Full Text CA-96-007 MINORITY ENHANCEMENT AWARDS NIH GUIDE, Volume 25, Number 4, February 16, 1996 RFA: CA-96-007 P.T. 34, FF Keywords: Cancer/Carcinogenesis Disease Prevention+ Disease Control+ National Cancer Institute Letter of Intent Receipt Date: March 20, 1996 Application Receipt Date: May 14, 1996 PURPOSE The Comprehensive Minority Biomedical Program (CMBP), Division of Extramural Activities (DEA), National Cancer Institute (NCI), invites research grant applications from interested investigators with access to large or predominantly minority populations to promote minority group participation in cancer research with a special focus on cancer control research. Support provided by this initiative would broaden the operational base of each institution by: 1. Expanding cancer control and prevention efforts in early detection, prevention, screening, pre-treatment evaluation, treatment, continuation care, and rehabilitation; 2. Increasing the involvement of minority population primary care providers early in the course of clinical treatment research; 3. Promoting the involvement in treatment research at the institutional level with a focus on the development of treatment protocols for cancers that have a high incidence in minorities; 4. Supporting programs involving diet and nutrition cancer control research activities; 5. Coordinating the contributions of investigators from various relevant disciplines, psychology and nutrition; and 6. Promoting the inclusion of minority individuals at all levels in the conduct of the research with the increased recruitment of minority scientists into the research base of the institution as an expected outcome. 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), Minority Enhancement Awards, 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,D.C. 20402-9325 (telephone(202) 783-3238). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Institutions are eligible if they can demonstrate the following: 1. Broad research capabilities in cancer prevention, cancer control and cancer treatment as evidenced by significant research support in these areas. This would include past and current examples of ability to design and implement strong clinical trials research programs. 2. An organizational infrastructure that promotes and sustains a strong interdisciplinary, interactive cancer research environment which links basic research effectively to research in patient and population settings (e.g., NCI-designated Comprehensive Cancer Centers); the dissemination of information to minorities about cancer and its prevention; investigations of patient perspectives of cancer risks; the design and evaluation of interventions to minimize and control distress of minority patients with cancer; the development of pilot studies for minority clinical prevention trials; and psychosocial studies and perception of cancer risk in minorities. 3. Clear access to large numbers of minorities who are representative of the minority populations in the communities and/or regions associated with the institution. 4. Demonstrated capability to work with minority populations in a research setting within communities and/or regions. Applicants who do not adequately meet the above eligibility requirements of this initiative may have their applications returned. Thus, the NCI strongly encourages applicants to communicate with the appropriate NCI program official before submitting a letter of intent (see INQUIRIES section). MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) research project grant (R01). 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 three years. The anticipated award date is September 30, 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 Funding in the amount of $1,600,000 in total costs has been set aside for the first year to specifically fund applications which are submitted in response to this RFA. It is anticipated that six awards will be made. This funding level is dependent on the receipt of sufficient number of applications of high scientific merit. The total project period for applications submitted in response to the present RFA may not exceed three years. The earliest feasible start date for the initial awards will be September 30, 1996. 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 NCI is committed to reducing the cancer mortality disparity between disadvantaged populations, which include African Americans, Hispanics and Native Americans, and the general population. One approach to achieving this objective is through the NCI DEA CMBP, which is committed to providing support to institutions for increasing their efforts to broaden minority involvement in programs developing the latest and most effective measures in cancer prevention, cancer control, and clinical treatment research. One primary goal is the delivery of state-of-the-art cancer prevention and control as well as treatment modalities to underserved and minority populations. Cancer survival statistics verify that certain segments of the population, African Americans for example, have substantially lower cancer survival rates than that of American Whites with the same disease. By targeting minority populations with the highest mortality in different regions of the country, it is hoped that this initiative will have significant impact on minority population cancer survival. This initiative is to encourage institutions to develop research programs in cancer prevention, cancer control and cancer treatment that will specifically benefit minority populations. General research objectives within the scope of this initiative include, but are not limited to, studies of smoking behavior in minority youth; studies of communication strategies for presenting information to minorities about cancer and its prevention; investigations of patient perspectives of cancer risks; the design and evaluation of interventions to minimize and control distress of minority patients with cancer; the development of pilot studies for minority clinical prevention trials; and psychosocial studies and perception of cancer risk in minorities. Specific research strategies include: 1. Targeting and facilitating the involvement of minority populations in cancer control research. 2. Investigating the impact of cancer therapy and control advances on minorities in community medical practice settings 3. Increasing the involvement of minority primary health care providers and other specialists in treatment and other cancer control research, thereby providing both educational opportunities for health providers and facilitating exchange of information about current advances in cancer control research. 4. Increasing the number of underserved patients entered into clinical cancer treatment protocols. 5. Delivery of state-of-the-art cancer treatment to underserved minority populations. 6. Significantly impacting minority population cancer treatment and survival. 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 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 492 B 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. Investigators proposing research involving human subjects should read the "NIH Guidelines for the 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 March 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 subsequent applications, the information that it contains allows NCI staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to: Lemuel Evans, Ph.D. Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 620 - MSC 7405 Bethesda, MD 20892-7405 Telephone: (301) 496-7344 FAX: (301) 402-4551 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 and may be obtained from the Grants Information Office, 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 NCI Information Office listed under INQUIRIES. The RFA label available in the PHS 398 (rev. 5/95) 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 it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2a 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 (U. S. Postal Service) Bethesda, MD 20817 (express/courier service) At the time of submission, two additional copies of the application must be sent to: Ms. Toby Freidberg Division of Extramural Activities National Cancer Institute Executive Plaza North, Suite 636 6130 Executive Boulevard - MSC 7405 Bethesda, MD 20892-7405 (U. S. Postal Service) Rockville, MD 20852 (express/courier service) Applications must be received by May 14, 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG and for responsiveness by the NCI Program Staff. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NCI staff will contact the applicant to determine whether to return the application to the applicant or 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 convened by NCI in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. REVIEW CRITERIA o Extent to which the proposed research plan addresses the goals and objectives of the RFA; 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; and o Appropriateness of the proposed budget and duration in relation to the proposed research. o Adequacy of plans to include both genders 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 and animal subjects, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA The earliest anticipated date of award is September 30, 1996. The following will be considered for making funding decisions: o quality of the proposed research project as determined by peer review o availability of funds o program balance among research areas o geographical distribution of awards INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Lemuel Evans, Ph.D. Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 620 6130 Executive Boulevard - MSC 7405 Bethesda, MD 20892-7405 Telephone: (301) 496-7344 FAX: (301) 402-4551 Email: evansl@dea.nci.nih.gov Direct inquiries regarding fiscal matters to: Ms. Joan Metcalfe Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard - MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, Extension 228 FAX: (301) 496-8601 Email: MetcalfJ@gab.nci.nih.gov AUTHORIZATION AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.3 99. 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 part 52 and 45 CFR part 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The 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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