Full Text PA-95-059

LOCAL POPULATION/AREA EPIDEMIOLOGIC RESEARCH ON DRUG ABUSE

NIH GUIDE, Volume 24, Number 15, April 28, 1995

PA NUMBER:  PA-95-059

P.T.


Keywords: 


National Institute on Drug Abuse

PURPOSE

The purpose of this program announcement is to encourage research on
the local population/area epidemiology of drug abuse and its
correlates and consequences.

HEALTH 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, Local Population/Area Epidemiologic Research on Drug
Abuse, is primarily 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
202-783-3238).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by foreign and 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 principal investigators.
Foreign institutions are not eligible for First Independent Research
Support and Transition (FIRST) (R29) awards.

MECHANISM OF SUPPORT

Research support mechanisms include research project grants (R01),
small grants (R03), and First Independent Research and Transition
(FIRST) (R29) awards.  Because the nature and scope of the research
proposed in response to this program announcement may vary, it is
anticipated that the size of an award will vary also.

Small grants provide research support of up to $50,000 per year in
direct costs plus appropriate indirect costs for up to two years.
FIRST awards provide support for five years and up to $350,000 in
direct costs over the entire project period.

RESEARCH OBJECTIVES

Background

Many national-level drug abuse epidemiologic studies have been
conducted to date, but at present, compelling public health needs
have mandated the development of a coordinated program of research on
the local-level population/area epidemiology of drug abuse and its
correlates and consequences.  Epidemiology, which is the study of
disease/health problems within and across populations and across
time, is both a method and a perspective that seeks to elucidate
factors associated with the causes of the disease/health problems as
well as with the progression of these problems and the variance in
their clinical manifestation.  These factors and their relationships
form "webs of causation," which need to be scrutinized through a mix
of epidemiologic research approaches.  In this respect, the need for
epidemiologic studies of local populations to determine underlying
connections between drug abuse, infectious diseases, and violence and
accidents was recognized at the recent (Nov 1994) White House
Conference on Health, Safety, and Food.

Various forms of local-level drug abuse epidemiologic research have
been undertaken in the past but rarely in a manner that coordinated
both quantitative (e.g., probability-based surveys) and qualitative
(e.g., "trained observational") approaches so as to maximize both
their unique contributions and their complementary/combined or
synergistic potential.  This program announcement encourages such
coordination.

Additionally, while the major focus of this program announcement is
on local drug abuse epidemiology, attention is encouraged on closer
coordination of epidemiology with, thus helping to guide, prevention
planning.  Such coordination has not been undertaken on a wide scale
and particularly with applicability for meeting local-level public
health needs.  Local-level applications of epidemiology together with
prevention will help to meet national-level public health needs.

"Local" in this case refers to the state level down to the community
level.  Community can be defined in census tract, mental health
catchment area and other geographic terms, as well as by demographic
terms, including cultural/racial groupings in defined local areas
(e.g., Hispanic or African American clusters in cities) and in
undefined geographic areas (e.g., Native Alaskan communities).
Community can also include groups designated by sexual orientation
(e.g., gays) in local geographic settings and also by numerous other
definitions.  Other terms for community include but are not limited
to "street-level," and "neighborhood."

The direction towards local population/area research, coupled with
better coordinated quantitative and qualitative research approaches
and with epidemiology more closely allied with and helping to direct
the dispersal of prevention resources, is important now as never
before, especially considering the public health prominence of drug
abuse and related correlates and consequences such as AIDS.  This
direction is also important because, in an era of both pressing
public health needs and major budget constraints, resource
distribution needs to be guided more efficiently.

Investigators are encouraged to build on existing locally-based
initiatives such as the Community Epidemiology Work Group (CEWG)
sites, Drug Use Forecasting (DUF) sites, Center for Substance Abuse
Prevention (CSAP)-funded Community Coalitions, and AIDS outreach
community systems.

Program Description

Two areas of research are sought through this program announcement.
These areas include methodological and content research as applied to
the local population/area epidemiology of drug abuse and its
associated problems.  Examples of the research areas to be addressed
are provided below.

Research Areas:  Methodology and Content

Applications are encouraged that focus on methodological research
dealing with improving our means (e.g., cross-sectional versus
longitudinal survey approaches) for determining the epidemiology of
local-level drug abuse and related problems.

Applications are also encouraged that concern "content" or the
determination of specific epidemiologic patterns of local drug abuse
and associated problems (e.g., transitions from non-injecting to
injecting drug use and vice versa among African Americans, Hispanics,
and whites in designated inner city areas; implications for the
spread of HIV or violence and crime).

The areas of methodology and content are not meant to be mutually
exclusive, however, and creative applications are encouraged that
address in a coordinated manner the need for better information in
both areas.

Additionally, methodological and/or content studies are encouraged
that strengthen bridge-building and coordination between local
population/area epidemiology and prevention.  Such enhanced
coordination, particularly in light of special public health problems
such as drug abuse's high association with AIDS and violence, is of
great importance.  Researchers are thus encouraged to test new
methods or new combinations of methods that meet the need for greater
understanding the epidemiology of these problems and their
interrelationships at the local level and with attention paid to how
epidemiology may guide prevention.

The following are intended as examples of areas of research interest:

Methodology

o  Refine and strengthen the procedures and parameters for both
determining and predicting local population/area drug abuse
epidemiology.

o  Refine our understanding of the strengths and weaknesses of
quantitative and qualitative research methodologies.

a.  Clarify the appropriateness and applications of quantitative
methods to provide accurate incidence, prevalence, trend, and
predictive estimates of local population/area drug abuse and its
correlates and consequences.

b.  Clarify the appropriateness and applications of qualitative
methods, both to provide

1.  an in-depth knowledge of behavior (e.g., quantitative surveys
have looked at needle sharing behavior among drug users but
apparently have ignored and/or been unable to obtain information on
needle sharing between drug users and their sexual partners; this is
the kind of difficult-to-obtain information necessary for
understanding local drug use patterns that can be provided through
qualitative methods); and

2.  a critical bridgehead into local populations/areas that can then
be exploited by quantitative methods (e.g., the original
NIDA-supported R01 AIDS outreach research that combined qualitative
and quantitative methods to develop epidemiologically-targeted and
assessed prevention).

o  Issues of research design, dealing with cross-sectional versus
longitudinal approaches for local-level drug abuse epidemiologic
research should be explored.

o  In both quantitative and qualitative research methodologies,
issues of precision, reliability, and validity of measures (e.g.,
self-report) should be explored.

o  In methodological research on both quantitative and qualitative
approaches, special emphasis should be placed on how to accurately
determine race, gender, socio-economic status, community, culture,
and other social and structural variables associated singly or in
combination (e.g., "webs of causation") with the epidemiology of drug
abuse and its correlates and consequences at the local level.
Special research emphasis should be placed on women, minorities, and
youth.

o  The use of alternative/complementary measures (e.g., "molecular
epidemiology":  polymerase chain reaction (PCR), which enables us to
determine needle sharing behavior and HIV status independent of, and
confirmatory to, self report) and their application to local drug
abuse epidemiology should be explored.

o  Methodological studies are needed that investigate both separate
use and integration of such various data elements as

a.  indicator data, including:  data from direct measurement (e.g.,
blood and urine samples, psychological exams), data from indirect
measurement (e.g., "ecological" indicators--census and vital
statistics data)

b.  observational data (e.g., ethnographic studies)

c.  survey data

d.  modeling data, which can integrate indicator, observational, and
survey data.

o  Methodological studies should be conducted to develop instruments
that are comparable between areas and between populations.
Geographic and demographic comparability is essential for the
efficacious and equitable allocation (i.e., targeting) of prevention
resources to local areas and populations.

o  Methodological studies should be conducted to specifically address
the issue of human subjects protection.  This is no small issue but,
indeed, grows bigger as the defined area and/or population grow
smaller.  Drug abuse, itself, and related problems such as AIDS carry
serious social stigma. The more delimited the geographic area and/or
demographic group, the greater risk of serious leaks of personal
information and compromise of human subjects protection agreements.
Such leaks can happen directly, as in the case of an acquaintance of
a drug user seeing them go into a test site.  Leaks can happen
indirectly, as in the case of rural drug abuse and AIDS in a southern
state, where, because of the public publication of vital statistics
data, direct pin-pointing of HIV positive drug users in small
communities was undertaken by non-public health persons.

Content

o  Describe incidence, prevalence, trends and predictions of drug
abuse patterns and related problems (e.g., HIV, crime, violence) and
associated high-risk behavior (e.g., needle sharing, sex for crack),
in local populations and areas.

o  Explore different forms of local drug use (e.g., non-injecting,
injecting) and the dynamics contributing to the prevalence of one
form versus the other, the transition/evolution from one form to
another, and the cessation of drug use (e.g., through death,
treatment, prevention, "natural recovery").  Special emphasis should
be placed on determining not only risk factors for various forms of
drug use but protective factors as well.

o  Identify situational factors (e.g., shooting galleries, crack
houses, economically depressed areas, prisons, migrant camps) that
contribute to varying patterns of local drug use and associated
problems.

o  Delineate the role of social and structural factors (e.g.,
community, culture, socio-economic status, race, gender), separately
or in combination (e.g., "webs of causation") in the epidemiology of
local drug use and its correlates and consequences.

o  Specify the role of cognitive processes (e.g., decision making) in
local drug use and associated risk taking.

o  Identify the role of economic forces (e.g., "supply" and
"demand"), and social and political forces (e.g., strong grass roots
and governmental opposition to the drug trade and drug use) in local
drug use epidemiology.

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 new policy results
from the NIH Revitalization Act of 1993 (Section 492B of Public Law
103-43) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations) which
have been in effect since 1990. The new policy contains some new
provisions that are substantially different from the 1990 policies.

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 reprinted
in the NIH GUIDE FOR GRANTS AND CONTRACTS of March 18, 1994, Volume
23, Number 11.

Investigators may obtain copies from these sources or from the
program staff or contact person listed under INQUIRIES.  Program
staff may also provide additional relevant information concerning the
policy.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) and will be accepted at the standard receipt dates
indicated in the application kit.  Application kits are available at
most institutional offices of sponsored research and may be obtained
from the Office of Grants Information, Division of Research Grants,
National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD
20892, telephone 301/435-0714.  The title and number of the program
announcement must be typed in Section 2a on the face page of the
application.

FIRST applications must include at least three sealed letters of
reference attached to the face page of the original application.
FIRST applications submitted without the required number of reference
letters will be considered incomplete and will be returned without
review.

The completed original application and five legible copies must be
sent or delivered to:

Division of Research Grants
National Institutes of Health
6701 Rockledge Drive, Room 1040 - MSC 7710
Bethesda, MD  20892-7710*
Bethesda, MD  20817 (for express/overnight delivery service)

REVIEW CONSIDERATIONS

Applications that are complete and responsive to the program
announcement will be evaluated for scientific and technical merit by
an appropriate peer review group convened in accordance with standard
NIH 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 the applications under review will
be discussed, assigned a priority score, and receive a second level
review by the appropriate national advisory council or board.  Small
grants (R03) do not receive a second level review.

Review Criteria

o  Scientific or technical significance and originality of the
proposed research;

o  Appropriateness and adequacy of the research approach and
methodology proposed to carry out the research;

o  Qualifications and research experience of the Principal
Investigator and staff;

o  Availability of resources necessary to the research;

o  Appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

The initial review group will also examine the provisions for the
protection of human and animal subjects, and safety of the research
environment.

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to the NIDA.  The following will be considered
in making funding decisions:  quality of the proposed project as
determined by the 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 on the scientific and programmatic aspects to:

Peter Hartsock, Dr.P.H.
Division of Epidemiology and Prevention Research
National Institute on Drug Abuse
5600 Fishers Lane, Room 9A-53
Rockville, MD  20857
Telephone:  (301) 443-6720
Email:  ph45z@nih.gov

Direct inquiries regarding fiscal matters related to drug abuse
relevant studies to:

Dr. Gary Fleming
Grants Management Branch
National Institute on Drug Abuse
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-6710
Email:  gfleming@aoada2.ssw.dhhs.gov

AUTHORITIES AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistant No. 93.279.  Awards are made under authorization of the
Public Health Service Act, Section 301, and administered under PHS
policies and Federal Regulations at 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.

Grants must be administered in accordance with the Public Health
Service Grants Policy Statement (DHHS Publication No. (OASH)
82-50-000 GPO 0017-020-0090-1 (rev. 4/94).

The PHS strongly encourages all grant and contract 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 routing 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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