NAMHC Minutes of the 269th Meeting

February 7 and February 8, 2023

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

Introduction

The National Advisory Mental Health Council (NAMHC) held its 269th meeting at 12:30 pm, February 7, 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 4:15 pm followed by the closed session on February 8, 2023. Joshua Gordon, M.D., Ph.D., Director of the National Institute of Mental Health (NIMH), presided as Chair for both sessions.

Council Members Present

• Edwin (Ted) Abel, III, Ph.D.
• Olusola Ajilore, M.D., Ph.D.
• Laura Almasy, Ph.D.
• Marjorie Baldwin, Ph.D.
• Pamela Collins, M.D., M.P.H.
• Daniel Gillison, Jr.
• Kamilah Jackson, M.D.
• Marguerita Lightfoot, Ph.D.
• Velma McBride Murry, Ph.D.
• Joel Nigg, Ph.D.
• Matthew Nock, Ph.D.
• Bryan Roth, M.D., Ph.D.
• Laura Scott, Ph.D., M.P.H.
• Joseph Telfair, DrPH, M.P.H.
• Sophia Vinogradov, M.D.
• Hongkui Zeng, Ph.D.

Council Members Absent

• David Goldstein, Ph.D.
• Patricia Recupero, M.D., J.D.

Department of Veteran Affairs (Ex Officio Member)

• Amy Kilbourne, Ph.D., M.P.H.

Liaison Representative

• Anita Everett, M.D.

Others present at Open Policy Session (Appendix B)

Others present at Closed Grant Review Session (Appendix B)

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 in-person and virtual videocast NAMHC meeting and welcomed Council members, NIMH staff, NIH staff, and members from various stakeholder communities. He extended his welcome to new Council members Olusola Ajilore, M.D., Ph.D.; Daniel Gillison, Jr.; Velma McBride Murry, Ph.D.; and Laura Scott, M.D., M.P.H.

   Following a review of virtual meeting procedures, the Council unanimously passed a motion approving the final Summary Minutes of the September 2022 meeting.

2. NIMH Director’s Report, Joshua Gordon, M.D., Ph.D. (NIH Videocast  @08:11)

   1. Congressional Interactions with NIMH

      In October 2022, Dr. Gordon briefed staff from the office of Senator Susan Collins (R-ME) and from the Senate Health, Education, Labor, and Pensions Committee. Dr. Gordon spoke alongside Rick Woychik, Ph.D., Director of National Institute of Environmental Health Sciences, and, Gary Gibbons, M.D., Director of National Heart, Lung, and Blood Institute, about the NIH Climate Change and Health Initiative , an initiative aiming to support the development of research funding to develop interventions, services, and approaches to mitigate the impact of climate change. In December 2022, NIMH experts briefed staff from the office of Representative Bonnie Watson Coleman (D-NJ) on youth mental health disparities research.

   2. Appropriations and Budget Updates

      Dr. Gordon summarized that President Biden signed the Consolidated Appropriations Act of 2023  on December 29, 2022, which included $47.5 billion for NIH and $2.3 billion for NIMH. Dr. Gordon highlighted that the NIMH appropriation included $25 million to expand research on the impact of the COVID-19 pandemic on mental health and an increase of $5 million to support research on mental health treatment approaches, service delivery, and system transformation. Dr. Gordon also noted a larger appropriation through the 21st Century Cures Act for fiscal year 2023 (FY23) and the total appropriation represented a continued increase above inflation.

      Dr. Gordon reviewed estimated NIMH expenditures from FY22. NIMH awarded an estimated 673 new and competing research project grants, and achieved an overall success rate of approximately 24%, including 652 direct awards and 21 awards from the 21st Century Cures Act budget.

   3. HHS and NIH Updates

      Dr. Gordon announced several leadership changes across the NIH. In October 2022, President Biden appointed Renee Wegrzyn, Ph.D., as the inaugural Director of the Advanced Research Projects Agency for Health (ARPA-H). In January 2023, Roger Glass, M.D., Ph.D., stepped down as Director of the Fogarty International Center (FIC) and NIH Associate Director for International Research. Dr. Glass was a champion for NIMH’s involvement in global health research and was integral to the development of the global mental health research portfolio. Peter Kilmarx, M.D., will serve as Acting Director of FIC.

      In December 2022, Anthony Fauci, M.D., stepped down as Director of the National Institute of Allergy and Infectious Diseases (NIAID), Chief of the NIAID Laboratory of Immunoregulation, and Chief Medical Advisor to President Biden. Hugh Auchincloss, M.D., will serve as Acting Director of NIAID. In November 2022, NIH appointed Joni Rutter, Ph.D., as Director of the National Center for Advancing Translational Sciences (NCATS). In addition, NIH appointed Nina Schor, M.D., Ph.D., as NIH Deputy Director for Intramural Research.

      In September 2022, the Department of Health and Human Services released a Roadmap for Behavioral Health Integration , which advances the President’s Strategy to Address the National Mental Health Crisis , and highlights HHS-supported high-impact programs and policies to address the national mental health crisis. In October 2022, the Office of Surgeon General Vivek Murthy, M.D., M.B.A., released the U.S. Surgeon General’s Framework for Workplace Mental Health and Well-being . In October 2022, the All of Us Research Program  began returning personalized genetic results  to many of its participants, delivering on its promise to return information of value to its participants. All of Us also hosted a virtual event to educate researchers and administrators on the process of accessing its data and tools to power research. Dr. Gordon reported that the All of Us cohort includes individuals that self-reported schizophrenia and depression diagnoses. He highlighted the NIMH and All of Us collaboration, Exploring the Mind, which seeks to provide quantitative information on cognitive and perceptual processes.

      The next phase of the Brain Research Through Advancing Innovative Neurotechnologies^® (BRAIN) includes funding for three projects aimed at enhancing the understanding of brain cell types and the tools needed to access them: 1) Brain Initiative Cell Atlas Network  (BICAN), 2) Armamentarium for Precision Brain Cell Access , and 3) BRAIN Initiative Connectivity Across Scales  (BRAIN CONNECTS).

      Dr. Gordon acknowledged the new NIH Data Management and Sharing Policy  in effect as of January 25, 2023. This policy requires all NIH applicants to develop and submit data sharing plans.

      NIH’s UNITE initiative released its inaugural UNITE Progress Report for 2021-2022 . NIMH continues its efforts to promote diversity in the workplace that align with the NIH Unite initiative. These efforts including funding announcements that aim to promote workforce diversity ; diversity, equity, inclusion, and accessibility (DEIA) mentorship ; and diversity centers for genome research . NIMH also participates in funding announcements in health disparities research including announcements that seek to increase participant diversity, inclusion, and engagement in clinical studies  and research the health of people that identify as bisexual or non-monosexual.

      Dr. Gordon highlighted that the NIH Center for Scientific Review (CSR) is contemplating changes to the research project grant peer review criteria towards a simplified framework intended to focus reviewers on scientific merit and to reduce bias in application scoring. The proposed framework is based on three factors: 1) the importance of research, 2) feasibility and rigor, and 3) expertise and resources. NIH CSR published a Request for Information (RFI)  to obtain feedback on these potential changes, which will remain open for comment until March 10, 2023.

      In October 2022, the Interagency Autism Coordinating Committee (IACC) held a virtual meeting  focused on research to support the employment for youth and adults on the autism spectrum. In January 2023, IACC held a virtual meeting  to discuss autism services and to finalize its 2021-2023 IACC Strategic Plan .

      In November 2022, NIH honored 24 recipients for the 2022 Outstanding Scholars in Neuroscience Award Program.

   4. NIMH News to Know

      Dr. Gordon highlighted the February 2023 release of the NIMH Strategic Framework for Addressing Youth Mental Health Disparities, which was requested by Congress and led by the NIMH Office for Disparities Research and Workforce Diversity. The Framework outlines NIMH’s plans and priorities for guiding research in this area over the next ten years and was developed with the support of other NIH institutes and federal agencies. NIMH supported the 2022 NIH national high school contest called Speaking Up About Mental Health! This is My Story, for which 15 high school students were awarded for their essays on the youth mental health crisis and the impact of stigma. Next, Dr. Gordon reminded the extramural research community that NIMH has approved two new concepts in the areas of advancing precision medicine: precision diagnostics research and biomarker development research.

      Dr. Gordon reviewed NIMH staff news. Maryland Pao, M.D., Clinical Director of the NIMH Intramural Program, was elected for the 2022-2023 term as President of the Academy of Consultation-Liaison Psychiatry. Elisabeth Murray, Ph.D., Chief of the Section on Neurobiology of Learning and Memory, received the Society for Neuroscience Mika Salpeter Lifetime Achievement Award . Andrea Horvath Marques, M.D., Ph.D., M.P.H., Program Chief of Suicide Prevention Research and Integration of Mental Health Care in the NIMH Center for Global Mental Health, for her work in supporting global mental health research. Barry Kaplan, Ph.D., senior investigator in the Intramural Research Program Section on Neurobiology, and Denise “Denny” Pintello, Ph.D., Chief of the Child and Adolescent Research Program, retired from federal service. Dr. Gordon also shared that Barbara Stanley, Ph.D., a longtime NIMH grantee and major contributor to suicide prevention research, passed away in January 2023.

   5. Science Highlights

      Dr. Gordon shared three science highlights. In the first study,¹ researchers transplanted organoids into mice, specifically in the brain pathways associated with reward-related behavior, to understand how the organoids integrated into neural circuitry. After conditional training, they found that activation of human cells in implanted mice influences their behavior to look for a food reward. This study has important implications for understanding how genetics influence behavior and may contribute to the development of novel treatments.

      Dr. Gordon described a clinical trial² of ketamine combined with psychosocial treatment intended to reverse negative self-bias. Although ketamine has been shown to be an effective, fast-acting treatment for depression, the effects are short-lived, and individuals must receive a repeat treatment to continue experiencing decreased depressive symptoms. People with depression tend to have an implicit negative bias against themselves. The researchers wanted to determine whether a psychosocial intervention would help extend the effect of ketamine. Those who received both ketamine and anti-bias training had a decrease in negative self-bias that was significantly different from those that didn’t receive both ketamine and a psychosocial intervention.

      Finally, Dr. Gordon reviewed a qualitative study³ to pilot test the acceptability of a novel approach to treat eating disorders. Despite a large demand for online eating disorder self-diagnostics, there remains a challenge of connecting individuals with eating disorders to treatment. The researchers developed a chatbot paired with online eating disorder screening to motivate individuals to seek mental health services. Interview feedback described the chatbot as humanlike, supportive, and encouraging while delivering novel and personally relevant content. This study provides preliminary evidence of the feasibility and acceptability of a chatbot designed to improve motivation to address eating disorders.

      Discussion

      Following Dr. Gordon’s update, Council members asked for clarification on the proposed CSR scoring framework. NIH issued a RFI  seeking feedback on simplifying the peer review framework for research project grant applications. The goal of this effort is to improve the existing scientific peer review process, which aims to identify the strongest, highest-impact research. The proposed changes would enable peer reviewers to focus on scientific merit by evaluating 1) the scientific impact, research rigor, and feasibility of the proposed research and 2) whether appropriate expertise and resources are available to conduct the research, thus mitigating the undue influence of the reputation of the institution or investigator.

      Council members discussed concerns about the rate of pay among predoctoral and postdoctoral researchers and the implications for equity. They suggested points to consider such as ensuring relevant stakeholders were in policy discussions and developing funding mechanisms that promote diversity in the mental health research workforce. Council members also discussed challenges of the new NIH Data Management and Sharing Policy. Specifically, they suggested developing resources to help investigators report the cost of storing data, develop a data sharing plan for mixed-methods studies, and address how to report already public data. NIMH staff highlighted NIH online resources  supporting the new policy.

3. SAMHSA-CMHS and NIMH Status and Opportunity: Science to Service and Service to Science, Anita Everett, M.D., Director, Center for Mental Health Services (CMHS), Substance Abuse and Mental Health Services Administration (SAMHSA) (NIH Videocast  @01:20:22)

   Dr. Everett discussed the relationship between SAMHSA and NIMH in the context of policy development. She stated that policy often begins with the definition of a problem, which can be initiated by advocacy groups that raise awareness to elected officials. Solutions to those problems often fall to the science community, such as NIMH, to identify potential approaches. Politicians and policymakers then generate a new authority and/or funding allocation to implement the solution. One successful example of this policy pathway was treatment for first episode psychosis. Advocacy groups identified the long duration of untreated psychosis as a problem area. NIMH-funded research demonstrated that shorter durations of untreated psychosis led to better outcomes and quality of life. Congress set aside funding for first episode psychosis programs, and SAMHSA then allocated those funds to states through block grants. SAMHSA funding supported 37 programs nationally when the program first began and has expanded funding to nearly 400 programs as of this year.

   Dr. Everett then provided an overview of SAMHSA. SAMHSA began as a component of NIMH prior to its separation in 1972 and was authorized in 1992. Dr. Everett summarized SAMHSA’s mission is to help individuals participate in society with a sense of purpose, community, and good health. There are four main centers within SAMHSA: the Center for Mental Health Services, the Center for Substance Abuse Treatment, the Center for Substance Abuse Prevention, and the Center for Behavioral Health Statistics and Quality. SAMHSA’s budget is nearly $10 billion, and its work primarily focuses on multiple block grant programs distributed across states and territories. In addition, SAMHSA supports 45 Discretionary Grants and approximately 2,400 individual grants. Another significant focus of SAMHSA is its technical assistance to states and grantees. In recent years, SAMHSA has moved its technical assistance from a webinar-based platform to a more hands-on and site-specific program. SAMHSA also develops guidance documents across a range of topics, including serious mental illness (SMI), and manages the new SMI Adviser , which provides clinicians with expertise and guidance.

   SAMHSA houses the recently launched 988 Suicide and Crisis Lifeline , which supports three components: 1) someone to reach out to, 2) someone to respond, and 3) a place to go. Regarding someone to reach out to, nearly all calls to 988 are answered by a call center within the caller’s state. In terms of someone to respond, SAMHSA block grants support mobile crisis services as an alternative to a police and law enforcement response to mental health crises. And, to support a place to go, SAMHSA promotes short-term, walk-in style centers. States with well-developed systems across all three components have seen measurable decreases in hospitalizations, calls to law enforcement, and incarceration. Dr. Everett added that SAMHSA supports training to help staff provide mental health and crisis services that meet the needs of youth, as outlined in its National Guidance for Child and Youth Behavioral Health Crisis Care .

   Dr. Everett described some of SAMHSA’s partnerships, including with the Centers for Medicare and Medicaid (CMS), regarding mental health services funding. SAMHSA seeks to further its partnership with NIMH to ensure that its grants are supported by research. NIMH and SAMHSA have also collaborated to develop an implementation science initiative called the Certified Community Behavioral Health Clinic  (CCBHC), which aims to expand the understanding of and reduce knowledge gaps concerning the successful adoption, implementation, and sustainment of evidence-based practices in community settings. The vision of this initiative is to move individuals out of institutions and into their communities of choice. The CCBHC has compliance standards and requires specific services related to access, screening, and treatment planning. It also involves peer and family support services, psychiatric rehabilitation services, and services for veterans. CCBHCs are currently in most states and SAMHSA is working with CMS to support the CCBHC model in the remaining states. She also highlighted that SAMHSA requires their CCBHCs to use electronic health records, presenting an opportunity to link medical records across centers to help answer research questions related to the longitudinal care and outcomes of SMI and severe emotional disorders. In addition, NIMH recently released a Notice of Special Interest  to create opportunities for partnerships with CCBHCs.

   Finally, Dr. Everett presented another implementation science initiative called Project AWARE , which funds school systems that aim to integrate interventions that increase the social-emotional climate of schools and monitor individuals who need treatment.

   Discussion

   Ted Abel, Ph.D. asked if there was an opportunity for NIMH to partner with SAMHSA through the NIMH Conte Centers . Dr. Gordon said that the Conte Centers mostly fund basic and translational science, and that ALACRITY Centers were created to fund treatment and service delivery research. Although he did not know the degree to which both centers partnered with SAMHSA centers, the Early Psychosis Intervention Network (EPINET) program worked with SAMSHA centers in support of first episode psychosis care. There may be an opportunity to expand similar efforts in other cooperative areas.

4. Global Mental Health Research at NIMH: Science to Improve Health Outcomes, Leonard Cubillos, M.D., M.P.H., Director, NIMH Center for Global Mental Health Research (NIH Videocast  @02:05:19)

   Dr. Cubillos provided an overview of the history of global mental health research at NIMH. He mentioned that, in 2010, NIMH and the Global Alliance for Chronic Disease, in collaboration with additional partners, convened of 400 researchers who identified 40 challenges in mental health as a part of the Grand Challenges in Global Mental Health Initiative. Dr. Cubillos highlighted five of these Grand Challenges: 1) biomarkers, 2) predicting treatment response and side effects, 3) understanding social determinants of health, 4) developing treatments that non-specialist health professionals can deliver, and 5) training health professionals in low- and middle-income countries (LMICs). Although much work is needed to address these 40 challenges fully, there have been important accomplishments across global mental health research. He highlighted several examples of NIMH’s global mental health research contributions led by different NIMH programmatic divisions and offices.

   To further its impact on global mental health, NIMH formed a Global Mental Health Team that brings together staff across NIMH. The Global Mental Health Team focuses on strategic engagement, capacity building, and reciprocal learning. The Global Mental Health Team works in collaboration with the Center for Global Mental Health Research (CGMHR) to shape NIMH priorities in global mental health research. The CGMHR aims to support research needed to inform decisions about the adoption and scale-up of evidence-based interventions in LMICs. CGMHR seeks to meet this mission by increasing research capacity among researchers in LMICs and high-income countries interested in conducting global mental health research. CGMHR also supports reciprocal learning through research from countries irrespective of income, development, or global position (i.e., Global North, Global South).

   CGMHR also supports international collaboration networks such as the Scale-Up Hubs that aim to adapt and adopt mental health interventions in LMICs. CGMHR gathered lessons learned from the Scale-Up Hubs to inform its research portfolio. Dr. Cubillos highlighted two lessons learned from the Hubs. First, he indicated that cross-group learning had a powerful impact and that CGMHR could continue to support this learning through collaboration and long-term support. Second, he encouraged continued focus on implementation science. Dr. Cubillos also stated that the International Alliance of Mental Health Research Funders recently conducted an evaluation of global and domestic mental health research. This evaluation identified that the majority of mental health research funding goes to basic science while minimal funding is allocated to implementation and services research. However, low accessibility, availability, and affordability continue to be tangible problems in global mental health. Improving access was one of the Grand Challenges in Global Mental Health identified in 2010. CGMHR aims to focus on implementation science. To better support implementation science, CGMHR initiated a series of activities based on capacity-building (i.e., one-on-one training, webinars, satellite sessions, and listening sessions); partnerships (i.e., support for continuing or new partnerships, conferences, and working groups); and health economics (i.e., participation in a recent health economics workshop).

   Finally, Dr. Cubillos discussed the six preliminary priority areas of CGMHR: 1) suicide prevention, 2) mental healthcare integration, 3) social determinants, 4) human mobility, 5) mental health systems, and 6) training and career development. CGMHR will also encourage data science and continue its focus on implementation science to further research in these priority areas. He also emphasized the importance of understanding how research influences mental health services in real-world settings, and what can be done to increase its influence.

   Discussion

   Council members suggested approaches for partnerships, financing, and capacity building. There was a discussion about learning from reciprocal processes, as well as from other federal agencies that conduct research involving rural areas and address workforce challenges. There was also a discussion about sustainable funding and the potential for learning from other pay-for-performance models, longer-term research investments, and other policy-level learning. Marjorie Baldwin, Ph.D., asked how CGMHR decides which areas to fund. Dr. Cubillos answered that there were no predetermined regions of priority.

5. Concept Clearances (NIH Videocast  @02:50:19)

   1. Mechanisms of Reciprocal Interactions between HIV Associated Neuroinflammation and Central Nervous System (CNS) Persistence: Implications in HIV Neuropathogenesis and Cure, Jeymohan Joseph, Ph.D., Division of AIDS Research

      Dr. Joseph presented a concept targeting research using novel CNS cell systems, organoid models, and single-cell technologies to examine reciprocal interactions between HIV-associated neural inflammation and HIV CNS persistence that occur despite effective antiretroviral therapy (ART). The scope of research aims to look broadly at mechanisms that drive HIV persistence and neuroinflammation, encourage studies of the mechanisms involved in immune dysfunction, and promote the development of therapeutic strategies to alleviate the reciprocal impact between persistent virus and neural inflammation.

      Discussion 
      Discussants: Hongkui Zeng, Ph.D.

      Dr. Zeng expressed support for this concept and suggested that the effect of the proviruses and different kinds of neuroinflammation may result from effects related to the long-term process of ART. She also suggested adding more in vivo approaches and an emphasis on genetic, epigenetic, and pathological changes within different cell types. Dr. Joseph responded that that NIMH would seek to fund in vitro studies investigating mechanisms such as defective proviral DNA or RNA and agreed that in vivo approaches would be critical for understanding the long-term effects of ART. Council members discussed two concerns with the concept: the focus on in vitro models and the granularity within in vitro or in vivo models.

   2. Novel Approaches to Understanding the Mechanisms of the Neuropsychiatric Symptoms in Alzheimer’s Disease and Related Dementias (ADRD) and Advancing Therapy Development, Jovier Evans, Ph.D., Division of Translational Research

      Dr. Evans discussed the need for better interventions to address persistent neuropsychiatric symptoms associated with ADRD. The purpose of this concept is to understand the mechanisms of neuropsychiatric symptoms associated with dementia for both target validation and intervention development. Potential research areas could include medication targets and mechanistic research that extend beyond the individual level and consider caregiver and environmental factors as potential targets. Other research could investigate behavioral intervention strategies that have fewer negative side effects than commonly used dementia treatments.

      Discussion 
      Discussants: Amy Kilbourne, Ph.D., Olusola Ajilore, M.D., Ph.D.

      Both discussants expressed enthusiastic support for this concept. Dr. Kilbourne suggested that including caregiving as potential target is important to implementation science and would also meet a White House priority to strengthen a caregiver workforce for an increasingly aging population. Dr. Ajilore suggested that the mechanistic approach should not only focus on whether an intervention works or not, but also for whom and why because patients with Alzheimer’s disease have high heterogeneity. Bryan Roth, M.D., Ph.D., talked about medications with fewer side effects that had not yet been tested in this population and asked whether this concept could include follow-on clinical trials of these pharmacologic interventions. Dr. Evans responded that this concept was focused on mechanism and target identification and that they hope to follow those efforts with a collaboration with the National Institute on Aging for clinical trials.

6. Comments from Retiring Members (NIH Videocast  @03:18:19)

   Dr. Gordon thanked the three retiring Council members for their insights and contributions and invited them to comment.

   Laura Almasy, Ph.D., expressed her gratitude for the opportunity to assist in serving NIMH’s important mission. She thanked NIMH staff for their hard work, grace, and resilience through the COVID-19 pandemic and Council members for their diverse perspective and extensive knowledge. Dr. Gordon mentioned that Dr. Almasy will continue to support Council as a co-Chair of the Workgroup on High Dimensional Datasets.

   Marjorie L. Baldwin, Ph.D., said she brought to Council her perspective of both an economist and parent of a son diagnosed with schizophrenia. She talked about the implicit biases that drive negative stereotypes associated with SMI, including the inability of people with SMI to have regular employment. She urged NIMH to promote positive messages about SMI and to encourage research on support services to individuals and families impacted by SMI.

   Sophia Vinogradov, M.D., talked about a family member with SMI and agreed with the suggestion to research resiliency and protective factors as mechanisms for recovery. She noted the thoughtfulness, fairness, and quality of interactions with NIMH program officers. She expressed gratitude for NIMH’s culture of inclusive excellence and her Council colleagues’ expertise and contributions to the NIMH mission.

7. Public Comment Period

   Dr. Gordon called for public comments from those registered to speak at the meeting. There were no comments offered. Refer to Appendix C for a summary of the comment submitted for public presentation.

8. Adjournment

   Dr. Gordon adjourned the open session of the meeting at 4:12 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 February 8, 2022.

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

Members of the Public Present: 
Juliane Baron, Federation of Associations in Behavioral & Brain Sciences

Others Present Virtually: 
Jonelle Duke, Project Director, Bizzell, US 
Debra Gilliam, Transcriber, Bizzell US 
Marie Rowland, Science Writer, Bizzell US 
Ronny Zavoski, Captioner, NIH 
Aimee Oczkowski, Webinar Support, 1Source Events LLC 
Jonathan Bennett, Producer, NIH 
 

Others Present Virtually: 
Jonelle Duke, Project Director, Bizzell, US 
Aimee Oczkowski, Webinar Support, 1Source Events LLC

APPENDIX C

NAMHC Open Policy Session 
Tuesday, February 7th, 2023

Public Comment

Description of the organization represented: People for the Ethical Treatment of Animals (PETA) is a 501(c)(3) nonprofit organization headquartered in Norfolk, Virginia. PETA works to replace the use of animals with modern methods in the research, clothing, food, and entertainment industries through investigations, corporate negotiations, campaigns, education, and legislation.

Description of the oral presentation: PETA wishes to present to the Council its concerns regarding brain-lesion experiments on monkeys conducted by National Institute of Mental Health investigator Elisabeth Murray. In particular, the presentation will describe our concerns about the financial cost of these experiments relative to the benefits, as well as concerns about specific procedures to which monkeys are subjected in this laboratory. Additionally, we would like to share information regarding specific monkeys in this laboratory, which has been gathered from veterinary records obtained via Freedom of Information Act requests to NIH. Time permitting, we would also like to offer several effective alternatives to these experiments.

Submitted by: 
Katherine Roe, Ph.D., Chief, Science Advancement and Outreach 
Laboratory Investigations Department 
People for the Ethical Treatment of Animals

References

¹ Revah, O, Gore, F, Kelley, KW et al. Maturation and circuit integration of transplanted human cortical organoids. Nature 610, 319–326 (2022). https://doi.org/10.1038/s41586-022-05277-w

² Price RB, Spotts C, Panny B, et al.: A Novel, Brief, Fully Automated Intervention to Extend the Antidepressant Effect of a Single Ketamine Infusion: A Randomized Clinical Trial. AJP 2022; appi.ajp.20220216

³ Shah J, DePietro B, D'Adamo L, Firebaugh M, Laing O, Fowler L, Smolar L, Sadeh-Sharvit S, Taylor C, Wilfley D, Fitzsimmons-Craft E 
Development and Usability Testing of a Chatbot to Promote Mental Health Services Use Among Individuals With Eating Disorders Following Screening 
iproc 2022;8(1):e39408, DOI: 10.2196/39408