THE IMMUNOLOGY OF AGING NIH GUIDE, Volume 21, Number 40, November 6, 1992 PA NUMBER: PA-93-014 P.T. 34 Keywords: Aging/Gerontology Immunology Immune System Pathophysiology National Institute on Aging National Institute of Allergy and Infectious Diseases PURPOSE It has been well established that overall immune function declines with advancing age. However, because the immune system is highly complex, it is essential to understand the multi-faceted nature of this age-related loss of immune function and to identify the primary changes in immune mechanisms leading to this decline in the immune responses. It has been proposed that the decline and/or dysregulation of the immune system may be a primary cause of aging or perhaps a pace-setter of the aging process. The possibility that changes in the immune system may be a fundamental predisposing factor in the aging process is also an appropriate field of scientific inquiry. Research is also indicated into the pathological consequences of age-related changes in the immune system, such as decreased resistance to infection with pathogens and an increased tendency toward autoimmunity and immunopathology. The Biology of Aging Program (BAP) of the National Institute on Aging (NIA) has responsibility for supporting extramural research and training in the fundamental studies of immunology as related to aging. The Geriatrics Program (GP) has responsibility for supporting clinical studies of the immune competence of aging humans, the transfer of promising immunological interventions, and the delivery of effective vaccines to geriatric populations. The Division of Allergy, Immunology, and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID) is responsible for promoting research into the basic mechanisms of the immune system and the changes that occur in the immune system that initiate or contribute to disease. The two institutes share the goal of achieving a better understanding of the behavior of the immune system and the specific deficits of various components of the immune system that occur during aging to permit intervention and prevent or reverse the immunologic deficits of aging. ELIGIBILITY REQUIREMENTS Applications may be submitted by foreign and domestic, for-profit and non-profit, public and private organizations, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Applications from minority individuals and women are encouraged. Applicants for K and F awards must be U.S. citizens, non citizen nationals, or have been lawfully admitted for permanent residence at the time of award. Applications related to the health of women and minorities are particularly encouraged. MECHANISMS OF SUPPORT o Research grant (R01) o Program Project grant (P01) o First Independent Research Support and Transition (FIRST) award (R29) o Career grants, which include: Research Career Development Award (K04); Clinical Investigator Award (K08); Physician Scientist Award (individual K11) o Training grants (T32) o Fellowships (F32, F33) Deadlines for applications are as follows: F-series and T-series grants: Jan 10, May 10, Sep 10 New R, K, and P-series: Feb 1, Jun 1, Oct 1 Competing continuation and revised: Mar 1, Jul 1, Nov 1 Foreign institutions are not eligible to apply for T32 Awards, Program Project (P01) Awards, or FIRST Awards (R29). RESEARCH OBJECTIVES The NIA and the NIAID invite investigators to submit applications for research and research training in all areas of immunology that relate to fundamental processes of aging. Applications to study the aging of the immune system in humans, animals, or cell culture systems are welcome. Applications that might lead to successful interventions in the aging of the immune system are particularly encouraged. The following topics are illustrative of appropriate research areas covered by this Program Announcement. However, applications need not be limited to the issues listed below. o Age related changes in the functions of lymphoid organs (thymus, spleen, lymph nodes, gut-associated lymphoid tissue) o The roles of changes in bone marrow cell production and thymic involution in the aging immune response. The possible role, source and mechanism of extrathymic T cell repopulation o Age-related changes in the genetic and ontogenic control of T and B cell production. Selection and deletion of involved cell types. The nature and function of different T and B cell subtypes (naive, memory, helper, and cytotoxic T cells) o Age-related changes in the mechanisms of antigen sequestration, transport, processing, and presentation, including the accessory cells involved (Langerhans cells, macrophages, dendritic cells, B cells) o Age-related changes in molecules involved in specific antigen recognition (B-cell and T-cell receptors, MHC-encoded molecules) and in lymphocyte and macrophage activation o Age-related changes in biochemical processes leading to lymphocyte and macrophage activation o Age-related changes in the production of lymphokines and other cytokines (and their receptors) involved in the immune response o The role of hormones and neuroendocrine factors in the regulation of T and B cell activity and in age-related changes in immune function. o Age-related changes in the regulation of the immune response (e.g., regulatory cells, immunoglobulin isotypes, the idiotypic network). Changes in the nature of the antibody repertoire with aging. o Immune responses to infectious agents and to vaccines in senescence; development of vaccine delivery systems. o Immunologic tolerance, autoimmunity, and immunopathology in senescence o The interrelationship between disease and immune function in the aging process o The role of nutrition and caloric restriction in the potentiation or prevention of age-associated deficits in immune function o Immune surveillance in aged individuals o Generalized immunosuppression due to viral, protozoal, and bacterial infections in aged individuals o Attempts to prevent or reverse the immunologic deficits of aging by immunotherapy (e.g., development of techniques for immune augmentation, biological response modifiers, hormonal treatment) o Attempts to prevent or reverse the immunologic deficits of aging through cellular or genetic engineering o Effects of drugs on the immune system of older individuals o Gender-related differences in any of the above areas of research. The Geriatrics Program of the NIA also supports research in the clinical aspects of several of the preceding topics, particularly those regarding immune responses to infectious agents in senescence and the development and delivery of effective vaccines. Inquiries considered more appropriate for the Geriatrics Program will be referred to them. STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH 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 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 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 Sections 1-4 of the Research Plan AND summarized in Section 3, Recruitment of Individuals from Underrepresented Racial/Ethnic Groups, and Section 5, Human Subjects. Applicants 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 Applications are to be submitted on the grant application form PHS 398 (rev. 9/91) and will be accepted at the standard application deadlines as indicated in the application kit. The receipt dates for applications for AIDS-related research are found in the PHS 398 instructions. National Research Service Award (NRSA) (F32, F33) applications must be submitted on grant application Form PHS 416 (rev. 10/91). Application kits are available at most institutional offices of sponsored research and may be obtained from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, Westwood Building, Room 449, Bethesda, MD 20892, telephone 301/496-7441. The title and number of the announcement must be typed in Section 2a on the face page of the application. Applications 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 could be included with the application. 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 Other institutes may also have interest in several of the topics mentioned here. All applications in response to this Program Announcement will be assigned to an Initial Review Group and reviewed by the usual Public Health Service Peer Review (Study Section) procedures. They will also be given appropriate primary and secondary Institute assignments in accordance with established PHS Referral Guidelines. The review criteria are the traditional criteria appropriate to each mechanism. In accordance with the standard NIH peer review procedures, research project grant (R01 and R29) applications, fellowships (F32, F33) and research career development awards (K04) will be reviewed for scientific and technical merit by an appropriate study section in the Division of Research Grants. All other applications will be reviewed by review groups of the appropriate funding component. Following the Study Section review, the applications will receive a second-level review by the appropriate advisory council. Funding decisions will be based on the above evaluations and on the availability of funds. AWARD CRITERIA Applications compete for available funds on the basis of scientific merit. The following will be considered in making funding decisions: o Quality of the proposed project as determined by peer review o Availability of funds o Program balance among research areas of the announcement INQUIRIES Researchers considering an application in response to this announcement are strongly encouraged to discuss their project, and the range of grant mechanisms available with NIA and/or NIAID staff. This can be done either through a telephone conversation or a brief letter. Correspondence and inquiries may be directed to: Dr. David Lavrin, Immunology Program Administrator Biology of Aging Program National Institute on Aging Gateway Building, Room 2C231 7201 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-6402 FAX: (301) 402-0010 Dr. Joseph Albright Program Administrator, Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases Solar Building, Room 4A20 Bethesda, MD 20892 Telephone: (301) 496-7985 FAX: (301) 402-0175 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.866 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. .
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