NAMHC Minutes of the 278th Meeting

March 6, 2026

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Mental Health Council

Introduction

The 278th National Advisory Mental Health Council (NAMHC) was convened on March 6, 2026, via Zoom and National Institutes of Health (NIH) videocast. In accordance with Public Law 92-463, the session was open to the public from 10:00 am until 12:45 pm ET. The open session was preceded by the closed session 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. Elizabeth Church, Ph.D., Acting Director of the Division of Extramural Activities, NIMH, presided as Executive Secretary.

Council Members Present

• Olusola Ajilore, M.D., Ph.D.
• Rinad Beidas, Ph.D.
• Daniel Gillison, Jr.
• Angus MacDonald, III, Ph.D.
• Velma McBride Murry, Ph.D.
• Jyotishman Pathak, Ph.D.
• Laura Scott, Ph.D., M.P.H.

Others present at Open Policy Session (Appendix A)

Others present at Closed Grant Review Session (Appendix A)

Open Portion of the Meeting

1. Open Policy Session Call to Order & Opening Remarks, Andrea Beckel-Mitchener, Ph.D. (NIH Videocast  @0:06)

   The Executive Secretary of NAMHC, Dr. Elizabeth Church, opened the virtual NAMHC meeting at 10:00 am and provided administrative updates before turning the meeting over to the chair. The Acting NIMH Director and Chair of NAMHC, Dr. Andrea Beckel-Mitchener, welcomed Council members, NIH and NIMH staff, and members from various constituent communities.

   The Council unanimously passed a motion approving the final Summary Minutes of the September 2025 Council meeting. Later, during the open session, Dr. Church reviewed the updated NAMHC Operating Procedures, followed by a discussion with Council. The Council unanimously passed a motion approving the 2026 NAMHC Operating Procedures.

2. NIMH Director’s Report, Andrea Beckel-Mitchener, Ph.D. and Elizabeth Church, Ph.D. (NIH Videocast  @ 06:21)

   1. Congressional Activities

      Dr. Beckel-Mitchener reported on three congressional activities. On February 3, 2026, NIH Director Jayanta Bhattacharya, M.D., Ph.D., testified before the Senate Health, Energy, Labor, and Pensions (HELP) Committee at a hearing entitled “Modernizing the National Institutes of Health: Faster Discoveries, More Cures. ” On February 4, 2026, Dr. Beckel-Mitchener participated in a briefing sponsored by the Congressional Neuroscience Caucus and organized by the American Brain Coalition entitled “Decoding Stigma: The Neural Science of Mental Health. ” The briefing drew standing-room-only attendance, and congressional staff demonstrated high interest. On February 27, 2026, Jane Pearson, Ph.D., Special Advisor to the Director of NIMH on Suicide Research, participated in a Lunch and Learn webinar on NIH efforts in suicide prevention research. The event was sponsored by the NIH Office of Legislative and Policy Analysis (OLPA) and presented to Congressional staff.

   2. Appropriations and Budget Updates

      Dr. Beckel-Mitchener reported on fiscal year (FY) 2026 appropriations and the current NIMH budget. On February 3, 2026, the House passed, and the President signed a minibus package that included the FY26 Labor, Health and Human Services, Education, and Related Agencies (LHHS) Appropriations bill. The bill sets overall NIH funding at $47.3 billion, an increase over FY25. The bill also provides NIMH with $2.3 billion, including $97.5 million from the 21st Century Cures Act, representing an increase of 2.4 percent over the FY25 budget. Dr. Beckel-Mitchener reviewed NIMH’s budget in appropriated and constant (FY17) dollars over the last ten years, noting that NIMH’s relative purchasing power for FY26 has been reduced by approximately nine percent compared to FY22 funding. In FY24, NIMH funded approximately 600 new and competing research project grants at a 21 percent success rate. Information on NIH-wide FY25 success rates was available on the NIH website .

   3. HHS Updates

      On February 18, 2026, Dr. Bhattacharya was named Acting Director for the Centers for Disease Control and Prevention (CDC) in addition to his role as NIH Director. He will serve in this capacity until the President names and the Senate confirms a permanent CDC Director.

      In December 2025, HHS released its Artificial Intelligence (AI) Strategy , which outlines HHS’s approach to making AI available across the federal workforce and integrating into internal operations, research, and public health. The strategy invites collaboration across all HHS operating divisions to develop an infrastructure to streamline workflows and enhance cybersecurity capabilities. NIH is developing solutions to implement the HHS AI Strategy.

   4. NIH Updates

      Dr. Beckel-Mitchener announced several NIH leadership appointments. Anthony Letai, M.D., Ph.D., was appointed Director of the National Cancer Institute (NCI), and Kyle Walsh, Ph.D., was appointed Director of the National Institute of Environmental Health Sciences (NIEHS). Within the Office of the NIH Director, Jon Lorsch, Ph.D., was appointed NIH Deputy Director for Extramural Research; Alissa Meister, Ph.D., was appointed the Director of the NIH Executive Secretariat; Richard Woychik, Ph.D., was appointed Senior Advisor for NIH’s Make America Healthy Again Strategy; and Nicole Kleinstreuer, Ph.D., was appointed NIH Deputy Director of the Division of Program Coordination, Planning, and Strategic Initiatives.

      Dr. Beckel-Mitchener also announced several new Acting Directors of NIH institutes and centers: David Goff, M.D., Ph.D., for the National Heart, Lung, and Blood Institute; Amy Adams, Ph.D., for the National Institute of Neurological Disorders and Stroke; David Shurtleff, Ph.D., for the National Center for Complementary and Integrative Health; Anna Mazzucco, Ph.D., for the National Institute of Arthritis and Musculoskeletal and Skin Diseases; and, Rohan Hazra, M.D., for the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Roland Owens, Ph.D., became NIH’s Acting Deputy Director for Intramural Research.

      Dr. Beckel-Mitchener updated the Council on the NIH Autism Data Science Initiative (ADSI) . In September 2025, the ADSI announced 13 awards drawing on genomic, epigenomic, metabolomic, proteomic, clinical, behavioral, and autism services data to explore the causes and increasing prevalence of autism spectrum disorder (ASD). Each research team will work in partnership with the autism community to ensure their perspectives inform the initiative. Also in September 2025, NIH announced contract awards for the Standardized Organoid Modeling (SOM) Center  at the Frederick National Laboratory for Cancer Research. The SOM Center will serve as a national resource for developing standardized organoid-based New Approach Methodologies (NAMs) and accelerating NAMs technologies for the broader scientific community.

      Dr. Beckel-Mitchener announced that the NIH Outstanding Scholars in Neuroscience Award Program (OSNAP) is seeking nominations of exceptional graduate students and postdoctoral fellows , due by March 23, 2026. She also reported that the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC)  recently released a roadmap of recommendations for involving the public in clinical research. NIH will begin implementing the recommendations by making participant research results available as a standard practice and encouraging the widespread adoption of electronic health records (EHRs) and other large-scale clinical information systems.

      Dr. Beckel-Mitchener provided an overview of the NIH Unified Funding Strategy , which serves as a framework to guide clear, consistent funding decisions across NIH. The strategy outlines six core tenets to guide funding decisions: mission alignment, scientific merit, program relevance and balance, investigator career stage, current funding distribution, and funding availability.

      Next, Dr. Church presented updates on NIH funding processes, policies, and considerations. She indicated that NIH has implemented several efforts to streamline communications with the extramural research community, including a centralized resource  for extramural funding opportunities across all NIH institutes, centers, and offices. Additionally, NIH encourages researchers to use the NIMH profile page  of this resource, where investigators can find IC-specific information, such as general NIMH interest areas, a list of NIMH Highlighted Topics, and links to NIMH funding opportunities and notices. In FY26, Grants.gov  became the official source for all NIH grant and cooperative agreement funding opportunities. Dr. Church conveyed the NIH remains committed to completing three full rounds of high-quality peer review in FY26. For FY26, NIH implemented emergency modifications for peer review following the lapse in appropriations.

      Dr. Church highlighted several notable policy updates . NIH no longer accepts applications requesting foreign subawards. Instead, domestic prime awards will be made with independent foreign sub-projects linked to the prime award. Legislative authority for Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs expired on October 1, 2025. During the lapse, new awards or non-competing continuations are not allowed, but active grants and contracts continue through the current budget period.

      At the beginning of FY26, the Code of Federal Regulations was updated to include a term regarding termination if the agency determines that the award no longer effectuates program goals or agency priorities. Next, due to the appropriations lapse, NIH announced short-term eligibility extensions for early-stage investigators and prospective applicants to the NIH Pathway to Independence Award. For researchers who are submitting applications related to Basic Experimental Studies in Humans, NIH will no longer apply the requirements for clinical trials. Applicants must continue to follow applicable NIH and clinical research laws and policies. NIH also implemented robust protocols to safeguard NIH-controlled data and human biospecimens, and updated its policy to prohibit the use of NIH funds for research involving human fetal tissue.

      NIH released two Requests for Information: 1) Draft Proposal for Harmonizing Research Participant Data Policies  (responses were due March 18, 2026) and 2) Reducing Reliance on Human Embryonic Stem Cells in NIH-Supported Research  (responses were due April 24, 2026).

   5. NIMH News to Know

      Dr. Beckel-Mitchener reviewed NIMH training and career development activities during FY25. NIMH funded more than 1,000 extramural investigators through Institutional Training Grants (T32), Research Education Projects (R25), fellowship awards (F), and Career Development Awards. Training and career development awards in FY25 declined 16 percent compared to FY24. On September 25, 2025, the 27th Annual NIMH Intramural Research Program (IRP) Fellows’ Scientific Training Day was held with approximately 300 NIMH faculty, staff, and fellows in attendance. In January 2026, NIMH staff helped organize a three-day virtual workshop for the Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative.

      Dr. Beckel-Mitchener recognized two NIMH staff members honored by external awards. Linda Brady, Ph.D,. received the Paul Hoch Distinguished Service Award from the American College of Neuropsychopharmacology. Maryland Pao, M.D., was the inaugural recipient of the Award for Excellence in Child and Adolescent Consultation-Liaison Psychiatry from the American Academy of Child and Adolescent Psychiatry. Dr. Beckel-Mitchener also announced the retirement of Alex Martin, Ph.D., from his roles as Chief of the Section on Cognitive Neuropsychology and Acting Chief of the Laboratory of Brain and Cognition in December 2025.

   6. Science Highlights

      Dr. Beckel-Mitchener presented three science highlights, all focused on youth. The first study¹ used a nationally representative survey to examine the prevalence, frequency, and perceived helpfulness of generative AI for mental health advice among adolescents and young adults. Approximately 13 percent of respondents reported using generative AI for mental health advice, with higher rates among those aged 18 to 21 (22 percent), with males in this age group showing the highest rates of use. Approximately 65 percent used it at least monthly, and nearly 93 percent found the mental health advice helpful. Black respondents reported lower perceived helpfulness than White non-Hispanic respondents.

      The second study² used data from the Adolescent Brain Cognitive Development^SM(ABCD) Study to examine health outcomes associated with smartphone ownership and age of acquisition among 10,500 12-year-old adolescents. Investigators found that smartphone ownership by age 12 was associated with higher risks of depression, obesity, and insufficient sleep. Among adolescents who did not acquire a smartphone by age 12, acquiring one within the subsequent year was associated with poorer mental health and sleep outcomes.

      Coming from NIMH’s Intramural Research Program, the third study³ used fMRI to measure neural efficiency—the brain’s ability to accommodate varying demands (e.g., at rest versus during a task) with minimal changes in functional connectivity—as a potential biomarker for treatment response among adolescents with anxiety disorders. Lower baseline neural efficiency was significantly associated with poorer response to exposure-based cognitive behavioral therapy (CBT), suggesting that neural efficiency could be a useful biomarker for patient stratification and as a potential target for intervention.

      Discussion
      Following Dr. Beckel-Mitchener’s update, Council members expressed concern about protecting the future for early career scholars. Specifically, they asked whether NIMH would monitor bias in the context of unified funding priorities and how it would preserve the future research workforce despite reductions in training and career development awards. Dr. Beckel-Mitchener responded that funding decisions continue to be made at the IC level with Council’s input and are publicly posted for transparency. NIMH monitors the trainee portfolio to ensure the sustainability of the next generation of investigators.

      Council members asked about the emergence of AI in research. One Council member asked about data privacy protection and the HHS AI Strategy, noting an intersection between the emerging use of AI in research and an increased focus on large-scale data sources such as EHRs. Another member asked about the balance between AI- and human-focused research. Dr. Beckel-Mitchener said NIMH monitors the balance of its research portfolio and that an internal NIH working group provides input to HHS for the development of AI policies. She referenced work to enhance controlled-access databases and a Request for Information on data harmonization practices that includes consent models.

      A Council member asked whether the NIH Unified Funding Strategy would reduce the number of concept clearances and funding opportunities requiring Council input. Dr. Beckel-Mitchener said that she did not anticipate any reduction in Council input despite the transition to Highlighted Topics. The Council member noted delays in approved grant funds despite a stable budget. Dr. Beckel-Mitchener confirmed that NIMH is monitoring delays and will issue awards as quickly as possible. Another Council member asked about the proportion of multi-year funded grants across the portfolio. Dr. Beckel-Mitchener said multi-year funding is an NIH-wide approach and emphasized that although multi-year funding reduces current year grant numbers, it will also free up future year funding.

      Another Council member asked whether there was feedback on the Simplified Peer Review Framework now that it has been in place for a year. Dr. Beckel-Mitchener and Dr. Church responded that there were two simultaneous changes to peer review—the simplified framework and the centralization of peer review to the NIH Center for Scientific Review (CSR). Although NIH currently has no data to report, a coordinated effort was underway to gather feedback. A Council member suggested a brief survey of study section members.

      A Council member asked about the future of the SBIR and STTR programs following the lapse in legislative authority. Dr. Beckel-Mitchener responded that continuation of the programs is beyond the purview of NIMH, though NIMH is poised to continue them should they be reauthorized. Another Council member asked Dr. Beckel-Mitchener to share highlights from the Congressional Neuroscience Caucus. She noted that the panel included representatives from organizations and people with lived experience and added that congressional staffers demonstrated notable engagement on different mental health topics.

      References
      ¹ McBain, R. K., Bozick, R., Diliberti, M., Zhang, L. A., Zhang, F., Burnett, A., Kofner, A., Rader, B., Breslau, J., Stein, B. D., Mehrotra, A., Pines, L. U., Cantor, J., & Yu, H. (2025). Use of Generative AI for Mental Health Advice Among US Adolescents and Young Adults. JAMA Network Open, 8(11), e2542281. https://doi.org/10.1001/jamanetworkopen.2025.42281 
      ² Barzilay, R., Pimentel, S. D., Tran, K. T., Visoki, E., Pagliaccio, D., & Auerbach, R. P. (2026). Smartphone Ownership, Age of Smartphone Acquisition, and Health Outcomes in Early Adolescence. Pediatrics, 157(1), e2025072941. https://doi.org/10.1542/peds.2025-072941  
      ³ Linke, J. O., Naim, R., Haller, S. P., Khosravi, P., Scheinberg, B., Byrne, M. E., Harrewijn, A., Leibenluft, E., Brotman, M. A., Winkler, A. M., & Pine, D. S. (2026). Reduced Threat-Related Neural Efficiency: A Possible Biomarker for Pediatric Anxiety Disorders. The American Journal of Psychiatry, 183(1), 48–57. https://doi.org/10.1176/appi.ajp.20241043 

3. Concept Clearances (NIH Videocast  @1:30:00)

   1. Immunotherapies for HIV Eradication in the CNS Compartment, Vasudev Rao, MBBS, M.S., Division of AIDS Research

      Dr. Rao said that despite advances in antiretroviral therapy, HIV persists in the central nervous system (CNS), driving chronic neuroimmune dysregulation that contributes to both neurocognitive disorders and neuropsychiatric conditions. This concept aims to generate evidence to determine whether immunotherapies can target HIV persistence within the CNS compartment to reduce neuroimmune dysregulation and improve mental health outcomes. The proposed approach would include a developmental phase using existing clinical trial data to test strategies and a confirmatory phase to demonstrate CNS target engagement, evaluate links between the CNS reservoir and cognitive and behavioral outcomes, and collect translational data for future clinical trials.

      Discussion
      Discussant: Dr. Olu Ajilore
      Dr. Ajilore expressed strong support for the concept and recommended including clear guidance on suggested model systems for the developmental phase. Another Council member suggested a third component for dissemination and implementation research that incorporates patient and clinician perspectives. Mr. Rao noted that an initiative called “Communications for a Cure” was underway to address implementation science research.

   2. Centers for Practice-Based Effectiveness and Services Research with Near-term Impact, Joel Sherrill, Ph.D., Division of Services and Intervention Research

      Dr. Sherrill presented a concept to reissue the Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) research center program. ALACRITY centers support high-impact, practice-based research programs with near-term potential to advance clinical practice and accelerate the translation of mental health research into real-world settings. The reissue aims to build on the outcomes of the first generation of centers and to expand the emphasis on emerging health information technologies, data science, and user-centered design.

      Discussion
      Discussant: Dr. Rinad Beidas
      Dr. Beidas expressed support for the concept and recommended strengthening the implementation science focus, changing the language from “consider” constituent perspectives to “embed,” requiring early career investigators as co-leads on all projects, promoting cross-center learning, and conducting a portfolio analysis of the first decade of the program. A Council member asked whether the reissue would include a greater emphasis on AI and digital health technology. Dr. Sherrill confirmed that these focus areas would be encouraged across the continuum of care. Another Council member noted that implementation science was relatively nascent, suggesting that ALACRITY was well-positioned to take an educational role in advancing implementation science principles.

   3. BRAIN Initiative: Data Archives for the BRAIN Initiative, Ruben Alvarez, Ed.D., Division of Data Science and Technology

      Dr. Alvarez presented a concept to continue supporting the BRAIN Initiative data ecosystem. The program has funded eight domain-specific data archives that collectively capture, store, and curate thousands of specialized datasets. Continued support for this concept is intended to maintain reproducible data pipelines, ensure ongoing compliance with data-sharing requirements, preserve data quality and accessibility, and scale infrastructure to accommodate the growing complexity and demand of BRAIN Initiative data.

      Discussion
      Discussant: Dr. Jyotishman Pathak
      Dr. Pathak expressed support for the concept and highlighted an opportunity for interconnectivity across NIH data systems and the need for more robust hardware, software, and data visualization capability. A Council member suggested that interim low-cost solutions, such as a spreadsheet, could allow investigators to write their own queries without requiring large data searches. The Council member also suggested using surveys and focus groups for feedback. Another Council member suggested provisions for tracking data usage and usability, and for capturing different levels of consent and permissions obtained throughout the BRAIN ecosystem. Dr. Alvarez responded that user feedback was a high priority and that conversations across NIH and the BRAIN Initiative were underway to develop a unified search interface.

   4. Brain Cell Atlas: From Data to Knowledge Base, Yong Yao, Ph.D., Division of Neuroscience and Basic Behavioral Science

      (BICAN) Coordinating Unit for Biostatistics, Informatics, and Engagement (CUBIE). CUBIE enables the exploration of large-scale BICAN data to inspire research and ensure scientific rigor and data reproducibility. As a first step towards a unified BRAIN Data Commons, CUBIE will support the development of common data processing pipelines and brain cell atlas data standards, provide governance structure and technical support, and create a comprehensive brain cell knowledge base.

      Discussion
      Discussant: Dr. Laura Scott
      Dr. Scott expressed support for the concept and cautioned that a reliance on AI-assisted discovery may be at odds with reproducible, understandable science. Dr. Scott encouraged human scientific oversight.

4. Public Comment (NIH Videocast  @02:17:49)

   Dr. Church noted that virtual meetings do not include verbal public comment. Two written public comments were shared with Council members. Refer to Appendix B.

5. Adjournment

   Dr. Church adjourned the open session of the meeting at 12:45 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).

Elizabeth Church, Ph.D., Executive Secretary of the NAMHC, explained policies and procedures regarding confidentiality and conflict of interest to the members of the Council.

Members were absent from the meeting during the discussion of and voting on applications from their own institutions, or other applications in which there was a conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

1. Review of Applications

   The NAMHC considered 1842 research and training applications with primary assignment to NIMH for a requested amount of $673,094,870 in first-year direct costs. The Council recommended 666 applications with a $269,520,540 in first year direct costs.

2. Adjournment

   Dr. Church adjourned the closed grant review session of the meeting at 4:15 pm.

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

APPENDIX A

Other Federal Staff Virtually Present:
John Coney, CSR
Lorie Shora, CSR
Jonathan Bernstein, NIH Videocast Producer
Robert Hamer, NIH Videocast Producer

Other Members Present Virtually for Open Policy:
Aimee Oczkowski, 1Source Events

Other Federal Staff Virtually Present:
Sue Andresen, CSR
Aruna Behera, CSR
Jessica Bellinger, CSR
Adam Can, CSR
John Coney, CSR
Aurea De Sousa, CSR
Victor Henriquez, CSR
Roger Janz, CSR
Maria De Jesus Diaz Perez, CSR
Brittany Mason-Mah, CSR
Preethy Nayar, CSR
Irina Nesmelova, CSR
Benjamin Shapero, CSR
Joanna Szczepanik, CSR
Robin Thompson, CSR
Todd White, CSR

Other Members Present Virtually for Closed Session:

Aimee Oczkowski, 1Source Events

Appendix B
Written Public Comment

March 2, 2026

Dear National Advisory Mental Health Council members:

On behalf of Science Advancement and Outreach, the biomedical science policy division of People for the Ethical Treatment of Animals, we request that the National Advisory Mental Health Council advise the National Institute of Mental Health (NIMH) Director to prioritize and support mental health research, training, and related programs that focus exclusively on non-animal methods, and to stop conducting and funding human mental health research that uses other animals.

1. Divest from animal use in mental health research

Animal models cannot replicate all aspects of any human neuropsychiatric conditions, and many human behaviors that characterize these disorders cannot be produced or assessed in animals. For example, to model human depressive disorders, animals are subjected to behavioral tests such as the forced swim test. The validity of this test for assessing an animal’s mood, screening antidepressants, or modeling stress is highly contested,¹ with one study noting that its use by leading pharmaceutical companies has not produced a single currently approved drug for treating depression in humans.²

Other commonly used behavioral tests—such as the sucrose preference test (for anhedonia)^3,4,5 and chronic unpredictable stress paradigms (to induce psychopathologies)⁶—suffer from the same lack of validity.

Beyond these ineffective assays, significant physiological differences between humans and other animals help explain the low rate of bench-to-bedside translation. For example, the tyrosine hydroxylase gene, which has been implicated in bipolar disorder and schizophrenia, is regulated differently in humans and mice.⁷ There are also substantial species differences in brain cell types and in how proteins essential for neurophysiological function are produced,⁸ as well as in neuronal diversity and organization, neural circuitry, neurotransmitter availability, and receptor distribution and kinetics.⁹

Several NIMH-funded studies use these poor behavioral models in attempts to study human neuropsychiatric disorders: the institute is currently funding four projects that describe the forced swim test  and sucrose preference test , and at least nine projects that describe chronic unpredictable stress paradigms .

In addition, for more than four decades, a NIMH intramural laboratory has subjected macaques to invasive surgeries, prolonged restraint, food and water deprivation, and social isolation, at a cost of over $50 million to taxpayers, yet these experiments have failed to produce meaningful insights for human mental health. We urge NIMH to discontinue funding studies that use the forced swim test and similar black-box behavioral paradigms, end experiments on monkeys in NIMH intramural laboratories, and redirect resources toward human-relevant methodologies.

2. Expand training and support for mental health researchers using human-based methods

Non-animal, human-based technologies are already transforming mental health research. Brain organoids are being used to study mood disorders,¹⁰ psychoses,¹¹ and neurodivergence.¹² These models can be combined into assembloids to investigate neurodevelopmental conditions such as autism,¹³ Tourette’s syndrome,¹⁴ and schizophrenia.¹⁵ In silico “virtual patient” models are being used to evaluate potential therapeutics for conditions such as attention-deficit/hyperactivity disorder.¹⁶ In addition, advanced brain imaging¹⁷ and longitudinal studies¹⁸ are being conducted with individuals who have lived experience of psychiatric conditions, generating clinically meaningful insights.

NIMH must act on NIH’s initiative to prioritize human-based research methods to fully “accelerate innovation, improve healthcare outcomes, and deliver life-changing treatments.”¹⁹

To enable researchers to make human-relevant discoveries, NIMH should:

• Create training grants and fellowships for researchers who use non-animal methods in mental health research.
• Assist universities and research institutes in developing continuing education and certification programs focused on non-animal methodologies.
• Provide transition and early-career awards that incentivize investigators to replace animal experiments with human-based systems and establish research programs centered on non-animal approaches.

These recommendations and others are expanded on in our policy roadmap, Research Modernization NOW , including an appendix relevant to neuropsychiatric disorders and neurodivergence on page 42.

Implementing these recommendations would position NIMH as a leader in advancing a more predictive, efficient, and human-specific research paradigm—ultimately improving patient outcomes and expanding effective treatment options for those living with mental health disorders.

Thank you for considering these recommendations.

Sincerely,

Gabby Vidaurre, Ph.D.
Research Associate
Science Advancement and Outreach Laboratory Investigations Department
People for the Ethical Treatment of Animals

References

¹PETA. The invalidity of the forced swim test. Published 2025. Accessed February 27, 2026. https://www.peta.org/wp-content/uploads/2025/07/The-Invalidity-of-the-Forced-Swim-Test-2025.pdf 
²Trunnell ER, Carvalho C. The forced swim test has poor accuracy for identifying novel antidepressants. Drug Discov Today. 2021;26(12):2898-2904. doi:10.1016/j.drudis.2021.08.003
³ Berrio JP, Hestehave S, Kalliokoski O. Reliability of sucrose preference testing following short or no food and water deprivation—a systematic review and meta-analysis of rat models of chronic unpredictable stress. Transl Psychiatry. 2024;14(1):1-10. doi:10.1038/s41398-024-02742-0
⁴Scheggi S. Still controversial issues on assessing anhedonia in experimental modeling of depression. Transl Psychiatry. 2024;14(1):1-2. doi:10.1038/s41398-024-03057-w
⁵Verharen JPH, de Jong JW, Zhu Y, Lammel S. A computational analysis of mouse behavior in the sucrose preference test. Nat Commun. 2023;14(1):2419. doi:10.1038/s41467-023-38028-0
⁶Markov DD, Novosadova EV. Chronic unpredictable mild stress model of depression: possible sources of poor reproducibility and latent variables. Biology (Basel). 2022;11(11):1621. doi:10.3390/biology11111621
⁷ Jin H, Romano G, Marshall C, Donaldson AE, Suon S, Iacovitti L. Tyrosine hydroxylase gene regulation in human neuronal progenitor cells does not depend on Nurr1 as in the murine and rat systems. J Cell Physiol. 2006;207(1):49-57.
doi:10.1002/jcp.20534
⁸ Hodge RD, Bakken TE, Miller JA, et al. Conserved cell types with divergent features in human versus mouse cortex. Nature. 2019;573(7772):61-68. doi:10.1038/s41586-019-1506-7
⁹Dixon TA, Muotri AR. Advancing preclinical models of psychiatric disorders with human brain organoid cultures. Mol Psychiatry. 2023;28(1):83-95. doi:10.1038/s41380-022-01708-2
¹⁰Li M, Duan W, Hao X, et al. Effects of esketamine on electrophysiology and metabolic reprogramming in brain organoids: insights into antidepressant mechanisms. Mol Psychiatry. 2025;30(12):6107-6118. doi:10.1038/s41380-025-03198-4
¹¹Ahn I, Chang S, Lee J, Choi SH, Han J, Kim Y. Exploration of novel biomarkers through a precision medicine approach using multi-omics and brain organoids in patients with atypical depression and psychotic symptoms. Adv Sci (Weinh).
2026;13(4):e08383. doi:10.1002/advs.202508383
¹²Li C, Fleck JS, Martins-Costa C, et al. Single-cell brain organoid screening identifies developmental defects in autism. Nature. 2023;621(7978):373-380. doi:10.1038/s41586-023-06473-y
¹³Wu J, Chen X, Zhang J, et al. Human microglia in brain assembloids display region-specific diversity and respond to hyperexcitable neurons carrying SCN2A mutation. Sci Adv. 2026;12(8):eady2977. doi:10.1126/sciadv.ady2977
¹⁴ Miura Y, Kim JI, Jurjuț O, et al. Assembloid model to study loop circuits of the human nervous system. 2024:2024.10.13.617729. doi:10.1101/2024.10.13.617729
¹⁵Walsh RM, Crabtree GW, Kalpana K, et al. Forebrain assembloids support the development of fast-spiking human PVALB+ cortical interneurons and uncover schizophrenia-associated defects. Neuron. 2025;113(19):3185-3203.e7.
doi:10.1016/j. neuron. 2025.06.017
¹⁶ Gutiérrez-Casares JR, Quintero J, Segú-Vergés C, et al. In silico clinical trial evaluating lisdexamfetamine’s and methylphenidate’s mechanism of action computational models in an attention-deficit/hyperactivity disorder virtual patients’ population. Front Psychiatry. 2023;14:939650. doi:10.3389/fpsyt.2023.939650
¹⁷Tozzi L, Zhang X, Pines A, et al. Personalized brain circuit scores identify clinically distinct biotypes in depression and anxiety. Nat Med. 2024;30(7):2076-2087. doi:10.1038/s41591-024-03057-9
¹⁸See CRZ, Tan AX, Valmaggia LR, Kempton MJ. The association between recent stressful life events and brain structure: a UK Biobank longitudinal MRI study. Eur Psychiatry. 2025;68(1):e18. doi:10.1192/j.eurpsy.2025.2
¹⁹National Institutes of Health. NIH to prioritize human-based research technologies. April 29, 2025. Accessed February 27, 2026. https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies 

March 2, 2026

Re: Prioritizing Human-Based Approaches for Mental Health Research; March 6, 2026 National Advisory Mental Health Council (NAMHC) Open Policy Session Written Comment

Sent via email

Dear Acting Director Beckel-Mitchener 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 with mental illness.

In April 2025, the National Institutes of Health (NIH) launched an initiative to prioritize human-based research methods, including new approach methodologies (NAMs),¹ and in August, NIH Director Bhattacharya reinforced this priority in a statement laying out a unified funding strategy.² Institute and Center directors are now implementing the unified strategy agency-wide, and the human-based initiative is already taking shape, including in strategic plans³ and new funding opportunities.⁴ We believe this initiative to prioritize human-based research holds a great deal of promise for mental health, which has seen few advancements in therapies and etiology.⁵ We are eager to see NIMH align its strategies, programs, and funding opportunities with this initiative.

While the safety and side effects of psychiatric medicines have improved over the years, it is widely acknowledged that there has been little progress in drug efficacy since first-generation antidepressants and antipsychotics were developed in the mid-twentieth century, the majority of which were discovered through serendipity and clinical observation.⁶ Exceptions to this are allopregnanolone (brexanolone and zuranolone) and N-methyl-D-aspartate receptor (NMDAR) antagonists for postpartum depression and major depressive disorder, respectively.⁷

While rodent studies are praised for their role in the development of brexanolone, the opposite is true for their predictive validity when testing NMDAR antagonists such as esketamine.⁸ Furthermore, rodents were used in this preclinical work to determine whether allopregnanolone is synthesized in the brain, its fluctuations in response to stress over time, and the mechanisms of its biosynthesis.⁹ Today, such investigations are more effectively carried out using NAMs, e.g., proton magnetic resonance spectroscopy combined with plasma analysis to assess allopregnanolone fluctuations and other GABA receptor modulations,¹⁰ and cerebral organoids for the analysis of neurosteroid production.¹¹ Moreover, rare instances of predictive correlation such as this must be considered alongside the generally poor predictive nature of animal tests for the efficacy and safety of new human drugs.¹²

PET imaging, ultra-high field magnetic resonance imaging, magnetic resonance spectroscopy, and multimodal approaches that combine these methods with others (e.g., EEG), allow researchers to answer questions ranging from assessments of synaptic density, neuroinflammation, and receptor targets to circuit and regional dynamics.¹³ Together, these tools offer means of advancing our understanding of human-specific pathophysiology and identifying novel therapeutic targets.

In the absence of demonstrable improvements to psychiatric medicine, and in light of shifting agency-wide priorities, the most fiscally responsible and scientifically sound course of action is for NIMH to shift funds from animal experimentation toward human-based research. We respectfully ask that the NAMHC support this recommendation, urging NIMH to prioritize human-based research using approaches like neuroimaging, patient-derived organoids, and community-based investigations.

Finally, we wish to reiterate our ongoing request that NIMH and the council end their support for projects that involve the forced swim and tail suspension tests. As these methods are reviewed by regulatory, professional, and legislative bodies, the scientific consensus as to their unreliability continues to grow. NIMH action on this issue will bring the Institute in line with other respected agencies, such as the United Kingdom’s Animals in Science Committee¹⁴ and Australia’s National Health and Medical Research Council,¹⁵ as well as the Fiscal Year 2026 Labor, Health and Human Services, Education and Related Agencies Appropriations Act, which urges NIH to limit funds for projects involving these methods.

Thank you for your time and tireless efforts on behalf of improved mental health outcomes.

Sincerely,

Stephen Farghali, MSc Research Advocacy Coordinator
Physicians Committee for Responsible Medicine
5100 Wisconsin Ave., NW, Suite 400, Washington, DC 20016
202-527-7327

¹ National Institutes of Health. (2025). NIH to Prioritize Human Based Research Technologies. https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies 
² National Institutes of Health. (2025). Advancing NIH’s Mission Through a Unified Strategy. https://www.nih.gov/about-nih/nih-director/statements/advancing-nihs-mission-through-unified-strategy 
³ National Institutes of Health Office of Research Infrastructure Programs. Strategic Plan Infrastructure for Innovation Fiscal Years 2026-2030. Accessed February 27, 2027. https://orip.nih.gov/sites/default/files/ORIP-Strat-Plan-Final-11-25-2025-508-updated-compressed.pdf 
⁴ National Institutes of Health. Expired RFA-AG-26-014: Aging Mammalian Tissues In Vitro (R21 Clinical Trial Not Allowed). Accessed February 27, 2026. https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-26-014.html 
⁵ Paul, S. M., & Potter, W. Z. (2024). Finding new and better treatments for psychiatric disorders. Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology, 49(1), 3–9. https://doi.org/10.1038/s41386-023-01690-5 
⁶ Ibid.
⁷ National Institute of Mental Health. (2025, May). Message from the Director. https://www.nimh.nih.gov/about/strategic-planning-reports/message-from-the-director
⁸ Viktorov, M., Wilkinson, M. P., Elston, V. C. E., Stone, M., & Robinson, E. S. J. (2022). A systematic review of studies investigating the acute effects of N-methyl-D-aspartate receptor antagonists on behavioural despair in normal animals suggests poor predictive validity. Brain and neuroscience advances, 6, 23982128221081645. https://doi.org/10.1177/23982128221081645 
⁹ Paul, S. M., Pinna, G., & Guidotti, A. (2020). Allopregnanolone: From molecular pathophysiology to therapeutics. A historical perspective. Neurobiology of stress, 12, 100215. https://doi.org/10.1016/j.ynstr.2020.100215 
¹⁰ Epperson, C. N., Haga, K., Mason, G. F., Sellers, E., Gueorguieva, R., Zhang, W., Weiss, E., Rothman, D. L., & Krystal, J. H. (2002). Cortical gamma-aminobutyric acid levels across the menstrual cycle in healthy women and those with premenstrual dysphoric disorder: a proton magnetic resonance spectroscopy study. Archives of general psychiatry, 59(9), 851–858. https://doi.org/10.1001/archpsyc.59.9.851 ; Shyu, C., Chavez, S., Boileau, I., & Le Foll, B. (2022). Quantifying GABA in Addiction: A Review of Proton Magnetic Resonance Spectroscopy Studies. Brain Sciences, 12(7), 918. https://doi.org/10.3390/brainsci12070918 
¹¹ Park, S. B., Koh, B., Kwon, H. S., Kim, Y. E., Kim, S. S., Cho, S. H., Kim, T. Y., Bae, M. A., Kang, D., Kim, C. H., & Kim, K. Y. (2023). Quantitative and Qualitative Analysis of Neurotransmitter and Neurosteroid Production in Cerebral Organoids during Differentiation. ACS chemical neuroscience, 14(20), 3761–3771. https://doi.org/10.1021/acschemneuro.3c00246 
¹² Bailey, J., & Balls, M. (2019). Recent efforts to elucidate the scientific validity of animal-based drug tests by the pharmaceutical industry, pro-testing lobby groups, and animal welfare organisations. BMC medical ethics, 20(1), 16. https://doi.org/10.1186/s12910-019-0352-3 
¹³ Wijtenburg SA, Rowland LM, Vicentic A, et al. NIMH perspectives on future directions in neuroimaging for mental health. Neuropsychopharmacology. 2024;50(1):294-297. doi:10.1038/s41386-024-01900-8
¹⁴ Animals in Science Committee. ASC response to commission on forced swim test. Gov.uk. Published June 2023. https://www.gov.uk/government/publications/asc-response-to-commission-on-forced-swim-test .
¹⁵ National Health and Medical Research Council. Statement on the Forced Swim Test in Rodent Models. Published December 2023. https://www.nhmrc.gov.au/research-policy/ethics/statement-forced-swim-test-rodent-models