CANCER PREVENTION AND CONTROL RESEARCH NIH GUIDE, Volume 21, Number 12, March 27, 1992 PA NUMBER: PA-92-61 P.T. 34 Keywords: Cancer/Carcinogenesis Disease Prevention+ Disease Control+ Epidemiology National Cancer Institute PURPOSE The National Cancer Institute (NCI) invites applications for studies covering a broad range of research related to cancer prevention and control. The Division of Cancer Prevention and Control (DCPC), NCI is mandated to conduct research on cancer prevention and control and the surveillance and monitoring of the incidence, mortality, and morbidity of cancer. A priority for DCPC is to develop the means for effective translation of the knowledge gained from research in prevention and control into disease prevention and health promotion activities for the benefit of the public. The goal of these efforts is to achieve significant reductions in cancer incidence, mortality, and morbidity with a concomitant increase in cancer survival. 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 program announcement, Cancer Prevention and Control Research, is related to priority areas of cancer, nutrition, tobacco, educational and community-based programs, clinical preventive services, and surveillance and data systems. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-011-00474-0) 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 Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local government, and eligible agencies of the Federal Government. Applications from minority individuals and women are encouraged. RESEARCH OBJECTIVES The DCPC conducts a broad array of cancer control research and application activities that emphasize validation, evaluation, and demonstration. The programs range from research on prevention, screening and early detection, to methods for applying the most effective regimens for cancer treatment, rehabilitation, and continuing care. The primary research areas are: o Chemoprevention - pre-clinical and clinical studies related to the identification and evaluation of agents including nutrients that may inhibit carcinogenesis, i.e., initiation, promotion, transformation and/or progression of the malignant process as presently understood. Biomarkers or cancer occurrence may serve as endpoints. o Nutrition and Diet - Role of nutrients, foods or other dietary components in cancer incidence. Influence of dietary factors on the modulation of cancer risk markers, early indicators of cancer risk or intermediate endpoints. Define biochemical and molecular mechanisms by which dietary components may act as metabolic effectors that protect, control, or increase cancer risk. Absorption and metabolism of nutrients and other dietary components associated with cancer risk and prevention. Dietary assessment in human intervention trials. Development of biochemical or biological markers for dietary compliance and exposure. Improved nutritional and dietary assessment instruments including nutrient data bases. Development of reliable methods for analysis of nutrients and other components in foods, body fluids, and tissues. o Screening and early detection of cancer - Research to significantly reduce cancer morbidity and mortality through early detection including identification of markers of risk, exposure, and pre-malignant events of progression that can be used to identify sub-populations at particularly high risk of developing cancer. Research is also encouraged in the use of artificial intelligence for image processing as well as new imaging technologies related to early detection. Research on quality control and quality assurance related to screening and early detection is also encouraged. o Community Oncology - The primary objective is to stimulate research that will provide a basis to reduce the time between research advances in prevention, screening, early detection, patient management, and continuing care and the application of those advances in community settings. o Rehabilitation and Pain Management - Research that focuses on the application of rehabilitative medicine and pain management for cancer patients. o Cancer Control Applications - The development and testing of intervention strategies to modify personal, social, and lifestyle factors known to contribute to the development and/or increased risk of cancer. o Special Populations - Multidisciplinary intervention research aimed at addressing and modifying the excessive cancer incidence and/or mortality rates, lower cancer survival rates, or inadequate cancer prevention and control services for minority, underserved and other special populations. o Surveillance - Data collection, statistical analysis and mathematical modelling, health services research and information data base linkage studies are required to monitor progress toward cancer control, particularly as it pertains to national goals. MECHANISM OF SUPPORT The mechanism of support will be the individual research project grant (R01). Policies that govern research grant programs of the National Institutes of Health will prevail. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 diseases, 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 and sample size appropriate for the scientific objectives of the study. This information should be included in the form PHS 398 in the Research Plan section, 1-4, AND summarized in 5, 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 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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. 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. 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. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional business and grant/contract offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496- 7441. The title and number of this announcement must be typed in Section 2a on the face page of the application. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections or an ad hoc group developed by the Division of Research Grants, NIH. Following scientific-technical review, the applications will receive a second-level review by the appropriate national advisory council. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to that ICD. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Requests for further information may be directed to the relevant Program Director: CHEMOPREVENTION: Dr. Winfred Malone Telephone: (301) 496-8567 DIET AND NUTRITION: Dr. Carolyn Clifford Telephone: (301) 496-8573 SCREENING AND EARLY DETECTION OF CANCER: Dr. Barnett Kramer Telephone: (301) 496-8544 COMMUNITY ONCOLOGY AND CONTINUING CARE: Dr. Susan Nayfield Telephone: (301) 496-8541 CANCER CONTROL APPLICATIONS: Dr. Thomas Glynn Telephone: (301) 496-8520 SPECIAL POPULATIONS: Dr. George Alexander Telephone: (301) 496-8589 SURVEILLANCE: Dr. Brenda Edwards Telephone: (301) 496-8506 All the above Program Directors are located at: National Cancer Institute Division of Cancer Prevention and Control Executive Plaza North 9000 Rockville Pike Bethesda, MD 20892-4200 Written and telephone inquiries concerning the objectives and scope of this program announcement and inquiries about whether or not specific proposed research would be responsive, clarifying scientific content and objectives of an application, size and focus of a research program, organization of an application, and appropriate use of consultants are strongly encouraged and should be directed to the relevant Program Director at the above address and telephone numbers. The Program Directors welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding fiscal matters to: Ms. Eileen Natoli, Team Leader, PC Team Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard Bethesda, MD 20852 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 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 System Agency review. .
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