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2016 Autumn Inside NIMH

Inside NIMH Autumn Edition

Welcome

Welcome to the latest edition of Inside NIMH! We publish Inside NIMH in conjunction with each meeting of the National Advisory Mental Health Council (NAMHC), which advises the Secretary of Health and Human Services (HHS), the Director of the National Institutes of Health (NIH), and the Director of NIMH on all policies and activities relating to the conduct and support of mental health research, research training, and other programs of the Institute. In addition, check out our website for regular updates on timely topics at NIMH. I hope you find this information interesting and helpful. Please let us know if you have questions or comments on this Autumn 2016 edition.

Sincerely,

Bruce Cuthbert, Ph.D.
Director, RDoC Unit
National Institute of Mental Health

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I. Message from the NIMH Director

Just as the leaves on the trees are changing color, NIMH is in transition this autumn. For example, we are pleased to welcome our new Director, Dr. Joshua Gordon! We are also celebrating the completion of the first phase of the Human Connectome Project, the progress of the BRAIN Initiative, and the launch of a new landmark study on adolescent brain development.

As I pass the baton to Dr. Gordon, I am confident that he will lead NIMH in fulfilling its mission to transform the understanding and treatment of mental illnesses. I am gratified to have had the opportunity to lead the Institute over the past several months, and I would like to thank everyone at the Institute for working together to keep NIMH functioning as smoothly as ever during this period. With Dr. Gordon’s arrival, I am resuming the role of Director of the NIMH Research Domain Criteria (RDoC) Unit, and Dr. Shelli Avenevoli is continuing her splendid work as Acting Deputy Director.

Autumn Updates

  • NIMH Welcomes New Director, Dr. Joshua Gordon: On July 28, 2016, NIH announced the selection of Joshua A. Gordon, M.D., Ph.D., as the new Director of the NIMH. NIH Director Francis S. Collins, M.D., Ph.D., noted “Josh is a visionary psychiatrist and neuroscientist with deep experience in mental health research and practice. He is exceptionally well qualified to lead the NIMH research agenda to improve mental health and treatments for mental illnesses. We’re thrilled to have him join the NIH leadership team.” Dr. Gordon officially joined NIMH on September 12, 2016. To provide a little background: Dr. Gordon received his degrees from the University of California, San Francisco, where he pioneered the methods necessary to study brain plasticity in the mouse visual system. Before coming to NIMH, Dr. Gordon was an Associate Professor of Psychiatry at Columbia University Medical Center and a Research Psychiatrist at the New York State Psychiatric Institute. His research focuses on the analysis of neural activity in mice carrying mutations of relevance to schizophrenia, anxiety disorders, and depression.
  • NIMH Council Workgroup on mHealth Technologies: A National Advisory Mental Health Council (NAMHC) workgroup focusing on Opportunities and Challenges of Developing Information Technologies on Behavioral and Social Science Clinical Research met again on June 13, 2016 to discuss issues related to new mHealth technologies. The group is charged with addressing how these technologies could be used to achieve more objective and precise diagnosis and treatment of mental illnesses, as well as contribute to improved prediction, prevention, and quality in the field of mental health care. The June meeting focused on two key questions: 1) How can these new technologies be used to improve quality in mental health practice? and, 2) How can these new technologies enable new questions to be asked, and enable research to move more rapidly and to become more nimble? The group is now working on a report that will reflect the discussions of this and prior meetings.
  • NIMH Answers Questions about Psychosocial Research: NIMH actively supports psychosocial research through a variety of mechanisms, and recently posted a helpful webpage of related questions and answers. Topics include: 1) How NIMH maintains a reasonably balanced portfolio of psychosocial and biological research; 2) How future funding for intervention research could be impacted by NIMH’s experimental therapeutics model for clinical trials; 3) Funding mechanisms for clinical trials; 4) NIMH’s support for treatment process research; 5) Social and community influences on mental health, as well as organizational and structural influences on access to mental health services; 6) Prevention of mental illnesses at all ages; and, 7) NIMH’s role in scientific clinical training and promoting innovative clinical researchers.
  • NIH Celebrates Completion of the First Phase of the Human Connectome Project: The NIH Human Connectome Project is an ambitious effort to map the neural pathways that underlie human brain function. On June 20, 2016, NIH celebrated the completion of the Human Connectome Project’s first phase with a public symposium, spotlighting the many successes of the Connectome Project. One such success comes from NIMH grantees Matthew Glasser, Ph.D., and David Van Essen, Ph.D., of Washington University in St. Louis, and colleagues at six other researcher centers, who reported on their discoveries in the journal Nature on July 20, 2016. These researchers used information derived from structural and functional MRI data collected on 210 subjects to create a new 180-region-per-hemisphere map of the cerebral cortex of the human brain. Not only did the researchers map more than double the human cortex’s known regions, but also at the highest resolution to date.
  • Future Directions of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative: The BRAIN Multi-Council Working Group (MCWG), which works to ensure a coordinated and focused effort on BRAIN across NIH, held their fifth meeting on August 2, 2016 in downtown Washington, DC. The workgroup consists of representatives from the ten NIH Institutes and Centers participating in BRAIN, five at-large members, and ex officio representatives from additional government agencies. Topics discussed included training, technology sharing, tools for cells and circuits, and noninvasive neuromodulation and human brain imaging and recording. The following day, the BRAIN MCWG Neuroethics Workgroup held a meeting to discuss and recommend overall approaches for how research programs like the NIH BRAIN Initiative might handle issues and problems involving ethical issues that can arise from innovative methods of studying the brain.
  • NIH Launches Landmark Study on Adolescent Brain Development: NIH recently announced the kick off of the Adolescent Brain Cognitive Development (ABCD) study, which will follow approximately 10,000 children ages 9 to 10 into early adulthood. Scientists will track exposure to substances, academic achievement, cognitive skills, mental health, and brain structure and function using advanced research methods. As the only study of its kind, the ABCD study will yield critical insights into the foundational aspects of adolescence that shape a person’s future. The ABCD study is led by the Collaborative Research on Addiction at NIH (CRAN; National Institute on Drug Abuse, National Institute on Alcohol Abuse and Alcoholism, and National Cancer Institute), and is being conducted in partnership with several institutes, including NIMH.
  • Streamlining Multi-site Review of Human Subjects Research: On June 21, 2016, NIH issued the Final NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research (NOT-OD-16-094). The new policy enhances and streamlines the IRB review process, setting the expectation that a single IRB of record will be used in the ethical review of non-exempt, NIH-funded, human subjects research protocols that are carried out at more than one site in the United States. This move to a single IRB model also presents a unique opportunity to harmonize the standards and agreements used in clinical research. For more information see the related blog post from the NIH Office of Extramural Research.
  • New Research Hospital Board at the NIH Clinical Center: A working group of the Advisory Committee to the NIH Director, called the “Red Team,” was asked to review multiple aspects of the Clinical Center following the FDA’s finding of significant deficiencies in the Clinical Center pharmacy in May, 2015. One of the Red Team’s recommendations was to establish a new Clinical Center Research Hospital Board. The board met for the first time on July 15, 2016, in an open meeting. Board members noted the importance of engaging the entire community in efforts to improve safety for both patients and employees. Some of the changes already underway include creating the Office of Research Support and Compliance, establishing a search committee for a new chief executive officer to manage the operations of the Clinical Center, and discussing a new governance structure for the Clinical Center. Future meetings and focus groups are being planned to discuss additional changes.

Budget Overview

  • Fiscal Year (FY) 2016 Budget: We are currently on track to award approximately 580 new and competing research project grants (RPGs) in FY 2016, an increase from the 531 we estimated for this year. The increase is primarily due to receiving fewer than expected meritorious research centers and research career applications. The projected success rate for competing RPGs in FY 2016 is 22%, an increase from the FY 2015 success rate of 20%. The projected success rate for Early Stage Investigators is 23%, which is consistent with FY 2015. We anticipate funding a total of 83 new Principal Investigators (PIs) in FY 2016, which is consistent with the number of new PIs we funded in FY 2015.

Figure 1: This chart shows the number of NIMH research project grants applications, awards, and success rates from 2013 to 2017 President's Budget. In 2013, NIMH received over 2,500 applications and awarded 512 grants, resulting in a success rate of 19%. In 2014, NIMH received over 2,500 applications and awarded 548 grants, resulting in a success rate of 19%. In 2015, NIMH received a total of 2,500 applications and awarded 507 grants, resulting in a success rate of 20%. In 2016, NIMH will receive over 2,500 applications and award an estimated total of 580 grants, resulting in a projected success rate of 22%. In the 2017 President's Budget, NIMH will receive an estimated total of 2,500 applications and will award an estimated total of 525 grants, resulting in a projected success rate of 20%.

  • Outlook for FY 2017: FY 2017 will almost certainly begin under a continuing resolution (CR). As in the past, while operating under a CR, non-competing grants will be awarded at levels below committed amounts, likely at 90%. As in previous years when operating under a CR, the commitment level for NIMH grants will be determined after we receive a full-year appropriation for FY 2017.

NIMH Staff News

  • There have been several recent changes to NIMH Leadership.
    • Gemma Weiblinger retired from her position as Director of the Office of Constituent Relations and Public Liaison (OCRPL). Ms. Weiblinger first came to NIH from Capitol Hill, working at the National Cancer Institute, and then at the National Institute for Neurological Disease and Stroke, before joining us at NIMH. Over the years she has been key to NIMH’s successful outreach to many Congressional offices and our strong positive relationships with advocacy groups. Ms. Weiblinger was instrumental in efforts to promote understanding about mental illnesses, and the stigma and discrimination affecting those diagnosed with them.
    • Phyllis Quartey-Ampofo, M.P.H., is currently serving as Acting Director of the OCRPL. Ms. Ampofo has been with NIMH since 2006, serving as the Institute’s public liaison officer. She has had a lead role executing meetings and interactions with the mental health advocacy and professional organizations, coordinating congressional activities, and facilitating NIMH participation in health education events.
    • Tracy Waldeck, Ph.D., Deputy Director of the Division of Extramural Activities, recently moved on to serve as Deputy Director at the Association for Psychological Science. Dr. Waldeck started at NIMH in 2002 as a Staff Psychologist in the Intramural Program under Drs. Manji, Vythilingam, and Drevets, then came to the Extramural Program in 2005 as a Scientific Review Officer, and eventually became Branch Chief of the Extramural Policy Branch. Her breadth of knowledge on extramural grants and grants policies, as well as her expertise in IT systems to support their management, her scientific knowledge, and her collegial work ethic, will be missed.
    • Meredith Fox, Ph.D., was officially named Director of the Office of Science Policy, Planning, and Communications (OSPPC). Dr. Fox joined the NIMH Division of Intramural Research Programs (IRP) in 2005, where she studied serotonin and its transporter in the Laboratory of Clinical Science. In 2012, Dr. Fox joined OSPPC, first via a detail and then as a Health Policy Analyst in the Science Policy and Evaluation Branch, rising to Branch Chief in 2014.
  • The Division of Intramural Research Programs (IRP) welcomed two new tenure-track investigators in August 2016.
    • Soohyun Lee, Ph.D., is Chief of the new Functional Neural Circuits Unit. Her research focuses on how endogenous brain states interact with sensory representation, using the rodent whisker system as a model for studying top-down modulation of sensory processes.
    • Argyris Stringaris, M.D., Ph.D., is Chief of the new Mood, Brain, and Development Unit. His research focuses on mood disorders in young people, using a variety of methodological approaches, including psychological and pharmacological interventions.
  • Other Staff News:
    • Bruno Averbeck, Ph.D., Chief of the Section on Learning and Decision Making in the NIMH IRP, was awarded tenure by the NIH Central Tenure Committee. Dr. Averbeck’s research focuses on understanding the role of frontal-striatal circuits, and particularly the role of dopamine in these circuits, on learning and the representation of beliefs.

Office Spotlight: NIMH Office of Clinical Research

The NIMH Office of Clinical Research (OCR) is involved in many aspects of NIMH-funded clinical research studies, including human subjects protection, data and safety monitoring, recruitment monitoring, regulatory compliance, and certificates of confidentiality. OCR also serves as a liaison between NIMH and other NIH Institutes/Centers, as well as other Federal agencies, for these issues. OCR is comprised of the Human Research Protection Branch and the Clinical Trials Operations and Biostatistics Branch, which has recently implemented the Proactive Site Monitoring Program to assure the highest quality research. OCR has also spearheaded an effort to increase compliance with the registration of clinical trials within ClinicalTrials.gov. This effort has resulted a rate of 97% of all applicable NIMH studies being registered with ClinicalTrials.gov.

OCR Explains: What is a Data and Safety Monitoring Plan and why do I need one? For each NIH-supported clinical trial, NIH requires a data and safety monitoring plan (DSMP) that will provide oversight and monitoring to ensure the safety of participants and the validity and integrity of the data. The level of monitoring should be commensurate with the risks, size, and complexity of the clinical trial. NIMH has developed a helpful resource for investigators creating a DSMP. This and many other resources can be found on the NIMH Clinical Research webpage.