CANCER PREVENTION AND CONTROL RESEARCH SMALL GRANT PROGRAM NIH Guide, Volume 22, Number 14, April 9, 1993 PA NUMBER: PA-93-070 P.T. 34 Keywords: Cancer/Carcinogenesis Disease Control+ Health Promotion Disease Prevention+ Psychology Sociology National Cancer Institute Application Receipt Dates: June 1 and October 1 of 1993, 1994, and 1995 PURPOSE The National Cancer Institute (NCI) invites applications for small research grants (R03) in cancer prevention and control. This program announcement 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 psychology, health education, sociology, and community organization) may submit applications to test ideas or do pilot studies. 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, Cancer Prevention and Control Research Small Grant Program, is related to the priority areas of cancer, nutrition and tobacco. 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 Eligible applicants include established researchers, new investigators, qualified staff of public health and collaborating agencies, and predoctoral investigators currently enrolled in an accredited doctoral degree program. Ineligible applicants are those who are or have previously been Principal Investigator (PI) on an NCI funded Cancer Control grant or contract for more than two years; previous recipients (PIs) of a DCPC Small Grant; and 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 the small grant (R03) funding mechanism. Total direct costs up to $50,000 are allowed. The total project period may not exceed two years. RESEARCH OBJECTIVES This program 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 universities, cancer centers, communities, schools, health departments, laboratories, and worksites. Investigators may choose any of the full range of scientific approaches to 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, testing of recruitment or compliance procedures for participants, and the like. Applications should include justification of study design and sample size, as well as clearly indicate the significance of the research and where it will lead. 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 - 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, etc.) for use in special populations, state and local health agencies, or other organizational and community setting. 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, pain and symptom management, rehabilitation 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. Although the specific study proposed may attempt only to obtain 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 PA. Any laboratory animal studies are not allowed. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are 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 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 and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants 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 Unites 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 must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies or etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not 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 review will be deferred until the information is provided. 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application from PHS 398 (rev. 9/91) and will be accepted at the application deadlines indicated in this announcement. Applications received after the October 1 receipt date will be returned to the applicant. Application kits are available at most institutional office of sponsored research and may be obtained from the Office of Grant Inquires, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone (301) 710-0267. The title and number of this announcement must be typed in Section 2a on the face page of the application. Note that the following additional page limitations (typewritten, single-spaced) apply to the Research Plan of the application: 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 Background and Significance - one page. o Progress Report and Preliminary Studies - if applicable, two pages. o Research Design and Methods - 10 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 not be accepted. The completed original application and four copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Also send a copy of the application to the Ms. Helen Meissner at the address listed under INQUIRIES when the grant is submitted. Applications responding to this PA should include one round trip, two- day meeting to Bethesda, MD in the budget. REVIEW PROCEDURES Applications will be assigned on the basis of established PHS referral guidelines. Applications will be reviewed for scientific and technical merit by an appropriate review group of the NIH. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the National Cancer Institute. Funding decisions will be based upon quality of the proposed project as determined by peer review, availability of funds, and program balance among research areas of the announcement. INQUIRIES Written and telephone inquiries are encouraged. Direct inquiries regarding programmatic issues to: Helen I. Meissner, Sc.M. National Cancer Institute Executive Plaza North, Room 330 Bethesda, MD 20892 Telephone: (301) 496-8520 Direct inquiries regarding fiscal matters to: Ms. Eileen Natoli Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, ext. 56 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 grant 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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