Full Text CA-93-04 INTERACTIVE RESEARCH PROJECT GRANTS FOR NUTRITION AND CANCER PREVENTION NIH GUIDE, Volume 21, Number 39, October 30, 1992 RFA: CA-93-04 P.T. 34 Keywords: Nutrition/Dietetics Cancer/Carcinogenesis Disease Prevention+ National Cancer Institute Letter of Intent Receipt Date: November 1, 1992 Application Receipt Date: January 19, 1993 PURPOSE The Division of Cancer Prevention and Control, National Cancer Institute (NCI), invites Interactive Research Project Grants (IRPGs; see NIH Guide, Vol. 21, No. 1, January 10, 1992), to encourage and facilitate formal interdisciplinary collaborations through the coordinated submission of related research project applications that share a common research focus relevant to nutrition and cancer prevention but do not require extensive shared physical resources or core functions. Complex questions in nutrition and cancer prevention research often require investigative efforts that extend beyond the level practical in a single project, or that require a mixture of technical approaches beyond the means of a single investigator. The perceived merit of individual research project (R01) applications sometimes may be limited by the lack of a comprehensive, interdisciplinary approach, or by limitations in resident technical expertise. There also may be areas of investigation that are under-represented in applications because they cannot effectively be exploited without a collaborative effort, yet local opportunities for such interactions are not available. The objectives of this Request for Applications (RFA) for IRPGs are: (1) to increase the investigator-initiated pool of quality applications in the area of nutrition and cancer research and (2) to stimulate an intermediate level of interdisciplinary collaborative efforts to build stronger research bridges between nutritional science and the disciplines that relate closely to basic and clinical research for the development and evaluation of new approaches to nutrition and cancer prevention research. A minimum of three independent investigators with related research objectives are encouraged to submit concurrent, collaborative, cross- referenced individual research project grant applications (R01) that share a common research focus. Applications may be submitted from either a single institution or a consortium of institutions. Applications will be reviewed independently for scientific merit. Meritorious applications will be considered for funding both as independent awards and in the context of the overall proposed collaboration. 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 could be included with the application. 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, Interactive Research Project Grants for Nutrition and Cancer Prevention, is related to the priority area of cancer prevention. 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 Domestic and foreign non-profit and for-profit organizations and institutions, governments and their agencies, are eligible to apply. Applications may be submitted from a single institution or may include arrangement with several institutions if appropriate. Applications from or involving minority institutions, individuals, and women are encouraged. Each application will be considered on its own merit as an individual research project. Therefore, applicants for IRPGs MAY NOT concurrently submit R01 applications that represent significant duplication of the efforts described in the applicant's IRPG. In this regard, it should be noted that the NCI will consider funding meritorious individual IRPG applications if it is not possible to fund the IRPG package as a whole. Concurrent submission of program project (P01) applications that request support for essentially similar work is prohibited. MECHANISM OF SUPPORT Support of this program will be by the research project (R01) grant. Applicants will be responsible for the planning, direction and execution of the proposed projects. The total project period for applications submitted in response to the present RFA should not exceed five years. This is a one-time solicitation. Future unsolicited competing continuation applications will compete with all investigator- initiated applications and be reviewed according to customary peer review. FUNDS AVAILABLE Approximately $2.5 million in total costs per year for up to five years will be committed to specifically fund applications that are submitted in response to this RFA. It is anticipated that six to nine 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 A. Background Historically, the NCI has relied on multi-component awards, such as program projects (P01) and Cancer Center Support grants (P30), to encourage interdisciplinary collaborations in areas requiring integration and central direction of basic and clinical research components. A hallmark of such awards is the provision for extensive core facilities/resources to support the common research efforts of the program and appointment of a program director to manage the overall effort. For many nutrition and cancer prevention research areas it may be more appropriate to consider an intermediate level of collaboration, less extensive than that described above, but beyond that practical for single projects. For such intellectually driven collaborative efforts, the exchange of data, materials, and ideas, rather than shared physical resources or central oversight, is the primary requirement. The concept of IRPGs put forth in this RFA aims to address and facilitate this class of research activities. Typically, the IRPG approach will be suited to many basic research questions in cancer prevention, as well as research to develop and apply innovative technology and to evaluate intervention strategies in individuals and target subpopulations. The IRPG mechanism is also well suited for conducting a series of short-term controlled clinical and/or metabolic and related correlative laboratory studies. Use of the IRPG mechanism will benefit applicants by establishing a larger framework of reference for the proposed work, by facilitating formal collaborations tailored to achieving research objectives, by providing a record of independently acquired awards credited to each funded investigator, and by allowing retention of research autonomy by the named Principal Investigator (PI) on each of the interactive grants. Each grantee will have the ability to submit on his/her own behalf competing supplements as appropriate to incorporate promising new directions of research as they evolve. The freedom to establish collaborations at separate sites, and the improved transferability of awards made to individual Principal Investigators, also are significant benefits. In contrast, translational research programs that span a variety of disciplines and programs that require extensive ties to co-located core resources would continue to be served best by traditional multi-component program award mechanisms. The NCI encourages qualified investigators to develop and submit concurrently coordinated research project applications that address areas of relevance to nutrition and cancer prevention to which the interactive research project concept may be applied. Applications submitted as a package should be tightly focused and the interactions and benefits of the proposed linkages should be made explicit as explained in the section on "SPECIAL INSTRUCTIONS FOR IRPG APPLICATIONS" below. B. Research Areas of Interest Representative areas of particular interest for this RFA focus on innovative research approaches for the development, evaluation and/or application of specific methodologies for elucidating the mechanisms of action and quantification of the role of diet and dietary components in cancer prevention. Several examples of research areas relevant to nutrition and cancer prevention in which the IRPG concept may be applied are as follows: o Metabolic effectors of dietary origin. Basic science projects may be combined that integrate multiple aspects of dietary factors that modulate signal transduction, DNA repair, antioxidants, hormonal regulation and gene regulation. o Interaction of diet and dietary components with drugs, hormones, metabolites and genes - synergistic and antagonistic effects. o Development of new and better methods to quantify dietary intake in individuals. o Further identification and evaluation of overall dietary patterns, foods and food constituents that alter cancer risk and elucidation of their mechanisms of action. o Identification of markers of dietary exposure and early indicators of risk. o Quantification of optimal ranges of dietary constituents that affect cancer risk. o Social behavioral research to identify motivation factors and barriers to changing food habits. o Nutrition as one component of healthy lifestyle modification. Studies of fundamental relationships between diet, nutrition and cancer and behavioral change affiliated with modification. Prospective applicants are encouraged to explore other areas of potential for the Interactive Research Project Grant mechanism with the NCI Program Director. The overall goal is to provide more definitive data for developing quantitative dietary guidance and translation into optimal and desirable eating patterns and food choices that have the potential for a substantial reduction in the risk of diet-related cancers in the general population. STUDY POPULATIONS SPECIAL INSTRUCTION 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 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 and sample size appropriate for the scientific objectives of the study. This information should be included in the Form PHS 398 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 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 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 tissue 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 application may be returned, or may be deferred until additional information can be 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 that do not comply with these policies. LETTER OF INTENT Prospective applicants are asked to submit by November 24, 1992, a letter of intent that includes a descriptive title of the proposed research, the name and address of the Principal Investigator, the names of other key personnel, the participating institutions, and the number and title of the RFA in response to which the application is being submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, it is requested in order to provide an indication of the number and scope of applications to be reviewed. The letter of intent is to be sent to: Carolyn K. Clifford, Ph.D. Diet and Cancer Branch National Cancer Institute Division of Cancer Prevention and Control Executive Plaza North, Suite 212 Bethesda, MD 20892-6130 Telephone: (301) 496-8573 FAX: (301) 402-0553 APPLICATION PROCEDURES General Instructions The research grant application form PHS-398 (rev. 9/91) 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 Inquiries, Division of Research Grants, National Institutes of Health, Room 449, Westwood Building, 5333 Westbard Avenue, Bethesda, Maryland 20892; 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, "Interactive Research Project Grants for Nutrition and Cancer Prevention", and the RFA number, CA-93-04, should be typed on line 2a of the face page of the application form. Submit a signed, typewritten original of the application, including the Checklist, and three signed, exact photocopies, in one package to the Division of Research Grants (DRG) at the address listed 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, two additional copies of the application must be sent to: Referral Officer Division of Extramural Activities National Cancer Institute Westwood Building, Room 828 5333 Westbard Avenue Bethesda, MD 20892 Applications must be received by January 19, 1993. If an application is received after that date, it will be returned. 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. Special Instructions for IRPG Applications One Principal Investigator from the IRPG group MUST be identified as the "Program Coordinator", and should be cited in all applications on Page 2 of form PHS 398 (rev. 9/91). Individual investigators may request funds for the time and effort contributed toward the coordination of the overall research and for collaborative resource activities. To facilitate referral, all applications submitted under the IRPG mechanism MUST be as a single package. Each application MUST be complete in itself, with all appropriate approvals, budgets and signatures. A cover letter MUST accompany the package identifying all principal investigators and project titles that are a part of the combined submission. The letter should be firmly attached to the face page of the top application. Each application MUST be identified by checking "yes" on line 2 of the PHS 398 face page and citing this RFA, "Interactive Research Project Grants for Nutrition and Cancer Prevention". The use of the IRPG mechanism should be mentioned briefly in form PHS 398 (rev. 9/91), Sections 1-4 of the Research Plan. The goal of the collaborative efforts MUST be identified in the specific aims of each application, with the major rationale and explanation for the use of the IRPG mechanism to be given in Section 7, Consultants/ Collaborators. A complete list of applications in the IRPG should be provided in Section 7, as well as an indication of the specific collaborations to be established for the individual application under consideration. Requests for limited shared resources, if any, should be proportionally budgeted in each application based on anticipated use, with a full explanation given in the budget. Personnel Time and Effort requests for management of shared resources are allowable. Where consortium arrangements between independent institutions are proposed that would make transfer of funds for required new equipment impractical, the entire equipment request may be budgeted by the responsible laboratory. This should be clearly justified. All PHS and NIH grant policies will apply to applications received in response to this RFA. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the 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. Questions concerning the responsiveness of proposed research to the RFA should be directed to the Program Director indicated in the Letter of Intent Section. If the number of applications is large compared to the number of awards to be made, the NCI may conduct a preliminary scientific peer review to eliminate those applications that are clearly not competitive. The NCI will remove from competition those applications judged to be noncompetitive for award to notify the applicant and institutional business official. Those applications judged to be both competitive and responsive will be further evaluated according to the review criteria stated below for scientific and technical merit by an appropriate peer review group convened by the Division of Extramural Activities, NCI. The second level of review by the National Cancer Advisory Board considers the special needs of the NCI and the priorities of National Cancer Program. The following factors will be considered in evaluating the scientific merit of each response to this RFA: o Scientific, technical or medical significance and originality of the 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 studies; o Adequacy of plans for coordination of the overall research and for collaborative resource activities; o Availability of resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research. For each application that is given a priority score, the review group will assign an adjectival descriptor that reflects the extent and effectiveness of its collaboration(s) with other applications included in the IRPG. This assessment will be documented in a brief administrative note in the summary statement to assist the NCI in making final decisions on each application in the context of the overall IRPG. AWARD CRITERIA The anticipated date of award is September 30, 1993. INQUIRIES Written and telephone inquiries concerning the objectives and scope of this RFA, and inquiries about whether or not specific proposed research would be responsive are encouraged and may be directed to the Program Director listed below. The program staff welcome the opportunity to clarify any issues or questions from potential applicants. Direct inquiries regarding programmatic issues to: Carolyn K. Clifford, Ph.D. Program Director, Diet and Cancer Branch Division of Cancer Prevention and Control National Cancer Institute Executive Plaza North, Suite 212 Bethesda, MD 20892-6130 Telephone: (301) 496-8573 FAX: (301) 402-0553 Direct inquiries regarding fiscal matters to: Eileen Natoli Grants Administration Branch National Cancer Institute 6120 Executive Boulevard Executive Plaza South, Room 243 Rockville, 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, Cancer Control. Awards will be made under the authority of the Public Health Services Act, Title IV, Section 301 (Public Law 78-410,;42 U.S.C. 241 and Section 412, as amended by Public Law 99-518, 42 U.S.C 258a-1); and administered under PHS grants policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12732 or Health Systems Agency review. .
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