Full Text AI-95-005 INTERDISCIPLINARY PROGRAMS IN AUTOIMMUNE DISEASE NIH GUIDE, Volume 24, Number 1, January 13, 1995 RFA: AI-95-005 P.T. 34 Keywords: Autoimmunity Biomedical Research, Multidiscipl National Institute of Allergy and Infectious Diseases National Institute of Diabetes and Digestive and Kidney Diseases Juvenile Diabetes Foundation International Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: June 15, 1995 PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK) of the National Institutes of Health (NIH) and the Juvenile Diabetes Foundation International (JDFI) invite applications for program project grants to support interdisciplinary programs in autoimmune disease. This Request for Applications (RFA) will support programs combining investigations of basic, molecular, immunologic, and genetic mechanisms in the pathogenesis of autoimmunity and the development of innovative therapies for human autoimmune disease. These programs may incorporate investigation into any autoimmune disease, including, but not limited to, Insulin Dependent Diabetes Mellitus (IDDM), or any field of science with relevance to the mechanisms and treatment of autoimmunity. Programs utilizing investigators from different scientific disciplines are particularly desirable, so as to utilize expertise in several areas simultaneously. Applications should be submitted to and will be reviewed by the NIH according to the usual NIH peer review procedures. Funds for each Program Project to be awarded under this RFA will be provided by the NIAID and the JDFI. One or more program projects will be cofunded by NIDDK. 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, Interdisciplinary Programs in Autoimmune Disease, is related to the priority area of diabetes and chronic disabling diseases. 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 202-782-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign organizations are not eligible to apply. 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 program project (P01) grant. This mechanism supports broadly based multi-disciplinary research programs that have a well-defined central research focus, theme, or objective. An important feature of the program project is that the interrelationships of the individual scientifically meritorious projects will result in a greater contribution to the overall program goals than if each project were pursued individually. The program project grant consists of a minimum of three interrelated individual research projects that contribute to the program objective. The program project grant also can provide support for certain common resources termed cores. Such resources should be utilized by two or more projects within the program project. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period may not exceed five years. At this time, the NIAID is administratively limiting the duration of P01 grants to four years. The earliest anticipated award date is March 1996. FUNDS AVAILABLE The estimated total funds (direct and indirect costs) available for the first year of support for this RFA will be $2.75 million: $1.5 million from NIAID; $1.0 million from JDFI; and $250,000 from NIDDK. In Fiscal Year 1996, the NIAID and the JDFI anticipate jointly funding approximately three or four program projects related to this RFA. Approximately 60 percent of the total costs of each grant will be funded by the NIAID and approximately 40 percent by the JDFI. One or more of these applications will be cofunded by the NIDDK. This level of support is dependent on the receipt of a sufficient number of applications of high scientific merit. Applications may not request budgets in excess of $750,000 total (direct and indirect) costs in the first year. The NIH is currently limiting annual inflationary increases to no more than four percent for future years. Funding rules and policies, including the determination of allowable indirect costs, of each funding organization will be applicable. Post award administration will conform to current policies and requirements that govern the research grant programs of the NIH and the JDFI as appropriate. Although this program is provided for in the financial plans of the NIAID, the JDFI, and the NIDDK, awards pursuant to this RFA are contingent upon the availability of funds for this purpose. Funding beyond the first and subsequent years of the grant will be contingent upon satisfactory progress during the preceding years and availability of funds. At this time, it has not been determined whether or how this solicitation will be continued beyond the period stated in the present RFA. The National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS) is interested in research on the immune mechanisms involved in rheumatic diseases and the development of new therapies for these diseases based on manipulation of the immune system. Applications that are of mutual interest are likely to be given dual secondary assignment to the NIAMS in accordance with NIH Division of Research Grants (DRG) referral guidelines. RESEARCH OBJECTIVES Background Autoimmune diseases affect five to seven percent of the population, resulting in significant morbidity and mortality, and cost billions of dollars annually for health care and loss of productivity. Insulin Dependent Diabetes Mellitus (IDDM) disproportionately affects children and young adults. In addition to IDDM, other diseases included in this category are rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, and inflammatory bowel disease. There is no known cure or prevention for these diseases. However, recent developments, including new animal models, the ability to generate transgenic animals, recent new paradigms for the stimulation of T and B cells, the finding of new co-factors for stimulation, and the development of new methods for detecting self-antigens, have revolutionized our thinking about the development of tolerance, both central and peripheral. These new developments in basic immunology may lead to important insights into the pathogenesis and therapy of autoimmune disease. Research Objectives and Scope Application of recent advances in basic immunology to the understanding of the pathogenesis of autoimmune diseases, including the development of novel therapies and possible preventive strategies, is a major goal of this RFA. The specific objectives of this program are to: facilitate the application of new advances in immunology and immunogenetics to the understanding and treatment of autoimmune diseases, including IDDM; increase the understanding of the etiology and pathogenic mechanisms involved in development and progression of autoimmune diseases; enable investigators working on various different autoimmune diseases to come together to work in a collaborative and synergistic way; and promote the collaboration between investigators working in disease-specific models and investigators focusing on basic studies of self tolerance and the defects in this process in several experimental systems. In addition to investigation of the initiation of the autoimmune process, the mechanism of the target organ damage in autoimmune disease is unclear. The elucidation of the destructive pathways resulting from the autoimmune process in these diseases could be useful for the development of therapeutic strategies and is a relevant topic for this RFA. The inclusion of clinical investigators may allow earlier transfer of new information to the clinical setting. SPECIAL REQUIREMENTS The NIAID, the NIDDK, and the JDFI plan to sponsor an annual meeting to encourage the exchange of information among investigators supported under this RFA, foster collaborative efforts, and identify resources that would enhance the productivity of this research program. Applications should include a statement indicating the willingness of the applicant institution to participate in such annual meetings. For this purpose, travel funds for an annual two- day meeting, to be held in the Washington, DC area, should be included in the budget request. Letter of Authorization This RFA is co-sponsored by the JDFI. In order for an application to be considered for funding by the JDFI, applicants must submit a brief letter of authorization co-signed by the Principal Investigator and the official signing for the applicant institution, authorizing release of the application and all related materials to the JDFI. This letter of authorization may be combined with the letter of intent or may be submitted directly to Dr. Elaine Collier at the address listed under INQUIRIES. The summary statement for such applications will be shared with the JDFI at the time of their availability. Applications without such authorization will not be considered for funding by the JDFI. 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 printed in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by March 15, 1995, a letter of intent that includes a descriptive title of the overall proposed research, the name, address, and telephone number of the Principal Investigator, a list of the key investigators and their institution(s), and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on form PHS 398 (rev. 9/91), the standard application form for research grants. Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/710-0267. Applicants must adhere to the format and requirements specified in the PHS 398 application kit. In addition, applicants for multicomponent grants are strongly advised to read the information brochure "NIAID Program Project Grants and Multiproject Cooperative Agreements", available from Dr. Elaine Collier at the address listed under INQUIRIES. 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 could be included with the application. For purposes of identification and processing, mark "YES" in item 2a on the face page of the application and type in the RFA number, AI-95-005, and the title "INTERDISCIPLINARY PROGRAMS IN AUTOIMMUNE DISEASE." The RFA label available in the form PHS 398 must be affixed to the bottom of the face page of the original 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. The signed, typewritten original of the application, including the Checklist, and three exact single-sided copies must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the time of submission, two additional copies and all five sets of appendices must also be sent to Dr. Mark Rohrbaugh at the address listed under INQUIRIES. To ensure their review, applications must be received by both the Division of Research Grants and Dr. Mark Rohrbaugh by June 15, 1995. Applications not received by June 15, 1995 will be considered non-responsive and will be returned to the applicant without review. Concurrent submission of an R01 and a Component Project of a Multi- project Application: Current NIH policy permits a component research project of a multi- project grant application to be concurrently submitted as a traditional individual research project (R01) application. If, following review, both the multi-project application and the R01 application are found to be in the fundable range, the investigator must relinquish the R01 and will not have the option to withdraw from the multi-project grant. This is an NIH policy intended to preserve the scientific integrity of a multi-project grant, which may be seriously compromised if a strong component project(s) is removed from the program. Investigators wishing to participate in a multi- project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. REVIEW CONSIDERATIONS Review Procedures Upon receipt, applications will be reviewed for completeness by the Division of Research Grants (DRG) and for responsiveness by the NIAID. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Complete and responsive applications will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIAID 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 their scientific merit relative to other applications received in response to the RFA. Applications judged to be competitive will be discussed and will be assigned a priority score. Applications determined to be non- competitive will be withdrawn from further consideration and the Principal Investigator and the official signing for the applicant organization will be notified. The second level of review will be provided by the National Advisory Allergy and Infectious Diseases Council and the National Institute of Diabetes and Digestive and Kidney Diseases Advisory Council. Review Criteria The review criteria for P01 grant applications are the review criteria for large, multicomponent, interdisciplinary program projects as outlined in the NIAID brochure entitled "NIAID Guidelines for Multiproject Research Awards." The program project grant application should include a justification for the appropriateness of that granting mechanism for the proposed project. The distinguishing features of a program project grant include: o A well-defined, unifying goal or problem area of research to which each project relates and contributes, thereby producing a research environment that allows each research effort to share the creative strengths of others. o A program director who possesses recognized scientific and administrative competence. He/she must demonstrate a substantial commitment to the program in time and effort thereby exercising leadership in providing overall direction and in upholding rigorous scientific conduct. o Each research project must, as assessed by peer review, stand on its own independent scientific merit, as well as complement other projects whenever feasible. o The projects require the participation of established investigators in several disciplines or investigators with special expertise in several areas of one discipline. All investigators must contribute to and share the responsibilities of fulfilling the program objective. o Ability of the proposed research to provide knowledge of basic, molecular and genetic mechanisms in the pathogenesis of autoimmunity and the development of innovative therapies for human autoimmune disease. The appropriateness of the proposed experimental plan to validate the utility of the chosen strategy will be considered in this regard. 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. AWARD CRITERIA Funding decisions will be made on the basis of scientific and technical merit as determined by peer review, program priorities, and the availability of funds. INQUIRIES Written and telephone inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Requests for the brochure "NIAID Application Guidelines for Multiproject Research Awards," as well as inquiries regarding programmatic issues may be directed to: Elaine Collier, M.D. Division of Allergy, Immunology, and Transplantation National Institute of Allergy and Infectious Disease Solar Building, Room 4A20 6003 Executive Boulevard Bethesda, MD 20892-7640 Telephone: (301) 496-7104 FAX: (301) 402-2571 Email: EC5X@NIH.GOV Joan Harmon, Ph.D. Division of Diabetes, Endocrinology, and Metabolic Diseases National Institute of Diabetes and Digestive and Kidney Diseases Natcher Building, Room 5AN-18G Bethesda, MD 20892 Telephone: (301) 594-8808 FAX: (301) 480-3503 Email: joanh@dvsgate.niddk.nih.gov Direct inquiries regarding review issues, mail two copies of the application and all five sets of appendices, and mail the letter of intent to: Mark L. Rohrbaugh, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C20 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-8424 FAX: (301) 402-2638 Email: MR28K@NIH.GOV Direct inquiries regarding fiscal matters to: Ms. Jacqueline Johnson Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4B26 6003 Executive Boulevard Bethesda, MD 20892-7610 Telephone: (301) 496-7075 Email: JJ19E@NIH.GOV Schedule Letter of Intent Receipt Date: March 15, 1995 Application Receipt Date: June 15, 1995 Scientific Review Date: October 1995 Advisory Council Date: January 1996 Earliest Award Date: March 1996 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 and No. 93.847. Awards will be made under the authority 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 (PHS) strongly encourages all grant recipients to provide a smoke-free work place and promote the nonuse 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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