Full Text CA-93-027 MINORITY ENHANCEMENT AWARDS NIH GUIDE, Volume 22, Number 21, June 11, 1993 RFA: CA-93-027 P.T. 34, FF Keywords: Clinical Medicine, General Cancer/Carcinogenesis Treatment, Medical+ Nutrition/Dietetics National Cancer Institute Letter of Intent Receipt Date: July 14, 1993 Application Receipt Date: September 22, 1993 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, DC 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 governments, and eligible agencies of the federal government. Applications from minority individuals and women are encouraged. 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 populations settings (e.g., NCI-designated Comprehensive Cancer Centers). 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) individual research grant (R01). Applicants will be responsible for the planning, direction, and execution of the proposed project. Except as otherwise stated in this RFA, awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 90-50,000, revised October 1, 1990. This RFA is a one-time solicitation. Generally, future unsolicited competitive continuation applications will compete with all investigator-initiated applications and be reviewed by the Division of Research Grants (DRG). However, should the NCI determine that there is a sufficient continuing program need, a request for competitive continuation applications will be announced. Only recipients of awards under this RFA will be eligible to apply. The average amount of direct costs expected per award is 200,000. 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 April 1, 1994. 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, 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 prevent 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 interchange 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. 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 must be placed on the need for inclusion of minorities and women in studies 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 must 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 must be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must 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 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 must be provided. For the purpose of this policy, clinical research is defined as 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. If the required information is not contained within the application, the application will be returned. 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 population is inadequate, it will be considered a scientific weakness or deficiency in the study design and 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. LETTER OF INTENT Prospective applicants are asked to submit, by July 14, 1993, 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 Dr. Lemuel Evans at the address listed under INQUIRIES. APPLICATION PROCEDURES 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, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267; and from the NCI Program Director named below. The RFA label available in the PHS 398 (rev. 9/91) 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 Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies of the application must also be sent to: NCI Referral Office Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 636 Bethesda, MD 20892 Applications must be received by September 22, 1993. 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. 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 may receive a preliminary scientific peer review (triage) by an NCI peer review group on the basis of relative competitiveness. The NIH will withdraw from further competition those applications judged to be non-competitive for award and notify the applicant Principal Investigator and institutional official. Those applications judged to be competitive will undergo further scientific merit review. Those applications that are complete and responsive will be evaluated in accordance with the criteria stated below for scientific/technical merit by an appropriate peer review group convened by the NCI. The second level of review will be provided by the National Cancer Advisory Board. Review criteria for RFAs are generally the same as those for unsolicited research grant applications. 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 a 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. AWARD CRITERIA The earliest anticipated date of award is April 1, 1994. 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 Written and telephone inquiries concerning the objectives and scope of this RFA or inquiries about whether or not specific proposed research would be responsive are encouraged and may be directed to: Dr. Lemuel Evans Division of Extramural Activities National Cancer Institute Executive Plaza North, Room 620 Bethesda, MD 20892 Telephone: (301) 496-7344 FAX: (301) 496-7911 For information regarding budgetary/administrative issues related to this RFA, contact: Ms. Carolyn Mason Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 Bethesda, MD 20892 Telephone: (301) 496-7800, Extension 59 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, Number 93.399, Cancer Control. Awards are made under the authorization of the Public Health Service Act, Title V, 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 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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