NAMHC Minutes of the 270th Meeting

Introduction

The National Advisory Mental Health Council (NAMHC) held its 270th meeting at 12:00 pm, May 16, 2023, via in-person, Zoom, and National Institutes of Health (NIH) videocast. In accordance with Public Law 92-463, the session was open to the public until approximately 4:40 pm., followed by the closed session on May 17, 2023. Joshua Gordon, M.D., Ph.D., Director of the National Institute of Mental Health (NIMH), presided as Chair for both sessions

OPEN PORTION OF THE MEETING

1. Open Policy Session Call to Order & Opening Remarks, Joshua Gordon, M.D., Ph.D. ( NIH Videocast @00:06)

   NIMH Director, Dr. Joshua Gordon, opened the NAMHC meeting and welcomed Council members, NIMH staff, NIH staff, and others present.

   Following a review of virtual meeting procedures, the Council unanimously passed a motion approving the final Summary Minutes of the February 2023 meeting.

2. Concept Clearances ( NIH Videocast @04:35)

   1. Advancing Learning Health Care Research to Improve Mental Health Services and Outcomes, Robert K. Heinssen, Ph.D., AABT( NIH Videocast @05:50)

      Dr. Heinssen discussed the gap between scientific discovery and translation to real-world settings, highlighting the need for a learning health system to bridge this gap. This concept aims to stimulate innovation in implementation research, data science, and the effectiveness of services research towards optimizing evidence-based mental health services. The scope of research will broadly encompass computational approaches, randomized and quasi-experimental trials, and implementation strategies to promote the rapid integration of new learning into routine clinical practices.

      Discussion
      Dr. Amy Kilbourne and Dr. Joseph Telfair( NIH Videocast @09:40)

      Drs. Kilbourn and Telfair expressed support for the concept. Dr. Telfair emphasized the need for more specificity, such as the appropriate level of researcher, a focus on equity in technology access, practical application for a constituent population, and expanding both grant mechanisms and potential partnerships. Dr. Kilbourne suggested the inclusion of foundational research on the sociotechnical infrastructure of a learning health system and aligning research priorities with community needs. Other Council members suggested utilizing lessons learned from the Early Psychosis Intervention Network (EPINET) and incorporating systems design to reduce practitioner workload. One Council member asked if there were opportunities to connect with primary care and school settings. Dr. Heinssen answered that the goal of the concept was to seek integrated care, which included links with the school systems.

   2. Advancing HIV Testing, Prevention, and Care through Pharmacists and Pharmacies, Michael Stirratt, Ph.D.( NIH Videocast @20:21)

      Dr. Stirratt discussed the influential role of pharmacies on vaccine delivery for COVID-19, which demonstrates their potential reach on HIV service delivery. This concept aims to facilitate research to enhance and scale HIV services in pharmacy settings by equipping pharmacy students and pharmacists with the skills and knowledge necessary for effective and equitable service delivery. The scope of research includes the role of pharmacy settings on increased screenings, improved uptake and delivery of HIV preventive medicines, and the prevention of lapsed HIV care. The concept also aims to determine the curricula needed to improve pharmacy students’ and pharmacists’ capacity to provide care.

      Discussion
      Discussants: Dr. Velma McBride Murry and Dr. Joseph Telfair( NIH Videocast @24:11)

      Drs. Murry and Telfair expressed support for this concept. Dr. Telfair emphasized the need for enhanced training that equips pharmacists across different skill levels to ensure they are prepared for this expanded role. He highlighted the importance of addressing co-morbidities through a reliable referral process, managing social and cultural challenges when disseminating information, ensuring quality control across all settings, and the replicability and scalability of research findings. Dr. Murry suggested addressing access challenges, particularly to overcome barriers in areas with pharmacy deserts and limited HIV funding. She emphasized the importance of sociopolitical structures when planning rollout and suggested partnerships between researchers, pharmacists, and community members to ensure inclusive access and overcome. One Council member suggested exploring how pharmacists could be resources for people seeking harm reduction, as well as HIV services for those who are at highest risk of HIV. Another Council member asked how people with lived experience could be involved. Dr. Stirratt answered that they plan to include community input in the design, structure, and delivery of services to ensure they are not only acceptable, but also desirable to those who would most benefit.

   3. Streamlining Mental Health Interventions for Youth Living with HIV in Low- and Middle-Income Countries, Theresa Senn, Ph.D.( NIH Videocast @35:53)

      Dr. Senn discussed the high rates of HIV and associated mental health disorders among youth, particularly in low- and middle-income countries (LMICs). This population faces unique challenges when transitioning from pediatric to adult HIV services, including the lack of mental health providers. The goal of this concept is to tailor and streamline mental health interventions for this population. The scope of research would include exploration of the adaptations needed for the population’s unique needs, the minimum necessary intervention components required to maintain quality care, the appropriate implementation strategies that lessen provider burden, and intervention intensity that is appropriately matched to the individual.

      Discussion
      Discussants: Dr. Pamela Collins and Dr. Marguerita Lightfoot ( NIH Videocast @39:39)

      Both discussants were enthusiastic about the concept. Dr. Collins suggested additional research directions such as understanding cultural and developmental needs, HIV status disclosure, parental and caregiver involvement, management of treatment fatigue, gender-specific needs, and the feasibility of single-session interventions. She also encouraged research identifying who might best deliver interventions in these settings; the need to address discrimination and stigma, including youth in intervention development; and exploring linkages to mental health services. Dr. Lightfoot echoed the importance of understanding parental involvement and suggested exploring youth-friendly spaces, cultural relevancy (not just adaptation), and the development of new interventions. She highlighted the need for including indigenous knowledge to develop local interventions and for capacity building across different settings. Another Council member asked about addressing congenital HIV. Dr. Senn answered that increased services to prevent perinatal transmission have reduced the number of adolescents born with HIV, but that it remained an important population to consider. Finally, a Council member suggested an emphasis on male involvement in services, dual screening for HIV and mental health, capacity building for service delivery from peer providers, and mixed methods approaches.

3. Implementation of the NIH Data Management and Sharing Policy, Cindy M. Danielson, Ph.D., Associate Director, Systems Integration, NIH Office of Research Reporting and Analysis, and Julia Slutsman, Ph.D., Director of Genomic Data Sharing Policy Implementation ( NIH Videocast @54:33)

   Dr. Slutsman provided an overview of the 2023 NIH Data Management and Sharing (DMS) Policy, which went into effect on January 25, 2023. She indicated that despite the existence of multiple data sharing policies, it has remained challenging for researchers to access shared data, which is important for replicating and validating studies. Additionally, public trust in scientific data is bolstered when data is openly accessible. In implementing the DMS Policy, NIH is looking to: 1) advance rigorous and reproducible research and 2) to promote public trust in research by ensuring transparency and accountability and that data generated by taxpayer dollars are responsibly stewarded.

   The DMS Policy has two requirements: 1) applicants must submit a DMS Plan, and 2) grantees must comply with the Plan once it is approved by NIH. The policy applies to all NIH-supported research that generates scientific data, defined as recorded factual material of sufficient quality to validate and replicate research findings, regardless of whether the data are used in publications. The policy does not apply to preliminary analyses, lab notebooks, or physical objects such as biospecimens.

   Under the DMS Policy, 1) data must be shared no later than the date of publication or 2) the end of an award for data that are not used in a publication, whichever comes first. Researchers are encouraged to develop data submission and storage plans early in the planning process. Plans should outline any appropriate limitations in data sharing, including participant privacy and confidentiality, as well as any existing laws or regulations that apply. The policy does not view situations like small datasets or a perceived lack of useful data as valid limitations. NIH staff will regularly monitor DMS Plans to ensure compliance across the project lifecycle. A lack of compliance may factor into future funding decisions.

   Dr. Danielson talked about the extensive community engagement, public outreach, and education that NIH has engaged in to ensure the community is prepared for the implementation of the DMS Policy. The process has focused on a two-way conversation—NIH has provided information and education to the community and sought feedback and questions. NIH staff have given presentations and webinars targeted to diverse audiences, including researchers, institutions, and scientific associations. Community feedback helped shape the resources provided on the NIH website. For example, NIH is participating in a pilot project with the Federal Demonstration Partnership (FDP) to test the effectiveness and usability of different resources and tools.

   This active engagement with the community has resulted in sample DMS Plans across different research contexts to help researchers navigate the DMS Policy. NIH has also provided a list of NIH-supported data repositories for researchers seeking an appropriate place to share their data. The policy does not prescribe the use of any particular repository. Instead, it aims to improve the findability, accessibility, interoperability, and reusability of data. NIH maintains responsiveness to the community, adapting and enhancing resources as needed. A second phase of the FDP pilot project will focus on the costs associated with managing and sharing data. Resources and guidance will continue to be updated as additional insights arise. NIH also plans to evaluate the policy's impact and effectiveness and ultimately aims to shift the research culture toward one that views data sharing as a fundamental component of science.

   Dr. Slutsman and Dr. Danielson highlighted several online resources such as NIH sharing polices and resources , a guidance document , DMS Plan FAQs , guidance for selecting a data repository , sample DMS plans , a DMS plan format page .

   Discussion
   Council members discussed privacy and consent issues across different types of data, such as smartphones or wearables data, geolocation data, qualitative data, and data generated from vulnerable populations. Some Council members voiced concerns about sharing raw data. Drs. Slutsman and Danielson responded by highlighting the flexibility of the DMS policy, which allows researchers to decide what data should be shared, but that is also balanced with published guidance and program officer review. In addition, decisions about sensitive data would likely be evaluated on a case-by-case basis and the NIH intends to continue learning from the community. Council members raised a point about how data sharing alone might not be useful without also sharing methodologies.

   Council members asked questions about how the NIH DMS policy would relate to other data policies. Drs. Slutsman and Danielson conveyed that DMS would not supersede other policies or authorities, such as HIPAA and the Common Rule. One Council member underscored the need for clear adjudication authority for conflicting policies. There was also a discussion about how other data repositories manage privacy and protection and the important factors to consider when choosing a repository for data sharing. Council members discussed acknowledgement of individual contributions in data sharing and collaboration. They also recognized the need for training among new researchers who might be unfamiliar with NIH policies and the legal and ethical considerations involved in data sharing.

   Council members generally agreed that the DMS policy was challenging, but not unprecedented. They talked about the need for metric developments to measure data sharing efficiency and ongoing continuous improvement to meet the evolving needs and shifting culture. For example, one Council member asked for a definition of ‘publications’ in the context of the DMS policy. Drs. Slutsman and Danielson said that a publication meant a peer-reviewed article, not preprints. The Council member responded that there was an ongoing shift towards publishing preprints that NIH should take into consideration.

   In conclusion, Council members expressed appreciation for NIH’s efforts to remain flexible and endorsed a proactive, iterative approach to refining the DMS policy. They emphasized the importance of ongoing, two-way communications to obtain the feedback necessary for meeting the evolving needs of data sharing practices..

4. NIMH Director’s Report, Joshua Gordon, M.D., Ph.D ( NIH Videocast @01:54:49)

   1. Congressional Interactions with NIMH

      Between February and May 2023, Dr. Gordon and NIMH staff participated in seven congressional briefings on topics such as suicide prevention, mental health disparities, serious mental illness, and the impact of technology and digital media on development and mental health. One of the briefings, sponsored by the Congressional Neuroscience Caucus and the Mental Health Caucus, in conjunction with the Friends of NIMH, focused on the real-world impact of NIMH research.

   2. Appropriations and Budget Updates

      Dr. Gordon reported that the House and Senate are reviewing President Biden’s budget request for fiscal year 2024 (FY24). Several hearings were convened between March and May 2023, including testimony from HHS Secretary Xavier Becerra, J.D., and Acting NIH Director Lawrence A. Tabak, D.D.S., Ph.D. On May 4, 2023, Dr. Tabak, along with Dr. Gordon and three other NIH Directors, testified before the Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee on the NIH budget request for FY24. Dr. Gordon answered several questions related to mental health specifically related to precision psychiatry and youth mental health.

      On December 29, 2022, President Biden signed the Consolidated Appropriations Act of 2023 into law, allocating $47.5 billion for NIH and $2.3 billion to NIMH). Notably, $25 million was allocated to NIMH to expand research on the impact of COVID-19 on mental health. An increase of $5 million was provided to support research on mental health treatment approaches, service delivery, and system transformation. There was a slight decrease in the number of awards anticipated for FY23 due to an increase in the size of awards.

      There has been a continued increase in buying power for NIMH-sponsored research. The President’s Budget Request for FY24 proposes $48.6 billion for NIH, with $2.5 billion allocated to NIMH —an increase of $200 million. This budget would support NIMH priorities such as precision psychiatry and mental health impacts of social media.

   3. White House, HHS, and NIH Updates

      Dr. Gordon highlighted the release of the White House Report on Mental Health Research Priorities , which included significant input from Shelli Avenevoli, Ph.D., NIMH Deputy Director, and Dr. Heinssen, NIMH Special Advisor. The report aligns with NIMH priorities and emphasizes the importance of addressing mental health inequities, understanding, and leveraging digital mental health interventions, and supporting the mental health workforce.

      In addition, as a response to the 2022 White House Office of Science and Technology Policy memorandum on ensuring free, immediate, and equitable access to federally funded research, NIH hosted a listening session to hear Public Access to the Results of NIH-Supported Research (NIH Public Access Plan). This memorandum will affect NIMH-supported research by improving public access to scholarly publications and eliminating the current 12-month waiting period for open access. NIMH has begun to hold listening sessions as part of its planning process to meet this directive.

      NIH developed a Strategic Plan for Diversity, Equity, Inclusion, and Accessibility (DEIA) for FY23-27. The NIMH’s Strategic Plan for Research aligns with the NIH plan. NIH also announced a new prize competition for Institutional Excellence in DEIA to award up to 10 prizes to institutions with transformative solutions that create cultures of inclusive excellence. The submission deadline is September 26, 2023.

      The All of Us Research Program has been actively enrolling participants, as well as releasing data packages, platforms, and analytic platforms. From March 29 to 31, 2023, the program hosted a virtual Researchers Convention to showcase research, data, and tools. The BRAIN Initiative® will be hosting its ninth annual meeting from June 12 to 13, 2023. The Accelerating Medicines Partnership® Program - Schizophrenia (AMP® SCZ) is a global effort to use biomarkers for treatment development that is managed by the Foundation for the National Institutes of Health (FNIH) and has begun enrollment for its research cohorts. In February 2023, AMP® SCZ researchers reported on the development of a clinical outcome assessment.

      NIH formed an Advisory Committee to the Director on Re-envisioning NIH-Supported Postdoctoral Training . The committee held listening sessions and issued a request for information (RFI) seeking feedback on various issues that postdoctoral fellows face, such as compensation, quality of life, childcare, and career prospects. NIH is also reviewing criteria for National Research Service Award (NRSA) fellowships with the aim to diversify the workforce and ensure merit-based support. The NIH Center for Scientific Review (CSR) released an RFI seeking feedback on proposed for improving the NRSA Fellowship review.

      The Interagency Autism Coordinating Committee (IACC) held a virtual meeting in April 2023 to discuss updates on autism prevalence as well as racial and ethnic disparities and inequities. On April 14, 2023, NIMH and the Office of Autism Research Coordination (OARC) hosted their 10th Annual Autism Awareness Month Special Event that featured work by autistic artists.

      Dr. Gordon highlighted the NIH Impact Pages , which emphasize the importance of recognizing public health advances that were developed through NIH and NIMH research. NIMH-funded research significantly impacts individuals with mental health disorders and their families and communities. Dr. Gordon provided specific examples of research impact such as the success of NIMH-related coordinated specialty care programs for first episode psychosis .

      Dr. Gordon announced several leadership changes across NIH. On May 15, 2023, President Biden announced his intention to appoint Monica Bertagnolli, M.D., as the next NIH Director, pending Senate confirmation. In May 2023, Carrie Wolinetz, Ph.D., stepped down from her role as Senior Advisor in the NIH Office of the Director. In April 2023, Karina Walters, Ph.D., M.S.W., began serving as Director of the NIH Tribal Health Research Office, replacing David Wilson, Ph.D., who is on assignment to the White House Council on Native American Affairs. In March 2023, Maureen Goodenow, Ph.D., transitioned from her role as NIH Associate Director for AIDS Research and Director of the NIH Office of AIDS Research (OAR) to a new role as Senior Advisor in the NIH Office of the Director, and Bill Kapogiannis, M.D., has stepped in as Acting NIH Associate Director of AIDS Research and Acting Director of OAR. In February 2023, Adrienne Hallett stepped down as the Associate Director of the NIH Office of Legislative Policy and Analysis, and Lauren Higgins is serving as the Acting Associate Director.

   4. NIMH News to Know

      Dr. Gordon reviewed the 2023 update to the NIMH Strategic Plan for Research . The Strategic Plan was updated to further emphasize NIMH's commitment to funding research aimed at reducing mental health disparities and promoting health equity. Other changes include but are not limited to a new title for Goal 4, more details on existing NIMH resources have been updated to foster data sharing, and a description of NIMH’s interest in the social determinants of health on mental illness trajectories. The 2022 Strategic Plan Progress Report highlights specific advances and initiatives funded in the past year, including the BRAIN Initiative, AMP® SCZ, autism screening, suicide risk in youth, and the new Approach to Mental Health Disparities Research .

      As part of its Precision Psychiatry Initiative, NIMH released two new funding opportunities on Individually Measured Phenotypes to Advance Computational Translation in Mental Health Mental Health (IMPACT-MH). These opportunities aim to gather various types of data, particularly on behavioral function across multiple domains to improve clinical predictions and aid clinical decision-making. IMPACT-MH aims to create a data-centric infrastructure to integrate multimodal datasets that represent diverse populations.

      NIMH is working hard to ensure equity in its review and grant-making system by expanding the diversity of perspectives on its peer review panels. Dr. Gordon invited researchers to register to be considered to serve as potential reviews. The James Jackson Memorial Award is accepting nominations from the research community for exceptional minority mental health and mental health disparities researchers. Nominations are due by May 22.

      Dr. Gordon reviewed NIMH staff news. Mary Rooney, Ph.D., has been appointed as the NIMH Associate Director for Prevention. Karen Berman, M.D., a senior investigator in the NIMH intramural research program, was recently elected as a Fellow of the American Association for the Advancement of Science. The NIMH community mourns the loss of Barry Kaplan, Ph.D., and Editha Nottelmann, Ph.D., two retired staff from the NIMH Intramural Research Program who made significant contributions to the NIMH mission.

   5. Science Highlights

      Dr. Gordon shared two science highlights. The first study aimed to understand the neurobiology underlying aggressive behavior. The researchers focused on a subset of neurons in the ventral medial hypothalamus (VMH), which previous studies had shown to be important for controlling aggression. They recorded neural activity of mice as they were engaged in different behaviors and found that the activity of specific neuronal population in the VMH changed over time, corresponding to certain patterns of aggressive-like behavior. For example, some changes in neural activity correlated with attack-like behavior, while other changes correlated with dominance behavior. Further, the strength of this correlation determined the intensity of mouse behavior. This research highlights the importance of studying correlated patterns of neural activity and behavior, is it informs researchers’ ability to intervene and disrupt the behavior.

      In the next highlight, Dr. Gordon talked about how early diagnosis and treatment for autism can contribute significantly to improved developmental outcomes. However, diagnosis (and resulting treatment) tends to occur later for minoritized populations as compared to other populations. This highlighted study evaluated the effectiveness of the Get SET Early program, an early detection program which uses a digital evaluation approach in primary care settings. The researchers sought to determine whether the program could lead to earlier diagnosis and referral, improved care among toddlers with autism, and reduce disparities in treatment outcomes. The researchers found that the average screening age of those in the program was 16 to 17 months, as compared to the average age of 20 months without the program. They also found no significant differences in parental engagement between Hispanic and non-Hispanic families, suggesting that the Get SET Early program could support equitable screening, evaluation, and treatment in practical locations such as community-based settings.

   6. NIMH 75th Anniversary

      Dr. Gordon announced that in September 2023, NIMH will kick off a year-long celebration of its 75th anniversary. NIMH will host various events including symposiums, lectures, sessions at scientific meetings, and stories about scientific discovery. The events will not only celebrate NIMH’s accomplishments, but also acknowledge its history and areas for improvement. The inaugural event will be held on September 13, 2023. Dr. Gordon encouraged attendees to save the date.

      Discussion
      Following Dr. Gordon’s update, a Council member underscored the approval of several new pharmaceutical treatments for conditions that previously had no specific treatment, as well as pharmaceuticals that were expected to receive approval within the next year. The member emphasized the crucial role of NIMH in funding the research that led to these advances. Another Council member asked about the timeline for recommendations from the working group on postdoctoral fellows. Dr. Gordon answered that an interim report is expected in June 2023, although it might not include specific recommendations.

5. Development of a Public NIMH Gene List , Jonathan Pevsner, Ph.D., Chief, Genomics Research Branch, Division of Neuroscience and Basic Behavioral Science ( NIH Videocast @03:03:47)

   Dr. Gordon opened the session by stating that the 2018 NAMHC Workgroup on Genomics recommended that NIMH prioritize supporting research on genes that have rigorous statistical support for association with mental illnesses. However, researchers proposing a gene study may not be familiar with NIMH criteria. Further, NIMH does not currently have a mechanism for obtaining feedback from the community. To assist both NIMH staff and researchers, NIMH has curated a gene list and proposes that the list be publicly shared on the NIMH website. Dr. Gordon asked Council to provide feedback and invited Dr. Pevsner to present the details of the gene list.

   Dr. Pevsner described the value of a gene list by presenting two examples. The first included genes with rare genetic variation, with each row of a spreadsheet corresponding to a gene with at least a 5 percent false discovery rate support. Currently, approximately 700 unique genes span more than 1,000 rows of data. The second list includes genes with common genetic variation, with a sample of approximately 200 genes identified through genome-wide association studies (GWAS). A group of NIMH staff created the gene list after a literature search and review of supplemental tables. They will maintain the gene list regularly, and feedback from the community is welcomed. NIMH also intends to introduce a list of copy number variants (CNVs) significantly associated with mental illnesses.

   NIMH staff will use the gene list when considering whether an application addresses criteria recommended by the Workgroup on Genomics. The gene list will also be useful for basic and translational researchers when considering whether the genes they propose to study are well-supported. The gene list may also help plan initiatives for notices of funding opportunities. NIMH will make the gene list and accompanying documentation available to the public, promoting transparency and supporting the preparation and prioritization of grant applications.

   Discussion
   Council members suggested including information about sample size and homogeneity of the population under study. Although statistical significance in GWAS implies a sufficient sample size, there is a need to ensure that the samples represent diverse populations. They also addressed challenges in interpreting GWAS data. For example, it can be challenging to identify the exact gene involved in common variations. There are methods to add more evidence, such as transcriptome-wide association studies, to reduce the number of false positives.

   A Council member expressed concern that the gene list might restrict the study of other variations that might have a significant role in disease. For instance, the gene list might not inform studies on highly specific behaviors such as aggression. Dr. Gordon said that the list is not intended to be restrictive, nor the only guidance for researchers. Council members also talked about polygenic diseases. Dr. Pevsner suggested that the gene list could be used to understand which genes relate to certain phenotypes that already have genome-wide evidence.

   Council members emphasized the importance of ongoing communication and transparency through the maintenance of the gene list. They agreed that it was a useful tool to guide researchers toward well-support genes.

6. Consultation Summary and Recommendations from the BRAIN Neuroethics Working Group, Nita Farahany, J.D., Ph.D., Co-Chairperson, BRAIN Research Through Advancing Innovative Neurotechnologies (BRAIN) Neuroethics Working Group. ( NIH Videocast @03:38:19)

   Dr. Farahany introduced the BRAIN Neuroethics Working Group (NEWG), which is a group of experts in neuroethics and neuroscience that serves to provide the NIH BRAIN Initiative with input relating to neuroethics. The BRAIN Initiative Cell Atlas Network (BICAN) collects brain specimens from diverse human donors and shares data that could potentially be re-identifiable. NEWG engaged in a discussion about the ethical implications of unrestricted versus controlled access to primary genetic sequence data.

   NEWG examined potential risks and benefits across unrestricted and open data access versus controlled data access. The group indicated that risks include the potential misuse of shared primary sequence data, risks to living donors and their families involving re-identification, and societal implications such as reduced public trust. Benefits included accelerated scientific discovery, reduced administrative burden, and respect for participant autonomy. NEWG noted a lack of clear evidence to quantify these risks and benefits. NEWG also discussed strategies to minimize risk, such as community engagement, improved informed consent processes, and requiring open access users to agree to certain principles of use (i.e., measures to avoid re-identification).

   NEWG noted that there were outstanding questions that needed to be addressed and concluded that the potential benefits of data sharing should be articulated clearly before justifying any potential risk. They also suggested embedding bioethicists within BICAN to assist researchers in their projects.

   Discussion
   A Council member asked whether there was a portfolio of research on these ethical questions. For instance, there may be different communities had different preferences for what they might be willing to share in research. Dr. Farahany answered that there had been several funding announcements related to different aspects of neuroethics and encouraged researchers to help answer outstanding questions. The group hopes to have data about preferences across different communities soon.

   Council members expressed appreciation for the idea of embedding neuroethicists in large projects to help promote ongoing dialogue and a proactive approach to ethics rather than a reactive one. They emphasized the importance of integration bioethics into the research process rather than viewing it as an afterthought.

7. Public Comment ( NIH Videocast @03:57:24)

   Dr. Gordon invited the registered public commenter, Alka Chandna, Ph.D., Vice President of Laboratory Investigations for the People for the Ethical Treatment of Animals to comment. She expressed concerns about the treatment of Rhesus macaques in NIMH intramural research and she asked the Council to consider the ethical implications of these practices.

8. Adjournment

   Dr. Gordon adjourned the open session of the meeting at 4:40 pm.

   CLOSED PORTION OF THE MEETING

   The grant application review portion of the meeting was closed to the public in accordance with provisions as set forth in Section 552b(c)(4) and 552b(c)6. Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended.

   Tracy Waldeck, Ph.D., Executive Secretary of the Council, explained policies and procedures regarding confidentiality and avoidance of conflict of interest to the members of the Council.

   Members absented themselves from the meeting during the 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.

9. Review of Applications

   Refer to Appendix D .

10. Adjournment

    Dr. Gordon thanked the Council members. The closed session of the NAMHC meeting adjourned at approximately 4:45 p.m. on May 17, 2023.

EX OFFICIO MEMBERS

Office of the Secretary, DHHS
Xavier Becerra, J.D.
Secretary
Department of Health and Human Services
Washington, DC

National Institutes of Health
Lawrence A. Tabak, D.D.S., Ph.D.
Acting Director
National Institutes of Health
Bethesda, MD

Department of Veterans Affairs
Amy M. Kilbourne, Ph.D., M.P.H.
Director, Quality Enhancement Research Initiative (QUERI)
U.S. Department of Veterans Affairs
Professor of Learning Health Sciences
University of Michigan Medical School
Ann Arbor, MI

Liaison Representative
Anita Everett, M.D.
Director
Center for Mental Health Services
US, HHS Substance Abuse and Mental Health Services
Rockville, MD

Special Consultants Present:
Jonelle Duke, Webinar Support, Bizzell US
Nita Farahany, J.D., Ph.D., Duke University
Aimee Oczkowski, 1Source Events, LLC
Marie Rowland, Science Writer, Bizzell US

Members of the Public In-Person:
Milton Aguirre, Livotion, LLC
Ashleigh Avina, University of Minnesota
Priyanka Baloni, Purdue University
Amanda Case, Purdue University
Alka Chanda, People for the Ethical Treatment of Animals
Katie DeGeorge, Federation of Associations in Behavioral and Brain Sciences
Patrick Hein, Purdue University
Perry Kirkham. Purdue University
Zainab Okolo, The Jed Foundation
Ranjie Xu, Purdue University

Others Federal Employees:
John Ngai, M.D., NIH Office of the BRAIN Director
Ronny Zavoski, NIH Captioner
Jonathan Bennett, NIH Television Operations Center
Cindy Danielson, Ph.D., NIH Office of Research Reporting and Analysis
Julia Slutsman, Ph.D., NIH Office of Extramural Research
Nia Hsu, National Institute of Aging

Meeting minutes from the NAMHC 270th meeting NAMHC Minutes of the 270th Meeting Default English