Full Text PAR-97-011 PLANNING GRANTS FOR BIOMEDICAL EPIDEMIOLOGIC AND INTERVENTION STUDIES NIH GUIDE PA NUMBER: PAR-97-011 P.T. 34 Keywords: Aging/Gerontology Epidemiology National Institute on Aging PURPOSE The National Institute on Aging (NIA) will provide grant support for planning and protocol development of biomedical epidemiologic and intervention studies in research areas supported by the Geriatrics Program (see Research Objectives section of this program announcement). The planning grant application and review process is intended to provide a mechanism for peer review of the rationale and basic design of an epidemiologic or intervention study which would require extensive detailed protocols and/or complex organization for proper implementation. The planning grant itself is intended to provide support for the development of a refined study design, organizational plan, detailed protocol, Manual of Procedures, and budget, for implementation of studies whose rationale and basic design are considered sufficiently meritorious. After these are completed, planning grant awardees may submit applications to conduct the full-scale study. These applications will also be peer-reviewed. Thus, the planning grant mechanism is intended to facilitate careful and detailed protocol development and peer review of proposed complex intervention and epidemiologic studies through a two-stage process (rationale and basic design first, detailed protocol and organization second), in order to minimize unnecessary effort by applicants and reviewers, and allow careful scrutiny of the methods proposed for projects whose basic rationale and design have been judged to be of high quality. 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 is related to the priority area of chronic diseases and disabling conditions of older persons. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No.017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic for-profit and nonprofit 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. Applicant institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC Program Director or Principal Investigator should be included with the application. MECHANISM OF SUPPORT The mechanism of support will be the NIA Planning Grant (R21), which will provide up to $100,000 in direct costs for one year. The award cannot be renewed. Applicants should note that NIA funding of a planning grant does not imply a commitment by NIA to fund the proposed full-scale study, nor even to accept a subsequent application for such a study. NIA decisions on acceptance of applications for projects whose proposed direct costs are $500,000 or more per year are determined by availability of funds and other programmatic considerations. Persons considering submitting an application for a planning grant to develop a project whose annual direct costs are likely to equal or exceed $500,000 per year are strongly encouraged to contact Geriatrics Program staff (see the "Research Objectives" section of this announcement) before writing the planning grant application, in order to obtain information on current program priorities and projected availability of funds. RESEARCH OBJECTIVES The NIA Geriatrics Program supports biomedical research on clinically-oriented aging topics. More detailed information on the range of research topics for which the Geriatrics Program provides support is available on the Geriatrics Program's section of the NIA Home Page http://www.nih.gov/nia/. Additional information regarding specific topics may be obtained from the staff contacts listed for specific research areas on the Home Page. Persons without access to the NIA Home Page may obtain the information from: Ms. Wanda Solomon Geriatrics Program, NIA Gateway Building, Suite 3E327 7201 Wisconsin Avenue Bethesda MD 20892-9205 Phone: (301) 435-3047 Fax: (301 402-1784 E-Mail: SolomonW@gw.nia.nih.gov Applicants for planning grants may request funds for activities such as: o Preparation of detailed protocols and a Manual of Procedures. These protocols and the Manual must be included in the Final Report for this award. o Analyses of existing data needed for refinement of study design and protocols (e.g., power calculations, dosage or intensity of intervention, budget estimates). o Preliminary studies to guide selection of, and/or refine, study procedures and instruments, and estimate recruitment and retention potential. o Travel expenses of individuals from multiple sites to planning meetings for the project. The planning grant proposal should describe: o The principal hypotheses to be tested, and the rationale for doing so. o Basic study design, estimated sample size, and time course. o The intervention(s) (if any), populations (including general eligibility and exclusion criteria), and outcomes to be studied, and the rationale for their selection. o Outline of strategies for recruitment, retention, and maintenance of subjects' adherence to study protocols. o Outline of methods for outcome measures and other measurements. o Outline of methods for data management and analysis. o The study elements to be planned or refined if the planning grant is awarded. These must be included in the protocol and draft Manual of Procedures to be produced by the awardees upon or before the end of the planning grant award period: e.g., number and identity of sites; power and sample size calculations; protocol elements; external data and safety monitoring procedures; quality assurance of data and study protocols; external data and safety monitoring; liaisons with industry (if any); data coordination and standardization; and planned staffing, organization, and budget. Applicants for planning grants for human intervention studies should review the NIA document "Implementation of Policies for Human Intervention Studies" (NIH Guide to Grants and Contracts: Volume 25, No. 33; October 4, 1996). This is available in the "Grants and Contracts" section of the NIH Home Page (http://www.nih.gov). Persons without access to the NIH Home Page may obtain copies of the policy from: Office of Extramural Affairs, National Institute on Aging; Gateway Building, Suite 2C218; Bethesda, MD 20892-9205. Phone (301) 496-9322) o Proposed preliminary analyses of existing data needed for refinement of study design and protocols (e.g., power calculations, dosage or intensity of intervention, budget estimates). o Proposed preliminary studies to guide selection of, and/or refine, study procedures and instruments, and estimate recruitment and retention potential. o The participants in the planning process, their roles in the development of the plan, and their experience in related studies. o The organizational approach and timetable to be followed in developing the protocol and draft Manual of Procedures over the course of the planning grant award. 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) and supersedes and strengthens the previous policies. 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 reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) and will be accepted at the February 1, June 1, and October 1 application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Grants Information Office, Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, Email: ASKNIH@odrockm1.od.nih.gov. The title and number of this program announcement must be typed in Section 2 on the face page of the application. The completed original application and three legible copies must be sent or delivered to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) At the same time, two additional copies should be sent to: Chief, Scientific Review National Institute on Aging Gateway Building, Suite 2C212 7201 Wisconsin Avenue, MSC 9205 Bethesda MD 20892-9205 (20814 for express/courier service) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by study sections of the NIH Division of Research Grants or by the National Institute on Aging, NIH, 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, assigned a priority score, and given a second level review by the appropriate National advisory council or board. Review Criteria In evaluating a Planning Grant application, the initial review group will consider the criteria outlined below. NIA strongly encourages applicants to address these criteria. o Scientific, technical, or medical significance and originality of the proposed research. o Appropriateness and adequacy of the overall approach and methodology proposed to carry out the proposed research o Qualifications and research experience of the Principal Investigator and staff in the area of the proposed research. o Availability of resources necessary to perform the research o Appropriateness of the proposed budget for the planning activities proposed. o Adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. o Validity of rationale for the study, including scientific, public health, and ethical aspects. o Quality and feasibility of basic study design; recognition of possible problems inherent in the design and the adequacy of plans for dealing with them. o Appropriateness of outcomes to be studied, and the methods used to measure them. o Appropriateness of population, sample size, and eligibility and exclusion criteria. o Appropriateness and effectiveness of overall strategies for data management and analyses. o Feasibility and appropriateness of general strategies for recruitment, retention, and maintenance of subjects' adherence to protocol. o Rationale for, and quality of proposed preliminary analyses and studies. AWARD CRITERIA NIA decisions on funding are determined by scientific merit of proposed projects as determined by peer review, availability of funds, and NIA program needs and balance. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Geriatrics Program National Institute on Aging Gateway Building, Suite 3E327 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 FAX: (301) 402-1784 E-mail: EH21f@nih.gov Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Grants and Contracts Management Office National Institute on Aging Gateway Building, Suite 2N212 7201 Wisconsin Avenue, MSC 9205 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: JE14j@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.866 and 93.846. 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. 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, 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. .
Return to NIH Guide Main Index
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
||||||||
Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files. |