$$XID RFA DK9112 DK-91-12 P1O1 ***************************************** DIABETES RESEARCH AND TRAINING CENTERS RFA: DK-91-12 P.T. 04, 44; K.W. 0715075, 0710030, 0785035, 0403004 National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: November 22, 1991 Application Receipt Date: December 20, 1991 The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for Center grants. NIDDK anticipates the competitive awarding of at least five Diabetes Research and Training Center (DRTC) grants in Fiscal Year 1993. 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), Diabetes Research and Training Centers, is related to the priority area of diabetes mellitus. 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). BACKGROUND At the present time, the NIDDK supports six DRTCs. These centers are part of an integrated program of diabetes-related research support within the NIDDK. Centers have provided a focus for increasing the efficiency and collaborative effort among groups of successful investigators at institutions with established comprehensive diabetes research bases. OBJECTIVES AND SCOPE The objective of the DRTCs is to bring together investigators from relevant disciplines in a manner that will enhance and extend the effectiveness of research and training being conducted in the field of diabetes and its complications. It should be stressed that a DRTC, although containing all of the elements present in a Diabetes Endocrinology Research Center (DERC, see RFA DK-91-11), contains substantial additional components described here. Diabetes Centers must be an identifiable unit within a single university medical center or a consortium of cooperating institutions, including an affiliated university. The overall goal of the DRTC is to bring together, on a cooperative basis, clinical and basic science investigators and those involved in diabetes training and information transfer in a manner that will enrich the effectiveness of diabetes research, training, and information transfer. When fully developed, the DRTCs are expected to encompass the following: (1) facilitating and strengthening basic and clinical research related to diabetes and its complications; (2) training health professionals about diabetes and its management; (3) developing a model demonstration facility to contribute to the above endeavors; and (4) transferring advances in the field of diabetes into improved care for people with diabetes through activities that identify and then overcome barriers to the application of new science to diabetes management and treatment. All of these areas need not be developed to the same degree. However, a strong base of biomedical research is the most important function of a center. Accordingly, a program of excellence in biomedical research in the area of diabetes and related metabolic and endocrine disorders in the form of NIH-funded research projects, program projects, or other peer-reviewed research must be in existence at the time of submission of a Center application. Close cooperation, communication, and collaboration among all involved personnel of all professional disciplines are ultimate objectives. Applicants should request a copy of the DRTC guidelines and consult with NIDDK staff concerning plans for the development of the Center. The DRTCs are based on the core concept. Cores are defined as shared resources that enhance productivity or in other ways benefit a group of investigators working in diabetes or diabetes-related areas to accomplish the stated goals of the Center. 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 new initiatives or feasibility research studies for new investigators or for established investigators in other research disciplines where their expertise may be applied to diabetes research. These include biomedical, epidemiologic, behavioral, and health care research as it pertains to the Center's mandate for the training of primarily health care professionals. The Center grant may also include limited funds for program enrichment such as 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. In such a case, a letter of agreement from either the GCRC program director or Principal Investigator must be included with the application. SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH and ADAMHA policy is that applicants for NIH/ADAMHA 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 Section 2, A-D of the Research Plan AND summarized in Section 2, E, Human Subjects. Applicants/offerors 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 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 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 or cooperative agreements that do not comply with these policies. ELIGIBILITY Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT NIDDK expects to award up to five DRTC grants in Fiscal Year 1993 on a competitive basis. The receipt of five competitive continuation applications is anticipated, and these will be in competition together with other applications received in response to this announcement. Awards will be for five years contingent upon the availability of appropriated funds. Requests for support must not exceed $1,250,000 per year in direct costs. Any application exceeding this amount will be returned to the applicant. REVIEW PROCEDURES Applications for a DRTC grant will be evaluated in national competition by the NIH grant peer review process. Applications will be reviewed initially by an ad hoc review group convened by the NIDDK and subsequently by the National Diabetes and Digestive and Kidney Diseases Advisory Council. METHOD OF APPLYING Applicants should request a copy of "Guidelines for Diabetes Research and Training Centers (DRTCs)." These guidelines contain important additional information on the format, content, and review of applications and review criteria. Letter of Intent: Potential applicants are strongly encouraged to submit a letter of intent by November 22, 1991. The letter of intent may only include names of the Principal Investigator/program director and principal collaborators, descriptive title of the potential application, and identification of the organization(s) involved. The letter of intent is to be sent to the Chief, Review Branch, NIDDK at the address noted below. Format for Application: Applications must be submitted on the form PHS 398 (rev. 10/88) available at most institutional business offices and from the Division of Research Grants, NIH, (301) 496-7441. On item 2 of the face page of the application, applicants must enter: Diabetes Centers, RFA number DK-91-12. The RFA label available in the current revision of 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 to the extent that it may not reach the review committee in time for review. Application Procedures: Applications must be received by December 20, 1991. The original and four copies of the application must be sent or delivered to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** Two additional copies of the application under separate cover must be sent to: Review Branch National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 406 Bethesda, MD 20892 Receipt, Review, and Start Dates: Letter of Intent Receipt Date: November 22, 1991 Application Receipt Date: December 20, 1991 Initial Review: June - July 1992 Council Review: September - October 1992 Earliest Start Date: December 1, 1992 INQUIRIES Inquiries and requests for guidelines should be directed to: Dr. Sanford A. Garfield Diabetes Center Program Director Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 Bethesda, MD 20892 Telephone: (301) 496-7418 For fiscal and administrative matters, contact: Linda Stecklin Supervisory Grants Management Specialist National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 639 Bethesda, MD 20892 Telephone: (301) 496-7467 These programs are described in the Catalog of Federal Domestic Assistance No. 93.847 - Diabetes, Endocrinology and Metabolic Diseases Research. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78-4110, as amended: 42 USC 241) 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 12372 or Health Systems Agency review.