Full Text CA-96-002 DIETARY EXPOSURE TO AND EFFECTS OF PLANT FOOD CONSTITUENTS NIH GUIDE, Volume 25, Number 1, January 26, 1996 RFA: CA-96-002 P.T. 34 Keywords: Nutrition/Dietetics Cancer/Carcinogenesis Disease Prevention+ National Cancer Institute Letter of Intent Receipt Date: February 20, 1996 Application Receipt Date: April 18, 1996 PURPOSE The Division of Cancer Prevention and Control, National Cancer Institute (NCI) seeks to encourage investigator-initiated research project grants (R)1) to assess dietary exposure to constituents of plant foods that may affect cancer risk and to assess their biological effects relative to cancer prevention in humans. The ultimate goal of the research to be supported is to increase knowledge of the role of plant food constituents in order to refine dietary guidance for the prevention of cancer in the population. 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 Request for Applications (RFA), "Dietary Exposure to and Effects of Plant Food Constituents" is related to the priority areas of nutrition and 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 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 governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. MECHANISMS OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01) as the mechanism of support. 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 RFA may not exceed four years. The anticipated award date is September 20, 1996. Because the nature and scope of the research proposed in response to this RFA may vary, it is anticipated that the size of an award will vary also. This RFA is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator-initiated applications and be reviewed according to the customary peer review procedures. FUNDS AVAILABLE Up to $2.0 million in total costs per year for up to four years will be committed specifically to fund applications that are submitted in response to this RFA. It is anticipated that eight to ten awards will be made. This level of support 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, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES Background Epidemiologic investigations (ecologic, cohort, and case-control studies) have shown remarkable consistency in finding lower risk for a variety of cancers among populations consuming large amounts of plant foods, particularly fruits and vegetables. The association is most marked for epithelial cancers, especially those of the alimentary and respiratory tracts, and is weaker for hormone-dependent cancers. The inverse association with cancer risk has been observed for a wide variety of dietary guidelines for Americans that encourage consumption of fruits and vegetables. They have also spurred development and expansion of the National Five A Day for Better Health program, a public-private partnership between the NCI and the Produce for Better Health Foundation to encourage Americans to consume at least five servings of fruits and vegetables daily. A large number of naturally occurring nutritive and non-nutritive constituents present in vegetables, fruits, and grain products has been shown to inhibit carcinogenesis in animals when fed in purified form and at pharmacologic levels. These include carotenoids; vitamin C; vitamin E; folic acid; selenium; dietary fiber; dithiolthiones, glucosinolates, indoles, isothiocyanates, and thiocyanates (found in cruciferous vegetables); coumarins; flavonoids; phenols; protease inhibitors (found in seeds and legumes); plant sterols; isoflavones; saponins; inositol hexaphosphate; allium compounds (found in onions, garlic, and chives); and limonene. Little information is available on the levels in food and the dietary intake of non-nutrient constituents of plant foods; the metabolism of plant food constituents in humans; the ability of various plant food constituents, when consumed at levels that can be obtained from foods in the diet, to modify cancer risk; and the mechanisms of action of their putative anticarcinogenic effects. Even less is known about interactions among the various plant constituents and with other components of the diet. Expansion of ongoing research is needed to proved a better understanding of the potential impacts of various constituents of plant foods on human cancer prevention, including information on dietary exposure, metabolism, and mechanisms of action. Such information should aid in refining dietary guidance on the amounts and types of plant foods that have the potential to reduce cancer risk. Specific Objectives Applications for multidisciplinary, investigator-initiated research project grants (RO1) examining plant food constituents that may mediate the cancer preventive effects of diets high in fruits and vegetables are encouraged by this RFA. Studies to develop methodologies for the identification and quantification of such non-nutrient constituents in food will be considered, as will studies to develop improved analytical methods for the identification and quantification of plant food constituents and their metabolites in biological specimens. Encompassed within the scope of this RFA are assessments of food composition and dietary exposure to non-nutrient plant food constituents, as well as the development of biomarkers for exposure to plant food constituents. Also encouraged are studies of plant constituents' biological activity, absorption, metabolism, and mechanisms of action and interactions for cancer prevention in humans. Although the major emphasis of this RFA is to address the effects of foods and diet in human subjects, the use of animal models may be considered provided its relevance to human cancer prevention can be justified. Proposed studies that include use of purified compounds should be designed to assess levels that can be obtained from foods in the diet, rather than nonphysiologic levels. Some (non-exhaustive) examples of relevant research areas are as follows: o Determining the amounts of non-nutritive constituents in plant foods and the amounts consumed in typical diets; o Elucidating molecular and cellular mechanisms of actions for possible anticarcinogenic effects of plant food constituents; o Examining the impact of interactions among various plant food constituents on their role(s) in cancer prevention; o Defining dose-response relationships for nutrient and non-nutrient plant food constituents on molecular and cellular events and alterations in metabolic pathways; o Identifying biochemical markers as quantitative measures of plant food intake, digestion, absorption, metabolic breakdown of specific nutrient and/or non-nutrient constituents; and o Determining the bioavailability of nutrient and non-nutrient plant food constituents at various intakes and from different food sources. 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 new policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43) and supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minorities in Study Populations), which have been in effect since 1990. The new policy contains some provisions that are substantially different from the 1990 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. LETTER OF INTENT Prospective applicants are asked to submit, by February 20, 1996, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Susan M. Pilch, Ph.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 212 Bethesda, MD 20892 Telephone: (301) 496-8573 FAX: (301) 402-0553 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. these forms are available at most institutional offices of sponsored research; from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: girg@drgpo.drg.nih.gov; and from the program administrator listed under INQUIRIES. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that is may not reach the review committee in time for review. In addition, the RFA title and number 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 three signed photocopies, in one package to: DIVISION OF RESEARCH GRANTS NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier services) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 6130 Executive Boulevard Bethesda, MD 20892 Rockville, MD 20852 (for express/courier services) Applications must be received by April 18, 1996. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG will not accept any application that is essentially the same as one already 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. Applicants from 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. In such a case, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If the application is no responsive to the RFA, it well be returned to the applicant, who may submit it for review in competition with unsolicited applications at the next review cycle. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and may undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o scientific, technical, or medical significance and originality of proposed research; o appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research; o qualifications and research experience of the Principal Investigator and staff, particularly, but not exclusively, in the area of the proposed research; o availability of the resources necessary to perform the research; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment, as well as conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Scientific merit, as reflected by the priority score; availability of funds; and programmatic priorities will be considered in making awards pursuant to this RFA. The anticipated date of award is September 30, 1996. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarity any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Susan M. Pilch, Ph.D. Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Room 212 Bethesda, MD 20892 Telephone: (301) 496-8573 FAX: (301) 402-0553 Email: PilchS@dcpcepn.nci.nih.gov Direct inquiries regarding fiscal matters to: Barbara A. Fisher Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800 Ext. 229 FAX: (301) 496-8601 EMAIL: FisherB@gab.nci.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control. Awards are made under authorization of the Public Health Services 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 Public Health Service (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. .
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