EPIDEMIOLOGIC RESEARCH ON DRUG ABUSE

Release Date:  October 2, 1998

PA NUMBER:  PA-99-002

P.T.

National Institute on Drug Abuse

PURPOSE

This PA replaces PA-94-007, "Survey Research on Drug Use and Associated
Behaviors," which was published in the NIH Guide, Vol. 22, No. 39, October 29,
1993.

The purpose of the National Institute on Drug Abuse"s (NIDA) epidemiologic
program is to characterize the nature and extent of drug abuse and its
development, to determine trends and the factors that influence them, and to
identify and measure public health problems associated with drug abuse.  In order
to accomplish this, NIDA funds investigator-initiated studies focusing on
defining factors and patterns associated with the initiation, escalation,
continuation, and cessation of drug use and on associated antisocial, health-
threatening and other problematic behaviors that arise as a result of drug abuse. 
The findings from this research serve to guide the development of interventions
that address the needs of the general population and defined subpopulations with
special needs such as those at risk for infection with HIV, TB, HBV, and HCV and
to inform public programs and policy.  Further, the epidemiologic research
findings provide future directions for all phases of NIDA research, basic,
clinical, and prevention.  As drug abuse is a constantly changing phenomenon, the
epidemiology research program will also attempt to identify early emergent
patterns of drug abuse, definition of their nature, and, where possible, the
prediction of their future course.

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 primarily
related to the priority area of Alcohol and Other Drugs.  Potential applicants
may obtain a copy of Healthy People 200 (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 foreign and domestic for-profit and nonprofit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State or local governments, and eligible agencies of the
Federal Government.  Foreign institutions are not eligible for program project
or centers (P-Series) awards.  Women and minority investigators are encouraged
to apply.

MECHANISM OF SUPPORT

The mechanisms available for support of this program announcement includes
Project Grants (R01), small grant (R03), exploratory/developmental grant (R21),
program project (P01), and research centers (P30, P50, and P60).  Application for
Research Centers must be in accordance with the NIDA guidelines for Research
Center applications.  More specific information about individual research
mechanisms can be obtained from the NIDA home page at:
http://www.nida.nih.gov/Funding.html.

Because the nature and scope of the research proposed in response to this program
announcement might vary, it is anticipated that the size of an award will vary
also.

Applications requesting direct costs of $500,000 or more in any one year must
obtain agreement from the assigned institute that the application will be
accepted for review and consideration of award, in accordance with NIH policy,
which is available at http://www.nih.gov/grants/guide/notice-files/not98-
030.html
.  Applicants must identify, in the cover letter sent with the
application, the specific NIH office and staff member who agreed to accept
assignment of the application.  Applicants seeking funding under this program
announcement must contact the appropriate program official to discuss the
proposal well in advance of the submission date, ideally early in the planning
phase, and submit a brief (not over 5 pages) concept paper and tentative budget
for NIDA internal review.

RESEARCH OBJECTIVES

Background and Significance

Epidemiologic research has historically been the foundation for developing an
understanding of the nature and extent of drug abuse, for developing strategies
to prevent drug use, and for providing scientific support for other types of
basic, clinical, and treatment research.  The etiologies of drug abuse vary
across individuals, families, age, sex, and populations with different
predisposing or protective factors and co-morbid conditions.  This announcement
is to encourage studies which have the potential to expand and refine
epidemiologic research on drug abuse in new areas, to develop innovative
statistical methods, to develop diagnostic and developmental assessment protocols
for use in general populations, and to explore the origins and pathways to drug
use, abuse, and dependence.

Key questions addressed by epidemiologic research on drug abuse include:

1.  What is the extent of drug-using behaviors?  How do they vary over time,
across genders, across populations, for different substances, and in relation to
cultural and other factors.

2.  What are the patterns of drug-using behaviors (e.g., groups affected,
specific drugs or drug combinations, forms of the drugs, routes of
administration, contexts of use, geographic variations, etc.), and how do these
develop in individuals and groups?

3.  What are the characteristics of persons using drugs?  What factors
distinguish those whose use escalates from those who resist increased drug
involvement?

4.  What factors influence temporal trends in drug use in the overall population,
and how do these relate to changes in subpopulation drug use patterns such as
those listed in question 2?

5.  What factors predispose an individual to the use of drugs and influence the
onset of drug-using behaviors and continued use of drugs?

6.  What factors are related to the discontinuation of drug use, including
discontinuation that may occur in association with, and independent of,
treatment?

7.  What factors protect individuals who may be at risk from abusing drugs?  How
do predisposing and protective factors interact?

Program Objectives

Drug abuse epidemiology derives concepts and methods from a wide range of
disciplines including statistics, psychology, biology, sociology, and
anthropology.  Use of multidisciplinary perspectives to investigate key questions
is encouraged.  Investigators should also consider a wide range of statistical
methods and study designs appropriate to the research question and consider cost
efficiency in research design.  Where appropriate, secondary analysis of existing
data is encouraged.

Theory-driven, longitudinal studies that focus on the origins of drug abuse and
dependence, and natural history studies of populations at risk for drug abuse or
who have already initiated drug-abusing behaviors, will help clarify the impact
of the many complex factors found to be associated with drug abuse and its
outcomes.  Of particular importance is the examination of the cumulative impact
of multiple interacting risk and protective factors affecting different stages
of human development, indicating factors that appear to exert the greatest
influence.

Research following drug abusers over time to determine the natural trajectories
of their lives is also encouraged, such research may yield information valuable
in intervention planning.  Natural history studies comparing drug abusers and
non-drug abusers are needed to assess the increased risk of medical/health,
behavioral, social, psychological, and psychiatric problems due to drug abuse,
and similar studies are needed to compare subgroups of drug abusers to determine
factors associated with differential risks.

Finally, methodological research will be encouraged to improve response rates,
validity, precision, and efficiency of epidemiologic studies.  Development and
application of innovative sampling, surveillance, ethnographic, and data
collection methods, and refinement of statistical tools to analyze epidemiologic
data will also be encouraged.

This program announcement invites research proposals within the broad spectrum
of epidemiologic research on drug use and abuse:

1.  Studies of the incidence (i.e., onset), prevalence, trends, and patterns of
drug use, associated beliefs and attitudes, and related affective, cognitive, and
behavioral characteristics among children, adolescents, young adults, and older
populations.

2.  Studies that document and attempt to account for phenomena such as the
resurgence of drug use in the 1990s, emergence of new substances of abuse,
influences of new trafficking patterns, shifts in routes of administration, and
use of drugs in combination, particularly at the community or local area level. 
These studies should assess the nature and extent of newly identified drug
problems, characteristics of affected populations and individuals, impact on the
individual and the community, and factors which affect the spread of the problem.

3.  Studies of the natural history of substance use and abuse, multivariate
etiologic studies that examine the direct and mediating factors contributing to
or protecting against the initiation and/or escalation of drug use to dependence,
and studies examining patterns of drug use initiation, maintenance, escalation,
and discontinuation in general or defined populations.

4.  Studies that assess prevalence of drug abuse and dependence using specified
nosologic systems such as the DSM-III-R or DSM-IV, studies that examine the
comorbidity of drug-using behaviors and drug abuse disorders with psychiatric
disorders, and studies that examine risk and protective factors and co-factors
associated with these disorders and comorbid conditions.

5.  Multivariate studies that relate drug-using behaviors to factors representing
a variety of domains, including, but not limited to: genetic, social (e.g.,
family, peer group, community) and cultural, environmental, personality,
perinatal, developmental, psychopathological, cognitive, behavioral, affective,
and dispositional factors, as well as interactions among these factors.

6.  Studies focusing on the prevalence of drug use and associated impairment in
behaviors such as driving, parenting, job performance, etc.

7.  Studies focusing on drug use and associated behaviors and factors among
special populations such as runaways, abused and neglected children, teenage
mothers, pregnant women, ethnic minorities, school dropouts, institutionalized
persons, rural populations, juvenile and adult offenders, gays and lesbians,
veterans, the elderly, children of alcoholics/substance abusers, homeless
individuals and families, etc., especially when particular characteristics of
these groups are assessed to determine their specific association with drug use
patterns.

8.  Methodological studies of several types, including development and evaluation
of new data collection techniques and instruments, development and testing of
enhanced sampling strategies, refinement of imputation procedures, development
of more efficient estimators, development of innovative analytic procedures and
statistical models, and development and evaluation of procedures to determine and
reduce risk of disclosure of identifiable data in public use files.

9.  Studies to examine the validity of self-report based on the use of biological
markers, external records, or statistical models.

10.  Studies that address nonresponse in household and nonhousehold populations,
including usefulness of incentives and development of improved nonresponse
adjustment procedures using state-of-the-art statistical methods.

11.  Studies addressing other related substantive or methodological issues using
secondary analysis of existing data.

International studies on similarities and variations in drug abuse behaviors,
factors influencing the initiation, progression, and cessation of drug abuse, and
social and health consequences of drug abuse including HIV transmission.

Studies on the role of environmental factors including social, cultural,
political and economic factors on drug use behaviors in different national and
regional contexts.

Additional information about the epidemiologic research program will be posted
on the homepage of the Division of Epidemiology and Prevention Research, NIDA
located at:  http://www.drugabuse.gov/about/organization/DESPR/DESPRHome.html.

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 were published in the Federal Register of March 28, 1994 (FR 59
14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11,
March 18, 1994.

NIH POLICY AND GUIDELINES ON THE 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 website:
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 the
NIDA Home Page at http://www.nida.nih.gov/, 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:
[email protected].  The title and number of the program announcement 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 in accordance with the
standard peer review procedures.  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

The goals of NIH-supported research are to advance the 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.

(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:

- 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.

- The reasonableness of the proposed budget and duration in relation to the
proposed research.

- 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 all 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.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.

Direct inquiries regarding the programmatic issues to:

Arthur Hughes and James Colliver, Ph.D.
Division of Epidemiology and Prevention Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 9A-53
Rockville, MD 20857
Telephone:  (301) 443-6637
Email:  [email protected] and [email protected]

Direct inquires regarding fiscal issues 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
Email:  [email protected]

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 78410), as amended by Public Law 99-158, 42 USC 241
and 285), and administered under PHS grant 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 strongly encourages all grant recipients to provide a
smoke-free workplace and promote the nonuse 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 of 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)