RAPID ACTION DEPLOYMENT OF AIDS RESEARCH (RADAR) Release Date: August 5, 1999 PA NUMBER: PA-99-132 National Institute of Mental Health THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. THIS PA INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA. PURPOSE The purpose of this program announcement (PA) is to provide a mechanism for research which requires rapid funding in order to address an unexpected and time-sensitive research opportunity. Under the Rapid Action Deployment of AIDS Research (RADAR), research studies that can capitalize on natural experiments (e.g., new media campaigns, health policy changes, new legislation, natural disasters will be supported. There is no intention to support the development of policy but to study the consequences of a change in policies or laws that impact public health in order to inform policy makers about their formulation of future health-related policy. RADAR recognizes that prompt assessment may be crucial to many kinds of mental health and HIV/STD prevention studies, including those that focus on service seeking after a disaster, a change in outreach and prevention efforts based on an organizational policy change, or the change in prevention options resulting from a state or federal law. Even though AIDS grants are considered on an expedited review process, there is still significant delay between the conceptualization of the grant, submission, review, and finally funding. Unless there is a special mechanism to investigate these natural occurring experiments, they will probably be missed. A special review group will be convened as rapidly as possible after submission to provide a scientific review for an application deemed appropriate for this program announcement. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS led national activity for setting priority areas. This PA, Rapid Action Deployment of AIDS Resources, is related to the priority areas of mental health and mental disorders and HIV infection. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000/ ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Foreign institutions are not eligible. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) small research grant (R03), which provides for $50,000 indirect costs in each of two years. Continued support may be requested only through submission of a regular research project grant (R01) application to be reviewed through the regular peer review process. The NIMH Small Research Grant is located at: https://grants.nih.gov/grants/guide/pa-files/PAR-97-015.html. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at https://grants.nih.gov/grants/funding/modular/modular.htm Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 2 years. RESEARCH OBJECTIVES Although this program announcement is designed to support research on unexpected opportunities, the following are some of the areas in which research might be anticipated: o the HIV/STD prevention consequences of a natural disaster (hurricane, tornado, flood, earthquake) or man-made catastrophe (fire, toxic waste spill, riot, terrorism) o change in policies at an organization providing HIV/STD prevention or treatment services (decision to notify partners of HIV/STDs, criteria for receiving prevention or treatment services) o change in laws by state or federal government (partner notification, mandatory HIV testing, support of needle exchange programs) 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: https://grants.nih.gov/grants/guide/1994/94.03.18/notice-nih-guideline008.html 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html 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 To meet the goals of this RADAR program, applications will be accepted at any time and should be submitted as rapidly as possible. There will be no regular receipt dates for this PA. Applicants are strongly encouraged to contact the program contact listed under INQUIRIES with any questions regarding the responsiveness of their proposed project to the goals of this PA. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. 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: GrantsInfo@nih.gov. Applications are also available on the World Wide Web at: https://grants.nih.gov/grants/forms.htm. 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 $50,000 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 $50,000) 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 https://grants.nih.gov/grants/funding/modular/modular.htm 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: https://grants.nih.gov/grants/funding/modular/modular.htm - 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. Applications not conforming to these guidelines will be considered unresponsive to this PA and will be returned without further review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, and four signed photocopies 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) Applicants should simultaneously send a complete copy to Willo Pequegnat, Ph.D., at the address listed under INQUIRIES, in order to facilitate an expedited review of the application. The research plan should be brief (not to exceed 10 pages) and include clear statements of why the proposed research should be considered urgent, how it would relate to future research plans, and why a RADAR award is the appropriate mechanism for supporting the work. Applications should propose a clearly discernible research design, involving generation and/or testing of hypotheses, and a justification for the proposed methodology. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. RADAR applications will be handled on an expedited external peer review to meet the goals for this program. Applications that are complete will be evaluated for scientific and technical merit by an special scientific review group convened by NIMH in accordance with the standard NIH peer review procedures specifically for an application that is submitted under this program announcement. 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. 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 method? 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? The initial review group will also examine: the appropriateness of proposed project budget and duration; the adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research and plans for the recruitment and retention of subjects; the provisions for the protection of human and animal subjects; and the safety of the research environment. Criteria for scientific/technical merit review of applications will also include the following: o Urgency and suitability of the research to the RADAR award mechanism o Clearly discernible research design, involving generation and/or testing of hypotheses o Rationale for the proposed methodology o Feasibility and timeliness of the proposed research o Relation of the project to future HIV/STD prevention research plans o Availability of adequate facilities and resources necessary for the research o Qualifications of the research personnel AWARD CRITERIA Peer review recommendations, program balance in type of emergency event, and availability of funds are taken into consideration in determining which projects will be funded. Applications will compete for available funds with all other recommended applications. INQUIRIES Potential applicants are strongly urged to submit a letter of intent or to contact Dr. Willo Pequegnat, before submitting a RADAR application, in order to determine whether the proposed work meets the guidelines described in this program announcement, or whether the idea should be considered for submission as a fully developed research application. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Willo Pequegnat, Ph.D. Division of Mental Disorders, Behavioral Research and AIDS National Institute of Mental Health 6001 Executive Boulevard, Room 6205, MSC 9619 Bethesda, MD 20892-9619 Telephone: (301) 443-6100 FAX: (301) 443-9719 Email: wpequegn@nih.gov Direct inquiries regarding fiscal matters to: Diana S. Trunnell Grants Management Branch National Institute of Mental Health 6001 Executive Boulevard, Room 6115, MSC 9605 Bethesda, MD 20892-9605 Telephone: (301) 443-2805 FAX: (301) 443-6885 Email: Diana_Trunnell@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.242 (Mental Health Research Grants). 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. Awards will be administered under PHS grants policy as stated in the NIH Grants Policy Statement (October 1, 1998). The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use 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, and 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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