Full Text DK-95-003 CYSTIC FIBROSIS CORE CENTER NIH GUIDE, Volume 23, Number 41, November 25, 1994 RFA: DK-95-003 P.T. Keywords: National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 22, 1995 Application Receipt Date: July 20, 1995 PURPOSE Cystic Fibrosis (CF) Core Centers provide shared resources to enhance research ranging from elucidation of the molecular pathogenesis of CF to development of new therapies for this disorder. Biomedical research cores are intended to enhance the efficiency of research and foster collaborations at institutions with strong existing bases of research relevant to CF. In addition to biomedical research cores, Centers provide support for pilot and feasibility studies and an enhanced environment for research training. 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), Cystic Fibrosis Core Center, is related to the priority area of chronic diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or 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. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. An outstanding interdisciplinary program of CF research must be in existence at the applicant organization. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) core center grant (P30). 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 five years. The maximum budget request is limited to $750,000 in direct costs in any annual budget period. The anticipated award date is April 1, 1996. This RFA is a one-time solicitation. FUNDS AVAILABLE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) anticipates funding one core center grant application submitted in response to this RFA, and will commit up to $1.1 million total costs in FY 1996 for this purpose. The receipt of one competing continuation application is anticipated, which will be in competition together with other applications received in response to this RFA. Although this program is provided for in the financial plans of the NIDDK, the award of a grant pursuant to this RFA is contingent upon the availability of funds for this purpose and upon the receipt of at least one application of high scientific merit. RESEARCH OBJECTIVES CF is the most common fatal genetic disease in caucasians, affecting approximately one in 2500 newborns. Since the cloning of the CF gene and identification of its protein product as a cAMP-regulated chloride channel, there has been impressive progress in the molecular understanding of this disorder. CF Core Centers are part of an integrated program of CF-related research support within the NIDDK directed at further defining the molecular mechanisms underlying CF and translating information about the molecular basis of the disease into new treatments. Continued progress will depend on multidisciplinary collaborations among clinical and basic scientists. Core centers provide a focus for enhancing such collaborations. Centers promote efficient management of resources, interaction and collaboration among scientists in multiple disciplines, and a multifaceted approach to a common goal. The objective of the core center is facilitation of progress in research on CF with the ultimate goal of developing new therapies for this disorder. CF Core Centers are designed to enhance the efficiency and effectiveness of an established, ongoing program of research through provision of core resources, support of pilot and feasibility studies, and support of program enrichment activities. Thus, an outstanding existing program of biomedical research in the area of CF is an essential prerequisite for a CF Core Center. This research should be in the form of NIH-funded research projects (R01 or R29), program projects (P01), Specialized Centers of Research (P50), or other peer-reviewed research such as that supported by the Cystic Fibrosis Foundation. This established research program must be in existence at the time of submission of a CF Core Center application. A CF Core Center is composed of shared resources (cores) that enhance productivity or in other ways benefit a group of investigators pursuing a multifaceted approach to significant problems related to the pathogenesis and treatment of CF. The CF Core Center is intended to improve the quality and efficiency of research on CF by providing shared access to specialized technical resources and expertise. Examples of cores that would be considered responsive to this RFA include the following: electrophysiology, cell morphology, microscopy, imaging, assay, tissue culture, protein expression, mutagenesis, transgenic, animal models, structural biology, vector, and clinical resources. Specific cores should be proposed based on the requirements of the investigators at the applicant institution. Two other types of activities may also be supported with center funding: a pilot and feasibility program and an enrichment program. The pilot and feasibility program provides modest support for initiatives by new investigators, established investigators entering CF research, or established CF investigators exploring a new research direction related to CF. The Center grant may also include limited funds for program enrichment such as, but not limited to, seminars, visiting scientists, consultants, and workshops. 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. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. SPECIAL REQUIREMENTS Applicants must be willing to participate in an annual centers directors meeting and are advised to include such travel in their budget request. 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.
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