Full Text DK-96-012 DIABETES INTERDISCIPLINARY RESEARCH PROGRAMS NIH Guide, Volume 25, Number 20, June 21, 1996 RFA: DK-96-012 P.T. 34 Keywords: Diabetes Biomedical Research, Multidiscipl National Institute of Diabetes and Digestive and Kidney Diseases National Institute of Allergy & Infectious Diseases Juvenile Diabetes Foundation International Letter of Intent Receipt Date: September 19, 1996 Application Receipt Date: October 24, 1996 PURPOSE The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institute of Allergy and Infectious Diseases (NIAID), and the Juvenile Diabetes Foundation International (JDFI) invite investigator-initiated program project grant applications. These applications should incorporate an interdisciplinary research approach to: (1) the development of innovative prevention and treatment strategies for insulin-dependent diabetes mellitus (IDDM) and/or its complications, (2) the etiology and pathogenesis of IDDM and its complications, and/or (3) the genetic susceptibility for IDDM and the complications of diabetes. This solicitation is intended to stimulate the application of advances in basic molecular biology, genetics, immunology, cell biology, and biophysics to the study of IDDM and its complications. Applications will be submitted to and reviewed by the National Institutes of Health (NIH) according to usual NIH peer review procedures. Applications judged meritorious but not funded by the NIDDK and NIAID may be considered by the JDFI for funding. Applicants wishing to have their application considered by the JDFI must authorize the NIH, in writing, to provide a copy of their application and NIH-prepared summary statement of the initial review to the JDFI. 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, Diabetes Interdisciplinary Research Programs, is related to the priority area of diabetes and chronic disabling conditions. 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 202-512-1800). 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. MECHANISM OF SUPPORT The mechanism of support will be the NIH program project grant (P01) award. Program project grants are used to support broadly-based multidisciplinary or multifaceted research programs that have a specific major objective or central theme. The award may support research components and core functions. Collectively, these components should demonstrate essential elements of unity and interdependence and result in a greater contribution to program goals than if each activity were pursued individually. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The current policies and requirements that govern the research grant programs of the NIH or the JDFI will prevail depending on the funding source. Applicants should note that grants funded by the JDFI will be subject to the indirect cost policy of JDFI. 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. This RFA is a one-time solicitation. The total requested project period for an application submitted in response to this RFA may not exceed five years. The maximum dollar request is limited to $750,000 in direct costs for the initial budget period. Any application exceeding the direct cost amount indicated will be returned to the applicant. The maximum dollar request is limited to $3.75 million in direct costs (approximately $5 million in total costs) for the five-year budget period. The earliest possible award date will be July 1, 1997. FUNDS AVAILABLE For FY 1997, the NIDDK will commit $1.5 million and the NIAID will commit $250,000 (total costs) to fund applications submitted in response to this RFA. The NIDDK and NIAID anticipate awarding two Diabetes Interdisciplinary Research Program (DIRP) Awards in Fiscal Year 1997 on a competitive basis. The JDFI plans to make two awards. The receipt of four applications currently supported by NIDDK and JDFI is anticipated, which will be in competition with other applications received in response to this RFA. This funding level is dependent upon the receipt of a sufficient number of applications of high scientific merit. Although this program is provided for in the financial plan of the NIDDK and NIAID, the award of grants pursuant to this RFA is also contingent upon the availability of funds for this purpose. RESEARCH OBJECTIVES General Background The National Diabetes Advisory Board in 1987 formulated a National Long-Range Plan to Combat Diabetes. A number of significant recommendations were made by the in this plan. One of these was to establish DIRPs to be supported by the NIH. The DIRPs would promote the integration of new research methodologies into diabetes research. As a result of establishing these programs, new as well as established scientists with diabetes research commitments would be given the opportunity to immerse themselves in new technologies at the cutting edge of modern science. The NIDDK and NIAID are coordinating efforts with the JDFI to implement DIRPs in areas of research that appear particularly relevant to the cure, prevention, and improved treatment of IDDM. Toward this end, the JDFI has embarked on a major long-term capital fund raising campaign targeted at establishing programs of excellence in diabetes research. Scientific Background It has been established that IDDM is an autoimmune disease with major genetic influences. Much has been learned about the nature of the immunologic process involved but many questions remain. Informative animal models of IDDM (i.e., BB/Wor rat and NOD mouse) continue to be a central focus of research. Genes in the HLA locus have been associated with IDDM, but the specific genes associated with this locus have yet to be identified and the role of these gene products in the pathogenesis has not been defined. The Diabetes Control and Complications Trial has established the crucial importance of metabolic control for preventing or delaying the onset of diabetic complications. The present methods for achieving metabolic control are arduous, expensive, and only partially effective. Innovative approaches for maintaining euglycemia are essential. There is a great deal of epidemiologic, clinical, and physiologic information on the long-term microvascular, macrovascular, and neurologic complications of diabetes. There are also biochemical theories of causation that have prompted research over the last decade. At this time, however, the molecular pathophysiology of diabetic complications is still unclear. Despite epidemiologic and clinical evidence of genetic factors in the development of complications, very little is known about the identity or function of specific genes in these processes. Recent advances in basic biomedical research have revolutionized our ability to study complex diseases such as diabetes. Further application of the new capabilities of molecular biology, genetics, immunology, cell biology, and biophysics to diabetes research are essential. Importantly, the increased utilization of these technologies and approaches promises an improved understanding and enhanced development of potential preventive and therapeutic strategies. Scope and Objectives It is the intention of the NIDDK, NIAID and JDFI to further stimulate the integration of the most current basic biomedical research approaches into diabetes-related research. It is expected that this will be accomplished by bringing to the diabetes arena those who are skilled in these approaches by the support of meritorious, synergistic, multidisciplinary research program project applications. Applications should include the involvement of both basic and applied scientists in collaborative endeavors. The JDFI will NOT consider studies aimed at primary prevention for this particular RFA; however, such studies would be within the scope of NIH support (see list of examples below). Research applications should be in the broad areas of etiology, pathogenesis, prevention or cure of IDDM or its complications. Relevant topics listed below are examples and should not be construed as required or limiting. o Development of safe and effective techniques to maintain euglycemia by biological or mechanical means, including investigation of the metabolic performance and biocompatibility of the technique o Beta cell replacement therapies: glucose sensors, implantable pumps, and bio-artificial pancreas o Genetic manipulation of beta cells or surrogate cells to replace physiologic insulin secretion capacity that has been destroyed in IDDM o Immunoalteration of beta cells/islets or the immune response in an attempt to prevent autoimmune and graft- versus-host destruction of beta cells/islets o Regulation of beta cell differentiation and its role in diabetes o Molecular mechanisms of beta cell destruction in IDDM o Identification and characterization of targets for the autoimmune process in IDDM o IDDM prevention strategies to identify high risk individuals and prevent the clinical onset of disease, perhaps by induction of tolerance o Identification and functional characterization of genes for IDDM and IDDM-susceptibility o Identification and functional characterization of genes influencing the development of long-term complications of IDDM o Identification of basic molecular or cellular processes leading to complications and interventions to prevent or halt the progression of long-term complications of diabetes SPECIAL REQUIREMENTS Letter of Authorization Applicants should submit a brief letter to the NIH indicating whether or not they wish their application to be considered for funding by the JDFI. While applicants may request that their applications be considered only by the NIH and not by the JDFI, it is necessary that the record indicate the applicant's consideration of this opportunity. For those applicants who wish to have the JDFI consider their application, all materials relating to the application will be promptly forwarded to that organization and the summary statements for such applications will be shared with the JDFI when available. The NIH will provide no information to the JDFI related to applications from applicants who request that the JDFI not consider their application. Letters of authorization should be prepared by the principal investigator and co-signed by the official signing for the applicant organization. This letter may be combined with the Letter of Intent (see below) or may be submitted as a cover letter accompanying the application. In all cases, the NIDDK and NIAID will make their funding decisions prior to those of the JDFI. Periodic Meetings Upon initiation of this program, the NIH and JDFI plan to sponsor periodic meetings to encourage exchange of information among investigators, to foster collaborative efforts among program grantees, and to identify resources that would enhance the productivity of grantees. For this purpose, applicants should request travel funds for a two-day meeting each year, probably to be held in Bethesda, Maryland. Applicants should also include a statement in their applications indicating their willingness to participate in such meetings and to cooperate with other researchers at other diabetes interdisciplinary research program sites. 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 sub-populations 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 may also obtain copies from these sources or from the program staff or contact person listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by September 19, 1996, 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 NIH staff to estimate the potential review workload and to avoid possible conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC-6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8886 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 5/95) is to be used in applying for these grants. The form is available from most institutional offices of sponsored research and from the Office of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC-7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: asknih@odrockm1.od.nih.gov. Applicants should request a copy of the publication entitled "NIDDK Program Projects Grants: Administrative Guidelines." These guidelines contain important additional information on the suggested format of applications and on review criteria. Prospective applicants may obtain these guidelines from: Joan T. Harmon, Ph.D. Diabetes Research Section National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8808 FAX: (301) 480-3503 Email: JOAN_HARMON@NIH.GOV 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, "Diabetes Interdisciplinary Research Programs," and number, DK-96-012, must be typed on line 2 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 service) At time of submission, two additional copies of the application must also be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F - MSC-6600 Bethesda, MD 20892-6600 Applications must be received by October 24, 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. However, it is allowable to submit the same project as both an R01 and as a component project of a program project. 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 but such applications must include an introduction addressing the previous critique. 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 NIH peer review procedures. It is not anticipated that site visits or applicant interviews will be part of the review process; therefore, each application should be complete in itself. 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 will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council and the National Advisory Allergy and Infectious Diseases Council. Review Criteria o scientific, technical, or medical significance and originality of proposed research, specific to the objectives of the RFA; 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 resources necessary to perform the research; o synergy of subprojects to achieve the goals of the program project; o appropriateness of the proposed budget and duration in relation to the proposed research; and o adequacy of plans to include both genders and 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. The initial review group will also examine the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA The anticipated date of the award is July 1, 1997. Awards will be based upon the following criteria: o scientific merit as determined by peer review o availability of funds o programmatic priorities of the funding Institute INQUIRIES 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: Joan T. Harmon, Ph.D. Diabetes Research Section National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8808 FAX: (301) 480-3503 Email: JOAN_HARMON@NIH.GOV Elaine Collier, M.D. Chief, Autoimmunity Section National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, MSC 7640 Solar Building, Room 4A20 Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: ec5x@nih.gov Direct inquiries regarding fiscal and administrative matters to: Usha Ganti Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8868 FAX: (301) 480-3504 Email: GANTIU@EP.NIDDK.GOV Pam Fleming Division of Extramural Affairs National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, MSC 7610 Solar Building, Room 4C25 Bethesda, MD 20892-7610 Telephone: (301) 402-6580 FAX: (301) 480-3780 Email: pf49e@nih.gov Schedule Letter of Intent Receipt Date: September 19, 1996 Application Receipt Date: October 24, 1996 Initial Review: February/March 1997 Second Level Review: May 1997 Anticipated Date of Award: July 1, 1997 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.847 and 93.855. 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 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 routing 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. .
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