DRUG USE AND RELATED ADVERSE BEHAVIORAL AND SOCIAL CONSEQUENCES

Release Date:  June 14, 1999

PA NUMBER:  PA-99-113 (see replacement PA-04-100)

National Institute on Drug Abuse

THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

Drug-related behavioral and social consequences are complex, interrelated
problems that significantly affect the Nation's public health.  The purpose of
this program announcement (PA) is to stimulate research on behavioral and
social adverse consequences of drug use and/or abuse. It is intended to
elucidate the nature and extent of drug-related consequences and their
development.  An understanding of the full range of these consequences and the
factors that contribute to or protect against these consequences is essential
to the development of effective prevention programs.  This announcement
encourages local, national, and international research on community/contextual
and individual level risk and protective factors and processes that influence
drug use and/or abuse and their consequences.

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 PA 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. 017-001-0047400 or Summary
Report: Stock No. 017-001-0047301) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone
202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and/or foreign for-profit and
nonprofit organizations, public and private, such as universities, colleges,
hospitals, and 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.

MECHANISM OF SUPPORT

Support mechanisms include: Project Grants (R01), Small Grants (R03), and
Exploratory Grants (R21).  Because the nature and scope of the research
proposed in this PA may vary, it is anticipated that the size of an award will
vary also.

Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and  detailed instructions and information on Modular Grant
applications can be found at
http://www.nih.gov/grants/funding/modular/modular.htm

RESEARCH OBJECTIVES

Summary

The major goal of this PA is to enhance the understanding of the relationships
between drug use and/or abuse and their associated adverse behavioral and
social consequences.  In order to achieve this goal, it has become evident
that studies of the adverse social and behavioral consequences of drug use
and/or abuse need to integrate both community and individual level factors. 
As used here, community is defined in its broadest sense to include social
groups comprised of individuals who have formed attachments based on a variety
of shared factors, such as, beliefs and values, race and ethnicity, and
territory (e.g., neighborhood).  Researchers need to examine individual
behavior in the context of community membership, recognizing that an
individual may be part of many different social groups/communities at any
given time and subject to multiple social influences.  For example, while
living in a particular neighborhood may put adolescents at risk for drug abuse
and gang associated activity, strong ties to religious groups or extended
family may exert protective effects.

Behavioral consequences of interest include, but are not limited to,
educational and occupational problems (illiteracy, school dropout,
unemployment, job absenteeism and turnover), individual criminal activities
(violence, vandalism, homicides, sexual abuse, delinquency), and other
comorbid conditions (mental illness, injuries/accidents, overdoses).  Social
consequences of drug use include poverty, dysfunctional neighborhoods,
homelessness, gang activities, drug trafficking and distribution systems, and
family disruption and dislocation (family violence, divorce).

Background

Over the long term, the consequences of drug use and/or abuse in society take
a profound toll on families, schools, and other community institutions and
burden the criminal justice, health care, and social welfare systems. 
Understanding the underlying mechanisms that foster drug-related consequences
and assessing their impact on individuals' quality of life and on society need
to be studied further in order to facilitate the formulation of effective
prevention interventions.  The costs to society cannot be measured solely by
economic costs--there are human costs of disrupted families, dysfunctional
neighborhoods, injury and loss of life.  In particular, the effects of
substance use and/or abuse adversely impact society's youth and
disproportionately affect the Nation's ethnic and racial minority populations. 
Evidence has shown that not only does drug abuse have detrimental effects on
adolescent lives but also has adverse ramifications for their transition into
adulthood (e.g., marriage, continuity of employment, criminal activities,
parenting behavior). The existence of persistent relationships between drug
use and abuse and other behavioral, social, and environmental factors has been
known for several decades.  Researchers have identified links between drug
use, drug abuse, and other phenomena, including illiteracy, poverty, sexual
abuse, and work-related problems.  Moreover, such research initiatives have
led to a better understanding of these relationships and provided empirical
evidence of links between high levels of drug involvement and social and
behavioral dysfunction/problems.  Despite such progress, there are substantial
gaps in our knowledge about the connections between drug abuse and these
behavioral and social phenomena.

Because substance use and abuse among adolescents adversely affects the
developmental course of large numbers of society's youth, studies of
adolescents are of special interest.  The Nation's ethnic and racial minority
populations and out-of-treatment subgroups in both rural and urban communities
disproportionately suffer adverse consequences of drug use and abuse, so this
announcement encourages research focusing on these groups.  In addition,
inasmuch as research is beginning to show that the social and behavioral
consequences of drug abuse are often different for males and females,
investigators are urged to take a gender perspective in their research design.

Research Areas

This PA is intended to stimulate research from many diverse disciplines
(including, but not limited to, epidemiology, prevention, anthropology,
sociology, psychology, public health).  Moreover, multi-disciplinary and
interdisciplinary research approaches to advance the scientific knowledge base
of drug use and abuse and its co-occurring behavioral and social consequences
are encouraged.  This research initiative also encourages exploring the role
of individual level characteristics along with community factors (i.e., macro
level) in predisposing or protecting individuals from adverse drug-related
consequences.  Social contexts of interest include family relationships,
intimate partner and marital relationships, social networks, peers, schools,
workplace settings, and other social institutions.

For example, many previous research projects have examined adolescent drug use
by focusing on individual level factors (risk and protective factors), but
broader environmental factors (such as social structural factors and social
capital) need to be integrated in new research initiatives.  However, it has
been suggested that neighborhoods characterized by high levels of social
disorganization increase the potential for the emergence of illegitimate
opportunity structures,  such as drug markets and dysfunctional lifestyles
(e.g., drug use and/or abuse, school dropout, unemployment).  Yet, the
majority of youth growing up in socially disadvantaged neighborhoods manage to
reach maturity without serious involvement in drug use.  Research is needed to
link structural and environmental characteristics with individual level
characteristics and specific behavioral outcomes to better understand both
risk and resiliency.

Additionally, studies that strengthen the link between epidemiology and
prevention of drug-related consequences are strongly encouraged.  Researchers
are thus invited to test new methods or new combinations of methods that
address the need for a better understanding of the epidemiology of these
problems and how epidemiology may guide prevention.  Applications are
encouraged that focus on improving our means for efficient monitoring of the
epidemiology of drug-related consequences and the formulation and evaluation
of efficient prevention interventions.  Epidemiologic studies of diverse
populations are needed to determine the underlying factors and stability of
the connections between drug use and drug abuse and their related behavioral
and social consequences.  For example, although various forms of epidemiologic
research on consequences of drug use have been undertaken in the past, typical
efforts rarely attempted to integrate quantitative and qualitative approaches
to maximize both their unique contributions and their complementary/combined
or synergistic potential.  This PA  encourages collaborative efforts among
these two different research orientations along with other research
specialties to help guide a multidisciplinary approach to drug-related
consequences prevention planning (i.e., development, implementation, and
evaluation).

To this end, NIDA will support the following kinds of studies:

(1) National, and local-level community epidemiology studies to document and
monitor trends in the nature, extent, and patterns of co-occurring drug use
and/or abuse (including polydrug use) and drug-related behavioral and social
consequences in general and in special populations;

(2) Studies of the common and unique risk/protective antecedents (at
individual and contextual level) and correlates of co-occurring and sequential
behavioral and social consequences;

(3) Studies that attempt to specify and test causal pathways of drug use
and/or abuse and drug-related consequences, as well as their temporal
stability and generalizability across subpopulation groups and life stage
(developmental stage/transitions)

(4) Evaluation studies of theoretically-based prevention interventions to
reduce/prevent adverse drug-related consequences;

(5) Studies that perform secondary analysis of current data sets pertaining to
drug use and/or abuse, crime, drug trafficking/distribution systems, and other
drug-related consequences (including cost-of-illness studies)

(6) Methodological studies to improve the measurement, data collection, and
analysis of drug use and drug abuse and their complex array of co-occurring
behavioral and social consequences; and

(7) Research on drug-related consequences among ethnic/racial minority groups
and other underserved populations.  Underserved populations include, but are
not limited to, school dropouts, gang members, children of drug users, the
homeless, migrant groups, recent immigrant groups, the unemployed or working
poor, the elderly, veterans, incarcerated adults and juveniles, the mentally
ill, or other vulnerable groups.

Examples of research topics include:

Examining the strength and consistency of the relationships, the dynamic
sequencing of life events, and the persistence of connections between drug use
and/or abuse and dysfunctional behavior (e.g., deviance).  Such efforts might
explore whether certain phenomena have only episodic or transitory connections
to drug use and/or abuse.

Exploring the connections among such factors as unemployment and poverty, and
the development of drug abuse careers within families and communities.

Gang membership, juvenile drug use and abuse, and the escalation of juvenile
criminal activities.

Effects of incarceration of large numbers of community members (for drug-
related offenses) on the social structure of the community.

Interrelationship between drug use and/or abuse and deviant-prone lifestyle,
particularly in adolescents and young adults.

Relationship between specific patterns of drug use and/or abuse and associated
consequences.

Effects of changes in trafficking patterns and drug distribution networks on
individual drug use and/or abuse within communities.

Adapt/integrate theoretically sound drug abuse prevention approaches with
interventions directed at drug-related consequences (e.g., criminal
activities, educational and occupational achievement).

Identification of situational/contextual factors that contribute to varying
patterns of local drug use and/or abuse.

Identification of potential adverse behavioral consequences associated with
abuse of prescription and over-the-counter medications and dietary
supplements.

Role of drug use and/or abuse in aggressive and violent behavior including
sexual assault, victimization, elder abuse, school and workplace violence.

Influence of laws and law enforcement and the criminal justice system on
decision-making and behavior change.

Socioenvironmental influences that explore the complex inter-relationships
among economic, cultural, social, and environmental influences on drug use
and/or abuse and their consequences.

Interventions that utilize community resources and organizations (e.g.,
workplace, churches, etc.).

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 are 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 20, 1994 (FR 59 14508-14513) and in
the NIH Guide for Grants and Contracts, Volume 23, Number 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 subject research, conducted or supported by the
NIH, unless there are scientific and/or 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 of the Council before
submitting an application that will administer compounds to human subjects. 
The guidelines are available on NIDA's Home Page at www.nida.nih.gov under
Funding or may be obtained by calling (301) 443-2755.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398
(revised 4/98) 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 Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda MD 20892-7910, telephone
301-435-0714, E-mail:  GrantsInfo@nih.gov; and from the program official
listed under INQUIRIES.  The PA title and number must be typed on section 2 of
the face page of the application form.

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

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DR. ROOM 1040, MSC 7710
BETHESDA MD 20892-7710
BETHESDA, MD  20817 (for express/overnight courier service)

The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach.  The
just-in-time concept allows applicants to submit certain information only when
there is a possibility for an award. It is anticipated that these changes will
reduce the administrative burden for the applicants, reviewers and Institute
staff.  The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for  these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications  will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year. (Applications that
request more than $250,000 direct costs in any year must follow the
traditional PHS 398 application instructions.)  The total direct costs must be
requested  in accordance with the  program guidelines and  the modifications
made to the standard  PHS 398 application  instructions described below:

PHS 398

o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required and
will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See http://www.nih.gov/grants/funding/modular/modular.htm for sample
pages.) At the top of the page, enter the total direct costs requested for
each year.  This is not a Form page.

o Under Personnel, List key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language 
salary cap and the NIH policy for graduate student compensation in developing
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the nearest
$1,000. List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project. Indicate whether the collaborating institution is foreign or
domestic. The total cost for a consortium/contractual arrangement is included
in the overall requested modular direct cost amount.  Include the Letter of
Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for all
key personnel, following the instructions below. No more than three pages may
be used for each person. A sample biographical sketch may be viewed at: 
http://www.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
- List selected peer-reviewed publications, with full citations;

o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the type
of agreement and the date. All appropriate exclusions must be applied  in the
calculation of the F&A costs for the initial budget period and all future
budget years.

o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established referral guidelines. 
Applications will be evaluated for scientific and technical merit by an
appropriate peer review group convened in accordance with the 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 applications under review, will be discussed, assigned a priority
score, and receive a second level review by the appropriate national advisory
council or board, when applicable.

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 review, comments on the following aspects of the application will
be made 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 the assignment of 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
methods?  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, and 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, or justification for exclusion.  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

Awards will be made based on scientific merit as determined by peer review, on
programmatic priorities, and on the availability of funds.

INQUIRIES

Written, E-mail, and telephone inquiries concerning this PA are encouraged. 
The opportunity to clarify any issues or questions from potential applicants
is welcomed.

Direct inquires regarding programmatic issues to:

Jacques Normand, Ph.D.
Community Research Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 5160, MSC 9589
Bethesda, MD  20892-9589
Telephone:  (301) 443-6720
FAX:  (301) 480-4544
Email:  JN86a@NIH.GOV

Direct inquiries regarding fiscal matters to:

Jack Manischewitz, Ph.D.
Grants Management Branch, OPRM
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  jmanisch@ngmsmtp.nida.nih.govjmanisch@ngmsmtp.nida.nih.gov

Direct inquiries regarding review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Program Review
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3158, MSC 9547
Bethesda, MD  20892-9547
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tl25u@nih.gov

The National Institute on Aging (NIA) has released a program announcement on
Diversity in Medication Use and Outcomes in Aging Populations (PA-99-097),
which identifies several areas of research of relevance to this program
announcement.  NIA is interested in research on drug-related behavior and
social consequences as they apply to middle-aged and older populations.  We
support both basic and applied research on how individual and population aging
interact with other contextual factors to affect people's risk factors,
treatment options, and health-related outcomes associated with drug use and
abuse.  For further information on this NIA initiative contact Dr. Marcia Ory
at telephone: 301/402-4156 or email: Marcia_Ory@nih.gov.

Although not a participant in the program announcement, the National Institute
of Mental Health (NIMH) is interested in research on risk for, and prevention
of mental disorders co-morbid with other disorders, as well as research on the
functional consequences of co-occurring disorders.  For further information
contact Karen Bourdon at 301-443-5944.

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 Part 52 and CFR Part 74.  This program is not subject to
the intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.

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 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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