NAMHC Minutes of the 276th Meeting

Introduction

The 276th National Advisory Mental Health Council (NAMHC) was convened on June 17, 2025, via Microsoft Teams and National Institutes of Health (NIH) videocast. In accordance with Public Law 92-463, the session was open to the public from 12:00 pm until 1:00 pm and was followed by the closed session at 1:15 on the same day. Andrea Beckel-Mitchener, Ph.D., Acting 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, Andrea Beckel-Mitchener, Ph.D. ( NIH Videocast @02:00)

   Elizabeth Church, Ph.D., Acting Director of the Division of Extramural Activities, NIMH and Executive Secretary of NAMHC, opened the virtual NAMHC meeting. Dr. Andrea Beckel-Mitchener, Acting NIMH Director and Chair of NAMHC welcomed Council members, NIMH staff, NIH staff, and members from various constituent communities.

2. NIMH Director’s Report, Andrea Beckel-Mitchener, Ph.D. ( NIH Videocast @03:29)

   1. HHS and NIH Leadership Changes

      Dr. Beckel-Mitchener noted that there had been significant changes at NIMH. She then thanked Shelli Avenevoli, Ph.D., for her service as the previous Acting NIMH Director.

      Dr. Beckel-Mitchener reported that Robert F. Kennedy, Jr., J.D., was sworn in as the Department of Health and Human Services (HHS) Secretary on February 13, 2025, and James O’Neill was sworn in as HHS Deputy Secretary on June 9, 2025. Jayanta “Jay” Bhattacharya, M.D., Ph.D., was confirmed as the NIH Director on March 25, 2025, and Matthew Memoli, Ph.D., was invited to serve as NIH Principal Deputy Director. Dr. Bhattacharya’s five key priority areas for NIH to focus: 1) improving population health by preventing, treating, and curing chronic diseases; 2) ensuring reliable results through a focus on reproducibility and scientific rigor; 3) investing in innovation and collaboration to embrace new technologies and approaches; 4) strengthening public trust by improving oversight and maintaining transparency; and 5) encouraging academic freedom by fostering a culture in which researchers can engage in open academic discussions.

      Dr. Beckel-Mitchener noted some of the leadership changes across other NIH Institutes and Centers, including: Courtney Aklin, Ph.D., Acting Director of the National Institute of Nursing Research; Alison Cernich, Ph.D., Acting Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development; Monica Webb Hooper, Ph.D., Acting Director of the National Institute on Minority Health and Health Disparities; Carolyn Hutter, Ph.D., Acting Director of the National Human Genome Research Institute; and Jeffery Taubenberger, M.D., Ph.D., Acting Director of the National Institute of Allergy and Infectious Diseases.

   2. Appropriations and Budget Updates

      In FY 2024, NIMH funded 600 new and competing research grants, with a success rate of 21 percent. President Donald Trump signed the Full-Year Continuing Appropriations and Extensions Act of 2025 on March 15, 2025. This continuing resolution included $48.5 billion to NIH for fiscal year 2025 (FY25), $2.3 billion of which was allocated for NIMH. The NIMH budget included a reduction of $40.5 million from its 21st Century Cures Act appropriation. The proposed President’s FY26 budget was released on May 2, 2025, which requested $94.7 billion in discretionary budget authority for HHS (a 25% reduction compared to FY25 enacted levels) and $27.9 billion for NIH (a 39% reduction from FY25 enacted levels). On May 14 and May 20, 2025, Secretary Kennedy testified on the President’s Budget Request for HHS before the House and Senate Committees. On June 10, 2025, Dr. Bhattacharya testified on the FY26 NIH Budget Justification before the Senate Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee.

   3. HHS Updates

      HHS adopted a new Scientific Integrity Policy on October 16, 2024. President Trump established the Make America Healthy Again (MAHA) Commission on February 13, 2025, which is chaired by Secretary Kennedy to focus on combating chronic disease by reforming food and health systems.

   4. NIH Updates

      On April 29, 2025, NIH announced its intent to establish an Office of Research Innovation, Validation, and Application (ORIVA) to promote human-based research technologies and scale the use of non-animal approaches. On May 27, 2025, NIH released a Research Opportunity Announcement for the Autism Data Science Initiative, which would bring together multiple data resources to explore the possible causes of autism. Dr. Beckel-Mitchener highlighted several NIH grants policy updates that were recently released. There were several changes to the NIH grant application review process, including the implementation of simplified peer review framework and revisions to instructions and review criteria for fellowship and training grant applications. NIH’s planned adoption of the Common Form for Biographic Sketch and Biographical Sketch Supplement is postponed. The implementation of the NIH Public Access Policy , which removes embargo periods for NIH-funded research articles, was accelerated from December 31, 2025 to July 1, 2025.

   5. NIMH News to Know

      Dr. Beckel-Mitchener presented a few key findings from the NIMH Triennial Report: NIH Policy on the Inclusion of Women and Minorities in Clinical Research (FY22-24), which is a federally mandated report on efforts to ensure that populations are included in NIH-funded research. Within the extramural program, there was a significant increase in participation, due in part to a large digital mental health study. However, many participants in this study did not report their sex or race. For both extramural and intramural clinical research, most participants identified as white, with the largest racial/ethnic minority groups being Black or African American and Asian participants. Council reviewed and electronically voted to approve this report prior to the meeting.

      Dr. Beckel-Mitchener reviewed NIMH staff updates. Elizabeth Church, Ph.D., was appointed as Acting Director of the Division of Extramural Activities; Mi Hillefors, M.D., Ph.D., as Acting Director of the Division of Translational Research; Ruben Alvarez, Ed.D., as Acting Director of the Division of Data Science and Technology; and Christina Borba, Ph.D., M.P.H., as Acting Director of the Division of Services and Intervention Research. She also recognized several NIMH staff awardees, including Mark Chavez, Ph.D., (Academy for Eating Disorders Meehan/Hartley Leadership Award for Public Service and/or Advocacy); Hugo Tejada, Ph.D., (Presidential Early Career Award for Scientists and Engineers); Tonya White, M.D., Ph.D., (Norbert and Charlotte Rieger Award for Scientific Achievement); Karen Berman, M.D., (American College of Neuropsychopharmacology’s Women’s Advocacy Award); and Carlos Zarate, M.D., (National Academy of Inventors Fellow, American Society of Clinical Psychopharmacology’s President-Elect).

      Discussion
      Following Dr. Beckel-Mitchener’s update, Council members asked about potential budget cuts, peer reviewer training for the simplified review framework, and the recruitment timeline for the new NIMH director.

      Dr. Beckel-Mitchener clarified that NIMH aims to maintain funding for previously identified priority areas, described the training resources that were available to study section members and the extramural community, and noted NIH’s intention for restarting the recruitment process for a NIMH Director.

3. Concept Clearances ( NIH Videocast @30:45)

   1. Research to Optimize the Effectiveness and Deployment of Suicide Prevention Services,
      Joel Sherrill, Ph.D., DSIR

      Dr. Sherrill stated that the purpose of this concept is to encourage research focused on optimizing and testing training and quality monitoring to ensure the sustained fidelity of evidence-based suicide prevention services, and to develop and test scalable and sustainable peer support interventions to complement clinical services. This concept would encourage research that would be informed by end users and may involve clinical trials to optimize approaches, validation of scalable measures, the use of novel technologies, and pilot trials to test peer support models.

   2. Advancing Research on Empirically Supported Interventions for Older Adults Living with Serious Mental Illness,
      Jovier D. Evans, Ph.D., DTR

      Dr. Evans stated that the purpose of this concept is to fill the gap of evidence-based approaches for older adults with severe mental illness (SMI), especially in settings where older adults with SMI are likely to receive mental health services and other routine care. Research approaches could include adapting, optimizing, and implementing effective treatments and strategies to improve both clinical and functional outcomes in this population, as well as strategies for improving treatment uptake and maintenance.

   3. Accelerating Solutions to Understand the Potential of Fast-Acting Psychotomimetic Agents,
      Jonathan Sabbagh, Ph.D., DTR

      Dr. Sabbagh noted the increased interest in psychotomimetic agents (PMAs) such as psilocybin and 3,4-Methylenedioxymethamphetamine (MDMA), and several challenges related to PMA research. For instance, participants experience powerful subjective effects that unblind clinical studies. There are also several unknowns in terms of the mechanisms of action, the role of psychotherapy, and the complexities of polypharmacology. This concept aims to address these challenges through research focused on optimized trial designs, pharmacodynamic biomarkers, and mediators of PMA efficacy.

   4. Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ),
      Suzanne Garcia, Ph.D., DNBBS

      Dr. Garcia reviewed the purpose and status of the AMP®SCZ study, which is projected to be completed by June 2027. This concept would allow the continuation of support for the data collection, processing, and analysis required to finish the study with a complete dataset. The expected outcomes of AMP SCZ include a high-quality multimodal dataset of clinical outcomes to be shared with the research community, a set of validated biomarkers and clinical measures for clinical trials, and support for the development of new therapies.

      Discussion
      Dr. Beckel-Mitchener invited Council members to comment on the concepts. Council members expressed support for all concepts. Dr. Ajilore expressed strong support for concept on older adults with SMI and noted the need to develop better interventions for the multimorbidity seen in this population. Dr. Beidas suggested more emphasis on multimodal approaches for suicide prevention services, hybrid studies to accelerate implementation for interventions for older adults with SMI, and the early incorporation of implementation approaches in PMA research. Dr. Scott asked about the timeline of the AMP SCZ study. Dr. Garcia clarified that the concept would allow analysis to be completed. Dr. Murry suggested leveraging community health workers to broaden the reach to older adults with SMI, particularly in rural areas. Dr. MacDonald suggested working with the Substance Abuse and Mental Health Services Administration (SAMHSA) to support the implementation of suicide prevention approaches. Dr. MacDonald also expressed concern about AMP SCZ as a competitive funding mechanism. Dr. Church responded that NIH has a mechanism for single source applications that requires additional justifications and rigorous peer review. Dr. Beckel-Mitchener further clarified that the purpose of the presentation was to gain council review of the concept that could potentially continue the project.

4. Public Comment ( NIH Videocast @55:39)

   There were no oral public comments.

5. Adjournment

   Dr. Beckel-Mitchener adjourned the open session of the meeting at 1:00 pm.

CLOSED PORTION OF THE MEETING

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).

Dr. Elizabeth Church, Executive Secretary of NAMHC, explained policies and procedures regarding confidentiality and 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 signed a statement to this effect.

1. Review of Applications

   Refer to Appendix C

1. Adjournment

   Dr. Beckel-Mitchener adjourned the closed grant review session of the meeting at 2:15 pm ET.

Others Federal Employees:

Robert Hamer, NIH Videocast Producer

Ronny Zavoski, NIH Captioner

Others Members Present Virtually for Open Session:

Deborah Krat, Miami Environmental & Energy Solutions

Aimee Oczkowski, 1Source Events

Marie Rowland, Science Writer

Others Members Present Virtually for Closed Session:

Deborah Krat, Miami Environmental & Energy Solutions

Aimee Oczkowski, 1Source Events

EX OFFICIO MEMBERS

Office of the Secretary, DHHS
Robert F. Kennedy, Jr., J.D.
Secretary
Department of Health and Human Services
Washington, DC

National Institutes of Health
Jayanta Bhattacharya, M.D., Ph.D.
Director
National Institutes of Health
Bethesda, MD

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

Appendix E

Public Comment

June 12, 2025

Re: The Need to Prohibit Animal Testing and the Use of Private Medical Data in Autism Research; June 17, 2025 National Advisory Mental Health Council (NAMHC) Open Policy Session

Dear Director Avenevoli and members of the NAMHC,

On behalf of the Physicians Committee for Responsible Medicine, a nonprofit health advocacy organization supported by nearly one million members and supporters worldwide, thank you for the opportunity to comment on this meeting and for your ongoing work to improve the well-being of individuals who rely on mental health research.

With a recent investment in federal resources to study autism, I ask that the funding is not used for animal studies, and that any human-based approaches protect individuals’ privacy. I applaud the recent announcement by the National Institutes of Health (NIH) to invest further in New Approach Methodologies (NAMs) and move away from the use of animals. This announcement underscores the need for autism research to utilize human-specific research methods. Human-specific research methods involve the collection of data from humans, as with clinical trials, epidemiological studies, and the use of human-derived data using other approaches like in vitro studies using human cell lines, organ-on-a-chip technology, and computational modeling. While shifting to human-based approaches is essential, they must be conducted with the highest ethical standards. Broad, centralized registries of personal medical data, even anonymized, can be misused and risk eroding public trust. Instead, studies should use de-identified datasets that participants consent to share.

There is a need for research that assesses how to improve the lives of autistic individuals. The utilization of applied social research, participatory action research (PAR), and community-based participatory research (CBPR) could improve the lives of autistic individuals, which should be a priority.

I urge the National Advisory Mental Health Council (NAMHC) to adopt two clear principles for autism research funded through the NIH:

1. No federal funding for autism studies that use animals. These methods are ill-suited to address complex human neurodevelopmental conditions.
2. Only ethical, privacy-protective human-based research. Ensure research protocols include meaningful informed consent, privacy protections for individuals, as well as secure and anonymized data handling.

This approach will demonstrate to the autistic community and the broader public that autism research is held to the highest standards of scientific integrity.

Sincerely,

Megan Amos, JD
Government Affairs Outreach Coordinator
Physicians Committee for Responsible Medicine

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