Full Text PA-97-030 OPPORTUNITIES FOR AIDS-RELATED RESEARCH AT RPRCs NIH GUIDE, Volume 26, Number 3, January 31, 1997 PA NUMBER: PA-97-030 P.T. 34 Keywords: AIDS Animal Breed. & Facil., Scientific National Center for Research Resources Application Receipt Dates: May 1; September 1; January 2 PURPOSE It is recognized that nonhuman primate research resources may not be readily available to all investigators who wish to use them in AIDS-related research. The purpose of this Program Announcement (PA) is to offer a mechanism through which these resources can be made more readily accessible to AIDS researchers. The National Center for Research Resources (NCRR) thereby invites investigator-initiated research grant (R01) and First Independent Research Support and Transition (FIRST) (R29) applications for AIDS-related research which utilizes nonhuman primates and other research resources at the seven Regional Primate Research Centers (RPRCs). The overall objectives of this initiative are 1) to promote cutting edge scientific research to identify basic pathogenic mechanisms of HIV/SIV infections and therapy which are oriented toward the prevention and treatment of AIDS and related diseases; 2) to enhance utilization of nonhuman primates and other resources within the RPRCs; and 3) to promote coordinated research efforts with Center staff scientists at the seven RPRCs. 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, Opportunities for AIDS-Related Research at RPRCs, is related to the priority areas of human immunodeficiency virus/AIDS and cancer. 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 foreign and domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments and eligible agencies of the Federal government. Racial/ethnic minority individuals, women and persons with disabilities are encouraged to apply as Principal Investigators. Foreign institutions are not eligible for First Independent Research Support and Transition (FIRST) Awards (R29). The proposed research must be conducted at one of the seven Regional Primate Research Centers (RPRCs), in collaboration with one or more RPRC staff scientists. To be eligible, the Principal Investigator must not currently be a center/core staff member receiving support (salary and/or other research support) from the NCRR-supported RPRC grant and may not be located at an RPRC. If the Principal Investigator's grantee institution is different than the grantee institution of the RPRC, a consortium or contractual agreement must be established with the RPRC. A consortium or contractual agreement is an agreement whereby a research project is carried out by the grantee and one or more other organizations that are separate legal entities; i.e. an agreement between two institutions. (See page 24 in the instruction booklet for "Application for a Public Health Service Grant, Form 398") MECHANISM OF SUPPORT Research support may be obtained through applications for an investigator-initiated research project grant (R01) or a FIRST (R29) Award. Applicants may request support for up to five years. FIRST Award applications must request five years of support. Total direct costs for the FIRST Award five-year period may not exceed $350,000, or $100,000 in any one budget period. FIRST awards are not renewable, but grantees may apply for R01 support to continue research on the same topics. FUNDS AVAILABLE Although NCRR desires to stimulate research in this area, the specific amount of funding available for this research area will depend on the level of annual appropriated funds, quality of research applications and program priorities at the time of the award. It is estimated that approximately $2.5 million will be available annually for this activity. RESEARCH OBJECTIVES Nonhuman primate species have played a key role in advancing our knowledge base in understanding HIV and it is important that research efforts utilizing the nonhuman primate models be expanded. Although much progress has been made in the development of nonhuman primate animal model systems for AIDS-related research during the past 10 years, a cure for this disease and effective preventive measures are still in the future. It is clear that further studies are needed to identify the basic mechanisms of the disease process in order to develop methods for its prevention and/or control. The major objective of this announcement is to encourage the establishment of well integrated and coordinated research programs by active AIDS investigators who will effectively utilize nonhuman primate resources at the RPRCs through the investigator-initiated research project grant (R01) and FIRST Award (R29) mechanisms in collaboration with an RPRC-based investigator. This will be accomplished by: 1) Encouraging mechanistic studies on HIV/SIV to improve our understanding of its basic etiology and pathogenesis and, at the same time, to develop effective therapy to control and/or prevent the disease; 2) Providing support for maintenance and further development of nonhuman primate models at the relevant RPRCs. 3) Providing support for scientists (currently not receiving support from a RPRC) to utilize RPRC facilities, animals and the primate expertise of staff at the RPRCs to expand their AIDS-related research. 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 policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). 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 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 AIDS-related grant application deadlines indicated on page 21 of the application kit. Applications kits are available at most institutional offices of sponsored research and may be obtained from the Office of Extramural Outreach and Information Resources, 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. Prior to application submission, an applicant must confirm the availability of resources at one of the RPRCs, and the application must contain a letter from the relevant RPRC director confirming the availability of the center resources. The research application must also propose a collaborative research arrangement with at least one RPRC-based investigator. In addition to a description of the proposed relationship with the RPRC, the application must also include appropriate budget expenses for utilization of the RPRC, including animal per diem costs. Detailed procedures for accessing a RPRC are published in the NIH Guide to Grants and Contracts, Volume 25, January 1997. A RPRC Director (see list below) may be contacted directly or contact the NCRR program individual listed below regarding accessing RPRCs. The applicant must also acquire protocol approval from the RPRC Institutional Animal Care and Use Committee. Applications for the FIRST award (R29) must include at least three sealed letters of reference attached to the face page of the original application. FIRST award (R29) applications submitted without the required number of reference letters will be considered incomplete and will be returned without review. 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) REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by DRG. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by an appropriate peer review group 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 the applications under review, will be discussed, assigned a priority score, and receive a second level review by the appropriate national advisory council. Review Criteria Criteria for scientific/technical merit review of applications for regular research grants (R01) are as follows: 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 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 and the safety of the research environment. The review criteria for FIRST Awards (R29) are contained in the program announcements for that mechanism. 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 priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquires regarding programmatic issues to: Jerry A. Robinson, Ph.D. Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Suite 6030 - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0744 FAX: (301) 480-3819 Email: jerryR@ep.ncrr.nih.gov Direct inquiries regarding fiscal matters to: Mr. Paul W. Karadbil Office of Grants and Contracts Management National Center for Research Resources 6705 Rockledge Drive, Suite 6086 - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 FAX: (301) 480-3777 Email: paulk@ep.ncrr.nih.gov Direct inquiries regarding a respective Regional Primate Research Center to: Andrew G. Hendrickx, Ph.D., Director California Regional Primate Research Center University of California, Davis Davis, CA 95616 Telephone: (916) 752-0420 FAX: (916)752-8201 URL: http://www.primate.ucdavis.edu/crprc/homepage.html Ronald D. Hunt, D.V.M., Director New England Regional Primate Research Center One Pine Hill Drive Southborough, MA 01772 Telephone: (508) 624-8002 FAX: (508)460-0612 M. Susan Smith, Ph.D., Director Oregon Regional Primate Research Center 505 N.W. 185th Avenue Beaverton, OR 97006 Telephone: (503) 645-1141 FAX: (503) 690-5532 URL: http://www.teleport.com/~orprc Peter J. Gerone, Sc.D., Director Tulane Regional Primate Research Center 18703 Three Rivers Road Covington, LA 70433 Telephone: (504) 892-2040 FAX: (504) 893-1352 URL: http://www.tpc.tulane.edu William R. Morton, V.M.D., Director Washington Regional Primate Research Center P.O. Box 357330 University of Washington Seattle, WA 98195-7330 Telephone: (206) 543-0440 FAX: (206) 685-0305 Joseph W. Kemnitz, Ph.D., Interim Director Wisconsin Regional Primate Research Center University of Wisconsin - Madison 1220 Capitol Court Madison, WI 53715-1299 Telephone: (608) 263-3500 FAX: (608) 263-4031 URL: http://www.primate.wisc.edu Thomas R. Insel, M.D., Director Yerkes Regional Primate Research Center Emory University 954 Gatewood Road, N.E. Atlanta, GA 30329 Telephone: (404) 727-7707 & 727-7721 FAX: (404) 727-0623 URL: http://www.cc.emory.edu/YERKES AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.306. Awards are made under authorization of the Public Health Service Act, Title III, Part A, and Title IV of the Public Health Service Act and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR 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 routing 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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