MINORITY INSTITUTIONS' DRUG ABUSE RESEARCH DEVELOPMENT PROGRAM NIH Guide, Volume 26, Number 35, October 17, 1997 PA NUMBER: PAR-98-001 National Institute on Drug Abuse PURPOSE In its efforts to broaden and strengthen drug abuse research in minority institutions, the National Institute on Drug Abuse (NIDA) is initiating the, Minority Institutions' Drug Abuse Research Development Program (MIDARP). This program replaces the "Minority Institutions' Research Development Program (MIRDP)" last printed April 1989, which was previously supported under the Alcohol, Drug Abuse, and Mental Health Administration. Grants will be provided to develop the capacity of minority institutions and their faculty, staff and students to conduct rigorous drug abuse research in all areas of research supported by the NIDA including neuroscience, behavioral, clinical, social science, public health, biological, HIV/AIDS, and health services areas. In addition, this PA seeks to broaden the scientific knowledge base in drug abuse in those areas where minority institutions may have particular interest, knowledge, and commitment. 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 is related to many of the priority areas of alcohol and other drugs. 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, D.C. 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic universities and colleges that meet one of the following criteria: (1) A public or private nonprofit university, 4-year college, or other institution offering undergraduate or graduate degrees with a traditionally high (more than 50 percent) minority (Black, Hispanic, Native American or Alaskan Native, Asian or Pacific Islander) student enrollment; (2) An institution with a substantial enrollment of minority students (e.g., 25 percent in each of the previous four years). Applicants must demonstrate commitment to minority research development goals through (a) evidence of efforts to recruit faculty and students who are members of minorities nationally underrepresented in behavioral and biomedical research, (b) demonstration of the institution's need for support under this program, and (c) demonstration of efforts to provide support and resources to minority faculty and students. (3) An Indian tribe which, in conjunction with one or more institutions of higher learning, offers undergraduate and graduate degrees in disciplines relevant to drug abuse, which has a recognized governing body, and which performs substantial governmental functions; or an Alaska Regional Corporation (ARC) as defined in the Alaska Native Claims Settlement ACT (43 U.S.C. 1601 et seq.). In addition, non-profit community-based organizations that provide drug abuse treatment and services may submit if they apply in collaboration with a minority institution as defined above and if they can demonstrate (a) a research mission and commitment, (b) substantial service to minority populations, and (c) significant minority staff and trainees and/or efforts to recruit underrepresented minorities as staff and students who are nationally underrepresented in behavioral and biomedical research. The applicant must indicate which of the above eligibility conditions apply to the institution and provide documentation in support of the eligibility claim. Potential applicants are strongly advised to contact NIDA program staff listed under INQUIRIES to discuss eligibility requirements prior to preparing an application. MECHANISM OF SUPPORT Awards under this Program Announcement will use the R24 grant mechanism. Applicants are responsible for the planning, direction, and execution of the proposed project. The total project period for applications submitted in response to this Program Announcement may not exceed five years. RESEARCH OBJECTIVES Background Participation of minority institutions in supported biomedical and behavioral research is low. Reasons for this underrepresentation in research include the following: (1) the primary, historic mission of many minority institutions has been to provide excellent teaching in order to prepare its students for work and/or advanced studies at other institutions, (2) community service has been an important, time-consuming expectation of faculty and staff members, (3) many minority-serving institutions have not had graduate research programs, and (4) support for research (e.g., facilities, equipment, release time, library resources, personnel) has been either unavailable or inadequate. Many minority institutions, however, are redefining and expanding their mission to include a strong emphasis on research and have made strides in recent years to broaden and strengthen their research infrastructure and endeavors. In addition, minority institutions have increased their interest and involvement in drug related activities and are particularly poised to expand these endeavors into the research arena. For example, many are engaged in various drug and HIV/AIDS education, HIV/AIDS risk reduction and prevention, and training activities; some have some current but limited drug abuse research; some have strong ties to community- based organizations, agencies, and schools who are seeking partnerships to address drug abuse problems; and almost all have indicated interest in developing competency in drug abuse related studies and research. This program is intended to provide research support to minority institutions that demonstrate a commitment and nascent capacity to developing a strong research environment for drug abuse research among faculty and students. Research Goals There are three primary emphasis areas of the program: (1) to enhance the research infrastructure of the institutions which will enable them to encourage and foster increased research activity in drug abuse; (2) to provide research development support and experiences to faculty and staff to facilitate independent drug abuse research careers; and (3) to stimulate research interest in students and provide them research experiences. A long-term goal of this program is the expectation that recipient institutions and participating individuals will become active in other drug abuse sponsored research programs. Research Issues Research in all areas of drug abuse research supported by the institute is encouraged. NIDA is interested in both biomedical and behavioral research. NIDA supports research on drug abuse in the following broad areas: epidemiology, etiology, prevention, treatment and services, basic research, and medications development. Research on HIV/AIDS is also a focus of NIDA's research portfolio. Examples of specific areas of drug abuse-related NIDA research are: develop new knowledge concerning the mechanisms and sites of action underlying drug abuse; develop new methodologies for testing the abuse potential of new compounds; determine the short- and long-term neurological, biological, behavioral, and societal effects of drugs of abuse; study the effects of drugs on the central nervous system and physiological systems; study metabolism, pharmacodynamics, pharmacokinetics, synthesis, analysis, and structure-function relationships of drugs of abuse and compounds used to study their actions; develop and assess the efficacy of new and existing treatment techniques and treatment modalities; develop and evaluate methodologies for recruiting drug abusers into treatment, retaining them, and preventing recidivism to drug abuse; study the diagnosis and treatment of drug abuse/addiction and comorbid mental disorders; study the effectiveness of existing treatments in real-world settings; advance research focused upon school, media, family workplace, and community based prevention strategies; study the nature, extent, patterns, and emerging trends in drug use/abuse and HIV risk behaviors/seroprevalence; study the efficacy and effectiveness of community-based interventions in reducing HIV risk behaviors and averting HIV incident infection; identify and study resiliency and risk factors; study the incidence and prevalence of drug abuse and related conditions and consequences among general and special populations; and develop and test prevention theories and prevention interventions that are grounded in, consistent with, and reflective of findings from epidemiologic research about the nature, extent, distribution, and consequences of drug abuse with special attention upon ethnic, cultural and gender-relevant issues, concerns, and risk and protective factors. In the case of drug abuse-related HIV/AIDS, for example, collaborative studies and efforts to incorporate knowledge from other fields are essential to understanding the links between drug abuse and AIDS, and to the development of effective strategies for stemming its spread and addressing its consequences. The areas of research interest listed above are not exhaustive. Any research area described above in this program announcement will be considered appropriate for the NIDA MIDARP program. Applicants are encouraged to contact staff at the NIDA if additional information regarding specific research interests is needed. Program contacts are listed later in this announcement. Program Description The MIDARP is designed to increase the capacity of minority institutions, faculty/staff, and students to conduct research in drug abuse. Required components. Each application must include plans for the two following core activities: (1) an institutional research development plan, and (2) individual investigator research project(s). Institutional research development plan. The program will provide support for resources and activities that will strengthen the institution's research infrastructure and enhance the capability of individual faculty members and students to engage in competitive drug abuse research. A core research issue or focus area must be identified as part of and be used to guide the development of, the institutional research development plan. Depending on demonstrated need and importance of the support for proposed individual projects and future related drug abuse research, requests may be made for such infrastructure enhancements as the following: laboratory supplies, limited equipment support, support for collaborative linkages with established scientists at other institutions, data management and statistical analysis needs, data sets, special courses/seminars for faculty or students, pilot work that can form the basis for individual research projects, limited costs associated with establishing research linkages with community drug abuse treatment services, and limited library/information resources. Individual investigator research project(s). At least one individual investigator research project must be proposed. The program will provide support for developmental research projects by one or more selected faculty members. These projects must relate to the core research focus area or project and the institutional infrastructure support that is requested. The expectation is that this support in concert with the institutional infrastructure enhancement plan will enable the individual project investigators to become competitive in other sponsored research programs. In addition to costs associated with the particular study proposed, individual investigators may request support for minority undergraduate and graduate students underrepresented in the biomedical and behavioral sciences to serve as research assistants. Optional component. Faculty members who are currently conducting drug abuse research sponsored by other sources (e.g., federal, state, private sector) may be designated as Associate Project Directors. They may request additional funds to support minority undergraduate or graduate students to serve as Associate Research Assistants on these already funded projects. These funds may not be used to replace any research assistant positions supported by other federal or non-federal awards, and strong explanation of the benefits to be gained by the proposed research assistants and the research itself must be provided. Application Description The applicant must provide a plan for the MIDARP that (1) provides information that clearly and critically assesses the current capacity of the institution and individual faculty/staff members to conduct drug abuse research, (2) convincingly demonstrates that the proposed plan will significantly enhance the research infrastructure of the institution and provide continuing research support for the individual faculty/staff members, and (3) addresses an important area of drug abuse research need and shows that significant knowledge will be gained from the research proposed. An applicant proposing a collaborative program between a minority institution of higher learning and a non-profit community-based organization that provides drug and/or HIV/AIDS treatment and services must address the above-stated requirements in addition to elucidating how the proposed program will foster a continuing collaborative relationship, complement and enhance the research infrastructure of both the college/university and the community- based organization, and contribute over time to our understanding of drugs and/or HIV/AIDS related problems. Institutional research development support Needs. The applicant should assess the institution's needs for resources and facilities that are important to conducting research in the identified focus area. The plan should describe, for example, research equipment, laboratory space, administrative support, faculty development and support needs, consultant expertise, and data management and analysis support that are necessary for the research focus area proposed. Current resources. The applicant should describe the current capacity of the institution to support drug abuse research, identifying all available resources such as faculty/staff with drug abuse research experience or related experience, equipment, space, and other relevant resources. Any current or recent drug abuse research or related research projects should be summarized. The summary should provide the title and substantive focus of the research; the name, discipline, and department of the principal investigator; the names, disciplines, and departments of other participating faculty; the amount, source, and level of funding by year; the time-line for completion of the project; any cross- institutional collaboration; and the significance of the project. Critical assessment. The applicant should discuss the probable success of the proposed plan by describing the realistic changes in institutional policies, procedures, resources, and practices germane to drug abuse research that are likely to occur. Applicants are expected to identify areas where development or change is desirable but may be difficult or not possible to address within the scope of this announcement. Show how the proposed plan of infrastructure development and research project support is likely to have a significant impact on the impetus and capacity of the institution to engage in drug abuse research. Discuss how the proposed plan will change the institution's ability to develop a drug abuse research focus and agenda to seek and support drug abuse research; prepare its students and faculty for drug abuse research and sponsored research, in general; provide sufficient time and incentives for faculty to engage in drug abuse research; develop collaborations with established researchers/research institutions or drug abuse facilities; and expand library and resource materials. (These are examples of issues that can be used to demonstrate changes in institutional capacity and competency.) Program Director. The Program Director of the applicant institution will be responsible for the scientific and technical direction of the MIDARP. He/She will be responsible for the implementation of the institutional research development plan and will provide scientific oversight for the individual research project(s). He/She should be a scientist with appropriate training and experience and institutional authority and support to provide effective leadership to the project and guidance and support to project director(s). The Program Director will have overall responsibility for the goals, organization, administration, integrity, and conduct of the MIDARP. He/She will be responsible for (1) the recruitment of faculty to participate in the individual research development activities; (2) assisting faculty in obtaining appropriate consultation and research training during the grant period; (3) the development of the institutional infrastructure required to implement drug abuse research; (4) the provision of needed fiscal and other project support; and (5) the overall administration of the grant. He/She will assist faculty in obtaining appropriate additional research training and consultation on research which will help faculty carry out research in drug abuse with the primary objective of enhancing their skills and expanding their knowledge in preparation for a research career. Individual investigator research projects There must be at least one individual research project proposed. Each project must be well developed and include a detailed research proposal, although it is recognized that the initial projects may often be early, developmental, or small-scale. Each project must provide the information requested for preparation of research grant applications in the PHS 398 application form; namely, specific aims, background and significance, progress report/preliminary studies (if applicable), research design and methods, protection of human subjects (if applicable), protection of vertebrate animals (if applicable), consortium/contractual arrangements (if applicable), and literature cited. If more than one research project is proposed, it is suggested that there be some discipline- related thematic link across the projects. Project Directors/Investigators. Individual research project directors/investigators are responsible for the administration and implementation of their projects, with the support of the Program Director and the institution. Project directors should have sufficient training to enable them to conduct developmental or pilot research. HUMAN SUBJECTS/VERTEBRATE ANIMALS. If human subjects and/or vertebrate animals will be involved in the research, evidence of the required institutional review must be given on the face page of the application, see pages 7-8 of the PHS 398 application kit. Furthermore, the instructions on pp. 17-18 of the application kit must be followed. 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 are 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 28, 1994 (FR 59 14508-14513) and reprinted 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. NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS The National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research. Potential applicants are encouraged to obtain and review these recommendations before submitting an application that will administer compounds to human subjects. The guidelines are available on NIDA's Home Page at www.nida.nih.gov under the What's New (June 1997), or they may be obtained by calling 301-443-2755. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev.5/95) and will be accepted on the standard receipt dates indicated in the application kit. Application kits are available at most institutional offices of sponsored research or 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 this PA must be typed in Item 2 on the face page of the application. A limit of 25 pages applies to the institutional research development plan. Individual investigator projects are each limited to an additional 20 pages for the sections on Specific Aims, Background and Significance, Progress Report/ Preliminary Studies, and Experimental Design and Methods. Applications exceeding the specified page limits will be returned. Detailed budgets are required for the institutional infrastructure development plan and each individual research project that is proposed. The completed original and five legible copies must be sent or delivered to: CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants) NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE MSC-7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for courier/overnight service) REVIEW CONSIDERATIONS Upon receipt, all applications will be reviewed by the Center for Scientific Review (CSR). Incomplete applications will be returned to the applicant without further consideration. Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with the review criteria stated below. Review Criteria The scientific peer review group will review the application for the merit of the entire proposed institutional plan and for each individual research project separately. A priority score reflecting technical and scientific merit of the entire project will be assigned by the reviewers. All applications will be reviewed according to these criteria: o Appropriateness and adequacy of the proposed institutional plan and the likelihood that it can be successfully implemented. o Appropriateness and adequacy of the research and research methodology proposed. o Appropriateness of the proposed budget. o Adequacy of the faculty and student research development support. o Adequacy of plans for inclusion of both gender and minorities, and adequacy of plans for the protection of human subjects, animals, or the environment, as appropriate. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Staff members are available for consultation concerning application development. Potential applicants are encouraged to contact NIDA staff for information and guidance in developing research applications. Direct inquiries regarding programmatic issues to: Lula Beatty, Ph.D. Special Populations Office National Institute on Drug Abuse 5600 Fishers Lane, Room 11A-33 Rockville, MD 20857 Telephone: (301) 443-0441 FAX: (301) 480-8179 Email: lb75x@nih.gov Pushpa Thadani, Ph.D. Division of Basic Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-19 Rockville, MD 20857 Telephone: (301) 443-6300 FAX: (301) 443-6043 Email: pt24e@nih.gov C. Jamie Biswas, Ph.D. Medications Development Division National Institute on Drug Abuse 5600 Fishers Lane, Room 11A-55 Rockville, MD 20857 Telephone: (301) 443-5280 FAX: (301) 443-2599 Email: jb168r@nih.gov Jagjitsing Khalsa, Ph.D. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-08 Rockville, MD 20857 Telephone: (301) 443-1801 FAX: (301) 594-6566 Email: jk98p@nih.gov Arnold R. Mills, M.S.W. Division of Epidemiology and Prevention Research National Institute on Drug Abuse 5600 Fishers Lane, Room 9A-42 Rockville, MD 20857 Telephone: (301) 443-6720 FAX: (301) 480-4544 Email: am88k@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gfleming@ngmsmtp.nida.nih.gov AUTHORITY AND REGULATION This program is described in the Catalog of Federal Domestic Assistance No. 93.279. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-148, 42 USC 241 and 285) and administered under PHS grants 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 Public Health Service (PHS) strongly encourages all grant 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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