DRUG ABUSE TREATMENT AND SERVICES DISSERTATION RESEARCH Release Date: September 24, 1998 PA NUMBER: PA-98-109 P.T. National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) announces the availability of small grants (R03) to support doctoral dissertation research in drug abuse treatment and health services research. Grant support is designed to aid the research of new investigators and to encourage doctoral candidates from a variety of academic disciplines and programs to conduct research in these areas of interest to NIDA. It is hoped that this program will ultimately facilitate the entry of promising new investigators into the fields of drug abuse treatment and health services research. 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, Drug Abuse Treatment and Services Dissertation Research, is related to the priority area 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, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY The applicant investigator applying for a dissertation research grant must be enrolled in an accredited doctoral degree program in the behavioral, biomedical, or social sciences and must be conducting or intending to conduct research in one of the areas specified in this Program Announcement. The applicant must be a registered doctoral candidate student. All requirements for the doctoral degree other than the dissertation and clinical internship, if applicable, must be completed by the time of the award. This information and the approval of the dissertation topic by a named committee must be verified in a letter of certification from the thesis chairperson and submitted with the grant application. See "Letter of Certification." The applicant institution administering the grant on behalf of the proposed applicant must be domestic. Applications may be submitted by any public or private non-profit university, college, or professional school. The doctoral candidate must be a citizen or noncitizen national of the United States or hold a permanent residence visa. MECHANISM OF SUPPORT The mechanism of support is the National Institutes of Health (NIH) small grant (R03). Grants to support dissertation research will provide no more than $30,000 in direct costs per year; they are awarded for up to 2 years and may be extended without additional funds for up to 12 months. Awards will depend on the availability of funds. RESEARCH OBJECTIVES Research objectives in the drug abuse treatment area include studies that expand and improve therapies and HIV risk reduction interventions available to drug abusers and drug dependent persons. All drugs of abuse, with the exception of alcohol, are of interest (including nicotine, marijuana, and methamphetamine). Areas of interest include: Behavioral Therapies. Research on behavioral therapies for the treatment of drug addiction and HIV risk reduction interventions for individuals in drug addiction treatment. Research on behavioral therapies for drug addicted populations with co-occurring mental disorders. Research on brief behavioral interventions that can be used in office-based and other health care treatment settings. Research translating or integrating basic behavioral science into behavioral therapy research. Research on behavioral therapies for the treatment of children and adolescents. Pharmacotherapies. Research to improve the effect of marketed medications (e.g., methadone, LAAM, naltrexone, and nicotine delivery devices) for the treatment of drug dependence. Research integrating behavioral therapies with pharmacotherapies to maximize efficacy. Analysis and Assessment. Research on psychometric analysis and instrument development for assessing drug abuse and HIV risk. Research using secondary analyses of existing data sets. Research objectives in the health services area include studies of a wide range of factors drawn from many disciplines to improve drug addiction treatment access, services, and outcomes. Drug treatment services delivered in a variety of systems (e.g., managed care, social services, and criminal justice), and services delivered to defined populations (e.g., pregnant women, adolescents, and drug abusing offenders) are of interest. Research focus areas are: Organization and Management. Research on organizational and structural arrangements, and management strategies, to include their impact on access, services, and outcomes. Economics. Research on the impact of financing arrangements, reimbursement mechanisms, coverage and benefits, or regulations on programs, practices, and outcomes. Access and Utilization. Research on the adequacy of services and the differential use of treatment services by special populations (barriers and facilitators to service access and utilization); linkage with primary care; and the effect of different systems of utilization review on treatment process and outcome. Effectiveness. Research on improvement of treatment services to include outcome studies of enhanced services and research on cost-effectiveness of treatment services. HIV/AIDS. Research to assess HIV/AIDS services to reduce high-risk behaviors and to coordinate adequate treatment services for HIV/AIDS patients with special needs. 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 the NIH Guide for Grants and Contracts, Vol. 3, No. 11, March 18, 1994. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html. 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 http://www.nida.nih.gov under What's New or 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 at the standard application deadlines as indicated in the application kit. 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 301-435-0714, email: grantsinfo@nih.gov. The title and number of the program announcement must be typed in Section 2 on the face page of the application. o Allowable Costs Expenses usually allowed under PHS research grants will be covered by the NIDA dissertation research grant, but may not exceed $30,000 in direct costs for the project. An application that requests more than $30,000 will be returned to the applicant. Allowable costs include the investigator's salary (not to exceed $14,000 for 12 months full-time effort), research assistants salaries, and direct research project expenses, such as data processing, payments to subjects, supplies, and dissertation costs (e.g., printing and binding of the dissertation). Travel funds up to $750 may be requested to attend one scientific meeting; additional travel costs in connection with research at a remote performance site must be fully justified. No tuition, alteration/renovations, contracting costs, or space rental are allowed on dissertation research grants. Small equipment items may be requested if special justification is provided for them. Indirect costs are limited to eight percent of requested direct costs, less equipment. o Level of Effort Any level of effort that is less than full time (40 hours per week) must be fully justified, and the investigator's salary must be prorated accordingly. o Letter of Certification A letter from the faculty committee or university official directly responsible for supervising the development and progress of the dissertation research must be submitted with the application. The letter must (a) fully identify the members of the dissertation committee and certify their approval of the dissertation proposal; (b) certify that all requirements for the doctoral degree, except the dissertation and, if necessary, the clinical internship, are completed or will be completed by the time the grant award starts; (c) note that the university official or faculty committee expects the doctoral candidate to proceed with the approved project proposal with or without NIDA support; and (d) certify that the institution's facilities and general environment are adequate to conduct the proposed research. o Additional Material A copy of an official transcript of the applicant's graduate school record should be included with the application. Applicants must provide a statement of career goals, including reference to their interest in one of the two specific areas of research designated in this program announcement and a description of their intended career trajectory. A two page biographical sketch of the mentor, normally the dissertation director, should be sent. This should be on the biographical sketch form found in the form PHS 398. The applicant should also include material on the mentor's previous, pending (submitted), and active research support. The principal investigator must provide a narrative project description (not to exceed 10 pages) that contains a detailed scientific and technical discussion of the following specific points: a. A description of the research project and what it is intended to accomplish. b. A summary of related published research that addresses the identified problem(s). c. The questions to be answered or the hypotheses to be tested by the project. d. The methodological procedures to be followed and, whenever applicable, information on such matters as sampling procedures, including the size and composition of the population to be studied and the size and composition of the sample and control groups, as well as a description of the types and sources of data to be gathered, methodological problems to be encountered, specific statistical analyses to be used, and steps that will be taken to protect human subjects. e. The management of the project including a schedule of the main steps of the proposed investigation. f. The facilities and resources that will be available for the project. The applicant must submit the original and five copies of the completed application and letter of certification to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20897 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate institute peer review group convened in accordance with the standard peer review procedures. 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 and assigned a priority score. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application 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 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 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. In the context of this Program Announcement, investigator's academic record, career goals, and information from the letter of certification and additional material will inform considerations of these criteria. (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 the project employ novel concepts, approaches, or method? 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 principal 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 of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with al 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. Concurrent Support An applicant who receives support for dissertation research under a grant from NIDA may not at the same time receive support under a predoctoral training grant or fellowship grant awarded by any federal agency, nor be supported under any other research project grant. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Inquiries regarding programmatic issues may be directed to: Debra S. Grossman, M.A. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-10 Rockville, MD 20857 Telephone: (301) 443-0107 FAX: (301) 443-8674 Email: dg79a@nih.gov Peter J. Delany, D.S.W. Division of Clinical and Services Research National Institute on Drug Abuse 5600 Fishers Lane, Room 10A-30 Rockville, MD 20857 Telephone: (301) 443-4060 FAX: (301) 443-6815 Email: pd32n@nih.gov Inquiries related to fiscal matters or grants management issues may be directed to: Dr. Gary Fleming Grants Management Branch National Institute of Drug Abuse 5600 Fishers Lane, Room 8A-54 Rockville, MD 20857 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov AUTHORITY AND REGULATIONS 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 99-158, 42 USC 241 and 285), 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. 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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