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Transforming the understanding
and treatment of mental illnesses.

NAMHC Minutes of the 263rd Meeting

May 18, 2021

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 263rd meeting at 12:00 noon, May 18, 2021, via videocast. In accordance with Public Law 92-463, the session was open to the public until approximately 4:20 p.m. and closed thereafter for consideration of grant applications. The closed session was held on May 19, 2021 from 12:00 noon until 4:30 p.m. Joshua Gordon, M.D., Ph.D., Director of the National Institute of Mental Health (NIMH), presided as Chair.

Chairperson

Joshua Gordon, M.D., Ph.D.

Executive Secretary

Tracy Waldeck, Ph.D.

Council/Ad Hoc Members Present

  • Laura Almasy, Ph.D.
  • Marjorie Baldwin, Ph.D.
  • David Goldstein, Ph.D.
  • Kamilah Jackson, M.D.
  • Cheryl King, Ph.D.
  • Yael Niv, Ph.D.
  • Neil Risch, Ph.D.
  • Brandon Staglin, M.S.
  • Joseph Telfair, DrPH, M.P.H
  • Sophia Vinogradov, M.D.
  • Hongkui Zeng, Ph.D.

Department of Veteran Affairs (Ex Officio Member)

  • Amy Kilbourne, Ph.D., M.P.H.

Substance Abuse and Mental Health Services Administration (Ex Officio Proxy)

  • Charles Smith, Ph.D.

Members Absent:

  • CAPT Chad Bradford, Department of Defense (Ex Officio Member)

Ad Hoc Members Present:

  • Edwin (Ted) Abel, Ph.D.
  • Marguerita Lightfoot, Ph.D.

Public Members Present:

  • Chanda Chhay (Transcriber), Bizzell Group, LLC
  • Maria Rowland (Science Writer), Bizzell Group, LLC

Federal Employees Present (See page 15)

OPEN PORTION OF THE MEETING

I. Open Policy Session Call to Order & Opening Remarks, Joshua Gordon, M.D., Ph.D.
Dr. Joshua Gordon, Chairperson, called the meeting to order and welcomed Council members, NIMH staff, NIH staff, and members from various stakeholder communities to the virtual NAMHC meeting. Dr. Gordon welcomed two pending Council members serving in an ad hoc capacity for this meeting, Dr. Marguerita Lightfoot from University of California, San Francisco, and Dr. Ted Abel from the University of Iowa. He also welcomed Dr. Charles Smith of the Substance Abuse and Mental Health Services Administration (SAMHSA), acting on behalf of Dr. Anita Everett. Dr. Gordon introduced Dr. Tracy Waldeck, the new Director of the NIMH Division of Extramural Activities and NAMHC Executive Secretary, and thanked Dr. Becky Wagenaar-Miller for serving as the interim Deputy Division Director.

II. Review of Confidentially and Conflict of Interest Procedures

Dr. Waldeck explained policies and procedures regarding confidentiality and avoidance of conflicts of interest situations to members of the Council.

Following introductions, the Council unanimously passed a motion approving the final Summary Minutes of the February 2021 meeting.

III. NIMH Director’s Report, Joshua Gordon, M.D., Ph.D.

A. Budget and Appropriations Update
The Consolidated Appropriations Act of 2021 provides $2.11 billion to NIMH, , including the special appropriations for the Brain Research Through Advancing Innovative Neurotechnologies® (BRAIN) Initiative through the 21st Century Cures Act. NIMH anticipates awarding more than 550 new and competing research project grants (RPGs) in FY 2021, with an estimated success rate of 21 percent. Even with the three percent increase over the FY 2020 NIMH budget, there has been a larger increase in applications that is estimated to result in a slight decrease in success rate, although it remains above 20 percent. The NIMH budget has had significant increases over the last five years, which has resulted in the capacity to fund and conduct more research.

In April 2021, the White House released a blueprint of its FY 2022 Discretionary Funding that includes a request of $51 billion for the National Institutes of Health (NIH). A significant amount of this proposed budget is marked to create a new agency, the Advanced Research Projects Agency for Health (ARPA-H).

B. Updated Analyses of the NIMH Portfolio
Dr. Gordon provided an overview of the NIMH portfolio categorized across three broad areas: fundamental basic research, disease-related basic research, and therapeutics development and services. Over the last several years, there has been a shift in research investment, such that investments in both fundamental basic and therapeutics development and services research have increased, while investment in disease-related basic has decreased, such that the largest percent of our funding goes toward therapeutics development and services research, followed by disease-related basic research, and then basic research. NIMH has been providing support investigators to help them adapt to these shifts in investments

In response to a suggestion that NIMH is under-investing in clinical trials, Dr. Gordon asked the Office of Science Policy, Planning, and Communications (OSPPC) to analyze the NIMH research portfolio. OSPPC found that NIMH has consistently invested at least ten percent of research dollars in clinical trials and supportive activities, consistent with or exceeding the NIH average.

C. Legislative Update and Congressional Interactions
In March 2021, President Joseph Biden signed the American Rescue Plan Act of 2021, which provides $1.9 trillion as a supplemental relief package to combat the impact of the Coronavirus Diseases 2019 (COVID-19) pandemic. The law includes a number of mental health provisions to expand services, including in the areas of suicide prevention and pediatric mental health. Other Department of Health and Human Services (HHS) agencies that support mental health, such as SAMHSA, have also received substantial funds to improve access to care for those at highest risk.

In March 2021, NIMH staff met with Representative Bonnie Watson Coleman’s (D-NJ) staff to provide an update on research related to mental health disparities and black youth suicide. Dr. Gordon and NIMH staff also met with Representative David Trone (D-MD) to discuss NIMH research priorities and reflect on the impact of the COVID-19 global pandemic over the past year. They also participated in a virtual briefing organized by The Kennedy Forum in collaboration with the Congressional Mental Health Caucus on the impact of the COVID-19 pandemic on mental health and suicide prevention efforts. In April 2021, NIMH staff briefed members of the House Energy and Commerce Oversight and Investigations Subcommittee on the impact of COVID-19 on children’s mental health and the Congressional Neuroscience Caucus on COVID-19-related post-traumatic stress disorder (PTSD) among health care workers.

In early May 2021, Dr. Gordon along with Dr. Francis Collins, NIH Director, and Dr. Joyce Chung, Deputy Clinical Director of the NIMH Intramural Research Program, welcomed a congressional delegation led by Senator Roy Blunt (R-MO), who is the ranking senior member in the Appropriations Subcommittee that oversees the NIH budget, as well as several other subcommittee members from both parties. They toured the NIH Vaccine Research Center and heard presentations about the NIH-wide Rapid Acceleration of Diagnostics (RADx) Initiative. Dr. Gordon presented on the mental health impacts of the pandemic and related research being conducted at or supported by NIMH.

D. HHS and NIH Updates
In April 2021, Secretary Xavier Becerra testified before the House Appropriations Labor, Health and Human Services, Education, and Related Agencies Subcommittee on the FY 2022 discretionary funding request. The request includes investments in NIH-wide efforts to address COVID-19 and the effects of the pandemic, as well as the effects of climate change on health.

On February 11, 2021, President Biden visited the NIH Vaccine Research Center, recognized NIH staff for their outstanding response to the pandemic, and spoke to NIH director Dr. Francis Collins.

Dr. Christopher P. Austin has stepped down as Director of the National Center for Advancing Translational Sciences (NCATS).

The Helping to End Addiction Long-termSM (HEAL) Initiative held their second annual HEAL investigator meeting in May 2021, at which they presented on the HEAL data ecosystem that will make HEAL data public.

In FY 2021, the BRAIN Initiative has launched three transformative projects including a Cell Type-Specific Armamentarium (RFA-MH-21-180), a Phase III Brain Cell Census, and the Next-Generation Technologies for Brain Microconnectivity Analysis. The Armamentarium project is closely aligned with NIMH priorities and will produce the knowledge and technologies needed to understand the circuits that drive behaviors that underlie mental health disorders and to develop circuit therapeutics that allow manipulation of those circuits. Dr. Gordon also acknowledged the NIMH staff (especially Dr. Andrea Beckel-Mitchener) and the National Institute of Neurological Disorders and Stroke (NINDS) staff on their work to enhance diversity, equity, and inclusion in the BRAIN Initiative. Specifically, the BRAIN Initiative is the first project that requires specific diversity and inclusion language from applicants.

E. Ending Structural Racism in Biomedical Research
Dr. Gordon provided an overview of initiatives at NIH and NIMH to address structural racism in biomedical research. Following guidance from advisory panels and stakeholders, NIH Director, Dr. Collins, launched the UNITE initiative, which is comprised of five committees dedicated to understanding stakeholder experiences in research and health disparities, improving NIH internal culture, providing accountability and transparency among all stakeholders, and leveraging these efforts towards a more inclusive extramural research culture. The UNITE initiative developed and presented initial recommendations to Dr. Collins, many of which are in concert with NIMH efforts towards diversity and inclusion.

Dr. Gordon assembled the NIMH Anti-Racism Task Force which included more than 80 NIMH staff. The Task Force developed a set of recommendations across four areas: recruitment, hiring, retention, and leadership. Some of the near-term actions from these recommendations include publishing a Statement of Shared Values, conducting internal stakeholder listening sessions, appointing an Institute Director for Workforce Diversity, and revamping staff recruitment and retention strategies. The Task Force also recommended the inclusion of equity, diversity, and inclusion measures in supervisory evaluations and collect data on their efforts to track progress and adjust course as needed.

F. NIMH News to Know
Dr. Gordon talked about Friends of NIMH, which is an unaffiliated nonprofit organization created by some of the many organizations that collaborate with NIMH. Friends of NIMH aims to educate policymakers and other stakeholders about mental health science, advocate for the NIMH budget, facilitate communication between NIMH and stakeholder communities, provide feedback on the NIMH research portfolio, increase public awareness about NIMH research, support policies that positively impact the research workforce, and collaborate with the broader NIH community.

NIMH established a new award in honor of the late Dr. James Jackson, a renowned social psychologist and former Council member. The award will be given to an individual who represents the ideals that Dr. Jackson exemplified, specifically his focus on social determinants of health and health disparities research. The 2021 James Jackson Memorial Award winner is Dr. Enrique Neblett, Jr., Professor at the University of Michigan School of Public Health. Dr. Neblett’s research focuses on mental health disparities and the impact of racism on health and mental health outcomes.

Dr. Karen Berman, an NIMH Intramural Investigator, was awarded the Society of Biological Psychiatry George N. Thompson Award for Distinguished Service. Dr. Gordon then reviewed a number of new appointments within NIMH. New appointees include Dr Tracy Waldeck as the new Director of the Division of Extramural Activities (DEA), Dr. Becky Wagenaar-Miller as the Deputy Director of DEA, Dr. Leonardo Cubillos as the Director of the Center for Global Mental Health Research, and Dr. Andrea Beckel-Mitchener as the Deputy Director of the BRAIN Initiative.

Dr. Gordon announced the departure of several senior members of the NIMH community including Ms. Denise Juliano-Bult, Ms. Jeanne Radcliffe, Dr. Lois Winsky, and Dr. Ann Wagner. He also announced the passing of Dr. Stephen Koslow, who worked at NIMH from 1970 to 2005 and had established the Clinical and Basic Neuroscience program and Human Brain Project.

G. Science Highlights
Dr. Gordon highlighted three studies of note. The first study came from Dr. Edward Chang, who leads a research team studying the role of intracranial brain stimulation for the treatment of various neurologic and psychiatric disorders. The goal of the study was to identify brain areas related to depression, as well as brain areas that may be associated with positive emotions. Interestingly, the research team found that the types of experiences the patient felt were dependent on pre-stimulation state. Dr. Chang has been funded to continue this research, which will be a significant contribution to precision medicine using deep brain stimulation.

In the second science highlight, Dr. Gordon reviewed a study from Dr. Christopher Drake. Dr. Drake and his team tested racial discrimination as a mediator of racial disparities in insomnia disorder. The results showed that individuals from minority populations have higher levels of insomnia than White individuals. Moreover, they found that the effect of experiencing racial discrimination was far greater than the effect of race itself. This study is important not just in understanding mental health disparities but also towards understanding the mechanisms that lead to those disparities, such as access to care.

Finally, Dr. Gordon reviewed a study from the NMH Intramural Research Program led by Dr. Sooyun Lee. Dr. Lee examined somatosensation mediated by rodent whiskers. This study aimed to understand the role of microcircuitry in interpreting different endpoints from different brain regions. For example, input from the motor cortex excites inhibitory neurons called VIP neurons more than any other inhibitory neuron. Dr. Lee’s team then looked at the role of these neurons for transmitting information from the motor cortex to other parts of the brain circuit. Using opsins to turn on or off certain neurons, they stimulated inputs from the motor cortex while inhibiting VIP neurons and found that they do not inhibit the output neurons from the somatosensory cortex (the pyramidal neurons) directly. The results can inform how deficits in the brain that are related to psychiatric disorders affect the microcircuitry of different brain regions. This understanding will help develop therapeutics that target those deficits.

Discussion
Dr. Cheryl King asked if the COVID-19 impacted the pace of NIMH research and the distribution of research funds. Dr. Gordon answered that NIMH is evaluating the data on funds distribution, but is not seeing substantial trends at this time. NIH, along with individual institutes, including NIMH, have published specific supplements for research projects interrupted by the pandemic, for which there has been a robust response from applicants.

Dr. Ted Abel asked if there will be supplements provided to K99 awardees or other training grantees. Dr. Gordon answered that these awardees have been granted extensions as needed. Without the supplemental appropriations, they have been paying for half the salaries for up to an additional five months. Dr. Abel added that budget flexibility may help redistribute funds. Dr. Gordon said that budget flexibility has been granted to the extent possible.

Dr. Yael Niv asked about the balance of pharmacological treatment as compared to psychotherapy within the clinical research portfolio. Considering the research on effects of racism, there is a need to test psychotherapy methods across different environments and the interaction of those with mental health disorders. Dr. Gordon suggested that he could provide more detailed data in the future. Funding for clinical trials that are testing treatments for psychosocial interventions far exceeds those for pharmacological interventions. It is not an intentional strategy but represents what is coming in from applications.

Dr. Joseph Telfair asked if the Council is considering not only social determinants of health, but also structural determinants and their impact on the ability for diverse investigators to mature in their work. He also asked if there is a way to evaluate this at the NIH level as well. Dr. Gordon clarified that social determinants of health are related to disparities, but the framework is broader than disparities. When considering workforce issues, structural determinants, and specifically structural racism, impede diversity in the competition for NIH funding.

Dr. Sophia Vinogradov asked what high potential investments in NIMH will address a growing mental health crisis. Dr. Gordon reiterated that Congress appropriated several billion dollars to SAMHSA to expand mental health access. There is concern that there will not be enough care providers to respond to the growing mental health crisis. Within NIMH, there is research showing that telehealth for mental health services is effective and can help expand access to care. But the role of NIMH in the mental health crisis is to first understand what is actually happening and then provide an evidence base for intervention. There are a number of interventions being studied in the context of the pandemic and community-based and digital solutions for vulnerable populations. NIMH’s role is to understand the challenges and to identify the opportunities to respond to those challenges.

Dr. Neil Risch asked if NIMH is concerned about understanding the behaviors related to vaccine hesitancy for the COVID-19 vaccine, as there are differences across race/ethnicity. Dr. Gordon said that some NIMH staff have served on workgroups such as RADx to look at vaccine acceptance in different communities. NIMH is not directly sponsoring research on the topic, but NIH has invested significantly to this and related issues.

IV. Special Council Review, Becky Wagenaar-Miller, Ph.D., Division of Extramural Activities, NIMH
Dr. Wagenaar-Miller reviewed the Special Council Review policy that NIH implemented in 2012, which requires additional review of applications from well-supported investigators at a threshold of $1 million in direct costs. NIH policy also stipulates applications at the $1 million threshold that are exempt from additional review, including applications submitted to requests for applications and certain multiple principal investigator (PI) applications. NIH allows Institutes and Centers to set their own restrictions in addition to these guidelines.

NIMH staff are currently reviewing the Institute’s criteria for Special Council Review. Dr. Wagenaar-Miller presented proposed modifications to the draft policy to better distribute resources among investigators. For example, exceptions considered, include research in high priority areas, applications in which the PI supports workforce diversity, and applications in clear high-cost areas (with significant PI involvement). Dr. Wagenaar-Miller asked Council members for their feedback on the proposed modifications.

Discussion
Dr. Gordon added that NIMH is proposing a process in which an application needs to be one of the exceptions and meet the less subjective criteria to be funded. He added that they changed the threshold to $1.2 million based on Council feedback at the previous meeting.

Dr. Risch expressed concern about the exceptions for high priority areas, unique applications, and support of a diverse workforce, suggesting that these are areas of subjectivity. Dr. Gordon agreed that some exceptions could be potentially subjective, and that NIMH would identify priority areas before asking Council to provide feedback.

Dr. Gordon talked about defining how PIs support workforce diversity. For example, NINDS published a notice objectively defining workforce diversity. The other requirement for this exception is for the PI to have a substantial record of training, but this requirement also needs benchmarks. The BRAIN Initiative recommends that PIs describe their plan for supporting an inclusive workforce with the grant, and similar content could be used for this requirement.

Dr. Abel commented that it is important to define objectivity, but there is also intelligent subjectivity that supports opportunities for clearly outstanding science.

Dr. Telfair suggested that a rubric for decision-making would be helpful, even with objective and subjective criteria. Dr. Risch asked if Council was expected to make a judgment about meeting at least one of the exceptions.

Dr. Cheryl King said that she is in support of Special Council Review by exception only. She asked if any consideration was being given to early career researchers. Dr. Gordon answered that it was a good point and it had not been considered because NIMH wanted to focus large funding on a PI that plans to support a diverse workforce. If the applicant was good at supporting junior-level investigators, then the funds could go to that person as co-investigator.

Dr. Niv asked what happens if the application is not funded under the Special Council Review but received a good review. Dr. Gordon said that the application is active for 18 months after it is scored and could be brought to Council for review at a later time. NIMH intends to publish these criteria to clarify the Special Council Review process.

V. NIMH Funding Disparities, Ishmael Amarreh, Ph.D., MPA, Office for Disparities Research and Workforce Diversity; Elan Cohen, M.S., Office of Science Policy, Planning, and Communications; Dawn Morales, Ph.D., Office of Rural Mental Health Research; Abera Wouhib, Ph.D., Division of Translational Research, NIMH; Uma Vaidyanathan, Ph.D., Office of the Director
Members of the Data Science and Insight Group (DSIG), Dr. Ishmael Amarreh, Mr. Elan Cohen, Dr. Abera Wouhib, and Dr. Uma Vaidyanathan presented a portfolio analysis that was conducted over the last two years to determine if there are disparities at NIH are also present in the NIMH research portfolio and, if so, why they occur.

Mr. Cohen provided an overview of the data collection process. They examined data from 2008 to 2019, excluding data for any training and career development awards to limit their analyses to the general research portfolio. The resulting analysis included approximately 38,000 unique applications and nearly 15,000 individual PIs. They found that disparities do exist across the NIMH research portfolio, specifically across gender, race, and ethnicity. The largest disparities exist among Black applicants as compared to White applicants. Disparities also exist among American Indian and Alaska Natives, but these application numbers are too small to be meaningful.

To determine why these racial disparities exist, the group focused analyses on five decision points in the application review process: submission, discussed status, impact score, funded status, and resubmission. Mr. Cohen presented funnel charts used to put groups of different sizes on the same scale. The funnel charts illustrate the flow of applicants throughout the application process across submission, discussed status, and funding rates. On average, White PIs submit 3.5 applications as compared to 2.5 applications submitted by Black PIs. Additionally, two applications from White PIs are submitted for every one application from Black PIs. There is also a 3:1 ratio between White and Black PIs for funded applications. These three decision points together account for the 20 percent award rate among White PIs as compared to the 11 percent rate among Black PIs.

Mr. Cohen then illustrated racial disparities in impact scores, with 31 percent of White PIs receiving a competitive impact score as compared to 21 percent of Black PIs. The group also analyzed award rates for each impact score range and racial group. Generally, for PIs that receive a competitive impact score of less than 30, White and Black PIs have very similar award rates. However, as the scores increase (and therefore become less competitive), there is a shift in which White PIs are more likely to receive funding than Black PIs.

Dr. Vaidyanathan reviewed disparities in first-time submissions and resubmissions, looking at total number of applications. In both submissions and resubmissions, Black PIs have notably lower rates of success than other racial groups. But on the positive side, all racial groups, including Black PIs, show an increased probability of success in resubmission. The odds of a Black PI receiving an award increases by four-fold on resubmission as compared to two-fold among other racial groups.

Dr. Vaidyanathan provided an overview of all the results. The discrepancy between the number of applications from Black and White PIs is vast, despite plotting 12 years of data from both racial groups. For every application from a Black PI, there are 34 applications from White PIs. There is a similar ratio for the number of applicants across the racial groups. These ratios are much larger than the composition of racial groups in the United States, with approximately six White individuals for every one Black individual. The ratio of doctorate holders in the United States is 9:1. This means that the disparities in race in the NIMH research portfolio are not fully explained by base rates in the population. Only 43 percent of applications from Black PIs are discussed as compared to 57 percent from White PIs. Only 30 percent of applications from Black PIs receive a competitive impact score as compared to 40 percent from White PIs. Results suggest that there is not much difference in the percentage of applications awarded upon receiving a competitive score, however among those that did not receive a competitive impact score, only 3.2 percent of applications from Black PIs were funded as compared to 5.9 from White PIs.

Discussion
Dr. Gordon thanked the presenters and suggested that the challenging work comes in correcting the disparities. There are two potential pathways to act on – improving the resubmission rates among Black applicants and addressing the low-scoring applications that were awarded. Despite not being able to consider race in the decision-making process, there is clearly something that is reflecting these disparities.

Dr. Niv said that the presentations did not indicate the proportion of Black PIs in the neuroscience field, which is known to be less than two percent. Universities are looking at their recruiting disparities to increase diversity, which will help. Dr. Niv also suggested that there are two parts of the review process in which bias can creep. For universities with less funding,  an environmental factor may be the reason. There is also the bias to not fund researchers who have not been awarded many grants, creating a cyclical problem. Reviewer training may help deemphasize these two areas.

Dr. Risch asked why Black PIs submitted fewer resubmissions and if it was related to the original score. He also asked if Black PIs were made aware of NIMH’s high program priorities, and suggested mentoring for successful proposal writing. Mr. Staglin agreed that mentoring is a good idea that could also enhance one’s self-perception and self-efficacy, which may in turn increase resubmission rates.

Dr. Telfair said there is a difference between equality and equity. Mentoring may target equality, but it is critical to consider equity. He suggested that NIMH consider making resubmission a rule for all applicants. This would ensure that all applications are seen and not just encouraged to be resubmitted. It was indicated that other government agencies have implemented this policy and it increases the number of diverse individuals awarded.

Dr. Vinogradov suggested that it might be helpful to provide a list of volunteer mentors—senior PIs with a track record of funding. Dr. Abel talked about the challenges of deciphering the meaning of a review that has to be written as bullet points. He also wondered if the level of career was accounted for, considering the low representation in neuroscience among underrepresented racial, ethnic, and gender groups. Dr. Gordon said that the data show that seniority does contribute to some variance but not the majority of it.

Dr. Marguerita Lightfoot encouraged the Council to consider structural issues and not just individuals. Specifically, the data seems to suggest that people of color may study topics that are less valued than other topics. Dr. Gordon responded that topic choice contributes a great deal to variance. There are disparities across different Divisions, with Black PIs generally more interested in services and community-based research and social determinants of health, which have not been considered high priority areas in the past. NIMH is increasing investments to those area, which may have an effect on success rates. 

VI. Concept Review
A. Using Just-in-Time Adaptive Interventions to Optimize Adolescent Mental Health Treatments, Mary Rooney, Ph.D., Division of Services and Intervention Research

Dr. Mary Rooney presented a concept on the development and testing of just-in-time adaptive interventions to augment and optimize established adolescent mental health treatment. These interventions use smartphones and sensor data to monitor behavior and deliver responsive, tailored micro-interventions at opportune moments. Adolescence is a time of heightened risk for mental illness, as well as a time for peak engagement with technology. These interventions may also mitigate cognitive impairments associated with mental disorders and promote help-seeking or self-management behaviors. Dr. Rooney anticipates that these interventions may be informed by developmental science and grounded in behavior change models. 

Discussion
Dr. King said that this is a timely concept and there are enough evidence-based interventions to begin adapting them to technologies for more personalized treatment. The research would  also provide an opportunity to obtain real world data. She asked if there is a need for feasibility and acceptability data before funding effectiveness or efficacy trials. In addition, she suggested incorporating just-in-time interventions for parents as their role is also important. Dr. Rooney answered that they are considering a phased award to account for validation of target measures before moving into the next phase.

Mr. Brandon Staglin agreed with Dr. King’s comments and added that adolescents seem to respond well to interactive interventions administered digitally.

B. Research on Late Life Suicide: Mechanisms and Future Treatment Targets, Jovier Evans, Ph.D., Division of Translational Research
Dr. Jovier Evans presented a concept on the mechanisms and treatments of late-life suicide. Suicide prevention is a top priority of NIMH and late-life suicide is understudied. Research shows that the mechanisms by which social disconnection is related to suicidal behaviors are not well understood. This concept aims to advance translational research to better understand the mechanisms of social disconnection as a suicide risk in older adults.

Discussion
Dr. Amy Kilbourne said that this is an important topic that has not had enough focus. Isolation from the pandemic and isolation that has increased just from modern society are two trends that require more understanding. She suggested considering how to integrate technology in the mechanism studies and to consider environmental and societal factors regarding issues around privacy and biases related to capturing individual behaviors. There is potential value looking at existing data at the geographical or sociological level to consider how they impact isolation.

Dr. King agreed with Dr. Kilbourne and suggested that this topic be considered at a multifactorial level to understand any moderators of connectedness. She also said that the strength of this concept is its dual focus on identifying mechanisms and studying interventions.

C. NIMH Career Transition Award for Tenure-Track Intramural Investigators (Reissue), Ashlee Van’t Veer, Ph.D., Training Team
Dr. Ashlee Van’t Veer presented a concept to reissue the NIMH Career Transition Award for Tenure-Track Intramural Investigators. The program provides support for tenure-track intramural investigators who aim to transition from the NIMH Division of Intramural Research Programs to an independent research faculty position.

Discussion
Dr. Kilbourne asked if there is an opportunity to increase diversity of funded applicants through this transition and to support mentorship to, for instance, historically Black colleges and universities (HBCU). 

Dr. Telfair agreed with Dr. Kilbourne and asked what the parameters for success are. He is also concerned about providing support for finding a good fit with universities, which is an important factor. Dr. Van’t Veer said there would be opportunities for the individual to move into any position that has the resources to support the research they want to conduct and compete for research grant support from the NIH. 

Dr. Niv asked if the opportunity is for tenured or tenure-tracked. Dr. Van’t Veer said they could open the opportunity to both tenure-track and tenured, but it is currently only for tenure-tracked.

Dr. Baldwin asked if there were data on the proportion of intramural researchers who have taken advantage of this opportunity. She also asked if NIMH talks about this opportunity when recruiting new intramural investigators. Dr. Van’t Veer did not have exact numbers. Dr. Gordon added that the mechanism is part of recruiting intramural investigators because it provides an opportunity to compete for extramural jobs that may otherwise be difficult to obtain.

VII. Drug Development Workgroup Report, John H. Krystal, M.D. (Co-Chair); Robert L. McNeil, Jr. Professor of Translational Research Chief of Psychiatry and Behavioral Health Yale New Haven Hospital; Kalpana Merchant, Ph.D. (Co-Chair), President and Chief Scientific Officer, TransThera Consulting Company, Adjunct Professor of Neurology, Northwestern University
Dr. John Krystal provided the background for the Drug Development Workgroup, which was to address the challenges in clinical trials for drug development and its appropriateness to encourage mechanism-based drugs. There have been avoidable failures in drug development related to not having adequate target engagement. NIMH focused efforts to promote research in target engagement through a number of funding mechanisms. The Workgroup discussed how to address rapidly evolving clinical trial methods and the different biomarkers of pharmacodynamics and target engagement. They were concerned that there may not be an adequate workforce to conduct the biomarker-driven psychopharmacology clinical trials.

The Workgroup made a number of recommendations for target engagement, fast-fail trials, vulnerable pediatric and geriatric populations, confirmatory clinical trials, and the clinical trial workforce. They concluded that the field was rapidly evolving with opportunities for investigators to research early-stage drug development that incorporates target engagement biomarkers. They suggested that there is a range of funding mechanisms, including contracting, to advance innovation in this field. They also identified ongoing gaps such as populations that are not generally targeted by industry, drugs that industry generally has no incentive to develop (as was the case for ketamine), and the need to develop next generation clinical trialists with neuroscience and biomarker expertise.

Discussion
Dr. Gordon thanked Dr. Krystal and Dr. Merchant for their leadership in the Workgroup and suggested that there has been increasing interest in very small studies to examine the role of psychedelics in the treatment of psychiatric disorders. He wondered if applying the Workgroup’s recommendations to this example might lead the Council discussion. Dr. Krystal said the example of psychedelic research was applicable because there is a lot of pharmaceutical industry interest. They are not, however, seeing the biomarker-driven component in this research and there are important challenges in their study design. The challenge for NIMH is not to duplicate efficacy trials, but to examine clinical trial-informed biomarkers that can serve to orient the field onto a mechanistic path towards a foundational understanding. Dr. Gordon said that NIMH will review the report to consider any changes to future funding announcements on target engagement.

Dr. Waldeck called for a motion to accept the Workgroup’s report of recommendations. A motion to accept was passed.

VIII. Concept Clearances
D. From Genes to Biology: Scalable Approaches for Biological Characterization of Mental Illness Risk Genes Rebecca Beer, Ph.D., Division of Neuroscience and Basic Behavioral Science

Dr. Rebecca Beer presented a concept to implement systemic and scalable central nervous system profiling of risk-associated gene function at multiple levels of biological organization. Through this effort, a Genes to Biology Collaborative Network would be established to bring together a number of experts to pilot technologies and develop an open access portal to share resources.

Discussion
Dr. David Goldstein said that the field of genetics has progressed rapidly towards the understanding of how mutations influence mental illness. There are challenges that need a long-term effort to overcome, and this initiative is an important step forward.

Dr. Abel asked if the goal of this initiative is to understand the function of many individual genes or a group of genes. Dr. Beer answered that the goal encompasses both. Dr. Abel suggested that a challenge may be to understand how multiple genes and mutations interact to give rise to psychiatric symptoms. Dr. Goldstein commented that the effort could go towards studying interactions and also convergent effects across genes. He agreed that the inclusion of expression variants should be made explicit within scope.

Dr. Laura Almasy talked about the language being used acknowledging that the goal is to look for variants to biology, starting with associated variants rather than genes as a unit. Dr. Gordon agreed that this was good advice from a science perspective, if not a marketing perspective. Genes to Biology is a great title, but this effort moves beyond this and into a multi-pronged approach. Dr. Risch also agreed that it would be helpful to clarify the exact perspective being taken. Dr. Gordon asked if this meant a narrowing of scope to high impact genes such as in autism or schizophrenia. Dr. Risch clarified that a polygenic proposal would need to be dramatically innovative towards addressing disease where there is evidence from other disorders to support it.

Dr. Abel suggested that they review the Genomics Workgroup recommendations towards consistency about these ideas. Dr. Gordon agreed and added that the initiative does not specify brain or behavior to not skew towards individual mouse knockouts for behavior research. Dr. Risch suggested that they consider metabolic disorders in the brain manifested as secondary effects. 

E. Improving Use of Novel HIV Prevention and Treatment Options through Behavioral and Communication Science Dianne Rausch, Ph.D., Division of AIDS Research
Dr. Dianne Rausch presented a concept on improving the use of novel HIV prevention and treatment options through behavioral and communication science to advance public understanding and increase uptake and successful prevention. Uptake and adherence remain low despite the many advances in HIV prevention and treatment. Behavioral and communication research and the development of clear communications may increase uptake of prevention and treatment strategies. 

Discussion
Dr. King said that the lag time in the development and testing of these strategies is critical to consider and that there should be an emphasis on tailoring messages across different cultures. 

Dr. Lightfoot appreciates the highlighting of health disparities, which are significant in HIV. She commented that the concept seems to focus on the individual level but that there are other structural barriers to uptake and adherence to consider. The initiative also seems intervention-focused, and she wonders if there is also an opportunity to better understand the factors that drive uptake, adherence, and persistence in these treatments. 

Dr. Rausch said that the formative work of framing communications relies on cultural context and that is within their plan.
F. National NeuroAIDS Tissue Consortium (Contract), Dianne Rausch, Ph.D., Division of AIDS Research
Dr. Rausch reviewed this concept to fund the National NeuroAIDS tissue Consortium. The Consortium is currently funded by NIMH, NINDS, and the National Institute on Drug Abuse (NIDA). The objective of the Consortium is to maintain active cohort recruitment, community outreach, clinical assessments, research data, and tissue collection.

Discussion
Dr. Vinogradov said that this is a successful initiative that has provided useful biosamples and data related to HIV. She asked if the tissue bank might be made available for other viral neuro-infection. 

Dr. Hongkui Zeng asked for examples of the types of samples being used and the lessons learned from the many years that this Consortium has been active. Dr. Rausch answered that HIV research has resulted in a lot of understanding about how a virus integrates in the brain and how inflammation affects pathology.

Dr. Waldeck called for a motion to approve all six concepts. A motion to approve was passed unanimously.

IX. Adjournment

Dr. Gordon thanked the Council members. The open session of the NAMHC meeting adjourned at 4:20 p.m.


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 (5 U.S.C. Appendix 2). The closed session was set to resume on May 19, 2021 at 12:00 pm ET.

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

IV. Review of Applications

Refer to Appendix A.

VIII.Adjournment
Dr. Gordon thanked the Council members. The closed session of the NAMHC meeting adjourned at 4:30 p.m.

CERTIFICATION: I hereby certify that the foregoing minutes are accurate and complete.


_____________________________
Joshua Gordon, M.D., Ph.D.
Chair Person
National Advisory Council On Mental Health

Tracy Waldeck, Ph.D.
Executive Secretary
National Advisory Council on Mental Health

Attachments: Appendix A Council Roster

A complete set of open portion handouts is available from the Executive Secretary.
 
Department of Health and Human Services
Public Health Service
National Institutes of Health
National Advisory Mental Health Council
Summary of 263rd Meeting, May 18, 2021

Federal Staff Present Virtually:

Lisa Alberts
Susannah Allison
Rubin Alvarez
Ishmael Amarreh
Lizzy Ankudowich
Victoria Arango
Shelli Avenevoli
Susan Azrin
Crystal Barksdale
Anita Bechtholt
Andrea Beckel-Mitchener
Rebecca Beer
Iddil Bekirov
Yvonne Bennett
Michelle Bernal
Lora Bingaman
Bryoni Booker
Susan Borja
Jasenka Borzan
Beth Bowers
Linda Brady
Andrew Breeden
Pim Brouwers
Sandra Buckingham
Marcy Burstein
Holly Campbell-Rosen
Mindy Chai
Sharon Chang
Zieta Charles
Serena Chu
Jay Churchill
Elan Cohen
Lisa Colpe
Didi Cross
Bruce Cuthbert
Debra Dabney
Susan Daniels
Alexander Denker
Jamie Driscoll
Jovier Evans
Aileen Schulte
Lori Scott-Sheldon
Natasha Sefcovic
Teri Senn
Geetha Senthil
Pam Shell
Joel Sherrill
Belinda Sims
Rita Sisco
Ashley Smith
Charles Smith
Winette Smith
 

Gregory Farber
Jelena Fay-Lukic
Michele Ferrante
Michael Freed
Stacia Friedman-Hill
Nick Gaiano
Rebecca Garcia
Marjorie Garvey
Karen Gavin-Evans
Lisa Gilotty
Miri Gitik
Chris Gordon
Meg Grabb
Erin Gray
Greg Greenwood
Adam Haim
Wanda Harris-Lewis
Robert Heinssen
David Higgins
Lauren Hill
Mi Hillefors
Andrew Hooper
Andrea Horvath
Cathleen Hsu
Shuang-Bao Hu
Jennifer Humensky
Ann Huston
Steven Isaacson
Katelyn Janicz
Terri Jarosik
Jeymohan Joseph
Tamara Kees
Ashley Kennedy
Sabina Khan
Douglas Kim
Megan Kinnane
Collene Lawhorn
Tamara Lewis-Johnson
Jane Lin
Kelly Linthicum
Sarah Lisanby
Allen Lo
Nick Sokol
Claire Stevens
Michael Stirratt
Alexander Talkovsky
Julie Thai
Adam Thomas
Ira Tigner
Jessica Tilghman
Leo Tonelli
Farris Tuma
Christine Ulbricht
Uma Vaidyanathan

Tianlu Ma
Annette Marrero-Oliveras
Julie Mason
Doug Meinecke
Kristin Meredith
Enrique Michelotti
David Miller
Sandra Molina
Rhonda Moore
Dawn Morales
Sarah Morris
Eric Murphy
Laurie Nadler
Gretchen Navidi
Sarah Nickles
Nichole North
Katherine Noveras
Stephen O’Connor
Nicolette O’Reilly
Anna Ordóñez
David Panchision
Jane Pearson
Jonathan Pevsner
Courtney Pinard
Denise Pintello
Suzy Pollard
Greg Portner
Mary Lou Prince
Vasudev Rao
Dianne Rausch
Eve Reider
Laura Reyes
Syed Rizvi
Mary Rooney
Rebecca Rosen
Andrew Rossi
Monica Rowe
Laura Rowland
Matthew Rudorfer
Chris Sarampote
Tanisha Savage
Rachel Scheinert
Ashlee Van’t Veer
Siavash Vaziri
Aleksandra Vicentic
Jennifer Villatte
Becky Wagenaar-Miller
Ann Wagner
Tracy Waldeck
Abera Wouhib
Andrea Wijtenburg
Yong Yao
Steven Zalcman

Appendix A

Summary of Primary MH Applications Reviewed

Council:  May 2021

IRG Recommendation
Category Scored # Scored Direct Cost $ Not Scored (NRFC) # Not Scored (NRFC) Direct Cost $ Other # Other Direct Cost $ Total # Total Direct Cost $
Research 642 $955,471,400 511 $654,352,044 0 0 1153 $1,609,823,444
Research Training 1 0 0 1
Career 80 $63,016,660 31 $25,201,792 0 0 111 $88,218,452
Other 0 0 0 0 0
Totals 723 $1,018,488,060 542 $679,553,836 0 $0 1265 $1,698,041,896


Appendix B

Department of Health and Human Services
National Institutes of Health
National Institutes of Mental Health
National Advisory Mental Health Council
(Terms end 9/30 of designated year)

Chairperson

  • Joshua A. Gordon, M.D., Ph.D.
    Director
    National Institute of Mental Health
    Bethesda, MD

Executive Secretary

  • Tracy Waldeck, Ph.D.
    Director
    Division of Extramural Activities
    National Institute of Mental Health
    Bethesda, MD

Members

  • Edwin G. Abel, III, Ph.D. (pending Ad Hoc)
    Chair and Departmental Executive Officer
    Department of Neuroscience and Pharmacology
    Carver College of Medicine
    University of Iowa
    Iowa City, IA
  • Laura A. Almasy, Ph.D. (22)
    Professor
    Department of Genetics
    Perelman School of Medicine
    University of Pennsylvania
    Philadelphia, PA
  • Marjorie L. Baldwin, Ph.D. (22)
    Professor
    Department of Economics
    W.P. Carey School of Business
    Arizona State University
    Tempe, AZ
  • David Goldstein, Ph.D. (23)
    Director
    Institute for Genetic Medicine
    Columbia University
    Hammer Building
    New York, NY
  • Kamilah Jackson, M. D. (23)
    Medical Director
    PerformCare
    Robbinsville, NJ
  • Cheryl A. King, Ph.D. (21)
    Professor and Director
    Youth and Young Adult Suicide Prevention Program
    Department of Psychiatry
    University of Michigan
    Rachel Upjohn Building
    Ann Arbor, MI
  • Marguerita A. Lightfoot, Ph.D. (pending Ad Hoc)
    Professor in Residence
    School of Medicine
    Director, UCSF Prevention Research Center
    University of California, San Francisco
    San Francisco, CA
  • Yael Niv, Ph.D. (21)
    Professor
    Princeton Neuroscience Institute
    Department of Psychology
    Princeton University
    Princeton, NJ
  • Neil J. Risch, Ph.D. (21)
    Professor, Epidemiology and Biostatistics
    Lamond Family Foundation Distinguished Professor in Human Genetics
    University of California, San Francisco
    San Francisco, CA
  • Brandon Staglin, M.S. (21)
    President
    One Mind Institute
    Rutherford, CA
  • Joseph Telfair, DrPH, MPH, (23)
    Professor and Associate Dean
    for Public Health Practice and Research
    Karl E. Peace Distinguished Chair of Public Health
    Fellow, Royal Society of Public Health
    Jiann-Ping Hsu College of Public Health
    Georgia Southern University
    Statesboro, GA
  • Sophia Vinogradov, M.D. (22)
    Donald W. Hastings Endowed Chair
    University of Minnesota Medical School
    Professor and Department Head
    Department of Psychiatry
    Minneapolis, MN
  • Hongkui Zeng, Ph.D., (23)
    Executive Vice President and Director
    Allen Institute for Brain Science
    Seattle, WA

Ex Officio Members

Office of the Secretary, DHHS

Xavier Becerra
Secretary
Department of Health and Human Services
Washington, DC

National Institutes of Health

Francis Collins, M.D., Ph.D.
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

Department of Defense

CAPT Chad Bradford
Program Director for Mental Health Policy
Office of the Secretary of Defense
Health Services Policy and Oversight
Falls Church, VA

Liaison Representative

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