Full Text CA-92-04 CANCER PREVENTION AND CONTROL RESEARCH SMALL GRANT PROGRAM RFA: RFA CA-92-04 P.T. 34 Keywords: Cancer/Carcinogenesis Disease Control+ Disease Prevention+ Health Promotion Nutrition/Dietetics Behavioral/Social Studies/Service National Cancer Institute Application Receipt Date: May 6, 1992 PURPOSE The Division of Cancer Prevention and Control (DCPC) of the National Cancer Institute (NCI) invites Small Research Grant (R03) applications from interested investigators. This program is designed to aid and facilitate the growth of a nationwide cohort of scientists with a high level of research expertise in the field of human cancer control intervention research. New and experienced investigators in relevant fields and disciplines (e.g., disease prevention and control, medicine, public health, health promotion, epidemiology, social work, nursing research, nutrition, health policy, health services research, and behavioral sciences such as social psychology, health education, sociology, and community organization) may apply for small grants to test ideas or do pilot studies. This Request for Applications (RFA) is a modified reissuance of RFA CA-89-09. The six prior Small Grant RFAs have resulted in 89 awards. 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 RFA, Cancer Prevention and Control Research Small Grant Program, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Investigators are eligible to apply for a small grant to support research on a cancer control topic if they are interested in conducting exploratory studies in cancer control research. Eligible applicants include established researchers, new investigators, qualified staff of public health departments and collaborating agencies, and predoctoral investigators currently enrolled in an accredited doctoral degree program. Applications from minority individuals and women are encouraged. Non-profit and for-profit organizations and institutions, governments and their agencies, and occasionally individuals, are eligible to apply. The only INELIGIBLE applicants are: 1. Individuals who are or have previously been a Principal Investigator on an NCI-funded CANCER CONTROL grant or contract for more than TWO years; 2. previous recipients (Principal Investigators) of a DCPC Small Grant; 3. foreign institutions. Small grant research support may NOT be used to supplement research projects currently supported by Federal or non-Federal funds or to provide interim support of projects under review by the Public Health Service. MECHANISM OF SUPPORT Support of this program will be through the National Institutes of Health (NIH) small grant (R03) program. Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. The total project period for applications submitted in response to the present RFA may not exceed two years. The earliest possible beginning date will be March 1, 1993. Small grants are not renewable. FUNDS AVAILABLE Approximately $500,000 in total costs for two years will be committed to fund applications that are submitted in response to this RFA. Direct costs up to $50,000 for the two-year time period are allowed. It is anticipated that up to seven awards will be made. This funding level is dependent on the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plans of the NCI, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES The Cancer Prevention and Control Research Small Grants Award is designed to encourage investigators from a variety of academic, scientific, and public health disciplines to apply their skills to scientific investigations in the field of human cancer control intervention research. The research may occur in a variety of settings, such as communities, schools, health departments, and work sites. These investigators will become part of the new nationwide group of scientists pursuing cancer control research goals. RESEARCH APPROACHES Within this small grant program, investigators may choose any of the full range of scientific approaches in their work. Many studies and research designs may contribute to the design, implementation, or evaluation of future phase III-V studies, e.g., descriptive baseline surveys, testing, modification and validation of surveys or program materials for use in the proposed population groups, and testing of recruitment or compliance procedures for participants. Investigators must address the specific aims and hypotheses, background and significance of the proposed work, results of any preliminary studies, experimental design and methods including any relevant theoretical concepts that underlie the research, human subjects involvement and protection, and relevant literature (see instructions in the grant application). PROGRAM AREAS OF INTEREST The NCI has established a goal and a set of objectives for achieving a 50 percent reduction in the cancer mortality rate by the Year 2000 (Greenwald, P, Sondik, EJ. Cancer Control Objectives For the Nation: 1985-2000. NCI Monograph No. 2, 1986). In keeping with this goal and objectives, the following cancer control program areas are appropriate for HUMAN INTERVENTION research grant applications: o Prevention (chemoprevention, diet and nutrition intervention studies) o Screening and early detection, e.g., pilot studies of new methods; application of the "NCI Guidelines For Early Detection". In the area of breast screening and detection, studies of breast self-examination as a single modality will not be accepted. o Cancer control sciences (studies to change current behaviors and/or institute new behaviors or health promotion interventions effective in reducing incidence, morbidity, or mortality from cancer). o Smoking prevention and cessation pilot studies targeted at improving utilization of current technologies in target populations or organizations are encouraged. Minor enhancements of existing technology are not encouraged. o Applications research in modifying, feasibility testing, and adopting proven, state-of-the-art intervention programs and strategies from other research projects (e.g., screening, smoking prevention) for use in special populations, State and local health agencies, or other organizational and community settings. In addition, planning, epidemiologic, and survey studies aimed at developing cancer control operations research and evaluation studies are appropriate for human intervention research grant applications. o Community oncology (improving the application of patient management and continuing care research advances into community settings). o Applied epidemiology studies (using epidemiologic methods to determine the association between exposure to an INTERVENTION and its impact on disease) are acceptable within the above program areas. ALTHOUGH THE SPECIFIC STUDY PROPOSED MAY ATTEMPT TO OBTAIN ONLY PRELIMINARY DATA AND/OR CONDUCT PILOT STUDIES IN SUPPORT OF A FUTURE, MORE DETAILED PHASE III-V STUDY, IT IS IMPORTANT THAT A LONG-TERM HUMAN CANCER CONTROL HYPOTHESIS AND SUPPORTING SCIENTIFIC JUSTIFICATION BE PRESENTED. EXCLUSIONS Studies to determine the efficacy of chemotherapy, surgery, radiotherapy, and other primary treatment interventions are not considered cancer control research under this RFA. Other laboratory animal studies are not allowed. STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements will be required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis should be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale should be provided. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in Section 2, A-D of the Research Plan and summarized in Section 2, E, Human Subjects. Applicants/offerors are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups should be provided. For the purpose of this policy, clinical research includes human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the application will be returned. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) addressed and the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. REVIEW PROCEDURES AND CRITERIA Upon receipt, applications will be reviewed by DRG for completeness. Incomplete applications will be returned to the applicant without further consideration. Evaluation for responsiveness to the program requirements and criteria stated in the RFA is an NCI program staff function. Applications that are judged nonresponsive will be returned to the applicant, but may be submitted as investigator- initiated research applications at the next receipt date. Questions concerning the responsiveness of the proposed research to the RFA may be directed to program staff listed in INQUIRIES below. In cases where the number of applications is large compared to the number of awards to be made, the NIH may conduct a preliminary scientific peer review (triage) to eliminate those applications that are clearly not competitive. The NIH will administratively withdraw from competition those applications judged to be noncompetitive and notify the applicant and institutional business official. Responsive applications will be reviewed for scientific and technical merit by a multidisciplinary committee convened by the NCI consisting primarily of non-Federal technical, intervention, and scientific experts in relevant disciplines, such as cancer control, medicine, oncology, nursing research, public health, epidemiology, biostatistics, behavioral and social sciences (psychology, health education, sociology), community intervention, health policy, and health services research. REVIEW CRITERIA Applications will be evaluated subject to the following criteria: o The scientific/technical merit of the research, including originality, feasibility, adequacy of design, plans for analyses and evaluation of data, and soundness of the research plan. o The quality of the Principal Investigator's research training, intervention experience, and potential for contribution as an investigator in the field of cancer control intervention research. o The adequacy of resources and facilities, and the supportive nature of the research environment. The review group will critically examine the submitted budget and will recommend an appropriate budget and period of support for each approved application. Final decision will be made by the DCPC NCI on the basis of the initial review and the availability of funds. APPLICATION PROCEDURES The research grant application form PHS 398 (revised 9/91) must be used in applying for these grants. These forms are available at most institutional business offices; from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, MD 20892, telephone 301/496-7441; and from the NCI Program Director named below. The "RFA" label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the title of the application and the RFA number must be typed on line 2 of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and four signed, exact photocopies in one package to the DRG at the address below. The photocopies must be clear and single sided. DIVISION OF RESEARCH GRANTS National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, send two additional copies of the application to: REFERRAL OFFICER Division of Extramural Activities National Cancer Institute Room 848, Westwood Building 5333 Westbard Avenue Bethesda, MD 20892** **IF AN EXPRESS COURIER SERVICE IS USED FOR DELIVERY, USE ZIP CODE 20816. Applications must be received by May 6, 1992. If an application is received after that date, it will be administratively withdrawn and returned to the applicant. If the application submitted in response to this RFA is substantially similar to a grant application already submitted to the NIH for review, but has not yet been reviewed, the applicant will be asked to withdraw either the pending application or the new one. simultaneous submission of identical applications will not be allowed, nor will essentially identical applications be reviewed by different review committees. Therefore, an application cannot be submitted in response to this RFA that is essentially identical to one that has already been reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. The following additional page limitations (typewritten, single-spaced) apply to sections 1 and 2 (pages 12-22) of the PHS-398 application: Section 2: Research Plan (14 pages total; a suggested page distribution is as follows): o Specific Aims - one page. Clearly state the cancer control hypothesis and intervention to be studied. o Significance - one page. o Progress Report & Preliminary Studies - if applicable, two pages. o Experimental Design and Methods - ten pages. Following the research plan, include the discussion of human subjects and the literature cited. Appendices are acceptable. These page limitations and others in the PHS 398 application instructions must be observed or the application will be returned to the applicant. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify questions on specific proposed research from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Sherry L. Mills, M.D., M.P.H. Program Director, Prevention and Control Extramural Research Branch Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 320 Bethesda, MD 20892 Telephone: (301) 496-8520 Direct inquiries regarding fiscal matters to: Katharine Schulze Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 ext. 16 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399. 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. .
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