Welcome to the fall 2008 edition of Inside NIMH. Over the past few months, the National Institute of Mental Health (NIMH) has been involved in several noteworthy activities, which I am pleased to share with you in this newsletter.
Sincerely, Thomas R. Insel, M.D. Director, National Institute of Mental Health
In this edition of the newsletter, I would like to discuss several important topics: the Fiscal Year (FY) 2009 budget, NIMH’s partnership with the Department of the Army, implementation of the new NIMH Strategic Plan, financial conflict of interest, and NIH’s plan to phase out A2 applications as part of enhancing the peer review process at NIH. I will also update you about the status of a recent workgroup report from the National Advisory Mental Health Council (NAMHC).
As NIMH enters FY 2009, it is useful to review congressional actions on the budget. The FY 2009 President’s Budget Request is $1.4 billion for NIMH — a decrease of 0.5 percent from the FY 2008 Omnibus budget. In June, both houses of Congress recommended potential increases over the President’s Budget Request, but the House and Senate proposals have not been reconciled. Until the budget proposal is reconciled and finalized through signature of the President, NIH will operate at FY 2008 levels by means of a Continuing Resolution. During the time of the Continuing Resolution, NIMH will issue non-competing research grant awards at a level below that indicated on the most recent Notice of Award (generally up to 90 percent of the previously committed level). This is consistent with our practice during other recent Continuing Resolutions and the recent notice issued by NIH (NOT-OD-09-002). NIMH looks forward to upward adjustments to these levels after the final appropriation is enacted, but the Continuing Resolution could continue until March awaiting a new Congress and new administration.
So what does this mean for NIMH funding of new and competing grants in FY 2009? Although NIMH has no final FY 2009 budget at this time, the outlook is not good. NIMH plans to continue our FY 2008 funding policy of supporting grants below the 20th percentile, with priority based on: 1) Institute and division priorities, 2) balance in the existing research portfolio and 3) new investigator status. In FY 2008 we were able to support 581 new and competing grants and 95 new R01 investigators. Projections for FY 2009 show that we will support far fewer new and competing grants, perhaps as few as 450 new research project grants (R series grants) and less than 90 new R01 investigators. We are hopeful that these numbers may improve with careful management of the appropriated funds, but we are definitely looking at a year when several outstanding grants under the 20th percentile will not be funded.
Although the budget outlook for FY 2009 is discouraging, I am pleased to announce that NIMH is partnering with the Department of the Army to advance our understanding of suicide and develop prevention programs and practices. The Army has committed up to $50 million for a new research initiative to develop strategies to prevent suicides. I will provide additional information about this effort as it progresses.
I also want to update you on NIMH’s implementation of the new NIMH Strategic Plan. The Institute and division priorities used to make funding decisions will be heavily influenced by the new Strategic Plan, which will serve as a guide to the Institute for advancing mental health science over the next 5 years. The plan describes four main strategic objectives:
The Plan identifies a number of areas, from fundamental discovery to translational research to implementation science, which will be our goals for future investments. In December, NIMH will begin planning initiatives for FY 2010 that are closely aligned with the Strategic Plan. I will provide additional updates on NIMH’s implementation on the Strategic Plan in upcoming editions of Inside NIMH. As always, NIMH program officers are ready and willing to assist you in planning your proposals.
The issue of financial conflict of interest (FCOI) in NIH-funded research has received increasing attention recently from Congress and the media. NIMH research must be conducted with the highest scientific and ethical standards and in a manner that ensures both unbiased scientific results and public trust. In July, NIMH sent a letter to your institutional official reminding him or her of the importance of the FCOI regulations applicable to all institutions that apply for NIH research funding. If you are a grantee, you should have received an e-mail from me in late September about a new web-based NIH tutorial on FCOI, recommending its use as a training tool. Reports of an investigator's failure to fully disclose financial interests as required by the regulations or evidence of an institution’s failure to otherwise comply with the regulations are of great concern to all of us at NIMH. Ensuring objectivity in research requires a commitment from institutions and investigators to complete disclosure, appropriate review, and robust management of identified conflicts. NIH has the authority to take appropriate action to protect the safety of any research participants and to safeguard the integrity of the research. For more information on the FCOI regulations, see the “Frequently Asked Questions” on the NIH FCOI Web Site. Individual questions can be sent via e-mail to Rebecca Claycamp, NIMH Division of Extramural Activities.
I also want to update you on one aspect of NIH’s efforts to refine the peer review process, as recently published in the NIH GUIDE. In February 2008, NIH issued the Final Draft Report (PDF File, 1.63 MB), which describes recommendations for addressing seven major challenges of the NIH peer review system. Following the release of the Peer Review Report, the NIH Peer Review Oversight Committee finalized the recommendations and began immediate implementation of those recommendations, including a plan to phase out A2 applications. Beginning with original new applications (i.e., never submitted) and competing renewal applications submitted for the January 25, 2009, due dates and beyond, NIH will accept only a single amendment to the original application. An applicant who fails to receive funding after two submissions (i.e., the original and the single amendment) should substantially re-design the project rather than simply change the application in response to previous reviews. It is expected that this policy will lead to funding high quality applications earlier, with fewer resubmissions.
As a final note, I would like to introduce the recently released NAMHC workgroup report. The NAMHC Workgroup on Research Training was asked to advise the Institute on NIMH’s investment in research training and to provide strategic recommendations about how NIMH could better achieve its goals of recruiting, training, and retaining a workforce capable of integrating novel technologies and approaches across multiple levels of analysis. Their recently released report, “Investing in the Future”, provides recommendations to enable NIMH to develop a future research workforce that is equipped with the cutting-edge knowledge, skills, and perspectives that will facilitate their contributions to the research mission of NIMH. The report will soon be available on the NIMH Web site.
Each week, NIH electronically distributes the NIH GUIDE, a listing of all NIH Funding Opportunity Announcements (FOAs), which include requests for applications (RFAs), program announcements (PAs), and important notices for the scientific community. Below are samples of FOAs in which NIMH participates. The Research Funding page on the NIMH Web site has links to listings of all NIMH FOAs and other resources.
Note: You can subscribe to the NIMH Funding Opportunities ListServ to receive the latest information about RFAs and other research funding opportunities from NIMH, as well as administrative updates and changes to grant policies and procedures. You can also subscribe to a separate ListServ to receive weekly e-mails of the NIH GUIDE.
NIMH invites applications that will contribute directly to the goal of establishing empirically-demonstrated methods of preventing the development of trauma-related disorders among high trauma exposure occupational groups, for example, civilian employees and military personnel who regularly encounter traumatic situations. From a scientific perspective, occupations that involve exposure to trauma at higher than average frequency present unique opportunities for testing the effectiveness of preventive interventions designed to minimize posttraumatic adjustment disorders. From a public health and national security perspective, attending to the mental and behavioral health of individuals and groups who respond to emergencies, provide disaster relief, defend national interests, participate in peacekeeping missions, and maintain a civil society can be viewed as strengthening our national infrastructure. This RFA is being issued under the R01 and R34 mechanisms.
Release Date: April 12, 2007; Expiration Date: November 22, 2008
This FOA solicits Exploratory/Developmental Phased Innovation (R21/R33) grant applications from institutions/organizations that propose to study the development of the cerebral cortex and associated structures in humans or other mammalian model systems across three axes: time, species, and discipline. Responsive applications will integrate multiple levels of analysis aimed at defining the neurodevelopmental basis of complex behaviors related to mood, cognition, and social function. Studies should focus on postnatal developmental periods which could include birth until puberty. Since studies may require several areas of expertise, applicants are encouraged to include multiple PDs/PIs on the application.
Release Date: September 9, 2008; Expiration Date: November 29, 2008
This FOA solicits applications to study the impact of existing national, state, and/or local community-based programs addressing the adjustment and mental health needs of recent combat veterans, including returning National Guard, Army Reserve, and newly separated active duty personnel. Research projects supported through this FOA will produce new information concerning effective strategies for fostering successful transition from combat to civilian roles for returning service members. NIMH expects that knowledge gained will benefit service members and their families, employers, and relevant federal, state, and local agencies, and will inform future initiatives for recently returned combat veterans.
Release Date: July 24, 2008; Expiration Date: May 2, 2009
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), on behalf of the NIH Genes, Environment and Health Initiative (GEI), solicits Implementation Planning Grant (U34) applications from institutions/organizations that propose to plan for multicenter research on a) educational and communication initiatives for health care providers and consumers regarding interpretation of and findings from genetic studies of common diseases and the results of their dissemination, and b) behavioral or psychosocial aspects of clinical application of genetic findings. This FOA will support planning and preliminary or feasibility studies for investigator-initiated, multi-center clinical studies through an implementation planning (U34) grant. Completion of the required products of a U34 grant is a prerequisite for submission of a multi-center clinical study cooperative agreement (U01) application, which will support the actual conduct of the study.
Release Date: July 16, 2008; Expiration Date: November 26, 2008
NIDDK, on behalf of the NIH GEI, solicits Exploratory/Developmental Clinical Research Grant (R21) applications from institutions/ organizations that propose a) clinical studies using information from genome wide association or other genetic studies in common diseases; b) development and assessment of diagnostic, clinical trial, epidemiologic and risk analytic tools for use in clinical research or practice; and c) cost-effectiveness studies of clinical applications of genetic information. The proposed research must focus on using findings from genetic studies of common diseases with complex genetic etiology in clinical or public health settings. Through an Exploratory/Developmental Clinical Research (R21) grant, this FOA will support efforts to produce data that may be useful or pivotal in eventually designing large scale clinical trials or studies.
Release Date: July 9, 2008; Expiration Date: November 26, 2008
This FOA, administered by the National Cancer Institute as a part of the NIH GEI, aims to provide support for replication and fine-mapping studies of genetic regions that are putatively associated with common complex traits, primarily those identified by genome-wide association studies (GWAS). The proposed projects should aim to enhance the identification of causal variants influencing complex diseases. Any phenotype may be appropriate for these projects (i.e., studies need not be oriented on cancer or cancer-related phenotypes). This FOA will not support recruitment of human subjects, collection of human specimens, collection of medical or phenotype data, studies using animal models, or discovery genome-wide association efforts.
Release Date: September 30, 2008; Expiration Date: December 2, 2008
NIH and the U.S. Department of Veterans Affairs jointly issued this FOA to stimulate research grant applications focused on pharmacological treatments for Post-Traumatic Stress Disorder (PTSD). Medications along a continuum of development and testing (i.e., exploratory compounds ready for human testing, medications used in other areas of medicine and thought to be useful for a new indication (PTSD), and psychiatric medications currently used off-label to treat PTSD) are appropriate as the focus of a research grant application in response to this FOA. The sponsoring agencies seek to advance PTSD pharmacotherapy research by providing resources to better understand feasibility, tolerability, acceptance, safety, possible efficacy and risk/benefit ratios pertaining to symptoms and symptom severity, side effects, and treatment gains in functioning associated with available and novel medications. The sponsoring agencies anticipate the results of such studies will help identify potential medications suitable for larger scale efficacy, effectiveness and services research studies.
Release Date: October 20, 2008; Expiration Date: January 15, 2009
Since the beginning of August 2008, NIMH has published several program announcements highlighting areas of research interest, which span topics in genetics, basic neuroscience, behavioral science, translational research, interventions, and mental health services research. The NIMH Web site has a full listing of these program announcements.
The NIH Roadmap for Medical Research, launched in 2004, is a series of initiatives designed to address fundamental knowledge gaps, develop transformative tools and technologies, and foster innovative approaches to complex problems. Funded through the NIH Common Fund, these programs cut across the missions of individual NIH Institutes and Centers (ICs) and are intended to accelerate the translation of research to improvements in public health. In collaboration with all NIH ICs, the NIH Office of Portfolio Analysis and Strategic Initiatives (OPASI) oversees programs funded by the Common Fund. A full summary of Roadmap activities can be found online. Here I will review a few highlights especially relevant to NIMH.
The original Roadmap projects from 2003 are undergoing mid-course reviews and, in some cases, transition out of the Roadmap incubator or, in other cases, adjustment in scale and scope. One of the largest Roadmap efforts is the Molecular Libraries program, which is led by NHGRI and NIMH. This program has just entered a new production phase.
On September 1, 2008, the NIH Roadmap implemented the Molecular Libraries Probe Production Centers Network (MLPCN), the second phase of the Molecular Libraries Program which first began in 2004. In the new phase, a network of nine centers — funded at approximately $70 million annually over the four-year production phase — will use high tech methods to screen a library of more than 300,000 small molecules maintained in the program’s Molecular Libraries Small Molecule Repository. Data generated by the screening is available to the public through PubChem, a database created and managed by NIH’s National Library of Medicine. The network is designed to increase the pace of development and use of chemical (small molecule) probes, which have become invaluable tools for exploring biologic processes and for developing new therapies for disease.
The NIH Roadmap Epigenomics Program focuses on researching the origins of health and susceptibility to disease that are, in part, the result of epigenetic regulation of the genetic blueprint. This program will transform biomedical research by developing comprehensive reference epigenome maps and developing new technologies for comprehensive epigenomic analyses.
In July, the Program issued an RFA, “Epigenomics of Human Health and Disease.” This initiative aims to transform the understanding of epigenetic contributions to human disease. Studies will characterize global (epigenome-wide) marks or features, and their possible interactions, in cells and tissues that are representative of various human disease states, conditions, or processes. Rather than solely advancing knowledge this RFA is intended to transform or change the fundamental understanding of human health and disease by creating new paradigms for conceptualizing health and illness.
The NIH Roadmap initiated the Human Microbiome Project (HMP) to generate resources enabling comprehensive characterization of the human microbiome and analysis of its role in human health and disease. The NIH HMP continues the practice established by the Human Genome Project of international collaboration to create a comprehensive and publicly available data set. Recent RFAs include “Development of New Technologies Needed for Studying the Human Microbiome,” issued under the R01 and R21 grant mechanisms. The goal of this RFA is to develop new and improved technologies for obtaining samples of individual microbial isolates or strains suitable for complete genomic sequence analysis in order to expand the number of “reference” microbial genome sequences.
The most recent phase of the NIH Roadmap will commit $25M to transformational grants in several key areas: the science of behavior change, mitochondriome, pain, pharmacogenomics, protein capture, and 3D tissue models. More information is available. In addition, NIMH and NHGRI are leading a new Roadmap initiative in the genetics of tissue expression (GTEx). This effort will relate genomic sequence variation to variation in mRNA expression within 30 tissues taken from a large population. The purpose of this effort is to provide a database of functional variants in the human genome. We will use 2009 to establish the database and complete pilot studies in 2010-2011.
The Neuroscience Blueprint is a framework to enhance cooperative activities among 15 NIH Institutes and Centers that support research on the nervous system. The Blueprint aims to develop research tools, resources, and training and to make them available to the neuroscience community. The Blueprint will focus on neural development in 2008 and neural plasticity in 2009, with plans to continue the Blueprint initiative beyond FY 2009.
The Neuroimaging Informatics Tools and Resources Clearinghouse (NITRC): This Blueprint initiative can help researchers find and compare neuroimaging resources for fMRI and related structural analyses for potential use in their research. NITRC collects and points to standardized information about neuroimaging tools — including popular tools as well as non-traditional or cross-discipline tools, and less well known online tools — making the task of finding and comparing them easier than before. The NITRC team searches out relevant research tools to house on their Web site, and encourages user participation, ratings, and reviews to make NITRC a comprehensive source of information for researchers and developers. An active program announcement (PAR-07-417) is seeking applications to modify and enhance existing tools in NITRC or that are under consideration for inclusion.
This listing of potential future initiatives is meant to provide the earliest possible alert to the field of our research interests and of potential upcoming announcements to solicit that research. While NIMH plans to proceed with these initiatives, their publication and timing are not certain and depend on sufficient funding. The titles and brief descriptions are consistent with the information available at the time of concept clearance. The resultant FOAs may differ from the concepts in the final wording of their titles or other aspects. To send questions about a specific concept, follow the “Submit Comments” link at the bottom of the description.
The NIH Summit: The Science of Eliminating Health Disparities is a three day meeting sponsored by the National Center on Minority Health and Health Disparities to discuss the research progress of NIH on health issues among racial/ethnic minority and medically underserved populations, and to identify strengths and gaps in health disparities research. This meeting will be held on December 16-18, 2008, in National Harbor, MD.
Research workshops and scientific meetings are some of the best forums in which to identify research gaps and to stimulate new areas of mental health research. Below is a brief description of meetings that NIMH sponsored recently. You should send questions about a specific meeting to the program contact listed in the description.
NIH has also updated its transition schedule to Adobe-based grant application forms for electronic submissions of SF424 Research and Related (R&R) applications (see NOT-OD-08-117). Most electronic submissions to NIH must use Adobe application forms starting with the January 25, 2009, receipt date, with a few exceptions. As NIH waits to incorporate the latest updates to the Adobe forms by December 2008, there are two critical points applicants need be aware of:
Please help us spread the word about the results of NIMH funding by acknowledging our support of your research, for example, in journal articles (citing your NIMH award by number when possible) and other communications. NIMH has two primary methods of getting the word out:
These are all also distributed to the public through the NIMH ListServ, which now has more than 20,000 subscribers.
If you have a manuscript accepted for publication that describes an especially significant finding, please contact your NIMH program director to discuss the possibility of a news release or other forms of dissemination.