Full Text CA-96-003 WOMEN AND MINORITY RECRUITMENT: SMALL GRANT PROGRAM NIH GUIDE, Volume 25, Number 1, January 26, 1996 RFA: CA-96-003 P.T. 34, FF, II Keywords: Cancer/Carcinogenesis Disease Prevention+ National Cancer Institute Letter of Intent Receipt Date: February 20, 1996 Application Receipt Date: April 18, 1996 PURPOSE The Early Detection Branch (EDB), Division of Cancer Prevention and Control (DCPC), National Cancer Institute (NCI) invites Small Grant Program applications (RO3) to perform pilot studies, test new ideas, or gather information that will lead to the development of effective models and strategies to improve the participation of women and minority groups as subjects in cancer prevention and screening phase III research. Populations of research interest are defined in the NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research and include women and U.S. minority racial/ethnic groups (American Indian or Alaskan Native, Asian or Pacific Islander, Black, and Hispanic) and their subpopulations (DHHS 1994). 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 (Women & Minority Recruitment: Small Grants Program) is related to all of the special populations targets. 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 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. Eligible Principal Investigators include new investigators, established researchers, qualified staff of public health departments and collaborating agencies, and predoctoral investigators currently enrolled in an accredited doctoral degree program. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. Ineligible applicants include individuals who are or were previously a Principal Investigator (PI) on an NCI-funded cancer control grant or contract for more than two years; previous NCI small grant recipients; and foreign institutions. MECHANISM OF SUPPORT This RFA will use the National Cancer Institute (NCI) Small Grants (R03) Program. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Collaboration of investigators funded under this RFA is planned, see SPECIAL REQUIREMENTS section below. The total project period for an application submitted in response to this RFA may not exceed two 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 Approximately $400,000 in total costs per year for two years will be committed to fund applications submitted in response to this RFA. It is anticipated that four to five applications will be funded. Each award will be limited to $50,000 in direct costs per year. The total project period of these awards may not exceed two years. 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 The NIH Revitalization Act of 1993 directed NIH to establish guidelines for the inclusion of women and minorities in clinical research. The guidelines were to supersede and strengthen prior policies regarding the participation of women and minorities as subjects in clinical research, the manner in which clinical trials are designed and carried out, and the operation of outreach programs (DHHS 1994). The NIH published these guidelines in the Federal Register on March 28, 1994. The NIH guidelines are intended to ensure that all future NIH- supported research is designed to elicit information on both genders and diverse minority groups (DHHS 1994). Under these guidelines, the NIH will not award funds for projects which do not comply with the new policy. The level of participation of minorities and women as subjects in NCI~s treatment trials is currently close to their representation in populations at risk. This success is due in part to two recent NCI programs, the Minority-Based Clinical Community Oncology Program (MBCCOP) and the Increasing Minority Accrual to Cooperative Clinical Trials program. However, the numbers of women and minority groups participating in NCI~s prevention and screening trials lag behind those enrolled in its treatment trials. Unlike treatment trials, cancer prevention and screening trials focus on cancer-free populations. These trials generally require large numbers of subjects to participate over very long periods of time. Given that a significant proportion of many minority groups carry a heavy burden of poverty, worries about daily safety and well- being are likely to take precedence over concerns for a disease they do not yet have (Lacey 1993). The NCI is eager to gather information that will lead to the development of effective strategies and models to increase the participation of women and minority groups as subjects in cancer prevention and screening trials. Large gaps currently exist in our understanding of important health and clinical trial-related knowledge, attitudes, and behaviors for many women and minority population groups (ORWH 1994). This program is designed to help fill these gaps and enable investigators to develop more effective participation strategies. Research Objectives and Scope The objective of this RFA is to fund applications that will test new ideas, gather information, or perform pilot studies that can lead to the development of new, testable hypotheses and interventions to improve the participation of women and minority groups as subjects in cancer prevention and screening phase III research. To address program objectives, investigators should consider surveys of patient, provider, and/or public attitudes, knowledge, and behaviors related to clinical trials; pilot studies; or collection of baseline information. New, as well as experienced investigators in relevant fields and disciplines, are encouraged to submit applications for exploratory studies that address research issues within well-defined study populations, such as but not limited to the following: (1) Examining knowledge, attitudes, and behaviors of physicians and other health care providers, current and potential subjects, special interest groups, or the public about health, cancer screening and prevention, and clinical research. (2) Examining how population groups obtain information (the credible sources) and how this information is translated into disease prevention and health behavior activities. (3) Determining optimum ways to recruit subjects. (4) Examining ways to reduce barriers to subject participation and to enhance those factors that help motivate and facilitate participation. (5) Determining optimum ways to assure subject compliance with clinical trial protocols. (6) Determining optimum ways to retain subjects throughout the duration of a clinical trial. (7) Determining factors that influence a health care professional~s decision to refer patients to clinical trials. (8) Defining issues that should be addressed in the recruitment and informed consent process for subjects and their health care providers. (9) Defining the impact of participation in clinical trials on the subsequent behavior of subjects and their interactions with health professionals. (10) Identifying optimal referral sources and networks for potential clinical trial subjects. (11) Examining the role of economic barriers to subject participation in clinical trials including issues surrounding reimbursement of patient care costs. (12) Examining the role of partnerships between research institutions and communities on the participation of subjects and health care providers in clinical trials. (13) Examining ways to ensure the protection of ~vulnerable~ populations from research abuse (e.g., avoiding coercion or undue influence to participate or remain in a study). SPECIAL REQUIREMENTS This RFA is not intended to support or supplement new clinical trials. If the application calls for use of secondary data or primary data collected by someone else, the source (owner) of the data must be clearly indicated and written permission to use the data must be submitted with this application. The letter must state that the application and research plan were reviewed and approved by the source (owner) of the data. 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 or additional relevant information from the program staff listed under INQUIRIES. 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, telephone and FAX numbers 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: Nancy K. Simpson, Sc.M. Early Detection Branch National Cancer Institute Executive Plaza North, Room 305 6130 Executive Boulevard, MSC 7342 Bethesda, MD 20892-7342 Rockville, MD 20894 (courier express) Telephone: (301) 496-3893 FAX: (301) 496-8667 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 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 BETHESDA, MD 20817 (for express/courier express) 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, Suite 636 6130 Executive Boulevard - MSC 7405 Bethesda, MD 20892-7405 Bethesda, MD 20852 (courier express) 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the DRG and for responsiveness by the NCI. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, NIH staff may contact the applicant to determine whether it should be returned or submitted 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, and for adequacy and plans for addressing special considerations by an appropriate peer review group convened by the NCI in accordance with the review criteria stated below. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened 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 applications will be judged on evidence of an in-depth understanding of the target population; the ability to access and obtain the participation of target population members; and the innovativeness of proposed strategies. 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; o adequacy of plans to include both genders 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. AWARD CRITERIA The anticipated date of award is September 30, 1996. Applicants will compete for funding based on the quality and merit of the proposed research as determined by peer review, availability of funds, and programmatic priorities. It is the intent of this program to fund a portfolio of research projects that will target a variety of population groups, and, therefore, geographic and racial/ethnic variation will be considered in making funding decisions. INQUIRIES Written and telephone 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: Nancy K. Simpson, Sc.M. Early Detection Branch National Cancer Institute Executive Plaza North, Room 305 6130 Executive Boulevard, MSC 7342 Bethesda, MD 20892-7342 Rockville, MD 20894 (courier express) Telephone: (301) 496-3893 FAX: (301) 496-8667 Email: SIMPSONN@DCPCEPN.NCI.NIH.GOV Direct inquiries regarding fiscal issues to: Robert Hawkins Grants Administration Branch National Cancer Institute Executive Plaza South, Room 243 6120 Executive Boulevard, MSC 7150 Bethesda, MD 20892-7150 Rockville, MD 20852 (courier express) Telephone: (301) 496-7800 Ext. 213 FAX: (301) 496-8601 Email: HAWKINSR@GAB.NCI.NIH.GOV AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.399, Cancer Control Science Program. Awards are made under the 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. References Department of Health and Human Services (DHHS). NIH guidelines on the inclusion of women and minorities as subjects in clinical research. Federal Register 59(50):14508-14513, 1994. Lacey L. Cancer prevention and early detection strategies for reaching underserved urban, low-income black women: Barriers and objectives. Cancer Supplement 4(4):312-320, 1994 National Cancer Institute (NCI). Small Grants Program: 1984-1990 status report, cancer prevention and control research. NIH Publication No. 91-3233, Sept. 1991. Office of Research on Women~s Health (ORWH). Recruitment and retention of women in clinical studies: a Report of the task force on the recruitment and retention of women in clinical studies. NIH, Washington, D.C., August 1994. .
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