Inside NIMH: Funding News for Current and Future NIMH Awardees

Funding News for Current and Future NIMH Awardees • Winter 2011 Edition

Welcome to the winter 2011 edition of Inside NIMH. This edition of the newsletter discusses organizational changes at the NIMH as well as NIH, innovative new resources, and initiatives the Institute is considering for the future. We e-publish Inside NIMH after each meeting of the National Mental Health Advisory Council. In addition, check out the Director’s blog on our website for weekly 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 edition.

Sincerely,

Thomas R. Insel, M.D.
Director, National Institute of Mental Health

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I. Message from the NIMH Director

Budget Forecast

We have now completed the first quarter of our fiscal year (FY). NIH is currently operating under a stop-gap funding mechanism, or Continuing Resolution (CR), that extends through March 4, 2011, providing for funding at FY 2010 enacted levels, which is $1.489 billion for NIMH. The FY 2011 President’s Budget Request, submitted to Congress last winter, included $1.540 billion for NIMH, which would represent an increase of $50.6 million or 3.39 percent over the FY 2010 level. Between now and the expiration of the current CR, we anticipate that Congress will pass either another short-term CR, a CR for the full remainder of FY 2011, or a new budget for the remainder of FY 2011. A new budget could range from a reduction below FY 2010 funding, to the President’s request (a 3.39 percent increase over FY 2010). In the last issue of Inside NIMH, I predicted our expectations of 583 new awards in FY 2011 if we receive the President’s Budget. Under a full year CR (that is, no change from FY 2010) we are projecting 469 new awards. This would be the lowest total for new awards in more than a decade.

While operating under a CR, in accordance with NIH policy and consistent with our practice during the CRs of FYs 2006-2010, we have been issuing non-competing research grant awards at 90 percent of the previously committed level. We plan to continue this practice until a final FY 2011 appropriation is enacted. For new grants, until we have a final budget, NIMH is assuming a funding level below the FY 2010 budget. Under these constraints, we will not be issuing awards for grants beyond the 10th percentile. NIMH will consider adjustments to these levels once the final appropriation is enacted.

Regardless of the ultimate Federal budget for this year, we at NIMH will endeavor to advance mental health research through our Strategic Plan, promoting discoveries that can make the most difference for people with mental illness. This tough funding climate also reinforces the need for leveraging our investments by standardization, integration, and sharing of research results.

Scientific Management Review Board: Two Important Recommendations

In December 2010, the NIH Scientific Management Review Board (SMRB) recommended that the NIH realign its resources to establish a new Center devoted to advancing translational sciences. As currently envisioned, the central role of the proposed National Center for Advancing Translational Sciences (NCATS) would be to accelerate the development of new diagnostics and therapeutics across a wide range of diseases. The new Center is intended to support many current efforts in existing NIH Institutes, including NIIMH, by serving as a hub for resources (e.g., high throughput screening), platforms (e.g., medicinal chemistry), and expertise (e.g., technology transfer experience) required across NIH. NCATS would be formed initially by integrating selected translational research programs now located within the National Human Genome Research Institute, the National Center for Research Resources, and the NIH Common Fund. Another component could be the Cures Acceleration Network (CAN), but this has not yet been funded via the Congressional appropriation process. In order to facilitate ongoing input and interactions, NIH has launched a website, NCATS Feedback NIH, which I encourage you to visit. Members of the public can use the website’s comment link to provide direct, constructive feedback, and the question link to ask questions. The website will be updated regularly with answers to your questions. We intend to open NCATS by October 2011.

In addition, the SMRB has issued recommendations regarding the creation of a new Institute focusing on substance use, abuse, and addiction research and related public health initiatives. This new Institute would integrate the relevant research portfolios from the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and other NIH Institutes and Centers. NIH accepted the proposed realignment of NIH programs into a single, new Institute devoted to addiction. A task force is charged with looking carefully across the NIH’s 27 Institutes and Centers to determine which programs could be moved into the proposed Institute. Our working goal, pending Congressional approval, is to launch the new institute in October 2012. More information is available at the Feedback NIH website.

New and Notable

Among the Institute’s most recently funded projects that exemplify our efforts to accelerate mental health research and to advance the NIMH Strategic Plan:

  • Claudia Buss, Ph.D., (University of California, Irvine) an early-stage investigator, is conducting structural neuroimaging studies in neonates and infants at 2 to 4 weeks and 12 months of age and will combine those data with multiple biological and environmental measures of stress. She will evaluate the timing, nature, and cumulative effects of stress to determine how the prenatal and postnatal environment modifies the association between stress and neurodevelopment.
  • John Weisz, Ph.D., (Judge Baker Children's Center) will develop and pilot test an innovative, clinician-friendly, modular psychosocial treatment approach for treating the most commonly encountered childhood mental disorders. The flexible approach can be used to accommodate co-occurring conditions and shifting problem foci encountered in common mental health practice, and the modular, flexible format is potentially more easily taught and disseminated in comparison to existing, manual-driven approaches.
  • Marc Caron, Ph.D., (Duke University) is tackling the process by which a particular molecule can exert differential effects on the system through interactions with the same receptor, due to downstream signaling mediators or pathways — i.e., functional selectivity. In particular, he aims to determine the pathways by which dopamine differentially affects brain function and behavior, focusing on a novel signaling pathway, the glycogen synthase kinase/beta-arrestin pathway.
  • Diego Pizzagalli, Ph.D., (McLean Hospital), is extending his work on major depressive disorder and the cardinal symptom of anhedonia. His research will integrate molecular genetics, fMRI coupled with a pharmacological challenge, and a PET measure of dopamine transporter binding to extend our understanding of the pathophysiology of anhedonia and contribute to the identification of novel treatment targets.

Two New Offices formed within the Office of the NIMH Director

In recognition of the increasing complexity of our efforts in the areas of technology development and genomics research, especially with regard to coordination and broad sharing, we have established two new offices at NIMH: the Office of Genomics Research and Coordination (OGRC), and the Office of Technology Development and Coordination (OTDC). OGRC is charged with coordinating and overseeing all NIMH (extramural and intramural) genomics research efforts, ensuring a coherent strategic approach to the research being supported and related activities at the Institute. Thomas Lehner, Ph.D., M.P.H., who currently serves as the Chief of the Genomics Research Branch in the Division of Neuroscience and Basic Behavioral Science, will assume the responsibility of Director for OGRC.

OTDC will be responsible for oversight of all NIMH efforts related to technology development, bioinformatics, and repositories. This scope will include both intramural and extramural efforts. In addition, management for the National Database for Autism Research (NDAR) will be folded into this office. Michael Huerta, Ph.D., currently NIMH Associate Director for Technology, will be the Director for OTDC. In addition to the importance of coordinating activities in these two areas within NIMH, both Drs. Lehner and Huerta have been and will continue to be involved in many trans-NIH activities.

New Resource for Mental Health Statistics

NIMH recently launched a new mental health statistics resource on our website. This resource includes the best mental health research information from across the Department of Health and Human Services (HHS) and other federal departments, and places it within an easy-to-navigate format. It represents a vast expansion from NIMH’s previous statistics pages and is organized using navigational tabs for each of the four main categories of data: prevalence, disability, suicide, and cost. Each of the graphics found in the resource is accessible in PDF format for users to print and share electronically, and the data provided are consistent with the recommendations in HHS’s Healthy People 2020 initiative. This resource will be updated regularly as new mental health data from across the federal government are reported and its format will continue to evolve in order to ensure the most straightforward usability and clearest presentation of information.

II. New Announcements about Funding Opportunities

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 is a selection of recently issued FOAs in which NIMH participates. The Research Funding page on the NIMH website 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.

NIH Common Fund Initiatives

The NIH Common Fund was enacted into law by Congress through the 2006 NIH Reform Act to support cross-cutting, trans-NIH programs that require participation by at least two NIH Institutes or Centers or would otherwise benefit from strategic planning and coordination. To date, the Common Fund has been used to support a series of short term, exceptionally high impact, trans-NIH programs known collectively as the NIH Roadmap for Medical Research. As the Common Fund grows, and research opportunities and needs emerge in the scientific community, the portfolio of programs supported by the Common Fund will likely evolve to encompass a diverse set of trans-NIH programs, although the NIH Roadmap is likely to remain a central component.

Two new projects are being co-led by NIMH. The HMO Research Collaboratory will be developing a research partnership with large practice organizations to support mega-epidemiology and practical trials research. The Health Economics project will be supporting several pathways of research to inform the implementation of health care reform.

The following projects currently have active funding opportunities and/or notices for NIMH applicants:

Molecular Libraries

The PAR, Solicitation of Assays for High Throughput Screening (HTS) in the Molecular Libraries Probe Production Centers Network (MLPCN), offers public sector biomedical researchers access to the large-scale screening capacity necessary to identify small molecules that can be optimized as chemical probes to study the functions of genes, cells, and biochemical pathways. This increased access will lead to new ways to explore the functions of genes and signaling pathways in health and disease. As of July 2010, MLPCN accomplishments (FY 2005-2010) include 375 screening projects assigned to the centers, 282 screening projects completed, 175 probes produced, 95 leads in preclinical development outside of the MLP, 304 direct publications from the centers, and 845 indirect publications. The Small Molecule Repository (MLSMR) compound collection has reached 349,630 and growing.

Release Date: March 12, 2009; Expiration Date: January 5, 2012

Rapid Access to Interventional Development (RAID)

The NIH RAID program provides full development services for small molecules, peptides, oligonucleotides, and gene vectors, and all (except manufacturing and formulation) biologics. The program has resulted in at least six initial new drug applications (INDs), including one for mental health relevant disorders: a vasopressin receptor antagonist for depression. Recently, an additional mental-health-relevant project was funded, and a seminar was held for another project. Both address potential schizophrenia treatments. For more information, please contact the NIH-RAID program office: nih-raid@mail.nih.gov.

  • Notice on NIH-RAID Updates on Program Scope and Procedures: Biologics Manufacture, Lead Selection, and Product Development Plans (NOT-RM-10-012)

The Library of Integrated Network-based Cellular Signatures (LINCS)

The LINCS program aims to support the high-throughput collection and integrative computational analysis of informative molecular and cellular signatures generated in response to a variety of perturbing agents, including small interfering RNA (siRNAs) and small bioactive molecules, which are applied to a set of carefully selected cell types. Two high-scoring pilot center applications in response to the Large Scale Production of Perturbagen-Induced Cellular Signatures (U54) RFA have been approved for funding by the NHGRI National Advisory Council. Two additional RFAs have been released aimed at informatics and data analysis tool development, and experimental technology development: Advanced Technologies for Detection of Perturbation-Induced Cellular Signatures (RFA-RM-10-004) and Computational Tool Development and Integrative Data Analysis for LINCS (RFA-RM-10-005).

Release Date: August 6, 2010; Expiration Date: February 23, 2011

The following Common Fund projects have already yielded important scientific opportunities for NIMH:

Genotype-Tissue Expression (GTEx)

Through the GTEx program, correlations between genotype and tissue-specific gene expression levels will help identify regions of the genome that influence whether and how much a gene is expressed. GTEx will help researchers to understand how changes in DNA sequence that give rise to expression quantitative trait loci (eQTLs) affect gene expression in different normal human tissues. In October 2010, GTEx launched as a 2-year, $25 million pilot study supported by the NIH Common Fund. The pilot project currently supports three biospecimens source sites, and a laboratory data analysis and coordinating center. Organized under the National Cancer Institute’s cancer Human Biobank (caHUB) initiative, the biospecimens source sites will recruit donors and collect the tissues. Donor collections and tissue analysis are set to begin in the spring of 2011.

Human Microbiome Project (HMP)

The HMP is a five-year, $157 million project with goal of characterizing the microbiome of healthy adults, correlating changes of the microbiome in health and disease, and stimulating additional support for microbiome research in disease research. Project accomplishments include continued quality assurance standards development for genomic and metagenomic sequence data; an initial list of microbial strains for sequencing; an institutional review board-approved clinical sampling protocol; establishment of an interim Data Coordination Center; and, gathering of the first HMP Research Network Meeting with principal investigators from all HMP-funded grants.

Epigenomics

The Epigenomics Program studies the role of epigenetic regulation of the genome as it pertains to health and susceptibility to disease. Specifically, the program focuses on mechanisms that control stem cell differentiation into various tissues and how epigenomic marks contribute to the biological response to endogenous and exogenous stimuli that result in disease. The Program is creating an international committee; developing standardized platforms, procedures, and reagents for epigenomics research; conducting demonstration projects to evaluate how epigenomes change and their role in disease; developing new technologies for single-cell epigenomic analysis and in vivo imaging of epigenetic activity; and, creating a public data resource to accelerate the application of epigenomics approaches.

Science of Behavior Change (SOBC)

Ten new Common Fund awards are made in fiscal year 2010 in the Science of Behavior Change program to improve the understanding of basic mechanisms of behavior change that play a role in initiating or maintaining behavior change across a broad range of health-related behaviors. The projects bridge work done in laboratories and in the field, and are intended to stimulate investigations of basic mechanisms at the social, contextual, behavioral, psychological, neurobiological or genetic level of analysis.

Clinical Translational Science Awards (CTSA)

Launched in 2006, the purpose of the CTSA Program is to assist research institutions to forge a uniquely transformative, novel, and integrative academic home for clinical and translational science that has the consolidated resources to captivate, advance, and nurture a cadre of well-trained multi- and inter-disciplinary investigators and research teams; create an incubator for innovative research tools and information technologies; and, synergize multi-disciplinary and inter-disciplinary clinical and translational research and researchers to catalyze the application of new knowledge and techniques to clinical practice at the front lines of patient care. Nine new CTSAs have been announced for 2010, bringing the total number of awards to 55.

NIH Neuroscience Blueprint Initiatives

The Neuroscience Blueprint is a framework to enhance cooperative activities among 16 NIH Institutes, Centers, and Offices 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.

NIH Blueprint for Neuroscience Research Short Courses in Neurotherapeutics Development

The Blueprint has recently issued an FOA to solicit applications to develop and implement short courses on neurotherapeutics development for academic neuroscientists. The short courses should provide participants with a sufficient overview of the neurotherapeutics development process to (1) understand the steps required for therapeutics development; (2) anticipate and overcome common challenges in the process; and, (3) interact effectively with collaborators who have expertise in various aspects of therapeutics development. The short courses should primarily target independent academic neuroscience researchers and senior post-doctoral fellows interested in incorporating treatment development into their research programs.

Release Date: December 8, 2010; Expiration Date: April 11, 2011

Grand Challenge on New Drugs for Diseases and Disorders of the Nervous System

This program will set up a pipeline to move candidate drugs for nervous system disorders through preclinical development into early clinical trials. Successful applicants to the program will receive funding to conduct biological testing in their laboratories and unprecedented access to a full range of industry-style drug development services and expertise. The investigators will retain the intellectual property for compounds they develop through this program. The first release of the RFA resulted in a good response. The applications have been reviewed, and a budget plan has been developed. A new RFA is expected to be published in February 2011, with two receipt dates tentatively scheduled for August 2011 and January 2012.

Grand Challenge on Pain

The Grand Challenge will support research that explores how pain can change from an acute, temporary state to a chronic, potentially disabling condition. The initiative seeks to bring researchers from the neuroplasticity field into the pain field, and supplements have been made available to set up these collaborations under an existing NIH grant. In the next two years, this Grand Challenge will be expanded to promote larger collaborative projects on the transition from acute to chronic pain, and to train new investigators in state-of-the-art methods for studying pain. Applications have been received in response to the Grand Challenge RFA NIH Blueprint for Neuroscience Research Grand Challenge on the Transition from Acute to Chronic Neuropathic Pain, and they will be reviewed in February 2011.

III. Future Research Directions

National Advisory Mental Health Council (NAMHC) Concept Clearances for Potential New Research Initiatives

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.

Related Information

Summaries of NIMH-Sponsored Scientific Meetings

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. Questions about a specific meeting can be addressed by the program contact listed in the meeting description.

IV. Update on Electronic Submission of Grant Applications

Grant Application Submission News

Many changes affecting application submissions have gone into effect beginning with the January 25, 2011 application receipt date. These and other recent changes cover grant policy issues as well as electronic submission issues. Please see NOT-OD-11-021 for a list and links to the policy changes.

Specifically:

  • Elimination of the electronic 2-day error correction window (NOT-OD-11-023): plan to submit a few days before a deadline to ensure adequate time to make unanticipated needed corrections by the due date.
  • Adobe forms updated (Adobe B1): NOT-OD-11-007 (For F, K, T and D submissions in particular, see NOT-OD-11-008 — new forms available now!).
  • Policy on post-submission application materials, which narrows the circumstances under which such material may be submitted: see NOT-OD-10-115.
  • NIH policy concerning appendix materials, and where to find the instructions on what may be included in appendix materials and where (NOT-OD-10-077). Always check the FOA for specific instructions on appendix material.
  • New time limit for a resubmission (A1) application (generally speaking, a 37 month period): see NOT-OD-10-140.
  • Last legal A2 submissions (see NOT-OD-10-135): February 7, 2011 (only for AIDS application PIs who are eligible for continuous submission). For all other applications, only one resubmission is allowable.
  • New page limits for NIH Individual career development (K) awards: see NOT-OD-11-027, and for greater detail, the application instructions that come with the forms for the career development awards.
  • Letters of Reference for fellowships (F) and career development (K) applications must be received by the grant application deadline and will not be accepted late (see NOT-OD-11-036) starting with the April 8, 2011 deadline.

Grants Policy Update

  • In Grants.gov, the e-Business Point Of Contact (E-Biz POC) is the individual responsible for authorizing the individuals in your organization that are allowed to sign and submit grant applications (i.e., Authorized Organization Representatives (AOR)). If you are the E-Biz POC for your organization and have not logged into Grants.gov since they released their new security changes in October 2010, then you will want to take a few minutes to do so. You will need to establish a new Grants.gov password to maintain your ability to administer roles for your organization. For more information, see the last section on the January 21, 2011 NIH eRA eSubmission Items of Interest web page.

V. Research Training and Career Development

Instruction in the Responsible Conduct of Research: Reminder of Updated NIH Policy

Instruction in the responsible conduct of research (RCR) is a required component of all NIH individual training (F), institutional training (T), research education (R25), dissertation research (R36), and career development (K) applications. Here we highlight the updated policy on instruction in the responsible conduct of research (see NOT-OD-10-019), because the plans in many new applications submitted to NIMH since publication of the updated policy have not been acceptable. In addition, continuation (Type 5) applications submitted after January 1, 2011, have a reporting requirement related to instruction in the RCR. Potential applicants and awardees are encouraged to read the Policy Notice, as this is a list of highlights:

  • The updated policy lists a set of principles that guided its development.
  • The policy outlines five instructional components that must be described in any proposed plan for instruction in the responsible conduct of research.
  • For individual (e.g., F and K) applications, the applicant is expected to document any prior instruction and to describe the role of the sponsor/mentor in the proposed training.
  • Because issues inherent in RCR recur across a scientist’s career, and because the issues evolve with the changing scientific landscape, individuals supported on NIH training and education-related programs are required to obtain instruction in RCR at least once during each career stage, and at a frequency of no less than once every four years. Individuals at the early career investigator stage must receive instruction at least once during this career stage.
  • If the plan is not acceptable, then the applicant must provide a revised plan for review by NIMH Program staff members, who will use the principles described in NOT-OD-10-019 to determine the acceptability of the revised plan. Only when a revised plan is deemed acceptable may an award be made.

NIMH encourages applicants to tailor aspects of their plan for RCR instruction to their research proposal. For NIMH-supported research training, one of the following examples may be pertinent:

  • Ethical issues related to research using electronic media/online research ethical issues working with underserved communities;
  • Ethical issues working with patient and/or pediatric populations; and/or
  • Ethical issues in human genetics research, particularly with information from diverse populations.

Please direct any questions about this policy to an NIMH Training Officer (PDF File).

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We’re interested in feedback from the community; comments or suggestions related to NIMH’s support for research training and career development may be directed to NIMH_Training@mail.nih.gov.

VI. Recent NIMH Science News

The latest news and updates from NIMH-supported research:

Publicizing NIMH research is a communal responsibility — we need your help! 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: press releases and science updates. All releases and updates are posted to the Science News section of the NIMH Web site. 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.

VII. Stay Connected with NIMH

In pursuit of new ways to reach our stakeholders, NIMH has leapt into the world of social media. In addition to our email newsletters and RSS updates, NIMH now offers YouTube videos on mental health topics. We have also entered the world of Twitter, where we highlight Science Updates, Press Releases, and other timely matters. You can even find us on Facebook! Be sure to read our Director’s Blog for insights into the latest topics in mental health research.

Check us out!