CLINICAL RESEARCH EDUCATION PROGRAMS IN DRUG ABUSE AND ADDICTION Release Date: April 29, 1999 PA NUMBER: PAR-99-093 (see replacement PAR-04-054) P.T. National Institute on Drug Abuse PURPOSE The National Institute on Drug Abuse (NIDA) invites grant applications to support educational programs (Clinical Research Education Programs in Drug Abuse and Addiction) aimed at (1) developing the research skills of investigators who wish to focus on clinical, prevention, health services, or treatment issues in drug abuse or (2) developing a cadre of clinical drug abuse experts proficient in the use of research findings (for example, in public health, behavioral science, or medicine) to develop or implement early detection, diagnosis, treatment, or prevention interventions. This latter category would also include applications of health services research findings. Programs that address both of these aims are particularly desired. NIDA will grant awards to eligible institutions to develop or enhance research training opportunities for individuals, selected by the institution, who are training for careers as researchers, as clinicians (broadly defined), or (ideally) as a combination of the two. Educational partnerships between research institutions and drug abuse treatment organizations are highly encouraged in order to broaden research training and educational opportunities and as a result, increase the number of well-trained clinical and health services researchers in the field. HEALTHY PEOPLE FOR THE YEAR 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 (PA), Education Programs in Clinical Research with Drug Abusers, is related to the priority areas of tobacco, alcohol and other drugs, and maternal and infant health. Potential applicants may obtain a copy of Health 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 Institution Applications may be submitted by 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 program directors. The applicant institution must have a strong research program in the area(s) proposed for research training and must have the requisite staff and facilities to carry out the proposed program. Students All students must be U.S. citizens, nationals, or lawfully admitted permanent residents of the U.S. Predoctoral students must have an M.S., M.S.W., or equivalent degree in biostatistics, nursing, psychology, or other social sciences as a prerequisite to pursuing a doctorate degree. This award will not support a master"s level degree for a predoctoral student. Postdoctoral students may have either an academic or professional doctorate degree and, as an option, may elect to pursue an M.P.H. degree. MECHANISM OF SUPPORT The mechanism of support for this PA is the education project grant (R25) for up to 5 years of support and is renewable. EDUCATION PROGRAM OBJECTIVES There is a serious shortage of well-qualified individuals prepared to conduct needed clinical, prevention, health services, and treatment research with drug abusers and underserved populations of children and adolescents, women, and racial and ethnic minorities affected by drug abuse. At present, few academic institutions have a coordinated curriculum and other essential elements relevant to preparing individuals for a career in clinical research with drug abusers and related populations. A related need is for increased numbers of service providers who are sufficiently sophisticated consumers of research to evaluate and apply research-based findings. The purpose of this PA is to enlarge the infrastructure for training clinical, prevention, health services, and treatment researchers prepared to work with drug abusers and related populations. A parallel goal is to develop a cadre of clinical drug abuse treatment providers proficient in the application of research finding to improve health. This PA encourages collaborative programs involving clinical or applied settings and academic or research institutions such as schools of public health, departments of preventive and community medicine, or other entities with appropriate expertise for the development and establishment of educational training programs in drug abuse clinical, prevention, health services, and treatment research and practice. A comprehensive program of this nature requires the integration of many diverse elements such as: 1) a core curriculum covering topics in clinical research methodology (including epidemiology and biostatistics), prevention, health services, public health, neurobiology, and the social/behavioral sciences, 2) peer-reviewed, faculty-held drug abuse related research projects, 3) the availability of appropriate patient study populations and databases, 4) the availability of appropriate laboratory and clinical facilities, and 5) a pool of available, high quality candidates. Principal investigators and applicant organizations must demonstrate the ability to organize and administer this type of interdisciplinary drug abuse oriented clinical research training program whose structure may require linkage to other academic and programmatic components of the parent and/or collaborating institutions. Proposed programs should provide requisite educational skills in clinical and health services research and drug abuse treatment, prevention, and control through course work, seminars, "hands-on" intervention and/or treatment-type projects and other research experiences. Depending upon the program"s educational objectives, faculty, research, target student population, and other available resources, applicant institutions may propose a predoctoral and/or postdoctoral type program. The award would provide up to 3 years of support to predoctoral students who already have an M.P.H., M.S.W., M.S. or equivalent degree, as well as health professional students with a master’s degree in biostatistics, nursing, psychology, and other behavioral or social sciences. The postdoctoral program would provide support to candidates for up to 3 years and should prepare them for a career as independent drug abuse researchers. An active research base that includes funded drug abuse research projects should be available for the education of candidates enrolled in the program. The requisite faculty and the commitment of sufficient faculty time are critical factors for this educational program. Graduates of the program should have some basic knowledge of at least the following areas, with in-depth knowledge of some of them: Neurobiology, including topics such as rate hypothesis models of psychotropic drug effects and dopaminergic reward mechanisms. Clinical aspects of drug abuse, including knowledge of diagnostic methods, direct and indirect effects of drug abuse, major treatment modalities, complications of drug use, and associated medical conditions. Research methodologies such as epidemiology, biostatistics, qualitative and quantitative methods in research design and analysis, drug abuse surveillance, and data use. Methodologies for the identification of high-risk groups. Theories of health education and prevention and control. Racial/minority, diversity, and gender issues. Developmentally appropriate intervention designs and strategies. Systems theories that address individuals in context. Protection of human subjects and related ethical issues in the conduct of research. Examples of other courses that might have relevance to particular programs include: nutrition (related to prevention of drug abuse complications), health policy, health promotion, political science, and economics. In developing and implementing a curriculum for training clinical addiction research specialists, the specific details and courses will depend to a large extent on the goals of the overall program and the participants. Each individual enrolled in the program should investigate a research problem related to prevention or treatment of drug abuse or its complications commensurate with his or her academic standing and goals. Ultimately, however, research graduates should be able to formulate hypotheses and design and conduct research on the effectiveness of interventions in populations, while practitioner graduates should be able to apply the results of research studies to appropriate populations. Principal investigators and applicant organizations must demonstrate the ability to organize and administer this type of interdisciplinary drug abuse oriented clinical research program whose structure may require linkage to other academic and programmatic components of the applicant and collaborating institutions. In order to provide sufficient diversity and distribution of programs, awards will be limited to a maximum of $350,000 direct costs within the allowable costs described below. The total project period for applications submitted in response to the present PA should not exceed 5 years. Predoctoral compensation including fringe benefits of up to $15,000 and postdoctoral compensation including fringe benefits of up to $55,000 will be provided commensurate with the applicant institution"s salary structure for predoctoral students. A Cost of Education Allowance of up to $12,000 to partially support tuition and other fees, supplies, or other expenses, and a travel allowance of $1,000 for professional meetings will be provided for both predoctoral and postdoctoral students. A maximum of $50,000 can be allocated to cover program administrative costs. Indirect costs cannot exceed eight percent of direct costs. The educational program outlined above will require a broad range of drug abuse related and clinical disciplines, courses, clinical experiences, and research. A specific curriculum will depend upon the objectives of the proposed program and the target student population(s). Because it is likely that more than one school, administrative or departmental unit will be involved in the program, plans for administrative coordination, responsibilities, and logistics should be given. A proposed syllabus together with flowcharts and timetables might be useful in understanding these relationships. A multidisciplinary Clinical Addiction Research Education Committee is essential to the overall administration of a Clinical Research Education Program in Drug Abuse and Addiction. Among other things, it should be responsible for the recruitment and selection of students, procedures for the selection of research activities and mentors for students, and evaluation of student progress. It should consist of experts representing basic, behavioral and clinical disciplines concerned with drug abuse and its treatment and prevention. Schools, departments, and clinical sites participating in joint applications should be represented on the Committee. Evidence should be provided of the Committee"s function, structure, composition and frequency of meetings. These cross-disciplinary educational programs are likely to involve active collaborations or special arrangements between institutions and/or departments such as those with drug abuse research center support grants, schools of public health, departments of community and preventive medicine, and other departments and institutions that have the necessary expertise and resources to fulfill the objectives of this PA. Any of these entities may act as the applicant organization, as long as the qualifications of the participants and the focus of the program are on the training of clinical researchers to work with drug abusing and related populations. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) 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: asknih@od.nih.gov. The title and number of the PA must be typed in Section 2 on the face page of the application. The completed original application and five 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 (for express/courier service) REVIEW CONSIDERATIONS Applications that are complete will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the standard peer review procedures. In general, peer review will assess the quality of resources available to support the type of program proposed and the number of positions requested within the above limitations. 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 Applications are evaluated for merit by an Initial Review Group based on the following criteria: Objectives, design, and direction of the training program. Appropriate core curriculum covering topics in clinical research methodology, prevention, public health, neurobiology and behavioral sciences commensurate with the goals of the program and the needs of the trainees. Caliber of preceptors as researchers, including successful competition for research support. The institutional training environment, including the level of institutional commitment, quality of the facilities, availability of appropriate courses, and availability of research support. Adequacy of any collaborative and logistical arrangements across institutes, schools and/or departments. Adequacy of membership and functions of the Clinical Addiction Research Education Committee. Recruitment and selection plans for trainees and the availability of high quality candidates. Training in the responsible conduct of research. Applications must include a description of a program to provide formal or informal instruction in scientific integrity or the responsible conduct of research. Integration of core curriculum with ongoing clinical drug abuse research projects. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to NIDA. 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 issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Andrea Baruchin, Ph.D. Science Policy Branch Office of Science Policy and Communications National Institute on Drug Abuse 6001 Executive Boulevard, Room 5230, MSC 9591 Bethesda, Maryland 20892-9591 Telephone: (301) 443-6071 FAX: (301) 443-6277 Email: ab47j@nih.gov Cindy Miner, Ph.D. Science Policy Branch Office of Science Policy and Communications National Institute on Drug Abuse 6001 Executive Boulevard, Room 5230, MSC 9591 Bethesda, Maryland 20892-9591 Telephone: (301) 443-6071 FAX: (301) 443-6277 Email: cm171w@nih.gov Direct inquiries regarding fiscal matters to: Gary Fleming, J.D., M.A. Grants Management Branch National Institute on Drug Abuse 6001 Executive Boulevard, Room 3131, MSC 9541 Bethesda, Maryland 20892-9541 Telephone: (301) 443-6710 FAX: (301) 594-6847 Email: gf6s@nih.gov Direct inquiries regarding review matters to: Teresa Levitin, Ph.D. Office of Extramural Program Review National Institute on Drug Abuse 6001 Executive Boulevard, Room 3158, MSC 9547 Bethesda, Maryland 20892-9547 Telephone: (301) 443-2755 FAX: (301) 443-0538 Email: tl25u@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 are 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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