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 masterĂ¾s 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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