NIMH EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM Release Date: March 6, 2000 PA NUMBER: PA-00-073 National Institute of Mental Health PURPOSE The Division of Neuroscience and Basic Behavioral Science and the Division of Services and Intervention Research of the National Institute of Mental Health (NIMH) invites applications for Exploratory/Developmental Grants (R21) that fall within their research interests. The objective of this Exploratory/Developmental Grant (R21) mechanism is to encourage applications for one-time grants to support: 1) innovative research directions requiring preliminary testing or development, 2) exploration of the use of approaches and concepts new to a particular substantive area, 3) research and development of new technologies, techniques or methods, or 4) initial research and development of a body of data upon which significant future research may be built, i.e., the data should have a high level of impact on the field. While this program announcement is intended to encourage innovation and high impact research, and while no preliminary data are expected to be described in the application, applications should make clear that the proposed research and/or development is scientifically sound, that the qualifications of the investigators are appropriate, and that resources available to the investigators are adequate. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS- led national activity for setting priority areas. This program announcement PA "NIMH EXPLORATORY/DEVELOPMENTAL GRANT (R21) PROGRAM," is related to the priority area of Mental Health and Mental Disorders. Potential applicants may obtain a copy of "Healthy People 2010" at: ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic or foreign for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal Government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT Under this program announcement, applicants for the R21 award may request direct costs of up to $100,000 per year for up to two years. Competitive renewals of grants awarded under this program announcement will not be accepted. Specific application instructions have been modified to reflect the purpose and nature of this mechanism, as well as to accommodate the "Modular Grant" and "Just-In-Time" streamlining efforts being implemented by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at the website RESEARCH OBJECTIVES The R21 mechanism described in this program announcement may support research and/or development relevant to the mission of the Division of Neuroscience and Basic Behavioral Science and the Division of Services and Intervention Research of the NIMH. The Division of Neuroscience and Basic Behavioral Science provides extramural support of basic and clinical neuroscience research, genetics research, development of therapeutics, basic behavioral science research, research training and career development, and research and development of scientific technologies relevant to any of these substantive areas. The overarching goal of research supported in this Division is to increase understanding of basic behavioral mechanisms and the neural basis of normal and disordered mental function. Specific research funding programs of this Division are housed within the following office and branches of the Division: 1) Translational Research and Scientific Technology Office, 3) Behavioral Science Research Branch, 4) Behavioral and Integrative Neuroscience Research Branch, 5) Clinical Neuroscience Research Branch, 6) Genetics Research Branch, and 7) Molecular and Cellular Neuroscience Research Branch. The branches, offices and programs comprising the Division are described in more detail on the website The Division of Services and Intervention Research (1) directs, plans, supports and conducts programs of research in prevention and treatment interventions, services research and clinical epidemiology. These efforts include the support of research, research training, research demonstrations, and research dissemination. Specific research funding programs of this Division are housed within the following branches: 1) Adult and Geriatric Treatment and Preventive Intervention Research Branch, 2) Child and Adolescent Treatment and Preventive Intervention Research Branch, and 3) Services Research and Clinical Epidemiology Branch. This announcement complements other announcements such as PA-99-134, but highlights the following substantive areas: quality of care, mixed research methods, and socio-cultural issues. The branches, offices and programs comprising the Division are described in more detail on the website INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994 available on the web at the following URL address: INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applicants are strongly encouraged to contact the program contacts listed under INQUIRIES with any questions regarding their proposed project. Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, Email: Applications are also available on the World Wide Web at: When form PHS 398 is used, the following modifications should be included: 1. Face Page of the application: Item 2, Check the box marked Yes and type the number and title (NIMH Exploratory/Developmental Grant [R21] Program) of this program announcement. 2. Description: As part of the description, identify briefly how this application relates to the purpose of the R21 mechanism as stated in this program announcement (i.e., highly innovative research, exploration of the use of approaches and concepts new to a particular substantive area, research and development of new technologies, techniques or methods, or initial research and development of a body of data upon which significant future research may be built). Research Plan: The Research Plan may not exceed 10 pages. Item a, SPECIFIC AIMS: The instructions for this section suggest that the applicant state the hypotheses to be tested. Since some applications submitted in response to this program announcement may also be design- or problem-driven (e.g., development of novel technologies), or need-driven (initial research to develop a body of data upon which future research will build). In such instances, hypothesis testing per se may not be the driving force in developing such a proposal and, therefore, may not be applicable. Thus, the application should state the hypotheses, design, problem and/or need which will drive the proposed research. Item b, BACKGROUND AND SIGNIFICANCE: In this section it is important to clearly elaborate upon how the application serves the purpose of this program announcement. Item c, PRELIMINARY STUDIES/PROGRESS REPORT Although preliminary data are not expected for an Exploratory/Developmental Grant application, if such data exist they should be presented. Item d, RESEARCH DESIGN AND METHODS In many cases, an Exploratory/Developmental Grant mechanism will support novel research in an area or the research and development of new technologies. Where appropriate, specific criteria by which to judge the feasibility of novel approaches (including milestones that will mark progress) should be explicitly described in this section. SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $100,000 per year. The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $100,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list key project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of key personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: . - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years, - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. Submit a signed original of the application and five exact photocopies, including the checklist, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score and receive a secondary review by the appropriate national advisory council or board. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. Funding decisions will be made based on the quality of the proposed project as determined by peer review, program priorities, and availability of funds. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. A complete listing of contacts for both programmatic and fiscal/administrative inquiries may be found at: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. PHS strongly encourages all grant and contract recipients to provide a smoke- free workplace and promote the nonuse of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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