NEURAL, ENDOCRINE, IMMUNE, AND VIRAL INTERACTIONS, BEHAVIOR, ANDMENTAL HEALTH NIH GUIDE, Volume 21, Number 38, October 23, 1992 PA NUMBER: PA-93-009 P.T. 34 Keywords: Neuroscience Immunology Endocrine System Viral Studies (Virology) National Institute of Mental Health National Institute of Neurological Disorders and Stroke PURPOSE The National Institute of Mental Health (NIMH) and the National Institute of Neurological Disorders and Stroke (NINDS) invite research grant applications for studies of neuro-endocrine-immune interactions, neuroimmunomodulation, psychoneuroimmunology, and the effects of viral and other infectious challenges on such interactions. Applications are also invited for studies of the health and treatment implications of such interactions. The goal of this program announcement is to promote research which will advance understanding of how the brain influences, and is influenced by, the various systems that maintain homeostasis and defend/repair the body's tissues. This research will increase knowledge of the interrelationships between psychological states and physical health. Research is encouraged to improve behavioral and medical outcomes by the application of knowledge about neuro-endocrine-immune interactions. 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, Neural, Endocrine, Immune, and Viral Interactions, Behavior, and Mental Health, is related to the priority areas of mental health and mental disorders, HIV infection, and immunization and infectious 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 202-783-3228). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, public and private, non- profit and for-profit organizations such as universities, colleges, hospitals, laboratories, research institutions, units of State and local governments, and eligible agencies of the Federal Government. Foreign organizations may apply for traditional research (R01) and small (R03) grants only. Women and minority investigators are encouraged to apply. MECHANISMS OF SUPPORT Applications are requested under the following mechanisms: traditional research grants (R01), First Independent Research Support and Transition (FIRST) awards (R29), small grants (R03) program projects (P01), career development awards (K-series), institutional training grants (T32), and individual fellowships (F-series). RESEARCH OBJECTIVES Proposed research can be directed at any level of biological organization from molecular to organismic. However, at whatever level studies are directed, applications must contain well-developed research plans addressing questions of clear and direct biological relevance. Specifically, proposed in vitro experiments should ideally seek mechanistic explanations for well-documented in vivo phenomena or should be carried out in conjunction with in vivo experiments. Applications solely based on the use of cell lines should be justified by inability to realize research objectives in vivo or by using primary cell or organ cultures. Support is also provided for studies aimed at improving available methods for investigating the areas covered by this announcement. The following are examples of broad research topics that would be of interest. This list is not intended to be comprehensive, nor are the examples meant to be exclusive. o Mechanisms mediating functional interactions among the nervous, endocrine, and immune systems o Innervation of immune and endocrine organs and the functions accomplished by the innervating cell o Mechanisms involved in the conditioning of immune responses o Temporal and spatial distribution of immunocytes in brains of normal and ill individuals o Effects of cytokines and other products of immunocytes on neural cell function; expression and function of cytokines in the nervous system o Impact of immune deficiencies on function of the central nervous system and susceptibility to mental illness o Central neural circuitry and mechanisms of secretion of hormones which cooperate in the regulation of the immune response o Identification and characterization of molecules coordinating regulation of neuroendocrine and immune systems o Characterization of pathways of viral entry into the central nervous system and roles of neural and non- neural cells in this process o Roles of the blood-brain-barrier in impeding/facilitating brain-immunocyte-virus interactions o Mechanisms of viral neuropathogenesis; regional specificity; tropism for neural cells; replication and latency of slow-acting viruses such as HIV and other lentiviruses; effects on neuronal function and their mechanisms o Characterization of viral effects on psycho-neuro- endocrine-immune interactions o Use of transgenic, immunodeficient, and other mutant animals to investigate neuro-endocrine-immune interactions o Applications of novel techniques, such as in situ polymerase chain reaction and homologous recombination, to investigate immune and viral bases of mental disorders o Characterization of the effects of various mental states (e.g., stress and coping, sleep, intellectual activity, meditation) on endocrine and immune function and on health outcomes o Characterization of immune effects on psychological states and behavior 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 affects 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 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 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 polices 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 application 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 polices. 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 Application submission should follow the PHS review and award schedule as published in the current version of Instructions for Grant Application Form PHS 398 (rev. 9/91). Dates for the submission of new research applications (R01, R29, R03, P01, and K-series) and review cycles are as follows: Receipt IRG Council Earliest Dates Review Review Award Dates Feb 1/Mar 1* May/June Sep/Oct Dec 1 Jun 1/Jul 1* Oct/Nov Jan/Feb Apr 1 Oct 1/Nov 1* Feb/Mar May/Jun Jul 1 *Amended research applications, supplemental applications and competing renewals are to be submitted on the latter dates. Applications received after the above receipt dates are subject to assignment to the next review cycle or may be returned to the applicant. Because institutional training grants (T32) and individual fellowship applications (F-series) have different deadlines and application procedures, applicants should contact program staff listed on page 8 and obtain necessary documentation pertaining to those mechanisms. Applicants are to use the grant application form PHS 398 (rev. 9/91) for all grants except the F-series for which form PHS 416-1 (rev. 10/91) is to be used. The number and title of the program announcement, "PA-93-009: Neural, Endocrine, Immune, and Viral Interactions, Behavior, and Mental Health," must be typed in item number 2a on the face page of the PHS 398 application form. Application kits containing the necessary forms and instructions for regular research grants may be obtained from business offices or offices of sponsored research at most universities, colleges, medical schools, and other major research facilities. If such a source is not available, the program officials listed under INQUIRIES may be contacted for the necessary application material. The signed original and five legible copies of the completed application form PHS 398 or two copies of the form PHS 416-1 (rev. 10/91) must be sent to: Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** REVIEW PROCEDURES The Division of Research Grants (DRG), NIH, serves as a central point of receipt of applications for most discretionary PHS grant programs. Interest areas indicated in this announcement overlap with those of other Institutes, so applications received under this announcement will be assigned to an initial review group (IRG) in accordance with established PHS Referral Guidelines. The IRGs, consisting primarily of non-Federal scientific and technical experts, will review the applications for scientific and technical merit. Notification of the review recommendations will be sent to the applicant after the initial review. Applications will receive a second-level review by the appropriate Advisory Council whose review may be based on policy considerations as well as scientific merit. Only applications recommended for approval by the Council may be considered for funding. AWARD CRITERIA Criteria for scientific/technical merit review of applications will include the following: significance and originality, from a scientific or technical standpoint, of the goals for the proposed research; evidence of familiarity with relevant research literature; adequacy of the conceptual and theoretical framework for the research; adequacy of the methodology proposed to carry out the research; feasibility of the proposed research; qualifications and research experience of the principal investigator and other key research personnel; availability of adequate facilities, other resources, and collaborative arrangements necessary for the research; appropriateness of budget estimates for the proposed research activities; adequacy of plans to include women and minorities in study populations; and adequacy of provisions for the protection of human subjects and the welfare of animal subjects, as applicable. Applications recommended for approval by the appropriate National Advisory Council will be considered for funding on the basis of overall scientific and technical merit of the research as determined by peer review, Institute program needs and balance, and availability of funds. Grant funds may be used for expenses clearly related and necessary to conduct research projects, including both direct costs which can be specifically identified with the project and allowable indirect costs of the institution. Funds may not be used to establish, add a component to, or operate a treatment, rehabilitation, or prevention intervention service program. Support for research-related treatment, rehabilitation, or prevention services and programs may be requested only for costs required by the research. These costs must be justified in terms of research objectives, methods, and designs which promise to yield generalizable knowledge and/or make a significant contribution to theoretical concepts. Grants must be administered in accordance with the PHS Grants Policy Statement (rev. 10/90), which should be available from an office of sponsored research. Federal regulations at 42 CFR Part 52, Grants for Research Projects, and Title 45 CFR Parts 74 and 92, generic requirements concerning the administration of grants, are applicable to these awards. Support may be requested for a period of up to five years. The small grants (R03) are for up to two years and are non- renewable. The period of individual fellowships may not exceed five years in the aggregate for pre-doctoral training and three years in the aggregate for post-doctoral training. Annual awards will be made subject to continued availability of funds and progress achieved. A competing supplemental application may be submitted during an approved period of support to expand the scope or protocol of a project during the approved period. A competing continuation (i.e., renewal) application may be submitted before the end of an approved period of support to continue a project. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Ljubisa Vitkovic, Ph.D. Chief, Neuroimmunology/Neurovirology Program Division of Neuroscience and Behavioral Science National Institute of Mental Health 5600 Fishers Lane, Room 11C-05 Rockville, MD 20857 Telephone: (301) 443-5288 FAX: (301) 443-4822 BITNET: LV5@NIHCU N. Herbert Spector, Ph.D. Division of Fundamental Neurosciences National Institute of Neurological Disorders and Stroke Federal Building, Room 916 7550 Wisconsin Avenue Bethesda, MD 20892 Telephone: (301) 496-5745 FAX: (301) 402-1501 For further information on grants management issues, applicants may contact: Diana Trunnell Assistant Chief, Grants Management Branch National Institute of Mental Health 5600 Fishers Lane, Room 7C-23 Rockville, MD 20857 Telephone: (301) 443-3065 Mary Whitehead Chief, Grants Management Branch National Institute of Neurological Disorders and Stroke Federal Building, Room 1004 Bethesda, MD 20892 Telephone: (301) 496-9231 AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.242 and 93.853. 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 385) 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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