a listening session to solicit input on the accessibility challenges of current at-home COVID-19 tests and potential improvements for these products. Takeaways from the listening session are available in the executive summary. This effort will inform future product accessibility standards for broader groups.

The NIH Artificial Intelligence/Machine Learning (AI/ML) Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD) is hosting a series of events (a 2-day conference, startup competition, 4-week workshop series, and monthly webinars) in support of AIM-AHEAD goals to enhance the participation and representation of researchers and communities currently underrepresented in the development of AI/ML models and improve the capabilities of this emerging technology to address health disparities and inequities.

NEI Budget Update
NEI Budget Officer, Karen Colbert, reported that the FY 2022 appropriation for NEI represented a 3.4 percent increase over FY 2021. Estimated shares of the total NEI budget are as follows: extramural research, 83.8 percent; intramural research, 11.8 percent; and research support, 4.4 percent. Another Continuing Resolution is likely for FY 2023. She presented a comparison of NEI operating levels versus buying power for FY 1999 through FY 2022. Despite regular budget increases, buying power has not increased proportionately.

Dr. Dana asked Ms. Colbert how the proportion of the 11 percent for intramural research compares to other NIH Institutes and what is the dollar density at the NEI compared to some of the laboratories and institutions that NEI supports extramurally. Ms. Colbert replied that generally 10-11 percent is the NIH benchmark for Intramural Research Programs. However, depending on the Institutes’ research focus that amount can vary. For the latter question, Ms. Colbert did not have that data available. Dr. Dana explained the reason for his questions is based on data presented by his institutions, Massachusetts General Hospital and Brigham and Women’s Hospital, that showed the purchasing power of a typical $250,000 modular grant has decreased by 46 percent in 20 years. Dr. Dana stated that the decrease in purchasing power of this grant amount creates significant difficulties in providing salaries that will permit institutions to retain investigators, postdoctoral fellows, and other staff.

Real-World Adoption of Findings from Clinical Trials
During the February 2022 NAEC meeting, Council members called for strong efforts to connect science to clinical practice and specifically for increasing clinician awareness of clinical trials and studies relevant to their patients. According to a National Academies of Science report, it takes approximately 17 years for significant findings to become incorporated into clinical practice. Dr. Chiang asked for volunteers to serve on a Council Workgroup to develop priorities and recommendations on how to communicate, disseminate, and translate NEI-funded clinical research findings into real-world practice.

NEI Leadership
In September 2022, Dr. Michael Steinmetz will step down from his position as Director of the NEI Division of Extramural Science Programs (DESP). He joined NEI in 2003 and has served as Director of DESP since 2014. Dr. Chiang thanked Dr. Steinmetz for his exceptional leadership overseeing the NEI extramural grant portfolios and representing NEI on many trans-NIH and government-wide committees, including the BRAIN and Blueprint initiatives. Dr. Steinmetz made remarks on his work at NEI and the Institute’s successes, which include maintaining a high investigator-initiated award success rate, strong support for vulnerable groups of investigators (early-stage and at-risk), the development of initiatives for targeted research areas (e.g., AGI and ASI) to address knowledge gaps and barriers to progress and implementing a requirement that consortia be formed under these initiatives to promote collaboration. He attributed these successes to his outstanding mentors, NEI Program Officers, Scientific Review Officers, and Grants Management Specialists, and especially recognized the NEI Chief Grants Management Officer, Karen Robinson Smith.

Discussion
Dr. Maguire asked how the scope and operation ARPA-H projects will differ from NIH initiatives. Dr. Chiang noted that ARPA-H will emphasize nontraditional high risk/high reward projects to speed the development of deliverables that directly benefit the public, citing the development of the COVID vaccines as one example.

Dr. Hartnett inquired if the new vision for NEI will cause a change to the funding of investigator-initiated applications. She believes these grants are valuable for their creativity and ability to move science forward. Dr. Chiang indicated that the bulk of projects that NEI supports will continue to be investigator-initiated with an emphasis on at-risk and young investigators. The NEI mission includes a statement to recruit, inspire, and train a diverse workforce so it remains important to focus on young investigators and interest them in NEI research. For targeted initiatives, NEI will focus on identifying the important unanswered questions, anticipate future directions of science, and increase collaboration to push science and advance translation to the clinic. The number of targeted initiatives published each year will be relatively small and will not significantly impact the success rates of investigator-initiated grant applications.

Dr. Del Rio-Tsonis wondered if NEI has collaborations with other agencies on initiatives to remediate disparities in eye health. In response, Dr. Chiang pointed to ongoing trans-agency efforts with the Centers for Disease Control and Prevention (CDC), NIMHD, and other institutes. Future efforts will consider the impact of vision loss on education, quality of life, and how individuals interact in the real world. Dr. Kowluru mentioned that a recent meeting included a session on health disparities and eye health, with an emphasis on artificial intelligence. Dr. Chiang pointed out the strong expertise of NEI-supported investigators in clinical vision science, vision care, and technological methods. However, he noted that there are gaps in sociological expertise relevant to investigation of health disparities. The challenge will be to collaborate with researchers who bring this type of expertise to the investigative team. Translating clinical trial results to the community will provide opportunities to identify disparities and determine how best to communicate findings. It will be important to go beyond traditional methods (e.g., published papers, presentations) to effectively disseminate findings to the community.

Dr. Teller asked if NEI has internships for high-school students or medical school students. Dr. Chiang confirmed NEI and NIH training programs include students from high school through postdoctoral training. He encouraged everyone to contact Dr. Cesar Perez Gonzalez cesarp@nei.nih.gov for questions about these programs.

PORTFOLIO OVERVIEW: Structure, Function, and Diseases of the Cornea
—Dr. George McKie, Program Director, DESP, NEI

Dr. McKie presented an overview of the NEI corneal structure, function, and disease portfolio, which includes preclinical and clinical studies.

Studies of corneal structure and function look at differentiation, contractility, and patterning of corneal keratocytes; homeostasis of the cornea; and maintenance of corneal transparency. Techniques include culture models that mimic the three-dimensional tissue environment, models of corneal nerve damage and transgenic mouse models; multidimensional imaging approaches (in vitro, in situ, and in vivo); single-cell, real-time polymerase chain reaction (qRT-PCR); and flow cytometry. Preclinical studies of corneal disease focus on wound healing, infection (bacterial, fungal, viral), and limbal stem cells; structural conditions such as keratoconus, Fuchs endothelial dystrophy, lysosomal storage disease dystrophy, and Down syndrome; lacrimal gland concerns; treatments; and biomarkers (e.g., ASI NOSI NOT-EY-21-007).

Dr. McKie highlighted several ongoing clinical studies. Seasonal Conjunctivitis Outbreak Reporting and Improved Outcomes (SCORPIO) is an international collaboration that aims to identify pathogens, pathogen evolution, global trends, and immune responses involved in the epidemiology of conjunctivitis. The Mesenchymal Stromal Cell Secretome for Promoting Corneal Regeneration trial aims to accelerate corneal wound healing while limiting unnecessary inflammation and secondary scarring. The Cultivated Autologous Limbal Epithelial Cell (CALEC) project aims to rebuild a healthy surface for the damaged eye using cells from the healthy eye.

In 2021, NEI hosted two workshops relevant to this portfolio: Immunity and Inflammation in the Anterior Segment of the Eye and Investigating the Ocular Surface Microbiome for Low-Biomass Microbial Research. Recently, an NEI-funded investigator published mass spectrometry workflows for proteomic analysis of tear fluid collected via Schimer strips.

NEI is partnering with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Accelerating Medicines Partnership (AMP) – Autoimmune and Immune-Mediated Diseases (AIM). Sjögren’s is one of four autoimmune diseases included in AMP-AIM partnership. Dr. McKie anticipates that this effort will obtain biomarkers from the skin and gut microbiome of Sjögren patients and normal subjects to contribute to the Ocular Microbiome initiative.

Discussion

Dr. Del Rio Tsonis asked Dr. Mckie to explain how secretomes, used in one of the studies she highlighted, are collected for use in patients. Dr. Steinmetz explained that stem cell populations are grown in cultures and the secretomes collected from those cells are used to treat corneal injuries. Dr. Steinmetz noted that the Department of Defense is funding a companion project using stem cells to treat corneal injuries. Dr. Dana elaborated on cells being cultured and applied to injured eyes and while there are some concerns about immunogenicity and scalability of the secretome protein products, the approach is very promising.

PORTFOLIO OVERVIEW: Small Business Innovation Research and Technology Transfer Programs (SBIR/STTR)
—Dr. Paek Lee, Program Director, DESP, NEI

Dr. Lee described the NEI small business research program. The congressionally mandated SBIR is one of the largest sources of early-stage capital supporting small U.S. businesses with commercial promise for private research and development. The goals of the program are to (1) create innovative, high-risk technologies designed to improve health and save lives, and (2) translate these technologies from bench to bedside. In the case of NEI, the goal is to save sight-debilitating conditions and improve quality of life of the blind and visually impaired.

The mandated budget set-aside for SBIR is 3.2 percent. The STTR set-aside is .45 percent of the Institute budget. The STTR program requires a partnership with U.S. research or nonprofit institutions.

Both the SBIR and STTR are three-phase programs. Phase I (R41, R43) is the feasibility and proof-of-concept testing stage. Phase II (R42, R44) focuses on full research and development (R&D) over a 2-year period. Phase III is for commercialization is supported by non-SBIR/STTR funds (e.g., investors, FDA, the marketplace).

Technical and Business Assistance (TABA) awards are available to SBIR and STTR grantees. Small business may request up to $6,500 per year for Phase I and up to $50,000 per year for Phase II projects to support subcontracts or consultants. Details are provided in NOT-OD-21-062. Alternatively, applicants can take advantage of centralized TABA services, such as a needs assessment during Phase I and more specialized consulting services from the NIH Entrepreneur-in-Residence during Phase II. Additional entrepreneurial training is available through the NIH I-Corps™ (Phase I), National Institute on Biomedical Imaging and Bioengineering Concept to Clinic Program and investor coaching.

NEI SBIR/STTR is a cross-cutting program relevant to all areas of the NEI strategic plan. Key areas of interest include preclinical development and validation of therapeutics; clinical and rehabilitation tools; diagnostics and research tools; and assistive technology and telehealth applications. During 2012–2022, funded projects focused on devices (55%) and therapeutics (45%).

Dr. Lee described several current projects, including an aptamer technology that shows promise as an alternative to antibodies and aims for more effective, less frequent treatments with fewer side effects; PhotoBioModulation that uses specific light wavelengths to activate protective and disease-delaying processes in the retina, offering a less-invasive treatment and prevention for dry age-related macular degeneration (AMD) and diabetic retinopathy; devices that measure high-resolution ocular blood flow or oxygenation; adaptive optics-based devices; and artificial intelligence/machine learning-based disease screening technologies.

Dr. Lee also highlighted two initiatives: Translation of BRAIN® Initiative Technologies to the Marketplace (NOT-MH-21-125) for development of imaging and functional tools to revolutionize our understanding of the human brain; and Administrative Supplements to Promote Diversity in Research and Development for Small Businesses (PA-21-345) to attract a healthy influx of new entrepreneurs to engage in this field.

Discussion
Dr. Dana noted that the ultimate success of the program is reflected in the proportion of technologies that become licensed. He wanted to know what proportion of the technologies supported by NEI has made it through advanced rounds of price financing series B and series C or has made it through FDA approval in the past 10 years. Dr. Lee reported that approximately 20 clinical trials were started via the SBIR/STTR programs and that NEI is developing metrics to determine which of these have received FDA approvals.

Dr. Moore asked for clarification about patents, royalties, and license rights and whether there are differences in how SBIRs are handled from grants. Dr. Lee explained that the federal government does not claim any royalties or license rights for SBIR grants.

Dr. Coughlan inquired why the SBIR’s budget is seven times more than the STTR budget and are there major differences in the application success rates between the two portfolios. Dr. Lee reiterated that these budgets are congressionally mandated: 3.2 percent of each IC’s budget is set aside for SBIR and .45 percent for STTR. Dr. Lee noted that there are fewer STTR applications submitted but there are no major between in application success rates between STTRs and SBIRs.

BRAIN® MULTI-COUNCIL WORKGROUP REPORT
Dr. Tirin Moore, NAEC council member and NEI representative to the BRAIN Multi-Council Workgroup.

Dr. Moore is the NEI representative on the Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative Multi-Council Workgroup (MCWG). He highlighted key information from the MCWG’s May meeting, noting that no new concepts were presented for clearance. He encouraged everyone to view the meeting to hear about the scientific highlights that were presented.

BRAIN® Director Dr. John Ngai provided a brief overview of the budget, summarized demographics of BRAIN® investigators and their institutions, described efforts to enhance diverse perspectives among grantees, and outlined some recent scientific advancements.

Recent events include the Brain Behavior Quantification and Synchronization Workshop (March 1–2, 2022); The Brain Across the Lifespan: Tools and Technologies for Measuring the Changing Brain (April 18–19, 2022); and The Neuroethics Working Group (NEWG) Workshop on Continuing Trial Responsibilities (May 24 and May 25, 2022). The 8th Annual Brain Initiative Meeting on June 21 and 22 will serve as a forum to discuss BRAIN-supported projects and bring the BRAIN community together.

Dr. Ngai then discussed the demographics of BRAIN investigators and their institutions. Engineering is the most frequently listed discipline. Although women and minorities are still underrepresented compared to NIH overall, there is no discernable difference in success rate among women and minorities compared to other majority groups. Early and mid-career applicants are more successful than those from advanced career applicants. Applicant institutions are distributed across most states and Puerto Rico but are still concentrated on the East and West coasts. To increase the diversity of perspectives in research, a Plan for Enhancing Diverse Perspectives is required for applications to BRAIN initiatives. Finally, he noted that for research participants in BRAIN awards, the ethnic, racial, and gender representation is fairly well distributed.

CONCEPT CLEARANCE
NEI Center Core Grant for Vision Research (P30) Renewal
—Dr. Ellen Liberman, Program Director, DESP, NEI

Dr. Liberman presented a concept clearance for the renewal of the NEI P30 Center Core Grant for Vision Research (PAR-20-051). The goal of these institutional Center Core Grants is to build research infrastructure within an institution for the purpose of providing technical support to groups of NEI R01-funded investigators. The Core grant supports the cost of shared resources rather than individual R01 grants, creating an economy of scale for institutions that have intensive vision research. In addition, institutions benefit from promotion of a collaborative environment and cost-effectiveness. Grants are required to have an administrative core and three or more resource and/or service cores. Applicant institutions must have a minimum of eight active R01s to be eligible. Any researcher at the institute can use the core facilities.

Discussion

Discussants Drs. Borrás and Moore expressed strong support for the renewal, noting the importance of providing instruments and resources that are beyond the reach of individual R01 grant budgets. A suggestion was made to consider supporting a smaller core center grant for institutions that have less than eight R01s. Council members also recommended updating the examples of the cores provided in the rationale as the need for machine shops has diminished with the advent of 3D printing. Dr. Liberman agreed that the language in the funding opportunity should be updated to reflect new technologies available and resources needed to support those.

A motion to approve the concept was made, seconded, and approved unanimously.

IMPLEMENTATION UPDATE: NIH POLICY FOR DATA MANAGEMENT AND SHARING
—Dr. Mike Lauer, Deputy Director for Extramural Research, NIH

Dr. Lauer provided an update on the implementation of the NIH Data Management and Sharing Policy. The 21st Century Cures Act, passed in 2016, authorized the NIH Director to require data sharing from all NIH awards that generate data. The current policy implements this element of the law. Data sharing policies are not new and have evolved and expanded from the 2003 NIH policy to include sharing policies for specific data types (e.g., 2014 Genomic Data Sharing Policy), research activities (2016 NIH Policy on Dissemination of NIH-Funded Clinical Trial Information), disorders (e.g., Autism Data Sharing Policy), institutes (e.g., National Institute of Mental Health), and programs (e.g., BRAIN®). The updated policy and guidance were released in October 2020 and replace the 2003 data sharing policy. The new policy will be effective for competing applications received on or after January 25, 2023. This policy is not new but raises the level and depth of data sharing required.

The policy includes two requirements: applications must (1) submit a Data Management and Sharing Plan for all NIH-funded research and (2) compliance with the plan approved by the Institute, Center, or Office (ICO). Data sharing should be the default practice and maximized. The plan should be responsibly implemented in a way that protects privacy, rights, and confidentiality and abides by existing laws, regulations, and policies. Plans should be prospective and include all stages of the research process. Plans may be amended over time with approval by the agency.

The extramural plan submission and review process includes submission, assessment, and compliance. Plans must be submitted with the application and include a brief description of the plan in the budget justification section and a full plan as a separate attachment. Peer-reviewers comment on but do not score the budget for the plans. The plans are then assessed and approved by NIH program staff and incorporated into the Terms and Conditions of the Notice of Award. Plans can be revised at any time but need to be approved by agency staff. Compliance with the plan will be monitored at regular reporting intervals and may factor into future funding decisions.

All data should be managed, but not all data need to be shared. Scientific data refers to published or unpublished “factual material…of sufficient quality to validate and replicate research findings.” Data should be accessible as soon as possible but typically not later than publication of results or the end of the award.

Currently available information and tools for understanding the policy include webinars and FAQs. Additional supplemental information, sample plans, and harmonization with the Genomic Data Sharing Policy are planned for the summer and fall. Following implementation, the policy will be assessed for short and long-term goals. The goal is for data sharing to become something that scientists want to do rather than a burden. Dr. Lauer acknowledged Dr. Chiang as a key thought leader in this area and commended his work on thinking about ways to embed this into professional culture.

Dr. Lauer encouraged attendees to visit the NIH Data Sharing website (sharing.nih.gov), which includes the NIH sharing policies for scientific data, genomic data, research tools, model organisms, and clinical trials. The site includes policy overview infographics, decision tools, and step-by-step instructions. Detailed information is provided on planning and budgeting for data management and sharing, proper data management, and methods for sharing scientific data. Information on available repositories is also included.

Dr. Lauer acknowledged that there are additional costs associated for data sharing and that they should be requested in grant application budgets. The Data Management and Sharing Plans will be made public, possibly by posting on NIH RePORTER.

Dr. Chiang thanked Dr. Lauer and his team for their efforts in shepherding this big cultural change in the way science is done.

Discussion

Council members commented on the value of plan templates as well as having sample plans for a variety of experimental designs (e.g., a small mouse study versus a longitudinal study of a 4,000-person cohort including a large battery of tests). Dr. Lauer noted that a simple template will be available soon as well as a series of questions to assist investigators in developing their plans. Eventually there will be a web form to use. The goal is to have sample plans for different scientific fields. Once the policy is implemented, additional examples from the community will be made available.

In response to questions about how to budget for data sharing, Dr. Lauer noted that the policy guidance spells out costs that can be requested, such as fees for data deposition, curation, and maintenance in a repository. Some universities have developed their own framework for calculating the costs of data sharing. A National Academies study provided detail about an appropriate budgetary framework for data management and sharing. It is recognized that grants will become more expensive to comply with the policy.

One council member asked about available repositories for smaller studies (e.g., laboratory-based animal studies). Dr. Lauer pointed out that PubMed Central (PMC) accepts small datasets accompanying author manuscripts for inclusion on PMC. Guidance for authors is available in the NIHMS FAQ. Guidance on repository selection and a searchable database of different types of repositories are available on the sharing.nih.gov site.

Dr. Chiang asked for advice on specific ways to help everyday real-world investigators navigate the data sharing plan. He views this kind of communication as an NEI responsibility. For a long time, within the culture of biomedical research, the published paper has been viewed as the output of a project, and the data are subsidiary to the publication. There is a shift toward thinking about data more broadly as a second output and as something that others can use for the benefit of the community at large. How can NEI share this message and gain community buy-in?

Dr. Lauer noted that data sharing has been the norm in some academic fields (e.g., economics, physics, astronomy) for a long time. As a junior investigator at Cleveland Clinic in the 1990s, Dr. Lauer learned that the National Heart, Lung, and Blood Institute (NHLBI) had a repository for data from clinical trials and epidemiology studies. He obtained access to these data and was able published several important papers that included credit to the original investigators who collected the data.

Several years ago, NHLBI published a paper reporting on the use of their data repository, which highlighted the increasing demand for trial data for secondary analysis that led to high-quality publications that were not necessarily related to the original goals of the project. The world of science is enriched by data sharing. Nature’s Scientific Data journal publishes papers describing datasets and research that advances sharing and reuse of data.

A Council member raised some potential unintended consequences of this policy, for example peer-review judgments on the value, integrity and validity of the data that have not been published. How would this be handed by the peer review community? Dr. Lauer responded that it seems likely peer reviewers have used data from repositories and know their quality, which might lend credence to their use in an application. He acknowledged that this is an open question and that the experience of other areas of science that have a culture of data sharing can be informative. Another member asked about what types of restrictions would be imposed on creative commons licenses, for example. They requested guidance from NIH on these types of questions. Dr. Lauer noted that this was a reasonable request, and that NIH would follow-up on this issue.

GENERAL DISCUSSION
Council members highlighted the following concerns about the Data management and Sharing Policy: budgetary implications of implementing the policy, especially for investigators requesting modular budgets; the lack of data sharing and management expertise within their community, which might be addressed through NIH-wide training; institutions unprepared for the policy and/or lacking repositories; and the need to ensure that data are findable and useable.

A Council member pointed to the policy as an opportunity to upgrade the way research is done. To make reproducibility possible, shared data must be well-documented. Dr. Chiang described the policy as a mechanism for doing better research and increasing the value derived from the public’s investment in research. He hopes that vision science will be a leader in this effort.

OPEN SESSION ADJOURNMENT
Dr. Anderson adjourned the open session of the Council meeting at 2:07 PM.

CLOSED SESSION
This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as amended (5, USC Appendix 2). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

REVIEW OF APPLICATIONS
NAEC members considered 518 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $166,021,213 (direct costs year 01). The Council also considered 434 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $685,466,891 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 952 applications.

ADJOURNMENT
The 161st meeting of the National Advisory Eye Council was adjourned at 4:34 p.m. on June 17, 2022.

CLOSED SESSION ATTENDEES
Council Members Present:
Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Terete Borrás
Dr. James Coughlan
Dr. Reza Dana
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Tirin Moore
Dr. Benjamin Teller

NIH Staff Members Present:
Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Dr. Mary Frances Cotch
Ms. Ashley Dash
Mr. Donald Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Barbara Mallon
Dr. Lisa Neuhold
Dr. Maryann Redford
Dr. Jennifer Schiltz
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Afia Sultana
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Ms. Keturah Williams

CERTIFICATION
These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael F. Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 160th meeting at 10:00 a.m. on Friday, February 11, 2022. The entire meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended virtually. Michael Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen Anderson, PhD, served as Executive Secretary. The meeting was open to the public from 10:00 a.m. until 1:30 p.m. The meeting was closed to the public from 2:30 p.m. until 4:00 p.m. for the review of grant and cooperative agreement applications.

Council Members Present
Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Jose-Manuel Alonso
Dr. Terete Borras
Dr. James Coughlan
Dr. Reza Dana
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Maureen Maguire
Dr. Tirin Moore
Dr. Mary Ann Stepp
Dr. Benjamin Teller

NIH Staff Members Present
Mr. Shawn Adolphus
Dr. Neeraj Agarwal
Mrs. Lisa Applewhite
Dr. Houmam Araj
Ms. Cynthia Best
Dr. Sangeeta Bhargava
Ms. Stephanie Blackford
Ms. Holly Blake
Mr. Nathan Brown
Ms. Monique Clark
Mr. Roland Colbert
Ms. Karen Colbert
Dr. Mary Frances Cotch
Dr. Kevin Czaplinski
Ms. Ashley Dash
Dr. Sunit Dutta
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Ms. Alexandra Gavrilovic
Dr. Susan Gillmor
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Mr. David Higgins
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Jimmy Le
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Renee Livshin
Dr. Barbara Mallon
Dr. George McKie
Dr. Lisa Neuhold
Ms. Barbara Payne
Dr. Maryann Redford
Ms. Amberlynn Reed
Ms. Carissa Reilly-Weedon
Dr. Jennifer Schiltz
Dr. David Schneeweis
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Santa Tumminia
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Ms. Nora Wong
Dr. Chuck Wright
Mr. Michael Wright

Others Present Virtually:

Ms. Leigh Cook
Ms. Kathy Sedgwick, Science Writer

NOTE: Due to the open videocast format of this meeting, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.

Welcome and Introductions
Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA); Dr. Michael Chiang, Chair, NAEC, and Director, NEI

Dr. Chiang called the 160th NAEC meeting to order and welcomed Council members, members of the NEI research and advocacy community, NEI and NIH staff, guest speakers, and the research and advocacy community. Dr. Anderson welcomed new Council members Drs. Reza Dana, Maureen Maguire, and Tirin Moore, who had served in an ad hoc capacity during the October 22, 2021 Council meeting. She acknowledged retiring Council members Drs. Jose-Manuel Alonso and Mary Ann Stepp. Each Council member introduced themselves and gave a brief overview of their research areas.

Council Procedures and Related Matters
Dr. Anderson reviewed Council procedures and etiquette for the Zoom meeting. The open session of the meeting was videocast and will be available on the NIH videocast website.

The next Council meeting will be held virtually on Friday, June 17, 2022. Dates for future Council meetings are listed on the NEI website. An additional Council meeting will be held in August 2022 to review applications submitted to two NEI-issued Requests for Applications (RFAs) considered for funding in Fiscal Year 2022.

Minutes of the October 2021 NAEC meeting were provided in the Electronic Council Book prior to the meeting. A motion to accept these minutes was made, seconded, and approved unanimously by Council members. The approved minutes will be posted on the NEI website.

Director’s Report
Dr. Michael Chiang

Changes at NIH—Dr. Francis Collins stepped down as NIH Director in December 2021. A tribute to Dr. Collins is available. Dr. Lawrence Tabak is the White House appointment to replace Dr. Collins as Acting Director.

NEI Leadership Changes—Dr. Chiang expressed appreciation for the work of Dr. Brian Brooks, who retired as NEI Clinical Director but is continuing as Principal Investigator and Chief of the Ophthalmic Genetics & Visual Function Branch (OGVFB). He also acknowledged the hard work of other NEI staff, including Mr. Russ O’Donnell and Drs. Emily Chew, Teresa Magone, and Santa Tumminia.

Dr. David Schneeweis has been acting NEI Scientific Director since the retirement of Dr. Sheldon Miller in 2019. Applications for this position closed January 31, 2022, and NEI will begin interviews soon.

Acknowledgments and Awards—Dr. Chiang congratulated NEI grantee Dr. Nancy Kanwisher, McGovern Institute for Brain Research at the Massachusetts Institute of Technology, who received the 2022 National Academy of Sciences Award in the Neurosciences for groundbreaking work on the functional organization of the human brain. Dr. Kanwisher is credited with co-discovering and characterizing the fusiform face area in the brain, a region specifically engaged in the perception of faces.

Dr. Robert Hufnagel, Chief of the Ophthalmic Clinical Genetics Section of the OGVFB in the Division of Intramural Research (DIR), has been named NEI’s 2021 Lasker Clinical Research Scholar. Commander Angel Garced, NEI Senior Nurse Consultant/Clinical Trial Coordinator, was deployed to the Northern Navajo Medical Center in January, working alongside the center’s medical personnel to help treat COVID-19 patients.

NEI-funded Research Highlights— Dr. Cecilia Lee and NEI-mentored career awardee Dr. Aaron Lee at the University of Washington School of Medicine conducted a study of over 3,000 individuals with cataracts. The results indicate that post-surgical risk of dementia from any cause was nearly 30 percent lower among adults who had surgery than in those who did not.

NEI intramural researchers Drs. Ruchi Sharma and Kapil Bharti developed an Induced Pluripotent Stem Cell (iPSC)-derived model of geographic atrophy that provides a framework using iPSC-RPE cell lines to model complex disease.

Awardee Dr. Krzysztof Palczewski at the University of California, Irvine used Cryo-Electron Tomography (Cryo-ET) to observe the precise spacing of discs in rod outer segments (ROS), improving understanding of the pathologies of gene mutations in the ROS membrane. The data show that gene mutations could lead to disruption of ROS structural integrity and compromise retina viability in diseases such as retinitis pigmentosa.

NEI Strategic Plan, 2021–2025—The NEI Strategic Plan (Plan) was published in parallel with editorials in leading peer-reviewed ophthalmology and optometry journals that summarize the plan. The Strategic Plan outlines priorities over the next five years and includes seven crosscutting areas of emphasis to foster collaboration within the community and join mechanistic science with clinical applications. Dr. Chiang briefly outlined current and planned NEI activities related to several areas of emphasis.

Projects related to the Regenerative Medicine area of emphasis include the Age-related Macular Degeneration (AMD) Integrative Biology Initiative for studies using patient-derived iPSC lines to characterize cellular phenotypes and functional features. NEI also is setting up review panels and judges for the 3-D Retina Organoid Challenge (3-D ROC), a prize competition to develop a physiologically competent three-dimensional retina organoid model. The final submission deadline for 3D-ROC is June 1, 2022. Under the Audacious Goals Initiative (AGI), NEI issued NOT-EY-22-002 to encourage novel research that incorporates newly identified factors into new or existing models of visual systems regeneration.

The NEI Anterior Segment Initiative (ASI) is supporting current programs related to the Immune System and Eye Health area of emphasis including a recent RFA to explore neuronal cell types, cell-to-cell interactions, and peripheral and central circuitry involved with normal anterior segment homeostasis (RFA-EY-21-004) and a Notice of Special Interest (NOSI) for the Identification and Development of New Biomarkers and Effective methods to Diagnose Dry Eye Disease (DED) (NOT-EY-21-007). Other activities included the NEI ASI Symposium: Ocular Surface Microbiome—Best Practices for Low Biomass Research and the Immunity and Inflammation in the Anterior Segment of the Eye Workshop.

Current programs related to the Genes to Diseases Mechanisms area of emphasis include participation in the Accelerating Medicines Partnership® Bespoke Gene Therapy Consortium (BGTC) that is designed to develop platforms that ease roadblocks to gene therapy development for ultra-rare diseases. The BGTC aligns with NEI’s mission to accelerate paths to gene therapy for monogenic disorders relevant to NEI (e.g., Usher syndrome, Albinism) and facilitate scale-up of industry partners offering manufacturing capabilities and expertise as in-kind contributions.

NEI signed on to funding opportunities related to the Public Health & Disparities Research area of emphasis to improve research for persons with multiple chronic conditions, adults with Type 2 Diabetes, and immigrant populations as well as measures and methods and patient-clinician relationships. In addition, NEI is participating in Phase III of the NIH RADx-UP Initiative to decrease barriers to COVID testing in vulnerable populations. In addition, NEI released NOT-EY-22-010 to address accessibility inequities with COVID home-based testing for individuals who experience visual impairment.

Community Partnerships to Advance Science for Society (ComPASS)—In January 2022, the NIH Council of Councils approved the concept for ComPASS, a program to facilitate and implement a cross-Institute and Center framework for health equity structural intervention research. The program aims to catalyze, deploy, and evaluate community-driven interventions and partnerships to reduce health disparities. Dr. Michael Steinmetz represents NEI on the ComPASS Working Group.

Diversity, Equity, Inclusion and Accessibility (DEIA)—The NIH Office of the Director released a Request for Information (RFI) inviting public comment on the framework for the NIH-Wide Strategic Plan for DEIA. NIH-wide activities and events related to DEIA include the UNITE Initiative’s Power of an Inclusive Workplace Recognition Project and the Scientific Workforce Diversity Seminar Series — hosted by NIH Chief Officer for Scientific Workforce Diversity (COSWD) Dr. Marie A. Bernard — to galvanize the wider scientific community around the success of cohort recruitment models geared toward enhancing DEIA for faculty. Dr. Chiang noted that DEIA standards must be included in all calendar year 2022 performance plans across NIH.

NEI is participating in an NIH-wide NOSI NOT-OD-22-057 to offer administrative supplements to outstanding mentors who have demonstrated commitment to enhancing DEIA in science. Funds will support additional research within the scope of the parent grant to develop curricula or training activities to enhance mentor training, foster the research career development of additional trainees, and/or fill additional trainee slots.

NEI’s DEIA Strategic Plan is in phase 3, which includes continuing Council sessions, defining strategic pillars, establishing strategy groups, developing a strategic plan for 3–5 years, and preparing for organizational DEIA kickoff.

Data Science Updates—Following the October 2021 Council discussion on barriers to research involving images and a need for ocular imaging standards, NEI issued an RFI for input on ocular imaging standards (NOT-EY-22-008). The NIH Office of Data Science Strategy Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD) Program will study how to use artificial intelligence (AI) to address challenges of health disparities and minority health by developing diverse data sets, detecting bias, and emphasizing the role of objective image data in AI research. An advisory committee co-chaired by Dr. Chiang currently is being formed. A Virtual Community Building Convention was held February 16–18, 2022, to learn from the community, stakeholders, and those who work at all levels in diverse settings that reduce disparities and promote equality.

NEI Programs, Training, and Workplace—The NEI Clinician Scientist Reviewer Program aims to increase the pool of early-career clinician scientists to serve as reviewers for NEI and encourage clinician scientists from diverse backgrounds to apply. NEI also established the Diversity in Vision Research & Ophthalmology summer program for students in college and graduate and professional schools. Applications for the Program still are being accepted. In March 2021, NEI started the NEI DEIA Council to focus on workplace issues within the Institute.

NIH Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative—Statistics for fiscal year (FY) 2021 show that 20 to 25 percent of the BRAIN portfolio deals with vision research, and another 20 percent is research conducted by NEI grantees who are doing non-vision research. This highlights how closely visual neuroscience is tied to the larger neuroscience community.

NIH Blueprint Updates—The NIH Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) is a new network for neuroscience that focuses on large biologic macromolecules (e.g., proteins, antibodies), gene- and cell-based therapies, and other novel emerging therapies (e.g., microbial and microbiome therapies) from optimization to Phase I clinical testing.

NEI Budget Update—NEI is operating under a Continuing Resolution (CR) that expires on February 18, which means that the Institute is operating under the FY 2021 budget. A new CR is expected, but the timeframe for approval of a federal budget for FY 2022 is unclear.

Discussion

Council members asked about inclusion of children as vulnerable populations in research and commented on data sharing and harmonization incentives. Dr. Chiang noted that NEI is building relationships with the National Institute of Child Health and Human Development at the intersection of children and vision. Dr. Anderson noted that the NIH Office of Data Science Strategy (ODSS) is providing detailed compliance guidance for investigators. The ODSS website includes a list of general repositories where data can be stored. An ODSS representative can be invited to provide more detail at a future Council meeting.

Portfolio Overview
Low Vision and Blindness Rehabilitation: Dr. Cheri Wiggs, Program Director of Low Vision and Blindness Rehabilitation, Division of Extramural Science Programs (DESP), NEI

Dr. Wiggs presented an overview of the NEI low vision and blindness rehabilitation portfolio, which focuses on expanding opportunities for people who are blind or have low vision and aligns with NEI’s mission to eliminate vision loss and improve quality of life through vision research.

Visual impairment includes low vision due to lack of light detection; congenital conditions or advanced age; and ocular or cortical impairments.

The program encompasses basic science (studies on behavioral and perceptual neural systems affected by vision impairment); applied and translational science (assessments and intervention development and evaluation); and technology development (accessibility devices and early-stage technologies).

Dr. Wiggs described encouraging trends and future directions. Categories are less discrete in that basic science is being exported to applied settings and technology development is having an impact on assessments and rehabilitation strategies. Work is advancing through collaborations and integrated teams across many fields (e.g., engineers, vision scientists, rehabilitation specialists). Access to data and technology related to low vision and blindness rehabilitation is growing.

Discussion

Council members commented on progress in assisting individuals with disabilities, building a proactive channel between NEI and impactful media to promote feasible changes, increasing awareness of NEI funding in this area, and identifying optimal methods for targeting individuals with low vision. It was noted that the lack of a rich history and precedents for this understudied area leads to lower application scores due to disparate reviewer opinions.

TRANSLATIONAL RESEARCH PROGRAM—Dr. Tony Gover, Program Director, Bioengineering and Technology and Cornea Injury and Repair, DESP, NEI

Dr. Gover described the NEI Translational Research Program (TRP) on Therapy for Visual Disorders (PAR-20-319). Applications for these R24 awards should focus on producing preclinical data that support an investigational new drug (IND) or investigational device exemption (IDE) application to the U.S. Food and Drug Administration (FDA). Applicants may request up to $1.5 million per year total direct costs for 5 years.

During FY06–21, NEI made 20 awards, for a total investment of $175,368,286. More than half of these awards (55%) have closed, leaving 45 percent still active. TRP awards have produced 850 published articles, 15 patents, 8 IND/IDE approvals, 7 active clinical trials, and 1 FDA approved product.

Dr. Gover described three specific TRP projects: Transscleral Drug Delivery for Retinal Disorders, Photo-switchable Channel Blockers for Treatment of Blindness, and rAAV-CNGB3 Gene Therapy for Achromatopsia: Translational Research Studies.

NEI continues to support innovative and productive researchers to translate medical products to the clinic. Numerous NEI and NIH programs support translation research for NEI extramural investigators. Investigators should reach out to Program Officers to determine the best translational opportunity.

Discussion

Typically, these applications involve significant requirements for submission of plans to develop technology beyond specific aims. Applications with a well-planned regulatory strategy have minimized risk.

TRIENNIAL REPORT ON THE INCLUSION OF WOMEN AND MINORITIES IN CLINICAL TRIALS—Dr. Hongman Song, Program Analyst, DESP, NEI

Dr. Song summarized NEI’s triennial report certifying compliance with NIH policy on inclusion guidelines for the period 2019–2021. Gender, race, and ethnicity of participants enrolled in NEI-supported extramural and intramural clinical research studies were representative of the United States population during this 3-year period. Data for 2021 show broad age distributions in clinical trials. NEI strategies to achieve compliance include communication, education, training, documentation, tracking, monitoring of Phase III trial analyses, and Program Director oversight.

Discussion

One council member asked about differences between males and females for different trials and disorders. Dr. Song noted that this analysis was not performed for specific diseases but could be done in the future. Dr. Song also clarified that the data included both intramural and extramural studies. Another council member asked for the rationale for separating Hispanics from other ethnicities. Dr. Song indicated that this is how NIH classifies ethnicity and that this is separate from racial identity. One member asked about whether there was data about compliance from the different groups. Dr. Song noted that program officers are required to monitor compliance in individual trials and that they have seen no significant differences in compliance among the groups.

Concept Clearances
NEI Research Grant for Vision-Related Secondary Data Analysis (Reissue)— Dr. Sangeeta Bhargava, Program Director, DESP, NEI

Renewal of the NEI Research Grant for Vision-Related Secondary Data Analysis (PAR-19-260), was proposed. The Program Announcement with special review criteria (PAR) encourages submission of applications to conduct secondary analyses of existing vision-related data resources. Proposals will take advantage of the wealth of data generated by NEI’s extensive portfolio of clinical trials and large-scale epidemiology research projects. Applications may be related to, but must be distinct from, the specific aims of the original data collection and may be used to develop new statistical methodologies or test hypotheses. Grants must not be used to support the collection of new data.

Discussion

Discussants Drs. Maguire and Harnett reported that this Funding Opportunity Announcement will support new methodology in alignment with NEI’s mission of data transparency.

A motion to approve the concept was made, seconded, and approved unanimously.

NEI Clinical Research Study Planning Grant (Reissue)—Dr. Jimmy Le, Program Director, DESP, NEI

Renewal of the NEI Clinical Research Study Planning Grant (PAR-19-231), which expires this year, was proposed. The proposed PAR would employ an R34 grant mechanism to support planning of collaborative clinical research on eye and vision conditions, which would permit early peer review of the proposed study rationale, provide support for the development of a detailed Manual of Procedures (MOP), and support the development of other essential study elements. The grant may not be used to generate data on the effects of any proposed intervention. Funding of a planning grant also does not guarantee nor imply funding for any subsequent competitive application for the support of a full-scale collaborative clinical study.

Discussion

Concept discussants Drs. Maguire and Gardner commented on the value of preliminary screening of clinical studies that prevent researchers from investing in a project that may not succeed. Planning grants are important for new clinical research groups that have not already established ongoing research.

A motion to approve the concept was made, seconded, and unanimously approved.

BRAIN Multi-Council Working Group (MCWG) Update—Dr. Tirin Moore

Dr. Moore is the NEI representative on the BRAIN® Initiative MCWG. He highlighted key information from the Working Group’s January meeting. BRAIN Director Dr. John Ngai’s commentary, “BRAIN 2.0: Transforming neuroscience,” described the Initiative’s new phase and three large new projects that promise to transform neuroscience research and treatment of human brain disorders.

Dr. Moore mentioned three upcoming BRAIN-sponsored workshops:

April 18-19, 2022: The Brain Across the Lifespan: Tools and Technologies for Measuring the Changing Brain
March 1-2, 2022: Brain Behavior Quantification and Synchronization Workshop
June 21, 2022: 8th Annual BRAIN Initiative Meeting
The MCWG approved a brain functional imaging and technology development concept to address priority areas from the 2025 Brain Report and seeks to improve high-resolution functional magnetic resonance imaging by an order of magnitude and analyze naturalistic behaviors. Current BRAIN initiatives can be found here.

Retiring Council Member Remarks—Drs. Jose-Manuel Alonso and Mary Ann Stepp

Dr. Alonso commented on the joy of meeting with colleagues, the hardworking NEI team, the Program Officers who helped him with his applications, and especially acknowledged Dr. Shefa Gordon for his efforts in developing the NEI Strategic Plan.

Dr. Mary Ann Stepp stated that she was honored to be part of a group of talented professionals. She expressed excitement about Dr. Chiang’s energy and leadership and her expectation of positive change for the future.

Dr. Chiang thanked Drs. Alonso and Stepp for their contributions to the institute and expressed appreciation for their comments, advice, and input. He looks forward to meeting in person again and for their continued contributions to communicating with the extramural community.

General Council Discussion
Dr. Anderson opened the floor for general discussion by Council members. Council comments focused on the importance of connecting science to practice and related communications challenges. She acknowledged that NEI has initiated several new avenues of communications (blogs, newsletters, press releases). Another member raised the issue of increasing clinician awareness of clinical trials and studies relevant to their patients perhaps through some sort of portal; building awareness of funding opportunities; and encouraging members of the research community—particularly new investigators—to connect with Program Officers.

Dr. Chiang asked members to NEI know when they have new publications coming out so that NEI can highlight them. He also acknowledged that connecting science with clinical practice is an important problem and asked whether it would be useful to form a workgroup to develop recommendations on how to translate research to the real word. One member noted that clinicians often have limited bandwidth to follow the science but that there are some platforms that offer this service. They suggested linking NEI-sponsored research to these platforms.

It was generally agreed that a working group should be formed to consider ways to address these communications and awareness challenges. It was suggested that the group could start with how to communicate the clinical trials findings to clinicians and provide some type of referral service. Another member suggested it would be helpful to connect researchers with businesses to develop their product. Dr. Chiang asked how NEI could better communicate funding opportunities supported by NEI and encourage new investigators to contact program officers with their ideas. Council members reiterated the importance of new investigators reaching out to program officers.

Review of NAEC Operating Procedures—Dr. Kathleen Anderson

Dr. Anderson noted that revised NEI Advisory Council Operating Procedures were provided in the Electronic Council Book. She noted that revisions include minor changes to clarify policy language and streamline text. One substantive change is proposed: to include an option for Council members to provide expedited application review electronically. This option would be implemented for applications that involve time limits or unique resources, such as applications received in response to RFAs, applications deferred for some reason, or applications reviewed due to a successful appeal. Council members have the option to request that these applications be discussed at a meeting if they are not comfortable providing concurrence electronically.

There was a motion and a second to approve the revised Operating Procedures; the motion carried.

Open Session Adjournment
Dr. Anderson adjourned the open session of the Council meeting at 1:40 PM.

Closed Session
This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as amended (5, USC Appendix 2). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

Review of Applications
NAEC members considered 562 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $171,698,381 (direct costs year 01). The Council also considered 405 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $238,217,604 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 967 applications.

Adjournment
The 160th meeting of the National Advisory Eye Council was adjourned at 4:00 p.m. on February 11, 2022.

Closed Session Attendees
Council Members Present:

Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Jose-Manuel Alonso
Dr. Terete Borras
Dr. James Coughlan
Dr. Reza Dana
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Maureen Maguire
Dr. Tirin Moore
Dr. Mary Ann Stepp
Dr. Benjamin Teller

NIH Staff Members Present

Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Sangeeta Bhargava
Ms. Holly Blake
Mr. Nathan Brown
Mr. Roland Colbert
Mr. Samuel Edwards
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Ms. Alexandra Gavrilovic
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Ms. Lateefah Hill
Dr. Brian Hoshaw
Ms. Alicia Kerr
Dr. Jimmy Le
Dr. Paek Lee
Dr. Ellen Liberman
Dr. Barbara Mallon
Dr. George McKie
Ms. Barbara Payne
Dr. Maryann Redford
Ms. Carissa Reilly-Weedon
Dr. Jennifer Schiltz
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Afia Sultana
Dr. Santa Tumminia
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Ms. Keturah Williams
Ms. Nora Wong
Dr. Charles Wright

Certification
These minutes were submitted for the approval of the council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 162nd meeting at 1:30 p.m. on Tuesday, August 9, 2022. The entire meeting was closed to the public for the review of grant and cooperative agreement applications. All participants attended virtually. Michael Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen Anderson, PhD, served as Executive Secretary. The meeting concluded at 3:05 pm.

Closed Session
This meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as amended (5, USC Appendix 2). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

Review of Application
NAEC members considered 24 research grant applications on which NEI was the primary Institute; these applications requested a total of $13,208,531 (direct costs year 01). The Council also considered 4 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $16,956,355 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 28 applications.

Adjournment
The 162nd meeting of the National Advisory Eye Council was adjourned at 3:05 p.m. on August 9, 2022.

Closed Session Attendees
Council Members Present:
Dr. Michael F. Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Terete Borras
Dr. James Coughlan
Dr. Reza Dana
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Tirin Moore
Dr. Benjamin Teller

NIH Staff Members Present:
Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Mr. Donald Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tom Greenwell
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Paek Lee
Dr. George McKie
Dr. Lisa Neuhold
Ms. Barbara Payne
Ms. Melanie Reagan
Dr. Jennifer Schiltz
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Santa Tumminia
Dr. Cheri Wiggs
Dr. Charles Wright

Certification
These minutes were submitted for the approval of the Council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 159th meeting at 10:00 a.m. on Friday, October 22, 2021. The entire meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended virtually. Michael F. Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair, and Kathleen C. Anderson, PhD, served as Executive Secretary. The meeting was open to the public from 10:00 a.m. until 1:38 p.m. The meeting was closed to the public from 2:00 p.m. until 3:15 p.m. for the review of grant and cooperative agreement applications.

Council Members Present
Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Jose-Manuel Alonso
Dr. Terete Borras
Dr. James Coughlan
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Mary Ann Stepp
Dr. Benjamin Teller

NIH Staff Members Present
Mr. Shawn Adolphus
Dr. Neeraj Agarwal
Ms. Lisa Applewhite
Dr. Houmam Araj
Ms. Cynthia Best
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Dr. Emily Chew
Ms. Karen Colbert
Mr. Roland Colbert
Dr. Mary Frances Cotch
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Ms. Alexandra Gavrilovic
Dr. Susan Gillmor
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Dr. Peter Guthrie
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Jeanette Hosseini
Dr. Jimmy Le
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Renee Livshin
Dr. George McKie
Dr. Sheldon Miller
Ms. Barbara Payne
Ms. Melanie Reagan
Dr. Maryann Redford
Ms. Amber Reed
Ms. Carissa Reilly-Weedon
Dr. Jennifer Schiltz
Dr. David Schneeweis
Dr. Mohor Biplab Sengupta
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Afia Sultana
Ms. Sharon Taylor
Dr. Santa Tumminia
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Ms. Maria Zacharias

Guests:

Dr. Reza Dana
Dr. Jayashree Kalpathy-Cramer
Dr. Curtis P. Langlotz
Dr. Maureen Maguire
Dr. Tirin Moore

NIH Contractors Present
Dr. Fernanda Ruiz

NOTE: Due to the open videocast format of this meeting necessitated by the COVID-19 pandemic, additional NIH staff and members of the public were able to live stream (251 views). the open session of the meeting. The videocast will be archived and available to the public for later viewing.

Welcome and Introductions
Dr. Kathleen Anderson, Executive Secretary, NAEC, and Director, Division of Extramural Activities (DEA); Dr. Michael F. Chiang, Chair, NAEC, and Director, NEI

Dr. Anderson called the 159th NAEC meeting to order and welcomed Council members, the NEI research and advocacy community, NEI and NIH staff, and guest speakers. Dr. Chiang welcomed new Council members Drs. Reza Dana, Maureen Maguire, and Tirin Moore, attending in an ad-hoc capacity. Drs. Reza Dana, Maureen Maguire and Tirin Moore introduced themselves and gave a brief overview of their research areas.

Council Procedures and Related Matters
Dr. Kathleen Anderson

Dr. Anderson reviewed Council procedures and etiquette for the Zoom meeting. The open session of the meeting was videocast and is available on the NIH videocast archive website.

The next Council meeting will be held virtually on February 11, 2022. Dates for future Council meetings are listed on the open session agenda and on the NEI website.

Minutes of the June 2021 NAEC meeting were provided in the Electronic Council Book prior to the meeting. A motion to accept these minutes was made by Council Member Mary Elizabeth Hartnett, seconded by Council Member Mary Ann Stepp, and approved unanimously by Council members. The approved minutes will be posted on the NEI website.

Director’s Report
Dr. Michael F. Chiang

Dr. Chiang noted that he has focused on how the Council can move the eye and vision research field forward. Each Council meeting will include a special session focused on a topic of importance to the eye and vision community. The special topic for today’s meeting is data sharing. He encouraged Council members to identify special topics of interest that could lead to actionable items and advance the field.

Upcoming Changes at NIH—Dr. Francis Collins will step down by the end of 2021. As the longest serving NIH Director, Dr. Collins has had many accomplishments, including work on diversity, equity, and inclusion, and the COVID-19 pandemic. His successor has not been named at this time. Dr. Michael Gottesman is planning to step down as the NIH Deputy Director for Intramural Research but will remain in the position while NIH undertakes a nationwide search for his replacement.

Recent Changes at NEI—Dr. Chiang expressed appreciation for the work of Dr. Steven Becker, who is leaving the Office of Regenerative Medicine (ORM). Dr. Tom Greenwell, a Program Director in NEI’s Division of Extramural Science Programs and active member of the Audacious Goals Initiative (AGI) Working Group, has been named Acting Associate Director, ORM. Ms. Carissa Reilly-Weedon joined NEI as a Grants Management Specialist in the DEA.

NEI Staff Searches—Dr. David Schneeweis has been acting NEI Scientific Director since the retirement of Dr. Sheldon Miller in 2019. A search committee comprising senior-level NIH staff and members of the extramural community has been established to identify a permanent NEI Scientific Director.

Awards—Dr. Chiang congratulated Dr. Joshua Miele, a former NEI grantee who has developed technologies for blind and visually impaired individuals, for receiving the 2021 MacArthur Fellow award. Dr. Chiang announced that NEI grantees Drs. Zhigang He, Kafui Dzirasa, and Marylyn Ritchie have been elected to the National Academy of Medicine.

Why NEI’s Work Matters—NEI-funded work has had an enormous impact on quality of life and science. NEI has supported the work of many Nobel Prize winners as well as many seminal innovations that have been generalized to other research.

Revised NEI Mission Statement—The NEI mission statement has been revised as follows: The mission of the National Eye Institute is to eliminate vision loss and improve quality of life through vision research. NEI aims to achieve this mission by providing leadership to drive innovative research; foster collaboration; recruit, inspire, and train a talented and diverse new generation of individuals; and educate health care providers, scientists, policymakers, and the public about advances in vision research and their impact. Dr. Chiang expressed hope that NEI becomes a mission-driven organization.

NEI Strategic Plan—The Strategic Plan is focused on seven cross-cutting areas of emphasis—From Genes to Disease Mechanism; Biology and Neuroscience of Vision; Immune System and Eye Health; Regenerative Medicine; Research Needs, Gaps, and Opportunities; Individual Quality of Life; and Public Health and Disparities Research—to foster collaboration within the community and join mechanistic science with clinical applications. The Strategic Plan will be published on November 1, 2021 in parallel with editorials in peer-reviewed journals that will explore different aspects of the plan and mission statement. The Strategic Plan also will be messaged via a podcast, academic talks, social media, and news outlets.

The Strategic Plan will be implemented through initiative concepts developed by seven internal trans-NEI workgroups including program staff, review officers, intramural researchers, and policy staff. NEI workgroups will collaborate on overlapping opportunities (e.g., building of artificial intelligence [AI] and bioinformatics databases, new disease models, cost-effective health services). Priorities will be established based on public feedback, existing initiatives, clinical impact, scientific opportunity, feasibility, and resource utilization. Dr. Chiang aims to bring recommendations to Council for clearance in February 2022.

Update on Anterior Segment Initiative—A symposium titled “Investigating the Ocular Surface Microbiome: Best Practices for Low-Biomass Microbial Research” was held in August 2021. The symposium focused on characterizing microorganisms in a low-biomass niche, which is a challenge due to high signal-to-noise ratio. The executive summary is available online.

NIH Council of Councils—The Council of Councils recently approved the Somatic Cell Genome Editing Program, which aims to accelerate development of genome-editing therapeutic agents by facilitating studies that enable Investigational New Drug applications, establishing pathways to regulatory approval, and disseminating successful strategies for first-in-human clinical trials.

Advanced Research Projects Agency for Health (ARPA-H)—President Biden recently communicated to Congress that NIH should create ARPA-H, which aims to benefit the health of all Americans by catalyzing health breakthroughs that cannot readily be accomplished through traditional research or commercial activity. Eye and vision research representative organizations (e.g., American Academy of Ophthalmology) participated in recent discussions between the White House Office of Science and Technology Policy (OSTP), NIH, and stakeholder groups.

Workforce Diversity in Vision Science—NEI has multiple training programs to achieve the NEI mission of recruiting, inspiring, and training a talented and diverse new generation to strengthen the vision workforce. These include the NEI Clinician Scientist Reviewer Program and the 2022 Summer Diversity in Vision Research and Ophthalmology Program (DIVRO), which has an application deadline of March 1, 2022. Individuals from diverse backgrounds and underrepresented groups are encouraged to apply to these programs.

Diversity, Equity, Inclusion, and Accessibility—The NEI Diversity, Equity, Inclusion, and Accessibility (DEIA) Council, comprising NEI staff and a consultant group, is surveying the NEI workforce to understand strengths, opportunities, and challenges within NEI and develop a plan to foster the best environment at NEI.

Dr. Chiang provided an overview of NEI funding for awards to promote diversity for Fiscal Years (FY)2015–2020. Funding awarded in the form of diversity supplements, F31 diversity awards, and Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Diversity awards has increased over time.

Artificial Intelligence/Machine Learning Consortium to Advance Health Equity and Researcher Diversity (AIM-AHEAD)—AIM-AHEAD was established to address the needs of marginalized communities through maximizing standardization of electronic health records and AI applications by building infrastructure and workforce. The University of North Texas Health Science Center was awarded $50 million to lead the program’s coordinating center. Other institutions were also funded to conduct training and research, build infrastructure, and collect data.

NIH Common Fund Programs—Grant applications are under review for the NIH Common Fund Bridge to Artificial Intelligence (Bridge2AI). Dr. Chiang noted that numerous applications were received from vision research groups.

Ophthalmic Imaging Standards—Dr. Chiang reminded Council members about his previous presentation on the lack of standardization of ophthalmic imaging devices as a challenge to clinical care. NEI is planning an Imaging Standards Workshop to identify opportunities and barriers to adoption of standards for interoperability in ophthalmic imaging for clinical care and research. In preparation for this workshop, NEI is meeting with the Office of the National Coordinator for Health Information Technology and the Food and Drug Administration (FDA) to gather perspectives from key stakeholders (e.g., clinicians, researchers, patients, industry).

NAEC Budget Update—Ms. Karen Colbert, NEI Budget Officer, provided an overview of estimated spending for FY 2021. Over 84 percent of the budget was allocated to extramural research, 12 percent was spent on intramural research, and 4 percent was spent on research support. The federal budget for FY 2022 has not been approved, and NIH is operating under a Continuing Resolution that is in effect until December 3, 2021. The funding NEI is awarded is equivalent to the number of days included in the bill (i.e., 17.53 percent of the FY 2021 budget). Although it is unclear when the federal budget for FY 2022 will be passed, Ms. Colbert expressed optimism that Congress will provide appropriations for FY 2022.

The President’s budget includes a 2.7 percent increase above last year’s appropriation, the House proposed a 5 percent increase, and the Senate proposed a 2.6 percent increase. Because all of the proposed federal budgets include an increase for NEI, it is likely NEI will receive an actual increase.

The FY 2022 President’s budget includes $51.7 billion for NIH (a larger increase than the House or Senate budgets) and $6.5 billion for ARPA-H. The funding research priorities highlighted in the President’s budget and House and Senate bills include Alzheimer’s Disease, the BRAIN Initiative, the Helping to End Addiction Long-term Initiative℠ (HEAL)/opioids/pain research, health impacts of climate change, firearm research, and cybersecurity.

NEI Audacious Goals Initiative—Dr. Tom Greenwell, Acting Director of the Office of Regenerative Medicine, presented an update on the AGI. Three new AGI Translational Model awards have been made. The recipients are Dr. Jason Meyer, Indiana University and Oregon Health Sciences University; Dr. Juliette McGregor, University of Rochester, Wisconsin, and University of California, Berkley; and Dr. Yinbing Fu, Baylor College of Medicine. Two of these projects focus on photoreceptor replacement, and one focuses on retinal ganglion replacement. The awardees will join a group of five previously awarded projects in a consortium.

AGI progress over the past 7 years is being assessed. The AGI Steering Committee is drafting an outline of the roadmap for the future of this initiative. AGI achievements will be highlighted in a publication in the near future. A second publication will outline the steps needed to achieve AGI’s goals.

Council Discussion—Council Member Jose-Manuel Alonso asked about barriers to the development of imaging standards and suggested that vendors are an important partner in these discussions. Dr. Chiang agreed that researchers must work with both vendors and users to address this challenge. Council Member Benjamin Teller asked about when the 2022 budget would be announced. Karen Colbert explained the status of the current budget discussions in Congress.

Data Sharing and Management Session
Dr. Michael F. Chiang; Ms. Kerry Goetz, Associate Director, NEI Office of Data Science and Health Informatics; Dr. Jayashree Kalpathy-Cramer, Harvard University; Dr. Curtis Langlotz, Stanford University

Dr. Chiang introduced the session and emphasized the need to harmonize the vast amounts of data that are being produced to advance the field. A new NIH policy for data management and sharing (Final NIH Policy for Data Management and Sharing) will become effective on January 25, 2023.

NIH Data Management and Sharing Policy—Ms. Goetz described the rationale for data sharing in the scientific community and the history of the data sharing policy at NIH. Data sharing contributes to the conduct of better science through facilitation of reproducibility, collaboration, and acceleration of science.

The Findability, Accessibility, Interoperability, and Reuse (FAIR) data principles optimize the reusability of data and guide data sharing and management. Implementation of these principles must involve policymakers, researchers, and data repository creators.

The new NIH data management and sharing policy is designed to make data management and sharing a default practice and ensure that investigators conduct prospective planning for informed consent and data reuse. This policy applies to all NIH-funded research and includes draft data management and sharing plan templates and guidance for selection of data repositories. NIH Institutes, Centers, and Offices can develop their own frameworks. Scientific data (including negative results) are to be shared no later than time of publication or end of award. The policy includes allowable costs such as data curation, development of supporting documentation, and local data management considerations. Applicants must submit a data sharing and management plan that describes the qualitative and/or quantitative output they expect to share and explains how data will be managed. The plan can be updated as the project progresses.

Many details for policy implementation remain to be determined. Additional training and supplemental materials for extramural investigators and NIH staff will be released closer to the effective date.

Benefits and Challenges of Data Sharing: A Data Scientist’s Perspective—Dr. Kalpathy-Cramer thanked the scientific community for sharing data that enabled her to conduct research. The value derived from data sharing includes reproducibility, ethical and societal good (i.e., maximal use of resources), support of all aspects of data science research, new research, technical methods development, and education.

Evidence shows that patients and patient advocates are supportive of sharing their clinical data. Dr. Kalpathy-Cramer noted that diverse datasets are necessary to reduce healthcare disparities, but these are currently lacking. The paucity of appropriate bioinformatics and tools is a challenge for data sharing.

Data sharing is also critical for data science because it enables building of new models, transfer of learning, external validation, and continuous learning. The availability of datasets has facilitated the recent explosion of AI and data science publications in medical literature. Public datasets are also critical to the development and dissemination of novel methods and for the development of educational opportunities. They also lead to numerous citations that benefit researchers.

The value of data increases through annotation and curation, use of common terminology, and adherence to FAIR guidance. The challenges of data sharing include cost (e.g., time, storage, computation), risk of personal health information leaks and reidentification, and institutional barriers.

Data repositories also create challenges for data sharing such as barriers to data migration due to policies, loss of demographics, and loss of synchronization to additional data elements in anonymized data. Thus, central and distributed data resources are needed to support different use cases and scenarios.

Overcoming Barriers to Data Sharing—Dr. Langlotz thanked his colleagues at the Center for Artificial Intelligence in Medicine and Imaging (AIMI) who are using deep learning algorithms and big data to improve health. He briefly described the different projects funded through the AIMI Seed Grant Program. He described his past work on the development of frameworks for the use and sharing of clinical data and a roadmap for translational research on AI in medical imaging. Through this work, he found that data sharing is both a barrier (i.e., lack of data is a bottleneck) and enabler of great research.

A number of available large imaging datasets are not easy to access, and some are not structured for machine learning research. As part of its data release program, AIMI has publicly released a large number of AI-ready radiology datasets that are browsable and searchable. Interdisciplinary collaboration is involved in solving clinical questions by formulating a research question, requesting a dataset, curating and labeling the data, conducting the experiment, publishing the results, and releasing the data. The availability of these datasets is highlighted through data science challenges that engage a broad audience.

Dr. Langlotz described the barriers to data sharing (AI- and organizational readiness) and how AIMI overcame these challenges. Barriers to AI-readiness include volume of the dataset, labels, and diversity. Barriers to organizational readiness include organization capacity (many or no privacy offices, lack of an Institutional Review Board), risk aversion (Health Insurance Portability and Accountability Act [HIPAA] breaches, public announcements), legal deliberations (patient consent, data use agreements, commercial use), technical factors (deidentification, format harmonization, data hosting, user tracking), and cost.

An analysis of the geographic distribution of cohorts to train deep learning algorithms showed that the datasets used for deep learning primarily come from California, New York, and Massachusetts. This lack of diversity prompted the development of the Medical Imaging and Data Resource Center (MIDRC), an NIH-funded research data repository, by the American College of Radiology, the Radiological Society of North America, and the American Association of Physicists in Medicine. MIDRC receives and processes data, conducts machine learning, and aggregates the data, which are then made public. MIDRC also works with FDA and the National COVID Cohort Collaborative (N3C) on different research efforts. This repository contains over 60,000 COVID imaging studies from multiple sites across the country, which has increased data diversity.

Dr. Langlotz noted that wide public release of data is possible. Inexperienced organizations need help from centers of excellence, and large organizations need guidance on best practices. Sustainable models will require both central (e.g., MIDRC) and distributed (site of data origin) investment.

Council Discussion
Council members discussed the implementation of the new NIH data management and sharing policy, data ownership at academic institutions, and the burden of compliance with data sharing policies. Ms. Goetz reiterated that the implementation plan still is being developed. Since this policy includes many broad areas of science, no single template will apply to all investigators. Council members emphasized the need to educate investigators concerning the management and data sharing process and the data that are expected to be shared (e.g., variables, key identifiers) before experiments are carried out to avoid creation of ad hoc approaches—investigators who have more experience with this process (e.g., investigators in the imaging field) may help those with less experience.

Dr. Chiang noted that some organizations may be reluctant to share data due to various factors (e.g., privacy risks) and asked for advice on how to overcome these barriers. Dr. Langlotz recommended providing positive examples that illustrate how data sharing can be done and noted that deidentification for local use of data by researchers is not sufficient for public disclosure; resources are needed for this effort, which can be costly. Dr. Kalpathy-Cramer suggested that risk-averse institutions may be more willing to share data through a distributed data approach in which data can be accessed without making them public.

Dr. Langlotz clarified that central dataset repositories, which have more diverse datasets, are not a substitute for experiments that investigate specific questions in a specific population. Diverse data in a central repository that is designed to aggregate a large amount of multimodal data are beneficial because they allow the investigation of a wide array of scientific questions. However, datasets enriched with specific data points are needed to answer questions relating to specific and smaller populations.

Evaluation of data curation to ensure high quality is resource-intensive and a concern for investigators.

Ms. Goetz clarified that software is not classified as data to be shared under the NIH data sharing policy. The Office of Science Data is releasing guidelines on licensing and sharing of software and code. NEI has discussed with the Association for Research in Vision and Ophthalmology an effort to establish a publication for datasets and software code, which Dr. Chiang hopes incentivizes sharing of these data.

The NIH data sharing policy includes opportunities to discuss reasons (e.g., intellectual property, laws, and regulations) for not sharing specific data. Limitations are to be described in the plan that investigators are to submit with their applications.

Council members raised additional issues, including the need to standardize curation of animal model data and concerns about sustainability of existing animal model databases. The NIH data sharing policy includes suggested repositories for use by the investigator, some of which are funded by NIH. Increased usage of these repositories may support continued funding.

Dr. Chiang asked about approaches to help investigators harmonize their data. Dr. Langlotz noted that this has to be a collaborative process between the contributing site and the central repository. For example, MIDRC offers small grants to institutions to support their harmonization efforts, and within MIDRC, support staff help convert the data from sites.

NEI Training Opportunities and Loan Repayment Program for Early Career Scientists
Dr. Neeraj Agarwal, Program Director of Translational Research, Training, and Workforce Development, NEI

Dr. Agarwal presented FY 2021 statistics for NEI’s training programs, including individual fellowships, career transition and development programs, and institutional training programs.

The number of NEI-funded fellowships and T32s funded in FY 2021 was comparable to those funded by NIH. NEI funded 36 percent of submitted F30 applications, 31 percent of submitted F31 applications, 26 percent of submitted F32 applications, and 61.5 percent of submitted T32 applications.

To promote diversity in postdoctoral training programs (F32), a Notice of Special Interest (NOSI) was published. NIH published two notices (NOT-OD-21-177 and NOT-OD-21-074) to support childcare costs for Ruth L. Kirschstein National Research Service Award (NRSA) Institutional Research Training Awards and Individual Fellowships.

NEI career development and transition awards totaled 9 K12s, 36 K08s, 20 K23s, and 35 K99s. The success rate for career development included funding of 41 percent of submitted K08 applications, 40 percent of submitted K23 applications, 33 percent of submitted K99 applications, and 100 percent of submitted K12 applications.

An analysis of the subsequent research project grant (RPG) success rate (2011–2018) revealed the following: 97 percent ofR00 awardees applied for an RPG or equivalent grant and 75 percent obtained funding; 72 percent of K08 awardees applied for an RPG or equivalent grant and 52 percent secured funding; and 53 percent of K23 awardees applied for an RPG or equivalent grant and 72 percent were awarded funding. In 2021, 22.3 percent of Early Stage Investigator (ESI) and 15.9 percent of New Investigator (NI) R01 applications were funded. The success rate for NEI diversity supplements in 2021 was 96 percent.

NEI also participates in other trans-NIH diversity initiatives such the Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) K99/R00, NIH Blueprint Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award (F99/K00), and BRAIN Initiative Diversity K99/R00.

NEI and NIH is offering COVID-related extensions for ESI and K99 eligibility and for NRSA fellows and physician scientists, accepting a one-page update on preliminary date as post-submission materials, and supporting administrative supplements.

In FY 2021, NEI allocated $1.8 billion toward the Loan Repayment Program (LRP), funding 24 of 28 applicants. The LRP pays $50,000 in debt and accrued taxes and requires a 50 percent time commitment.

Concept Clearances
Dr. John Fedota, Program Officer, Behavioral and Cognitive Neuroscience Branch, Division of Neuroscience and Behavior, National Institute on Drug Abuse

The proposed NIH Blueprint for Neuroscience Research initiative concept aims to expand and improve the original computational training program established in 2006. The proposed concept would increase application, programmatic, and mentor diversity at each level and add training in “big data” methodology. Success would be measured by the number of trainees supported across institutions and the scientific career trajectories of trainees.

A motion to approve the concept was made by Council Member Dr. Mary Elizabeth Hartnett, seconded by Council Member Dr. Jose Manuel Alonso, and unanimously approved.

General Council Discussion
Dr. Anderson opened the floor for general discussion by Council members.

Dr. Agarwal indicated the K12 program is very successful and has expanded considerably—currently, there are nine programs. Council members noted these programs help in the transition from clinical fellowship to an academic career and provide academic research time. Programs are smaller and have a more limited budget now than when first established because of a decrease in the number of slots, limitations on the number of years of K12 and individual K awards, and a U.S. board certification requirement. A comparison of institutional and individual training awards revealed that investigators coming from individual awards are more likely to obtain subsequent RPG funding. For this reason, it was recommended that NIH consider the balance between these two types of awards. One Council member lauded the K12 program as an outstanding investment from NEI that has been a huge recruiting tool and has led to a strong ecosystem of young and dynamic investigators.

Dr. Chiang commented that NEI is considering the future of AGI and how it will expand.

NIH investigators are considering the safety of cloud environments used for data sharing. NIH cloud environments are routinely tested. The NIH data management policy requires that documented measures be taken for security and integrity.

Open Session Adjournment
Dr. Anderson adjourned the open session of the Council meeting at 1:38 PM.

Closed Session
This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as amended (5, USC Appendix 2). Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

Review of Applications
NAEC members considered 329 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $118,595,928 (direct costs year 01). The Council also considered 239 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $159,139,057 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 568 applications.

Adjournment
The 159th meeting of the National Advisory Eye Council was adjourned at 3:15 p.m. on October 22, 2021.

Closed Session Attendees
Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Jose-Manuel Alonso
Dr. Terete Borras
Dr. James Coughlan
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Mary Ann Stepp
Dr. Benjamin Teller
Dr. Tirin Moore (ad hoc)
Dr. Reza Dana (ad hoc)
Dr. Maureen Maguire (ad hoc)

NIH Staff Members Present

Dr. Neeraj Agarwal
Dr. Houmam Araj
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Mr. Samuel Edwards
Dr. Donald Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Ms. Alexandra Gavrilovic
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Dr. Peter Guthrie
Ms. Lateefah Hill
Dr. Brian Hoshaw
Ms. Alicia Kerr
Dr. Paek Lee
Dr. Ellen Liberman
Dr. Barbara Mallon
Dr. George McKie
Ms. Barbara Payne
Ms. Melanie Reagan
Dr. Maryann Redford
Dr. Jennifer Schiltz
Dr. David Schneeweis
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Afia Sultana
Dr. Santa Tumminia
Ms. Leslie West-Bushby
Dr. Cheri Wiggs
Ms. Keturah Williams
Ms. Nora Wong
Dr. Charles Wright
Ms. Maria Zacharias

Certification
These minutes were submitted for the approval of the council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes and attachment(s) are accurate and complete.

Michael Chiang, MD
Chair
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary
National Advisory Eye Council
 

NIH VideoCast

Meeting Minutes

The National Advisory Eye Council (NAEC) convened for its 158th meeting at 9:30 a.m. on Friday, June 11, 2021. The entire meeting was broadcast by the National Institutes of Health (NIH) videocast system, and all observers and participants, including members of the public, attended virtually. Michael Chiang, MD, Director of the National Eye Institute (NEI), presided as Council Chair and Kathleen Anderson, PhD, served as the Executive Secretary. The meeting was open to the public from 9:30 a.m. until 1:30 p.m. The meeting was closed to the public from 2:00 p.m. until 4:00 p.m. for the review of grant and cooperative agreement applications.

Council Members Present
Dr. Michael Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Jose-Manuel Alonso
Dr. Teresa Borras
Dr. James Coughlan
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Mary Ann Stepp
Dr. Benjamin Teller

NIH Staff Members Present
Dr. Neeraj Agarwal
Ms. Lisa Applewhite
Dr. Houmam Araj
Dr. Steven Becker
Dr. Thomas Beres
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Dr. Emily Chew
Ms. Karen Colbert
Ms. Monique Clark
Dr. Mary Frances Cotch
Dr. Donald Everett
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Dr. Susan Gillmor
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Ms. Alexandra Gavrilovic
Dr. Tom Greenwell
Mr. Peter Guthrie
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Jeanette Hosseini
Dr. Jimmy Le
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Barbara Mallon
Dr. George McKie
Dr. Sheldon Miller
Dr. Lisa Neuhold
Ms. Barbara Payne
Dr. Maryann Redford
Ms. Amber Reed
Dr. Jennifer Schiltz
Dr. Mohor Biplab Sengupta
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Afia Sultana
Mr. Brian Trent
Dr. Santa Tumminia
Dr. Cheri Wiggs
Ms. Keturah Williams
Ms. Nora Wong
Dr. Charles Wright
Mr. Michael Wright

NIH Contractors Present
Mr. Jonathan Bennett
Mr. Abraham Hanson
Mr. David Higgins
Mr. Daniel Marmorstein
Mr. Rick Marquez
Mr. Alexander Papadopoulos
Dr. Fernanda Ruiz
Ms. Natalie Van Eman
Mr. Edward Woodhouse

Members of the Public Present:
Dr. Paul P. Lee, University of Michigan
Dr. Scott E. Page, University of Michigan
Dr. Fernanda Ruiz, Nova Research
Ms. Natalie Van Eman, Access Interpreting Services
Mr. Abraham Hanson, Access Interpreting Services

NOTE: Due to the open videocast format of this meeting necessitated by the COVID-19 pandemic, additional NIH staff and members of the public were able to observe the open session of the meeting live and after it had been archived.

Call to Order, Council Procedures, and Related Matters
Dr. Michael Chiang, Chair, NAEC and Director, NEI

Dr. Chiang called the 158th NAEC meeting to order and welcomed attendees.

Dr. Kathleen Anderson, Executive Secretary, NAEC and Director, Division of Extramural Activities (DEA)

Dr. Anderson welcomed attendees and thanked Council members for their service. She expressed her appreciation for their advice and feedback and noted that the approval of the new members is still pending. She also welcomed the NEI research and advocacy community, NIH and NEI staff, and members of the public. Dr. Anderson extended special thanks to guest speakers Drs. Paul Lee and Scott Page.

Dr. Anderson indicated all fall Council meetings will be held virtually. She reviewed the procedures and etiquette for this Zoom meeting and noted that the open session of the meeting was being videocast and will be available on the NIH videocast website.

Director’s Report
Dr. Chiang noted NEI is hoping to use social media to enhance the dissemination of information to the research community, especially during the pandemic. He encouraged members to follow him on twitter and share relevant information with their colleagues. He provided a brief outline of the day’s agenda and highlighted the themes for this meeting—diversity, equity, and inclusion (DEI)—and the NEI strategic plan and revised mission statement. For this meeting, one of the goals is for Council members to suggest themes and topics for future council meetings that would be most relevant for the community to hear about.

Dr. Chiang introduced and welcomed new NEI extramural staff. Ms. Lisa Applewhite is Operations Coordinator; Mr. Nathan Brown is Lead Program Analyst and Committee Management Specialist; and Ms. Alexandra Gavrilovic, Ms. Holly Blake, and Ms. Stephanie Blackford are Grants Management Specialists. New NEI intramural staff include Ms. Devina Fan, Director of the National Eye Health Education Program in the Office of Science Communications, Public Liaison and Education, and Ms. Dorian Oliveira, Senior Program Analyst in the Intramural Administrative Management Branch.

Dr. Chiang congratulated NEI grantees Drs. Denise Montell, Tirin Moore, Rachel Wong, Marisa Carrasco, Arturo Alvarez-Buylla, John Maunsell, and Rachel Klevit for being elected to the National Academy of Sciences.

NAEC Budget Update—Ms. Karen Colbert, NEI Budget Officer, provided a brief overview of the NIH and NEI budget for Fiscal Year (FY) 2021. She noted that budget estimation for FY 2021 was challenging because there were many competing priorities, including the need to address funding for coronavirus relief.

The NIH budget of $42.7 billion is a 3 percent increase over the final FY 2020 allocation and includes an appropriation of $404 million authorized in the 21st Century Cures Act, which is an expected decrease of $88 million (18%) from FY 2020. Total Cures funding includes $195 million to the National Cancer Institute (NCI) for the Cancer Moonshot Project, $100 million to the National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH) for the Cures Brain Research Through Advancing Innovative Neurotechnologies® BRAIN Initiative, and $109 million to the NIH Innovation for the All-of-Us Program. NIH also received $1.25 billion in supplemental funding for coronavirus activities.

For FY 2021, NEI received a 1.5 percent increase over 2020. NEI anticipates funding over $700 million in extramural research. Of the total budget, extramural research accounts for 84 percent, intramural research accounts for 12 percent, and research support accounts for 4 percent. Ms. Colbert presented an estimate of competing and noncompeting awards that will be funded in FY 2021. Due to infrastructure costs, the number of competing research project grants (RPGs) that will be funded this year was reduced.

The President’s budget (FY 2022) requests include a $23 million (2.8%) increase for NEI. The transition to a new administration caused a delay to the budget release and it is unclear how this delay will impact the timing of the congressional appropriations process. The new fiscal year may begin under a continuing resolution, which would restrict available funds until NIH receives a final appropriation.

The proposed NIH increase in the FY 2022 President’s budget is $9 billion (21%), which includes $6.5 billion to establish the Advanced Research Projects Agency for Health (ARPA-H). The estimated NEI funding for FY 2022 represents a 2.8 % increase over 2021 and includes $718.7 million (84%) to extramural research, $104 million (12%) to intramural research, and 35.8 million (4%) to research support. This plan provides an additional $17 million for extramural research which would cover existing commitments, mandatory increases, and new awards.

The NIH-specific research priorities identified in the President’s budget include: Combatting the Opioid and Methamphetamine Crisis; Health Disparities and Inequities Research; Impacts of Climate Change on Human Health; Ending the HIV Epidemic in the U.S.; Improving Maternal Health; Addressing Gun Violence in America; Research of the Effects of COVID-19; Creating a Diverse Biomedical Workforce; Protecting Biomedical Research; and Research Infrastructure.

NEI Audacious Goals Initiative—Dr. Steven Becker, Office of Regenerative Medicine (ORM), presented an update on the NEI Audacious Goals Initiative (AGI) and regenerative medicine activities. The Functional Imaging Consortium Symposium (held in February 2021) videos and a summary of accomplishments stemming from the meeting are available online (Audacious projects develop imaging technology to aid eye tissue regeneration.).

A new notice of special interest (NOSI) for AGI-relevant R13 scientific meetings was released in March (NOT-EY-21-009). During the Association for Research in Vision and Ophthalmology (ARVO) special session, six AGI projects describing new factors in regenerative medicine for vision research were presented. An AGI perspective piece summarizing initiative activities and future plans will be featured in July’s Translational Vision Science & Technology (TVST) special edition.

Dr. Becker highlighted a new collaboration with the New York Stem Cell Foundation Research Institute (NYSCF) and Columbia University–NY Presbyterian Hospital to develop a therapy for age-related macular degeneration (AMD) using retinal pigment epithelium (RPE) patches developed by Dr. Kapil Bharti.

NEI hosted a webinar showcasing the new AMD Integrative Biology Initiative with NYSCF as a resource providing induced pluripotent stem cell (IPSC) lines from AMD patients with known risk alleles. Email respository@nyscf.org to request the lines.

The NEI 3-D Retina Organoid Challenge (3-D ROC) has three new company sponsors that are providing resources (e.g., technology) to participants. The 3-D ROC team deadline to register for the final phase of the challenge is October 1, 2021.

ORM is providing new trainee resources and sponsoring activities focused on targeting support for training. (K awardees are eligible.) A Careers Pathway Forum featuring a biotech career coach and speakers from academia, industry, and nonprofits was held recently. The ORM Trainee Committee has been established to advocate on behalf of trainees in regenerative medicine and serve as liaison to the extramural community. ORM plans to find liaisons to propagate this information and generate an information hub for trainees—including those seeking to obtain funding. Dr. Becker encouraged Council members to disseminate information about these resources to their trainees.

Anterior Segment Initiative—Dr. Chiang provided an update on the Anterior Segment Initiative (ASI). A prior request for information (RFI) identified dry eye as one pressing topic in anterior segments. Since the last NAEC meeting, a workshop was held in April that focused on immunity and inflammation in the anterior segment of the eye to identify knowledge gaps in immune homeostasis and regulation; aging, microbiome, and environment; neuroinflammation; and resolution of inflammation. Results from this workshop will be analyzed to define next steps. A workshop on Investigating the Ocular Microbiome: Best Practices for Low Biomass Microbial Research will be held on August 2, 2021.

Extramural Response to COVID—Dr. Chiang reported that many of the questions NEI is receiving regarding COVID are about productivity in the COVID era. The NEI Division of Extramural Science Programs (DESP) is advising researchers to apply for no-cost extensions. NEI is accepting administrative supplement (PA-18-591) requests on a case-by-case basis for active NEI-sponsored projects affected by COVID-19 and focusing resources on cases of extreme need.

NIH Council of Councils: Concept Clearances—Dr. Chiang reported on three concepts by the NIH Council of Councils (COC). An Office of Data Science Strategy concept that aims to address the workforce gap in data governance for Artificial Intelligence (AI) and Biomedicine, was referred for refinement due to potential overlap with the Bridge to AI (Bridge 2AI) Common Fund Program. Phase 2 of the Human BioMolecular Atlas Program, which aims to extend integration, visualization, and collaboration, was approved, and includes a project on 3D mapping of eye tissue. The Somatic Mosaicism Across Human Tissues (SMaHT) program was also approved. In the first phase, a 5-year program will create a census of somatic gene variation in the human body, but it does not currently include eye tissue. Dr. Van Gelder proposed that NEI join the SMaHT working group because retinal blastoma is possibly the best-understood example of how somatic mosaicism can cause fatal human disease. NEI plans to follow this effort and determine whether there are areas for NEI involvement.

Ophthalmic Imaging Standards— NEI recently endorsed the American Academy of Ophthalmology (AAO) call for standardization of ophthalmic imaging devices. Despite past efforts to improve interoperability between imaging devices, the lack of the adoption of standards remains a challenge for ophthalmology and clinical care. To produce a significant change, Dr. Chiang proposed sponsoring an Imaging Standards Workshop in fall 2021 to gather perspectives from key stakeholders (e.g., clinicians, researchers, government representatives, industry, patients) and identify opportunities and barriers for adopting standards for interoperability in ophthalmic imaging for clinical care and research. An RFI will be published this summer to get input and comments from these communities to inform the workshop.

The NIH Data Management and Sharing Policy (DMSP) becomes effective in January 2023 and applies to all NIH-funded research generating data regardless of type, size, or funding amount. Applicants will need to include data sharing and management plans in their applications which if funded, will be included in the terms and conditions of awards. NEI will begin piloting a DMSP policy in the Intramural Research Program. Dr. Chiang thanked Dr. David Schneeweis and Kerry Goetz for their efforts to implement this in the intramural program.

NIH Common Fund Programs—Dr. Chiang is working with various Common Fund programs including Bridge 2AI, which is chaired by five Institutes, including NEI, and aims to generate data to address the limited availability of robust datasets to train algorithms and use artificial intelligence (AI)/machine learning (ML) approaches. There is a need for standards for data collection, representation, and exchange. In total, $96 million will be awarded over a 4-year period for data generation centers and integration sites.

Dr. Chiang was a member of the Advisory Committee to the Director (ACD) working group on how to use AI and Electronic Health Records (EHRs) for research purposes, which worked to identify unique research opportunities for NIH to apply resources to EHR data, determine barriers to the widespread use of AI, and identify useful partnerships. The ACD focused on supporting AI/ML work to address challenges of health disparities and minority health and address errors, gaps, and racial and gender inequities/biases in EHR data. A consortium and coordinating center will be created to address data sharing, use AI approaches to detect bias, and generate data representation standards. Dr. James Gao is NEI’s representative for this effort.

Discussion

A question was raised on whether the AGI training committee included NEI mentored K-awardees. Dr. Becker noted that when the committee was created, they reached out to all NEI K-awardees and asked council members to help spread the word and encourage all trainees to use the resources on the AGI website. Another member emphasized the importance of communicating with all trainees not just those with current funding.

Council members discussed barriers to standardization of ophthalmic imaging devices and possible stakeholders. Dr. Chiang noted that vendors must implement standards and customers must want those standards. There may be specific cultural barriers (e.g., investigators and clinicians may not see the need to share data so there is not a push for standards). He noted that other fields, including radiology, have adopted imaging standards.

Another council member noted the importance of data standards and sharing and asked whether the workshop would address cultural issues that may be barriers? Dr. Chiang responded that there may be incentives that could promote data sharing. He also stated that the tenure system often values individual accomplishments over data sharing and suggested that a future Council meeting focus on data sharing as one way to disseminate this message to the community. He also invited members to become involved with the workshop on imaging standards and encouraged them to contact Drs. Chiang or Anderson if they are interested in participating.

Promoting Diversity in Vision Research
Dr. Michael Chiang; Dr. Paul Lee, University of Michigan; Dr. Scott Page, University of Michigan; Mr. Brian Trent, Executive Officer, Executive Officer, NEI; Dr. Michael Steinmetz, Director, Division of Extramural Science Programs, NEI

Dr. Chiang summarized NEI activities aimed at addressing DEI. An ARVO-NEI Diversity Symposium was conducted to raise awareness of this issue and identify activities to perform as a community. Dr. Chiang also had discussions with leadership of the AAO, ARVO, and other organizations to determine how best to work together to enhance diversity in vision-related research. Stressing that the vision community thrives when the most talented next generation from a wide range of backgrounds are involved, Dr. Chiang noted the goal of this session was to present evidence showing that the scientific workforce benefits with diversity and the roadmap for NEI collaboration with other organizations.

Diversity in Ophthalmology and Vision Research—Dr. Lee described the state of the vision workforce and the research opportunities presented by demographic changes in the U.S. Although the percentage of women faculty members at ophthalmology training institutions has been increasing, the proportion of investigators from underrepresented backgrounds in medicine have remained flat or in some cases, decreased. Underrepresented women have a higher interest in pursuing non-research careers than research-intensive careers, suggesting that efforts are needed for recruitment and retention. Multiple institutions are focused on increasing diversity.

Assuming current trends continue, the prevalence of visual impairment in the U.S. will grow significantly by 2050. Hispanics have the highest rates of visual impairment or blindness and other minority groups having higher rates than the national average. Different diseases cause vision loss in different ethnic groups. For example, in African Americans, glaucoma is one of the main causes of irreversible blindness, which may be due to African American Medicaid recipients receiving fewer glaucoma tests than White or Latino Medicaid recipients. Social determinants of health impact the ability to take advantage of NEI research and apply it to all individuals to prevent vision loss and restore vision. The AAO has commissioned two task forces: one to study DEI within the AAO and the second to generate a white paper on the state of visual disparities in the United States using data from population-based studies.

Benefits of Diversity in the Workforce—Dr. Page described how diversity makes people better able to perform their tasks. According to Cultural Logics theory, individuals apply different weights to criteria and view the world through different lenses based on the diversity of lived experiences. Dr. Page proposed looking at diversity through a different cultural lens rather than just in terms of normative and/or demographic terms. He suggested using a logic based on producing better outcomes within individual disciplines. He argued that diversity improves performance on complex tasks and can be defined as both identity – who we are - (e.g., gender, race, age) and cognitive – how we think - (e.g., education, information, heuristics) diversity.

He presented a case for how cognitive diversity makes us better at what we do. Interdisciplinary research across the sciences is on the rise. Since 1960, the number of authors on academic scientific papers has increased from one to two authors to more than five currently. Research papers authored by teams are 4.5 times more likely to be cited over 100 times than those written by an individual author. The NIH study on the Science of Team Science showed that teams are more innovative, but teams with too much diversity do not work as well (there is an inverted U for the benefits of diversity). One study showed that large, diverse teams develop whereas small, diverse teams disrupt (e.g., have breakthrough ideas). Cognitive diversity (e.g., members from different universities) also enhances the innovation of a team.

To explain why cognitive diversity enhances innovation, he described the science behind how cognitive diversity using the Diversity Prediction Theorem. Diversity is beneficial for prediction, problem solving, and creativity. For a prediction, crowd error equals average error minus diversity. The complexity of the task is also important—in a complex task, the average error is large, thus more diversity is needed for the crowd error to be small. Including individuals on a team who are really smart but use different approaches to the problem. He used an example that showed that individual teams from different schools (MIT, Michigan, and CalTech) vary in the amount of prediction errors they make but when combined provide the best prediction. He showed other examples of how teams/crowds with varying degrees of competence make better predictions than individuals, even very smart (high IQ) individuals. The examples all demonstrated that the more complex the problem, the more you need teams and diversity to solve. He similarly demonstrated that creativity benefits from more group into individuals through increased cognitive diversity.

He also showed how identity-diverse groups are more innovative than homogeneous groups because individuals’ identities and characteristics affect their experiences and the lens through which they see the world. Individuals also think differently and harder when around identity-diverse people. For example, there is a 5-10% increase in the mean number of citations if the authors are ethnically diverse. The cultures in which individuals operate also affect them as identity drives one’s purpose. He then described how identity matters more in problem searches (e.g., use of AI) and less in solution searches (e.g., curing macular degeneration).

Dr. Page advised thinking of diversity as useful in improving the profession (not just in terms of being the right thing to do). Work must be done on building pipelines by engaging, listening, attracting, encouraging, and creating spaces where it is permissible to differ. Diverse groups are more effective than homogenous groups. Cultures must support cognitive and identity diversity to realize the bonus that both provide for solving complex problems.

NEI Workforce Diversity Efforts—Mr. Trent described NEI efforts related to DEI. NEI’s commitment to DEI and the creation of environments where all are seen, heard, and valued will be integrated into leadership and strategy, culture, talent, and systems and structures of NEI. Leadership will connect DEI to NEI’s mission, vision, and strategy. DEI also informs NEI’s culture development efforts. NEI recognizes that DEI enables great vision research, translation, policy making, and administration, and, in the strategic planning process, allows for evaluation of talent processes and practices at each phase of the talent development life cycle. Systems, structures, and mechanisms are studied to normalize equity and inclusion at NEI.

Mr. Trent is working with consultants and the newly formed DEI Employee Council to find the balance between relationship building and delivering on planned activities. Members of the DEI Employee Council represent different Divisions and levels across NEI. The NEI three-phase project approach to DEI work during 2021 focuses on developing a strong project framework supported by the DEI Employee Council, conducting a DEI and culture assessment, and creating a strategic plan for future investments in diversity, equity, and inclusion. Employee engagement activities include DEI leadership messages, DEI coffee circles, a DEI Staff Pulse Survey, and a Leadership DEI Strategy Lab. NEI Leadership is committed to DEI efforts and the first Strategy Lab will be conducted in July 2021.

NEI Extramural Programs to Promote Diversity—Dr. Michael Steinmetz described the funding opportunities that are available to NIH and NEI to expand diversity across the full range of the workforce including underrepresented minorities, sex, disability, and economic status. Individual institutions are responsible for certifying the eligibility of applications. The list of funding opportunities he described include:

Research supplements (1–2 years) to promote diversity in health-related research, which are administrative supplements
Ruth L. Kirchstein National Research Service Award (NRSA) Individual Predoctoral Fellowship to Promote Diversity in Health-related Research [F31]
National Research Service Award (NRSA) F32 Postdoctoral Fellowship applications from individuals from diverse backgrounds, including underrepresented minorities
NIH Blueprint and BRAIN (Brain Research Through Advancing Innovative Neurotechnologies®) Initiative Diversity Specialized Predoctoral to Postdoctoral Advancement in Neuroscience (D-SPAN) Award [F99/K00]
BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity [K99/R00]
Maximizing Opportunities for Scientific and Academic Independent Careers (MOSAIC) Postdoctoral Career Transition Award to Promote Diversity [K99/R00]
Support for Research Excellence – First Independent Research (SuRE-First) Award [R16]
NIH Blueprint Program for Enhancing Neuroscience Diversity through Undergraduate Research Education Experiences (BP-ENDURE) [R25]
NIH Faculty Institutions Recruitment for Sustainable Transformation (FIRST) Program: FIRST Cohort [U54].
A new funding announcement for BP-ENDURE will be published in the NIH guide soon. Those interested in diversity supplements should contact Dr. Houmam Araj, and those interested in training and career development awards should contact Dr. Neeraj Agarwal.

Discussion
Dr. Santa Tumminia

Dr. Tumminia asked how to overcome feeling challenged by diversity (those who are different than us). Dr. Page commented that having a specific mindset is important—integrating diversity because it increases effectiveness, not for normative reasons. The type of conflict involved is also important; task conflict is good whereas personal conflict is bad. Thus, leadership must recognize and reward task conflict and confront personal conflict. In response to a related question, he noted that too many diverse individuals on a team may cause conflict; however, as leadership skills improve, the number of diverse individuals on a team may grow without causing conflict.

A council member asked whether there is a list of schools eligible to apply to the SUrE First program. Dr. Steinmetz replied that there is no set list of schools that can apply to the program, but institutions must satisfy requirement of having a large percentage of underrepresented minorities enrolled.

A council member asked how large the pool of available underrepresented minorities at the postdoctoral level. Dr. Steinmetz replied that there is a shortage of underrepresented minorities in ophthalmology and in other disciplines throughout the career pipeline and especially at the top. One Council member suggested that emphasis be placed on programs targeting undergraduate students at the beginning of the pipeline. Dr. Steinmetz responded that evidence shows that investments in investigators at higher career levels are far more likely to stay in the field than at earlier levels who are more likely to leave. Investments need to be made throughout the pipeline.

Another member asked about the success rate of the BRAIN K99/R00 Mosaic program. Dr. Steinmetz noted that there the program is still in its early stages so not a lot of data is available. However, the early data suggest that the K99/R00 grantees do successfully transition from the postdoctoral level to faculty positions. The pool of applicants is small but expected to grow. The same question was asked about the D/SPAN F99/K00 program. Dr. Anderson responded that the data she has seen for this mechanism indicates that the majority of trainees do transition to the postdoctoral level. One council member noted that success for these funding mechanisms should also include trainees who transition to other careers, not just faculty positions.

Dr. Chiang noted that diversity has become a polarizing topic in society and asked for advice on ways to communicate diversity efforts in ways that do not lead to increased polarization. Dr. Page responded that listening matters the most and that broader life experiences will inform how people respond. He emphasized the need to have talented, diverse people who share a common mission. Focusing on a shared mission and purpose can minimize polarization. Dr. Lee added that setting guiding principles on how we behave around others is important for minimizing conflict and moving forward with a shared purpose.

Dr. Chiang asked whether data or anecdotes are more effective at communicating the importance of and need for diversity. Dr. Page responded by noting the importance of three factors in persuasive communication: a compelling narrative or anecdote that elucidates the main concept; the concept needs to line up with logic; and the data supporting the concept needs to be used in situations only where it is useful (conditional).

One Council member asked how the success of the NEI DEI initiative will be defined and over what time-frame. Dr. Chiang expressed his opinion that meaningful change will take time and will require getting more people in the pipeline, especially for vision research. He suggested taking a broader definition of success beyond number of grantees from underrepresented backgrounds. Dr. Gardner suggested using both hard (e.g., numbers) and soft (e.g., satisfaction) metrics to evaluate success.

A council member noted the utility of the anecdotes and how to combine quantitative and qualitative data in communications around diversity. Dr. Chiang agreed and stressed the importance of working together with organizations and communities to enhance diversity rather than as an individual institute.

One Council member noted that while increasing overall diversity will take time, embracing cognitive diversity is one action that research programs can undertake now.

NEI Mission and Strategic Plan
Dr. Michael Chiang and Dr. Shefa Gordon, Director, Office of Program Planning and Analysis

NEI Mission Statement—Dr. Chiang thanked Council members for their contributions in the evolution of the NEI mission statement and reviewed the rationale for the new revised version, which states that the mission of the National Eye Institute is to eliminate vision loss and improve quality of life through vision research. The revised version was developed by a Council work group with input from NEI staff and the public and aims to be inspirational and to consider the impact of NEI’s work holistically. To achieve this, NEI will drive innovative research to understand the eye and visual system, prevent and treat vision diseases, and expand opportunities for affected people; foster collaboration to develop new ideas and share knowledge across other fields; recruit, inspire, and train a talented new generation to strengthen the vision workforce; and educate about advances in vision research and their impact on health and quality of life.

This statement has been released for public comment. Dr. Chiang asked Council members to share comments and concerns about the revised NEI mission statement. Council members commended the revised NEI mission statement, including inclusion of the themes of research and collaboration across many fields, comprehensiveness, and broadness of the message—it explicitly considers quality-of-life impact and emphasizes contributors and diverse stakeholders. The Council members also compared the current mission statement to the revised mission statement.

A motion to accept the council workgroup recommendation for the revised NEI mission statement was made, seconded, and approved unanimously.

NEI Strategic Plan: Vision for the Future—Dr. Chiang thanked Drs. Gordon and Tumminia and all who contributed to the NEI strategic planning process. He described the review process for the draft chapters for the strategic plan and noted that these drafts were provided to Council members in advance of the last Council meeting for comment. A new version was provided to Council members and released to the public for comment prior to this Council meeting. The goal is to publicly release the final version in October 2021.

Dr. Gordon thanked Council members and noted that Dr. Chiang has carefully considered how this strategic plan will guide the priorities of NEI and how recommendations will be implemented. Dr. Gordon described the content, structure, and focus of the NEI Strategic Plan: Vision for the Future, which focuses on the science and programs, includes plans that involve the community, contains substantial external input, and greatly emphasizes public health. Focusing on the seven areas of emphasis allowed the team to work across NEI core extramural programs, identify new synergies, and recognize areas in need of attention. These seven areas are: From Genes to Disease Mechanism; Biology and Neuroscience of Vision; Immune System and Eye Health; Regenerative Medicine; Research Needs, Gaps, and Opportunities; Individual Quality of Life; and Public Health and Disparities Research. Dr. Gordon stressed that the plan covers the scope of core programs, and areas of emphasis are layered on top of core extramural programs. A funding initiative from one area of emphasis may cut across various programs.

A recent RFI asking for input on the strategic plan draft generated responses (46 unique respondents inside and outside the vision community) with ideas, suggestions, and concerns that are being reviewed carefully. Once suggestions are incorporated, a draft of the plan will be provided to Council members for review. Implementation plans include establishment of NEI internal working groups to determine priorities and strategies, which will be implemented through workshops, initiatives, personnel hires, and strategic partnerships.

Discussion

Dr. Jose-Manuel Alonso summarized comments from a group of prominent scientists in the NEI portfolio about three important vision research areas they believe are not properly emphasized in the current draft, including nonhuman primate research, theory in visual processing, and amblyopia. Dr. Gordon thanked Dr. Alonso for coordinating the group’s response and noted that the comments will be considered, and an additional red line draft will be sent. Dr. Gordon also discussed the significant edits that have had to be made to keep the document manageable but still have proper emphasis. Dr. Gordon also mentioned that the National Academy of Sciences will be starting a study on nonhuman primate research that NEI will be co-sponsoring. Dr. Chiang added that one barrier to research is that clinicians and researchers are not connected. Thus, NEI could link theory and practice as teams are built. He commended Dr. Gordon and his staff for their efforts in reviewing the strategic plan. Unlike prior strategic plans, this plan includes cerebral visual impairment (CVI), which is a challenge that will require a community with a wide range of expertise (e.g., theoreticians and researchers using nonhuman primate models).

Dr. Del Rio-Tsonis expressed appreciation for the executive summary and Director’s message, which will make this document more accessible. She suggested creating a more simplified document for the general public and proposed that a planned collaboration with the Centers for Disease Control and Prevention’s (CDC’s) Vision Health Initiative be included in the strategic plan. Dr. Gordon noted that one of NEI’s goal is to establish more trans-agency collaborations and pointed out that NEI works closely with CDC on the Healthy People 2030 initiative.

One member asked how NEI plans to balance the strategic plan with the decreasing budget. Dr. Chiang responded that this will be done through prioritization—NEI staff will be organized to determine areas where an impact, even a short-term impact, can be made. He hopes NEI can stimulate connections between scientists and clinicians in different fields. Dr. Gordon added that the goal of the strategic plan is to understand NEI’s priorities and opportunities so that available resources can be allocated. Strategic planning may position NEI to capitalize on funds as they become available.

Concept Clearances
REGENERATIVE MEDICINE CLINICAL TRIAL PLANNING GRANT – Dr. Jimmy Le, Collaborative Clinical Research

The proposed clinical trial planning funding opportunity focused on regenerative medicine would support efforts to conduct clinical trials aiming to evaluate interventions that restore vision in humans by regenerating cellular function using strategies such as stem cells, stem cell-derived precursors, and progenitor cells or products from progenitor cells. NEI does not currently have a mechanism to support planning of clinical trials that evaluate regenerative strategies. This concept would facilitate creation of a clinical trial manual procedure for a trial that assesses regenerative strategies; preparation and establishment of agreements with GPC manufacturers and production facilities or data coordinating centers; and obtaining of regulatory approvals. This funding mechanism also could be used to support preliminary activities (e.g., studies that evaluate feasibility and collect safety and toxicity information).

Drs. Harnett, Gardner, and Stepp served as concept reviewers. During the discussion, Dr. Le clarified that this opportunity would be available to investigators who are working in any area of the regenerative medicine field. A Council member noted that the goals statement mentions the use of cell-based therapies rather than exosomes or products derived from stem cells. Dr. Le stated that this feedback will be taken into consideration.

A motion to approve this concept was made, seconded, and approved unanimously.

SINGLE-SITE CLINICAL TRIALS – Mr. Donald Everett, Division of Extramural Science Programs

The proposed initiative to support single-site clinical trials where the intervention represents greater than minimal risk to the participant. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than ordinarily encountered in daily life or during performance of routine physical or psychological examinations. This initiative would support investigator-initiated single-site clinical trials that are less complex and resource-intensive than those currently supported by other NEI clinical research funding opportunities.

Drs. Gardner, Hartnett, and Teller were the designated reviewers. Council members indicated this initiative would fill a niche that is not available in the current repertoire of NEI funding mechanisms.

A motion to approve moving forward with the single-site clinical trials concept was made, seconded, and approved unanimously.

General Council Discussion
Dr. Anderson opened the floor for general discussion by Council members.

Dr. Chiang commented that considering the day’s discussions, a pertinent topic to discuss in the next Council meeting is data sharing. Members who would like to communicate other possible topics for the next meeting should contact Dr. Chiang and Dr. Anderson.

Open Session Adjournment
Dr. Anderson adjourned the open session of the Council meeting at 1:40 PM.

Closed Session
This portion of the meeting was closed to the public in accordance with the determination that this session concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as amended (5, USC Appendix 2). Members absented themselves from the meeting during discussion of and voting on applications from their institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

Review of Applications
NAEC members considered 330 research and training grant applications on which NEI was the primary Institute; these applications requested a total of $109,297,133 (direct costs year 01). The Council also considered 424 applications on which another Institute/Center was primary and NEI was secondary. These applications requested a total of $302,290,527 (direct costs year 01). The Council concurred with the Institutional Review Group recommendations on these 754 applications.

Adjournment
The 158th meeting of the National Advisory Eye Council was adjourned at 4:00 p.m. on June 11, 2021.

Closed Session Attendees
Council Members Present:

Dr. Michael F. Chiang, Chair
Dr. Kathleen Anderson, Executive Secretary
Dr. Jose-Manuel Alonso
Dr. Teresa Borras
Dr. James Coughlan
Dr. Katia Del Rio-Tsonis
Dr. Thomas Gardner
Dr. Mary Elizabeth Hartnett
Dr. Renu Kowluru
Dr. Mary Ann Stepp
Dr. Benjamin Teller

NIH Staff Members Present:

Dr. Neeraj Agarwal
Ms. Lisa Applewhite
Dr. Houmam Araj
Dr. Steven Becker
Dr. Thomas Beres
Dr. Sangeeta Bhargava
Mr. Nathan Brown
Ms. Monique Clark
Dr. Mary Frances Cotch
Dr. Martha Flanders
Dr. Ashley Fortress
Dr. James Gao
Ms. Alexandra Gavrilovic
Ms. Kerry Goetz
Dr. Nataliya Gordiyenko
Dr. Shefa Gordon
Dr. Tony Gover
Dr. Tom Greenwell
Mr. Peter Guthrie
Ms. Lateefah Hill
Dr. Brian Hoshaw
Dr. Paek Lee
Dr. Ellen Liberman
Ms. Barbara Mallon
Dr. Lisa Neuhold
Ms. Barbara Payne
Dr. Maryann Redford
Ms. Amber Reed
Dr. Jennifer Schiltz
Dr. Mohor Biplab Sengupta
Dr. Grace Shen
Ms. Karen Smith
Dr. Hongman Song
Dr. Michael Steinmetz
Dr. Afia Sultana
Dr. Santa Tumminia
Dr. Cheri Wiggs
Ms. Keturah Williams
Ms. Nora Wong
Dr. Charles Wright

Certification
These minutes were submitted for the approval of the council. All corrections or notations were incorporated. We hereby certify that, to the best of our knowledge, the foregoing minutes are accurate and complete.

Michael Chiang, MD
Chair,
National Advisory Eye Council

Kathleen C. Anderson, PhD
Executive Secretary,
National Advisory Eye Council