Full Text PA-96-072 MECHANISMS OF AIDS PATHOGENESIS NIH GUIDE, Volume 25, Number 30, September 6, 1996 PA NUMBER: PA-96-072 P.T. 34 Keywords: 071508 Pathogenesis 0705048 National Institute of Allergy and Infectious Diseases National Institute of Dental Research PURPOSE This Program Announcement (PA) is intended to foster applications focusing on an hypothesis for AIDS-related pathogenesis applying state-of-the-art methods and approaches to in vivo research. In vivo research includes studies of human clinical or epidemiologic cohorts, animal models, or appropriate specimens from humans or animals. Where scientifically justified, applicants are encouraged to include both human and animal studies. While the research necessary to test a proposed pathogenesis hypothesis may be possible within a single laboratory, some applications may require separate components at the same or different institutions specializing in different scientific disciplines (e.g., molecular biology, biochemistry, cellular biology, cellular immunology, pathology, genetics and biophysics). 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 PA, Mechanisms of AIDS Pathogenesis, is related to the Priority area of HIV infection. 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 and foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State or local government, and eligible agencies of the Federal government. The total requested project period for an application submitted in response to this PA may not exceed five years; a foreign application may not request more than three years of support and will receive no support for indirect costs. Domestic applications may include international components but these components will receive no support for indirect costs. Foreign institutions are not eligible for the First Independent Research Support and Transition (FIRST) (R29) Award. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT The mechanisms of support will be investigator-initiated research project grants (R01), Interactive Research Project Grants (IRPG), the First Independent Research Support and Transition (FIRST) (R29) award, and the Small Research Grants (R03). Research support may also be obtained through applications for a competitive supplement to ongoing NIH-funded grants. Information on the IRPG mechanism is available in program announcement PA-96-001, published in the NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995. Applicants for R03 grants may request up to $50,000 annual direct costs for a period not to exceed two (NIDR) or three (NIAID) years. Applicants for R03 grants must follow special application guidelines, which are referenced below. Publications containing IRPG and R03 application guidelines are available from the program staff listed under INQUIRIES. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. Applicants are encouraged to coordinate, through the use of consortium arrangements or subcontracts, integrated approaches with individuals or institutions having relevant reagents and expertise in their use, demonstrated ability in a particular area of relevant research, or access to relevant animal or patient populations. Potential applicants are encouraged to contact the program staff listed under INQUIRIES for guidance concerning the organization and scope of the proposed work, the most appropriate support mechanism, and the preparation of the application. RESEARCH OBJECTIVES This PA encourages hypothesis-focused applications for HIV pathogenesis research linking in vitro studies to in vivo disease on the targeted areas of research identified in the 1995 NIAID HIV/AIDS Research Agenda listed below. Additionally, this PA encourages investigators with current NIH-funded grants on in vivo AIDS pathogenesis to submit competitive supplement applications to examine the effect of vaccination on lentiviral mucosal transmission and/or viral disease. The targeted research areas below are not listed in priority order and are intended to be illustrative rather than exhaustive examples. o Possible direct and indirect mechanisms of HIV-mediated immunodeficiency; e.g., the effect of HIV infection on immune regulation including signaling ligands, receptors, pathways, and cellular maturation processes. o Events at the cell and organ system levels that characterize or predict HIV entry or disease progression; e.g., virus and infected cell trafficking, viral burden and characteristics in blood and tissues (particularly in lymph nodes, oral and gut mucosa, spleen, bone marrow, and brain), and sites and kinetics of CD4+ cell destruction in vivo. o Host genes, alleles, corresponding proteins and their mechanisms of action that control susceptibility to HIV infection, level of infectivity for HIV transmission, and/or rate of disease progression, e.g., adhesion proteins, receptors, cytokines/chemokines and regulatory pathways. o Impact of vaccine-induced immune responses on mucosal transmission and in vivo pathogenesis. The most relevant studies are expected to examine molecular and cellular biology, virology, and immunology within the context of animal models and/or well-defined human cohorts or patient samples. Investigators are encouraged to minimize the number of new animals entered into research studies (and related support expenses) by using, whenever possible, animals in ongoing supported non-human primate research. Descriptive research that is not structured around a specific hypothesis(es) is not within the scope of this PA. For example, natural history epidemiologic studies in many DAIDS-supported cohorts are critically important for collecting information on the cause and course of disease. Although the information provided by such studies may provide a foundation for hypotheses that may be tested in research, this PA is intended to encourage the next step in research, the testing of these hypotheses. Clinical trials and recruitment or retention of cohorts are not encouraged under this PA. However, identified costs for patient visits, sample storage and handling specific to the applicant's proposed research are appropriate. Proposed analyses of samples acquired from epidemiologic or clinical trials are also appropriate. Investigators are encouraged to use existing supported epidemiologic or clinical cohorts instead of requesting funds to support or establish additional cohorts. Applicants are responsible for establishing components and/or collaborative arrangements. Program staff listed under INQUIRIES may be able to assist in forming collaborations and suggesting relevant cohorts or reagent resources. 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 subpopulations 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 20, 1994 (FR 59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 5/95) 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 also found in the PHS 398 instructions. Application kits are available at most institutional offices of sponsored research and may be obtained 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. The title and number of this program announcement must be typed in Section 2 on the face page of the application (i.e., "Mechanisms of AIDS Pathogenesis," PA-96-072). The completed original application and five legible copies must be sent or delivered 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) NIAID R03 APPLICANTS ONLY Applicants for NIAID R03 grants must follow application guidelines for SMALL RESEARCH GRANTS - NIAID, which appeared in the NIH Guide for Grants and Contracts, Vol. 25, No. 9, March 22, 1996, and are available from the NIAID program staff listed under INQUIRIES. The completed original and three legible single-sided copies of the application must be sent or delivered to the Division of Research Grants at the above address. In addition, mail two copies of the R03 application and all five sets of any appendices to the address below. Also, direct inquiries regarding review issues and special instructions for application preparation to the address below. Stanley Oaks, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4C06 - MSC 7042 Bethesda, MD 20892-7610 Telephone: (301) 496-7042 FAX: (301) 402-2638 Email: os4g@nih.gov NIDR R03 APPLICANTS ONLY Applicants for NIDR R03 grants must follow the guidelines for the Small Grants Program, which appeared in the NIH Guide for Grants and Contracts, Vol. 20, No.12, March 22, 1991. Applicants are also required to follow the R03 page limitations described in the NIH Guide Vol. 22, No. 1, January 8, 1993. Copies of these guidelines are available from the NIDR staff listed under INQUIRES. The completed original and three legible single-sided copies of the application must be sent or delivered to the Division of Research Grants at the above address. In addition, mail two copies of the R03 application to the address below. Also, direct inquiries regarding review issues and special instructions for application preparation to the address below. William Gartland, Ph.D. Division of Extramural Research National Institute of Dental Research Building 45, Room 4AN-32 Bethesda, MD 20892-6402 Telephone: (301) 594-2372 FAX: (301) 480-8303 Email: GartlandW@de45.nidr.nih.gov FIRST (R29) AWARD APPLICANTS ONLY FIRST (R29) applications must include at least three sealed letters of reference attached to the face page of the original application. FIRST applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications that are complete will be evaluated for scientific and technical merit by study sections of the Division of Research Grants, NIH (or by the review group of the relevant Institute, Center, or Division), in accordance with the standard NIH peer review procedures. 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, generally the top half of applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council or board. Review Criteria o Scientific, technical, or medical significance and originality of proposed research; 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 the resources necessary to perform the research; o Appropriateness of the proposed budget and duration in relation to the proposed research; o For studies involving human subjects, 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, the safety of the research environment, and conformance with the NIH Guidelines for the Inclusion of Women and Minorities as Subjects in Clinical Research. AWARD CRITERIA Applications will compete for available funds with all other approved applications. 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 Institute priority for area of proposed research INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Opendra K. Sharma, Ph.D. Division of AIDS National Institute of Allergy and Infectious Diseases Solar Building, Room 2C06 - MSC 7620 Bethesda, MD 20892-7620 Telephone: (301) 496-8378 FAX: (301) 402-3211 Email: os4g@nih.gov) Eleni Kousvelari, D.D.S., D.Sc Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-24 Bethesda, MD 20892-6402 Telephone: (301) 594-2427 FAX: (301) 480-8318 Email: Kousvelari@de45.nidr.nih.gov Direct inquiries regarding fiscal matters to: Ms. Jackie Johnson Division of Extramural Activities National Institute of Allergy and Infectious Diseases Solar Building, Room 4C16 - MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7075 FAX: (301) 480-3780 Email: jj19e@nih.gov Mr. Martin Rubinstein Division of Extramural Research National Institute of Dental Research Natcher Building, Room 4AN-44A Bethesda, MD 20892-6402 Telephone: (301) 594-4800 FAX: (301) 480-8301 Email: Martin.Rubinstein@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance, 93.856 - Microbiology and Infectious Diseases Research and 93.855 - Immunology, Allergy and Transplantation Research. 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 grant policies and Federal Regulations 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. 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 routine 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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