Full Text DK-95-001 DIABETES RESEARCH AND TRAINING CENTER NIH GUIDE, Volume 23, Number 35, October 7, 1994 RFA: DK-95-001 P.T. 04 Keywords: Diabetes Biomedical Research Training Biomedical Research, Multidiscipl National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 16, 1995 Application Receipt Date: March 16, 1995 PURPOSE The National Institute of Diabetes, Digestive and Kidney Diseases (NIDDK) supports six Diabetes Research and Training Centers (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. The NIDDK invites applications for funding of one DRTC grant to be competitively awarded in Fiscal Year 1996. 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), 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, 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. Minority individuals and women are encouraged to submit as Principal Investigators. Any institution with an outstanding, existing program of biomedical research in the area of diabetes may apply for a DRTC. In addition, existing Diabetes Endocrinology Research Centers (DERCs) may submit competing applications for conversion to DRTCs. Foreign institutions are not eligible to apply. MECHANISM OF SUPPORT This RFA is a one time solicitation. Support of this program will be through the National Institutes of Health (NIH) comprehensive center (P60) award. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. In addition to the requirements stated in this RFA, awards will be administered under PHS grants policy as stated in the PHS Grants Policy Statement. FUNDS AVAILABLE The NIDDK anticipates awarding one DRTC Grant in Fiscal Year 1996 on a competitive basis. The receipt of one competing continuation application is anticipated, which will be in competition together with the other applications received in response to this RFA. The anticipated award will be contingent upon the availability of appropriated funds. Requests for support must be limited to no more than $1,250,000 in direct costs per year. Requests for support for Demonstration and Education (D&E) supplements to convert an existing DERC to a DRTC must be limited to $300,000 in direct costs. If awarded, the D&E supplement funding would be added to the level of the existing DERC budget. The $1,250,000 direct cost application limit would then apply to future DRTC competing renewals. The NIDDK has allocated $1,657,000 in total costs to support this RFA. Any application exceeding the direct cost amounts indicated will be returned to the applicant without review. RESEARCH OBJECTIVES The NIDDK-supported Diabetes Centers program is comprised of DERCs and DRTCs. The objective of the Diabetes Research Center is to bring together investigators from relevant disciplines in a manner which will enhance and extend the effectiveness of research and training being conducted in the field of diabetes and its complications. These Centers have provided a focus for increasing collaboration and cost effectiveness among groups of successful investigators at institutions with established comprehensive diabetes research bases. Both types of centers 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. These centers also support 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 when 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, workshops, etc. While the above components are common to DERCs and DRTCs, DRTCs also include a substantial additional component, the Demonstration and Education (D&E) Division. The D&E Division: (1) carries out training programs for health care professionals, (2) is engaged in research in the translation of the outcomes of biomedical and behavioral science research into clinical care, and (3) develops, tests, and evaluates innovative methods and programs for translation activities. These features are described briefly in this RFA and in detail in the DRTC Guidelines. Each project or core within the D&E Division may not exceed 25 pages. A DERC is eligible to apply for conversion to the DRTC program. An existing DERC that elects to apply for such conversion in response to this RFA must follow the following procedures: (1) if the DERC will have at least one year of support remaining as of December 1, 1995 (the earliest funding date for applications submitted in response to this RFA), a competing supplement to the existing DERC may be submitted which includes only the components of a Demonstration and Education Division. In addition, information (limited to five pages) should be included describing how this D&E addition will interact with the existing DERC elements and enhance the comprehensive nature of the Center. A successful competition would result in the DERC being converted to a DRTC for the duration of that Center's current award. It would then be eligible to submit a DRTC proposal for its competing renewal. (2) If the DERC will have less than one year of support remaining after December 1, 1995, it must submit a full DRTC application. If funded the DRTC would have a five year award period. A DRTC 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 education and translation. As indicated above, the DRTCs are expected to encompass the following: (1) facilitate and strengthen basic and clinical research related to diabetes and its complications; (2) train health professionals about diabetes and its management. In addition, within the D&E Division of the DRTC: (3) develop a model demonstration facility to contribute to the above endeavors; and, (4) translate advances in the field of diabetes into improved care, especially, the translation of the intensive management shown to be effective by the Diabetes Control and Complications Trial (DCCT). The latter should focus on research to identify and overcome barriers to intensive diabetes management and treatment. All of these areas need not be developed to the same degree. A strong base of biomedical research is an essential prerequisite 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 to enhance research progress 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. 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. 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) ad supersedes and strengthens the previous policies (Concerning the Inclusion of Women in Study Populations, and Concerning the Inclusion of Minority in Study Populations) which have been in effect since 1990. The new policy contains some new 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 in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from program staff listed under INQUIIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 16, 1995, 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 is helpful in planning for the review of applications. It allows NIDDK staff to estimate the potential review workload and to avoid possible conflict of interests in the review. Prospective applicants may submit letters of intent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 APPLICATION PROCEDURES Applicants are strongly encouraged to request a copy of "Guidelines for Diabetes Research and Training Centers." These guidelines contain important suggestions and information on the format, content, and review of applications and review criteria. Prospective applicants may obtain guidelines from the program official listed under INQUIRIES. Applications are to be submitted on the form PHS 398 (rev. 9/91) available at most institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892, telephone (301) 710-0267. 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, plus three signed, exact photocopies, in one package to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At time of submission, two additional copies of the application must also be sent under separate cover to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Disgestive and Kidney Diseases 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Applications must be received by March 16, 1995. If an application is received after that date, it will be returned to the applicant. 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 previously reviewed. Such applications must not only include an introduction addressing the previous critique but also be responsive to this RFA. REVIEW CONSIDERATIONS 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 the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, a process (triage) may be used by the initial review group in which applications will be determined to be competitive or non-competitive based on the scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and be assigned a priority score. Applications determined to be non-competitive will be withdrawn from further consideration and the principal investigator/program director and the official signing for the applicant organization will be promptly notified. It is essential that the written application be in a form to be reviewed on its own merit, since no site-visit is anticipated. Following this review, the applications will be given a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. The initial review group will review each application using the criteria stated below and detailed in the DRTC Guidelines: New and Competing DRTC Applications: 1. Biomedical Research o Scientific excellence of the Center's research base that must have a broad and central focus in diabetes and may extend to related research in metabolism and endocrinology. The relevance of the separately funded research to the DRTC objectives (see above) and the likelihood for meaningful collaboration among Center investigators must be demonstrated. o Potential of the cores for contribution to ongoing research, their appropriateness and relevance, their modes of operation and, suitability of facilities. Renewal applications must include the use, utility, quality control, cost effectiveness, and demonstrated progress of any developmental research in the shared resources. o For new applications, the pilot and feasibility program is judged on the basis of: (1) scientific merit of the studies as submitted and (2) the merit of the administrative process for selecting subsequent studies. In competitive renewal applications, emphasis is placed on the program as a whole, including past track record and management of the program. o Adequacy of plans to include both genders and minorities and their subgroups as apropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evalusted. 2. Research Training o Although the Center does not specifically support research training, demonstration of accomplishments and future plans related to the training of investigators necessary to conduct research in diabetes and related metabolic and endocrine disorders will be considered in assessing the potential to meet Center objectives. The integration of these efforts into the overall Center, including core facilities is of particular importance. 3. Demonstration and Education o The applicant's existing or planned activities to overcome barriers to translating research knowledge into improved diabetes health care will be evaluated on the basis of: (a) The novelty, feasibility, and quality of programs, materials, and publications that address overcoming barriers to translation of scientific advances into clinical practice. This should include program and/or curriculum development in the education of health care professionals (including students) both within and outside the DRTC. Completed programs and materials should be translatable to other settings and should have undergone some form of evaluation. (b) Organization and use of the Model Demonstration Unit which is a required component of the DRTC. The MDU should include as a central mission the development, testing, and demonstration of model diabetes care. Ideally it should span all the Center activities, including basic and clinical research, research training and training of health professionals. (c) For existing Centers, future plans for continuing ongoing activities and initiating new activities and their evaluation. (d) The approach, results, and general utility of any outreach projects, including: transferability to other settings, demonstrated effectiveness, and plans for take over by local groups and/or funding from other sources. (e) Overall coordination and cooperation within the D&E component among the cores of the DRTC and with other groups (voluntary health organizations, Federal agencies, and other diabetes-related efforts, etc.). (f) Consideration of the potential impact of the activity on the national diabetes effort. 4. Supplemental Demonstration and Education Unit Applications: o The supplement will be evaluated on the basis of the D&E criteria presented above. o The D&E supplement should carefully present the rationale for extending the currently funded DERC to include this new element. o The interfacing of the additional D&E element to the existing DERC. How does this extension impact on the overall activities of the Center? o The overall rating of the DERC plus D&E supplement for conversion to a DRTC will be based on the above stated D&E criteria in addition to the existing DERC framework. The latter will take into consideration the previous DERC Summary Statement. The DERC elements will not be re-reviewed. 5. Administration o The scientific and administrative leadership abilities of the DRTC Director and Associate Director and their commitment and ability to devote adequate time to the effective management of the DRTC program. o The appropriateness of the DERC budgets for the proposed and approved work to be done in core facilities, for pilot and feasibility studies, and for enrichment in relation to the total Center program. o Efficiency and effectiveness of use and/or planned use of enrichment funds. o Institutional commitment to the program, including lines of accountability regarding management of the DERC grant and a commitment to establish new positions as necessary. AWARD CRITERIA The anticipated date of the award is December 1, 1995. Applications will compete for available funds with all other applications submitted in response to this RFA and recommended by peer review. The following will be considered in making funding decisions: o Quality of the proposed Center as determined by peer review o Availability of funds INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Dr. Sanford A. Garfield Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 626 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7535 FAX: (301) 594-9011 Email: sandyg@dvsgate.niddk.nih.gov Direct inquiries regarding fiscal matters to: Ms. Linda Stecklein Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases Westwood Building, Room 653 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7543 Schedule Letter of Intent Receipt Date: February 16, 1995 Application Receipt Date: March 16, 1995 Initial Review Dates: June-July 1995 Second Level Review Dates: Sep-Oct 1995 Anticipated Award Date: December 1, 1995 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847. 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 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. The Public Health Service strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. .
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