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 301-710-0267, 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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