PA-98-036: OPPORTUNITIES FOR RESEARCH AT REGIONAL PRIMATE RESEARCH CENTERS

Department of Health
and Human Services (HHS)

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OPPORTUNITIES FOR RESEARCH AT REGIONAL PRIMATE RESEARCH CENTERS Release Date: March 6, 1998 PA NUMBER: PA-98-036 P.T. National Center for Research Resources PURPOSE It is recognized that nonhuman primate research resources may not be readily accessible to all investigators who wish to use them in research. The purpose of this Program Announcement (PA) is to offer mechanisms through which these resources can be more readily accessible to researchers. The National Center for Research Resources (NCRR) thereby invites investigator-initiated research project grants (R01, R21) applications for research that utilizes nonhuman primates and other research resources at the seven Regional Primate Research Centers (RPRCs). The National Institute of Allergy and Infectious Diseases (NIAID) is a co-sponsor of this solicitation. Applications that are within the mission of NIAID will receive funding consideration from that Institute. The overall objectives of this initiative are to: (1) promote cutting edge scientific research, (2) enhance utilization of nonhuman primates and other resources within the RPRCs, and (3) promote coordinated research efforts with Center staff scientists who are located 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 Research at RPRCs, is related to the priority areas of infectious diseases particularly AIDS- related. 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. The proposed research must be conducted at one of the seven Regional Primate Research Centers (RPRCs)and 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 a RPRC. If the Principal Investigator"s grantee institution is different from 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 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 exploratory/development grant (R21). Total costs for R21 applications are limited to $100,000 direct costs per year. R21 grants are also limited to a two year period. The R21 is to be used for the support of innovative, exploratory/developmental research projects. Investigators with innovative ideas for research using the nonhuman primate model have previously had difficulty identifying potential funding sources. The R21 mechanism will provide investigators at all career levels with a defined level of funding adequate for the initial feasibility testing of high risk/high impact concepts and, if the concepts are viable, for the generation of experimental preliminary data. This would render the investigators competitive for funding through the research project grant (R01) award mechanism, thus potentially leading to the establishment of new research programs in areas that might have previously remained unexplored. Although NCRR desires to stimulate research in several areas, the specific amount of funding available for each 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 $4.0 million (2.5 million AIDS related) will be available for this activity in 1998. RESEARCH OBJECTIVES Nonhuman primate species have played a key role in advancing our knowledge base in understanding diseases processes and it is important that research efforts utilizing these models be expanded. Although much progress has been made in the development of nonhuman primate animal model systems, particularly for AIDS- related research, cures for many diseases and effective preventive measures are lacking. It is clear that further studies are needed to identify the basic mechanisms of disease processes in order to develop methods for prevention and/or control. The major objective of this program announcement is to encourage the establishment of well-integrated and coordinated research programs by active investigators which will effectively utilize nonhuman primate resources at the RPRCs through the research project grant (R01, R21) mechanisms. This will be accomplished by: 1) Encouraging mechanistic studies on addressing human disease using the nonhuman primate model to improve our understanding of the basic etiology and pathogenesis of a particular disease and , at the same time, develop effective therapies 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 to utilize RPRC facilities, animals and the nonhuman primate expertise of staff at the RPRCs to facilitate the research efforts. The following are examples of human health problems for which the nonhuman primate may be the most appropriate animal model. These are representative of potential areas for research and are not meant to be all-inclusive: o AIDS and AIDS-related research, especially vaccine developing and testing o Development and utilization of gene vector therapeutic methods for combating disease o New and re-emerging infectious diseases such as hepatitis, malaria, etc. o Pathogenesis as well as potential therapies for neurological diseases such as Parkinson"s Disease, Alzheimer"s and other Dementias o Developmental research on cryopreservation technologies for preserving sperm, ova, embryos and somatic cell lines o Development of non-human primate models to facilitate basic research and pre- clinical trials of tolerance induction for solid organ and bone marrow transplantation. o Development of non-human primate models of autoimmune diseases to facilitate basic research and pre-clinical studies of autoimmune diseases. o Studies of twinning and cloning to facilitate studies using any non-human primate models of disease specially developed for 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 in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Please note that all AIDS-related applications have a special receipt date and review and award schedule. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division 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@od.nih.gov. The title and number of the program announcement must be typed in section 2 on the face page of the application. Prior to applicant submission, an applicant is expected to 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 spell out any collaborative research arrangement with RPRC-based investigators. 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 17, 1997. A RPRC Director (See list below) may be contacted directly or contact the NCRR Program Director listed below regarding accessing RPRCs. The applicant must also acquire protocol approval from the RPRC Institutional Animal Care and Use Committee. The completed original application and four legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817-7710 (for express/courier service) At the time of submission one additional must also be sent to: Jerry A. Robinson, Ph.D. Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Suite 6030 Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 435-3819 Email: jerryR@ep.ncrr.nih.gov REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by a Center for Scientific Review initial review group convened 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 The five criteria to be used in the evaluation of grant applications are listed below. To put those criteria in context, the following information is contained in instructions to the peer reviewers. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The reviewers will comment on the following aspects of the application in their written critiques in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered by the reviewers in assigning the overall score weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have a major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. 1. Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? 2. Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 3. Innovation. Does this project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? 4. Investigator. Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principle investigator and other researchers (if any)? 5. Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence for institutional support? 6. Potential. Do these novel and innovative approaches clearly require additional preliminary data for their value to be established? What is the prospects of the preliminary findings leading to a full hypothesis-driven, R01 application? 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 for NCRR or questions from potential applicants is welcome. Direct inquires regarding basic research programmatic issues and the Regional Primate Research Center Program to: Jerry A. Robinson, Ph.D. Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Suite 6030 Bethesda, MD 20892 Telephone: (301) 435-0744 FAX: (301) 435-3819 Email: jerryR@ep.ncrr.nih.gov Direct inquiries regarding NIAID research program issues to: Stephen M. Rose, Ph.D. Division of Allergy, Immunology and Transplantation National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 4A14 Bethesda, MD 20892-7640 Telephone: (301) 496-5598 FAX: (301) 402-2571 Email: Steve_Rose@nih.gov Direct inquiries regarding fiscal matters to: Paul Karadbil Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, Suite 6210 Bethesda, MD 20892 Telephone: (301) 435-0836 FAX: (301) 480-6210 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.crprc.ucdavis.edu 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 or 727-7721 FAX: (404) 727-0623 URL: http://www.emory.edu/YERKES/ AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic No. Awards are made under authorization of the Public Health Service Act, Sections 301 and 464H, and administered under PHS policies and Federal Regulations at Title 42 CFR 52, "Grants for Research Projects," Title 45 CFR Parts 74 and 92, "Administration of Grants," and 45 CFR Part 48 "Protections of Human Subjects." 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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