Full Text PA-95-072


NIH GUIDE, Volume 24, Number 2, June 16, 1995

PA NUMBER:  PA-95-072

P.T. 34

  Drugs/Drug Abuse 

National Institute on Drug Abuse


The purpose of this program announcement is to stimulate
international research 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.  This program initiative expands
and advances the study of the interrelationship of the agent, host,
and environment to include environments across and within different
countries.  Increased understanding of the role of social, cultural,
political and economic factors on drug abuse behaviors, obtained by
examining configurations of these factors in varying national and
regional environments, is sought.  Comparative studies with U.S.
populations are encouraged.


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, International Research on the Epidemiology of 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


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 or local
governments, and eligible agencies of the Federal government.  Women
and minority investigators are encouraged to apply.  Foreign
institutions are not eligible for the First Independent Research
Support and Transition (FIRST) (R29) award.


The mechanisms available for support of this program announcement are
the research project grant (R01), small grant (R03), and FIRST (R29)

There are special requirements for the R03 and FIRST mechanisms.
Applicants intending to apply for either of these mechanisms should
contact the program person listed under INQUIRIES for further
information.  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.  Potential applicants
should contact the program staff listed under INQUIRIES for further

Research project grants (R01) provide support for up to five years
for domestic grants and for domestic grants with foreign components;
for research project grants to foreign institutions, the initial
project period and each competitive segment thereafter may be awarded
for up to three years.  Small grants (R03) provide research support
of up to $50,000 per year in direct costs plus appropriate indirect
costs for up to two years.  FIRST awards (R29) provide support for
five years and up to $350,000 in direct costs for the entire project


Background and Significance

Once considered an "American Disease," drug abuse is now recognized
as a global problem that is having an increasingly negative impact on
emerging as well as developing countries.  The political and economic
changes that have been taking place over the past 10 years have
resulted in increases in cross-border and cross-national
communication and commerce.  These changes, in turn, have had a major
impact on drug abuse, including manufacture and production,
trafficking patterns, drug use patterns, and consequences.

Political and economic conditions and events in other
countries/regions often directly impact the U.S. population through
large influxes of new populations.  U.S. border populations are
directly affected by public health issues, as well as economic and
political conditions, in Mexico and Canada.  Furthermore, there is
increasing evidence that the U.S., once the trend-setter in emerging
new drug abuse patterns, is becoming the recipient of such behaviors
(e.g., the use of flunitrazepam (Rohypnol or "rophies") and drug use
at "rave" scenes).

These changing conditions, as well as the expanded knowledge base for
understanding the dynamic nature of drug abuse and the increased
sophistication of the methodological tools for conducting
epidemiologic research, make this an opportune time for an
international epidemiologic research initiative.

Finally, cross-national studies offer opportunities to examine the
direction and strength of interrelationships between agent, host, and
environment in different cultural and political settings.

The following definitions and examples may be used in conceptualizing
research questions.  "Nation" or "national" refers to a political
state or country.  "Cross-national" refers to two or more countries,
not necessarily geographically proximate.  "International" refers to
that which transcends national limits; with regard to this program
announcement, "international" studies could include single country
projects focussed on research concepts of relevance to more than one
country such as, for example, the impact of childhood traumatic
experience on subsequent drug use, or could include projects
examining research questions in two or more countries.  "Border"
refers to the geopolitical boundary between countries.  Residents of
border areas may constitute unique populations while having different
national identities.  For example, research in the area of the U.S.
Mexico Border suggests that drug use patterns among populations on
each side of the border are more similar to each other than either is
to the U.S. or Mexican general populations.  "Region" refers to a
geographically circumscribed area including two or more proximate
countries.  Drug abuse patterns in a country may be influenced by
factors such as drug production, trafficking, laws, enforcement, and
political and economic instability in neighboring countries.

Program Objectives

The primary goal of this program announcement is to improve the
knowledge base on the similarities and variations in drug using
behaviors in different national and regional environments with the
goal of gaining a better understanding of the influence of
environmental factors including social, cultural, political, and
economic variables on the initiation, progression, and cessation of
drug using behavior and on the social and health consequences of the
behaviors including HIV transmission.  Very little drug abuse
epidemiologic research has been conducted outside the U.S.;
theoretical models and related epidemiologic research instruments
pertaining to vulnerability, resiliency, drug use progression, and
health and social consequences have primarily been based on research
conducted in U.S. populations.  Research on minority populations
within the U.S. has revealed wide variation in patterns of drug use
among different ethnic/racial sub-groups and has highlighted the
influence of social, economic, and cultural variables on drug using

This program announcement encourages the use of international
research to provide a broader context for the examination of social
and cultural variables as well as the opportunity for assessing these
variables in differing political and economic environments.
Comparative studies with U.S. populations and the assessment of the
cross-cultural applicability of theoretical models and epidemiologic
instruments are encouraged.  Studies are also sought that investigate
mediating and protective factors and processes in populations with
very low drug use where results could be used to help in the
development of effective prevention methods that could be transferred
or adapted to populations where drug abuse is more prevalent.
Methodological studies assessing the impact of social, cultural,
political, and economic factors on the accuracy, collection, and
reporting of epidemiologic data are also encouraged under this
program announcement.

Studies should focus on hypothesis generation and testing.
Quantitative and/or systematic qualitative methodological approaches
may be used, as appropriate.  All applications should address project
feasibility, collaborative arrangements, study design, sampling
procedures, instrumentation, measurement, data collection, quality
control, follow-up, and data analysis, as appropriate.  If research
is to be conducted in two or more countries, applicants must address
project implementation for each site and describe procedures to
ensure data comparability across sites.

Applications should also describe how the project presents special
opportunities for furthering the field of drug abuse epidemiology
through the use of unique resources, populations, or environmental
conditions in other countries and explain how the project has the
potential to advance knowledge in the field of drug abuse that will
benefit the United States.

Examples of areas of research interest include, but are not limited
to, the following:

o  The influence of socioeconomic and political factors on the
availability of illicit drugs, on patterns of drug use, and
differences by gender.  This includes the effect of cross-border free
trade on illicit drug availability, perception of availability, and
drug use patterns.  Studies of drug use patterns and determinants
along the U.S./Mexico and U.S./Canada borders are encouraged;

o  The impact of drug production and drug trafficking patterns and
mechanisms on the spread of drugs between countries or regions and on
the initiation of drug use in specific populations;

o  The extent to which cultural factors such as attitudes, beliefs,
perceptions, norms, and religion determine or influence drug use
patterns, description of the nature of these relationships, and
assessment of differences by gender;

o  In countries where there is a tradition of a particular pattern of
drug use (such as opium smoking among older men in Thailand or Laos),
identification of factors that alter the nature and extent of such
use (i.e., use documented among young men or women), and/or introduce
new forms or types of drug use (e.g., heroin intravenous use);

o  For countries with several ethnic groups, description of the
patterns of drug use among these groups and identification of the
determinants of the behaviors;

o  Drug use patterns within special populations such as (1) refugee
populations displaced by political instability, unrest, persecution,
or war, (2) seasonal cross-national migrant workers, (3) homeless
children, or (4) children working in the streets;

o  The impact of migration (rural to urban and cross-national) on
drug use including the extent to which migration history (1st, 2nd
and 3rd generation) or acculturation play a role in drug using
patterns.  With cross-national migration, comparison of patterns of
drug use in country of origin with populations that migrated out of
the country.  Studies comparing drug use patterns, determinants, and
consequences in U.S. ethnic minority populations with drug use
patterns, determinants, and consequences in the country of origin are
encouraged.  Studies of mediating and protective factors in these
populations are also encouraged;

o  Similarities and differences in the pathways and distal and
proximal determinants for the initiation, progression and maintenance
of comparable drug using behaviors across countries;

o  The impact of traumatic (political/economic/familial) childhood
experiences on subsequent drug abuse and, among vulnerable
populations, mediating factors that protect against initiation or
progression of drug abuse;

o  The extent to which variations in modes of administration of drugs
of abuse, such as heroin and cocaine, have differential physical,
health, social and psychological consequences in different national

o  The influence of social, cultural, political, and economic factors
on the relationship between drug use and HIV transmission.  How
injecting practices and needle sharing behaviors differ among
subgroups of drug users in different national environments;

o  How abusers with similar patterns of drug use and similar
characteristics in different countries seek treatment for drug abuse
and drug abuse consequences;

o  Cross-cultural validity of epidemiologic instruments; The impact
of social, cultural, political, and economic factors on the accuracy,
collection, and reporting of drug abuse epidemiologic data.  Examples
of possible variables include trust in government or authority, legal
sanctions on behaviors, religious proscriptions pertaining to
substance use, and social or religious barriers to accessing specific
populations such as women or ethnic minorities.


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 below.  Program staff may also
provide additional relevant information concerning the policy.


Applications are to be submitted, in English, on the grant
application form PHS 398 (rev. 9/91) and will be accepted at the
standard application deadlines as indicated in the application kit.
Application kits are available at most institutional business offices
or from the Office of Grants Information, Division of Research
Grants, National Institutes of Health, 6701 Rockledge Drive, Suite
3032 - MSC 7762, Bethesda, MD 20892-7762, telephone 301/435-0714.
The title and number of the program announcement must be typed in
Item 2a of face page of the application.

FIRST (R29) award applications must include at least three sealed
letters of reference attached to the face page of the original
application.  FIRST award 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:

6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710
BETHESDA, MD  20892-7710
BETHESDA, MD  20817 (for express/courier service)


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
established NIH referral guidelines.  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 and assigned a priority score and will
receive a second level of review by the appropriate national advisory
council or board.

Review Criteria

o  scientific, technical, or medical significance and originality of
proposed research;

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

o  qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  availability of the resources necessary to perform the research;

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

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

The initial review group will also examine the provision of the
protection of human and animal subjects, and safety of the research


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 the peer
review, availability of funds, and program priority.


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

Direct inquiries regarding the programmatic issues to:

Moira O'Brien
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:  mobrien@aoada2.ssw.dhhs.gov

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:  gfleming@aoada.ssw.dhhs.gov


This program is described in the Catalog of Federal Domestic
Assistance No. 93.279.  Awards are made under authorization of
Section 301 of the Public Health Service Act (42 USC 241) and
administered under PHS policies and Federal Regulations at Title 42
CFR 52 "Grants for Research Projects,"  Title 45 CFR Part 74 and 92,
"Administration of Grants" and 45 CFR Part 46, "Protection of Human
Subjects".  This program is not subject to the intergovernmental
review requirements of Executive Order 12372 or Health Systems Agency
review.  Sections of the Code of Federal Regulations are available in
booklet form from the U.S. Government Printing Office.

Grants must be administered in accordance with the PHS Grants Policy
Statement, (rev. 4/94), which may be available from your office of
sponsored research.

The Public Health Service 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 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.


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