CYTOKINES IN AUTOIMMUNITY NIH GUIDE, Volume 21, Number 11, March 20, 1992 PA NUMBER: PA-92-54 P.T. 34 Keywords: Autoimmunity Immune Enhancers Growth Factors Pathogenesis National Institute of Allergy and Infectious Diseases PURPOSE The Division of Allergy, Immunology and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health (NIH), invites research project grant applications (R01 and R29) for support of basic studies on the involvement of cytokines in the immunopathogenesis of autoimmune diseases and on their use as modulators of disease initiation and activity. 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 Program Announcement, Cytokines in Autoimmunity, 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 20402-0325 (telephone 202-783-3238). ELIGIBILITY REQUIREMENTS Research grant applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local governments, and eligible agencies of the Federal Government. Applications from minority individuals and women are encouraged. Foreign institutions are not eligible to apply for the First Investigator Research Support Transition (FIRST) Award (R29). MECHANISMS OF SUPPORT The mechanisms of support will be the individual research project grant (R01) and the First Investigator Research Support Transition (FIRST) Award (R29). Policies that govern research grant programs of the National Institutes of Health will prevail. RESEARCH OBJECTIVES During the last ten years, there have been great advances in the understanding of the biology and biochemistry of cytokines and of the mechanisms leading to autoimmune diseases. However, the precise role that cytokines have in susceptibility to, and promotion, initiation, and perpetuation of, autoimmune responses and induction of tissue injury remain largely unknown. One of the goals of the NIAID in this area is to promote research to achieve a better understanding of the pathogenic role of cytokines in self reactivity and autoimmune diseases. This knowledge will make a critical contribution to advance the opportunities for the development of new, specific and effective therapies for autoimmune diseases. Areas of interest include: o Identification and characterization of known and newly discovered cytokines involved in proliferation and function of autoreactive B cells o Analysis of cytokine involvement in the regulation of MHC molecule-self peptide expression in lymphoid cells and target tissues o Regulation of autoreactive T-cell functions by cytokines o Studies of cytokine effects on the generation and function of CD5+ B cells o Characterization of cytokine production and cytokine responses in monocytes and macrophages from autoimmune individuals o Research on cytokine signal transduction pathways in autoreactive cells o Studies on the role of cytokines in the induction or acceleration of disease in the autoimmune prone host o Studies on cytokine receptor modulation as a means of affecting disease development o Identification of the cytokine cascades leading to focal inflammation o Effects of cytokines and cytokine antagonists in tissue injury and repair during autoimmune diseases STUDY POPULATIONS 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 are 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 must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions that 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 must 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 must be included in the form PHS 398 in Section 2, 1-4 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 must be provided. For the purpose of this policy, clinical research is defined as 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. For foreign awards, the policy on inclusion of women applies fully; since the definition of minority differs in other countries, the applicant must discuss the relevance of research involving foreign population groups to the United States' populations, including minorities. If the required information is not contained within the application, the review will be deferred until the information is provided. 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. APPLICATION PROCEDURES Applicants are to use the standard research grant application form PHS 398 (rev. 9/91). For purposes of identification and processing, check yes on item 2 of the face page and enter the title: "PA-92-54: Cytokines in Autoimmunity". Applications will be accepted in accordance with the standard submission dates for new applications: February 1, June 1, and October 1. Application kits are available at most institutional business offices and may be obtained from the Office of Grants Inquiries, Division of Research Grants, Westwood Building, Room 449, National Institutes of Health, Bethesda, MD 20892, telephone (301) 496-7441. The completed original application and five legible copies must be sent or delivered to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES Applications will be assigned on the basis of established Public Health Service referral guidelines. Applications will be reviewed for scientific and technical merit by study sections of the Division of Research Grants, NIH, in accordance with the standard NIH peer review procedures. Following scientific-technical review, the applications will receive a second-level review by an appropriate national advisory council or board. AWARD CRITERIA Applications will compete for available funds with all other approved applications. The following will be considered in making funding decisions: quality of the proposed project as determined by peer review, availability of funds, and program balance among research areas of the announcement. INQUIRIES Requests for additional information or questions regarding the programmatic aspects of this PA may be directed to: Dr. S. Serrate-Sztein Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 Bethesda, MD 20892 (20852 if using overnight delivery services) Telephone: (301) 496-7985 or Dr. M. Michele Hogan Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 Bethesda, MD 20892 (20852 if using overnight delivery services) Telephone: (301) 496-7551 FAX: (301) 402-0175 Direct inquiries regarding fiscal matters to: Mr. Jeffrey Carow Chief, Immunology Grants Management Section, GMB, DEA National Institute of Allergy and Infectious Diseases Solar Building, Room 4B29 Bethesda, MD 20892 Telephone: (301) 496-7075 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, No. 93.855 - Immunology, Allergic and Immunologic Diseases Research. Grants are awarded under the authority of the Public Health Service Act, Section 301 (42 USC 241) and administered under PHS grants policies and Federal Regulations, most specifically at 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. .
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