Full Text AA-94-002

BIOMEDICAL AND BEHAVIORAL RESEARCH ON ALCOHOL AND YOUTH

NIH GUIDE, Volume 22, Number 36, October 8, 1993

RFA:  AA-94-002

P.T. 34, AA

Keywords: 
  Alcohol/Alcoholism 
  Behavioral/Social Studies/Service 
  Social Psychology 
  Disease Prevention+ 


National Institute on Alcohol Abuse and Alcoholism

Application Receipt Date:  January 12, 1994

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is
seeking research grant applications to study the development of
alcohol-related problems among youth, identify risk and protective
factors, and develop effective prevention and treatment
interventions.  This includes studies of the biological, behavioral,
and psychosocial causes and consequences of alcohol abuse among
youth.

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 Request
for Applications (RFA), Biomedical and behavioral Research on Alcohol
and Youth, is related to the priority areas of alcohol abuse
reduction and alcoholism treatment.  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

Applications may be submitted by domestic and foreign, public and
private, non-profit and for-profit organizations, such as
universities, colleges, hospitals, research institutes and
organizations, 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
First Independent Research Support and Transition (FIRST) Awards
(R29).
MECHANISMS OF SUPPORT

Research support may be obtained through applications for a regular
research grant (R01) or FIRST Award (R29).  Applicants for R01s may
request support for up to five years.  In FY 1992, the average total
cost per year for new R01s funded by NIAAA was approximately
$200,000.  Because the nature and scope of the research proposed in
response to this RFA may vary, it is anticipated that the size of an
award will vary also.  FIRST Award applications must be for five
years.  Total direct costs for the five-year period may not exceed
$350,000 or $100,000 in any one budget period.  FIRST Awards cannot
be renewed, but grantees may apply for R01 support to continue
research on the same topics.

Applicants for FIRST Awards may obtain copies of the FIRST program
announcement from the National Clearinghouse for Alcohol and Drug
Information, P.O. Box 2345, Rockville, Maryland 20852, telephone:
301-468-2600 or 1-800-729-6686.  Program project grants (P01) will
not be accepted for this RFA.

Applicants may submit Investigator-Initiated Interactive Research
Project Grants (IRPG).  Interactive Research Project Grants require
the coordinated submission of related research project grant (R01)
and, to a limited extent FIRST Award (R29) applications from
investigators who wish to collaborate on research, but do not require
extensive shared physical resources.  These applications must share a
common theme and describe the objectives and scientific importance of
the interchange of, for example, ideas, data, and materials among the
collaborating investigators.  A minimum of two independent
investigators with related research objectives may submit concurrent,
collaborative, cross-referenced individual R01 and R29 applications.
Applicants may be from one or several institutions.  Further
information on the IRPG mechanisms is available in program
announcement PA-93-078, NIH Guide for Grants and Contracts, Vol. 22,
No. 16, April 23, 1993.

FUNDS AVAILABLE

It is estimated that up to four million dollars in total will be
available for approximately 8 to 10 grants under this RFA in FY 1994.
This level of support is dependent on the receipt of a sufficient
number of applications of high scientific merit.  Although this
program is provided for in the financial plans of the NIAAA, the
award of grants pursuant to this RFA is also contingent upon the
availability of funds for this purpose.

RESEARCH OBJECTIVES

The objective of this RFA is to foster research that will lead to the
reduction in prevalence of alcohol problems among youth.  Such
research may address the underlying mechanisms through which alcohol
affects children and adolescents; identify risk factors and markers
predictive of various alcohol-related problems in youth; test models
of the development of alcohol-related problems and the mediation of
risk through interactions of genetic, individual, and environmental
factors; and develop and test interventions for the prevention and
treatment of alcohol-related problems in youth.

Background

While alcohol misuse presents a major risk for health and well-being
throughout the life span, the child may be especially vulnerable to
adverse effects both from direct exposure to alcohol and from the
consequences of others' alcohol abuse.  The presence of alcohol abuse
within the home environment is an important risk factor for the
development of social and behavioral problems, including alcoholism.
A variety of physical and behavioral problems follow directly from
exposure to alcohol.  Attitudes and expectancies regarding alcohol
use are established at a very early age and most persons first
experiment with alcohol use during childhood or adolescence.  Misuse
of alcohol by youth can have immediate devastating effects, including
traffic accidents and acute alcohol poisoning; can be associated with
other risky behaviors such as engaging in unprotected sex; can
interfere with school performance and contribute to a long term
pattern of poor social adjustment and failure; and can initiate a
lifetime pattern of alcohol abuse and dependence.  Genetic,
individual, and environmental factors may interact in determining
risk for these adverse outcomes. Effective age-appropriate prevention
and treatment interventions are essential, and increased
understanding of the nature, etiology, and mechanisms of alcohol-
related risks for youth is needed to inform such interventions.

Areas of Research Interest

For the purposes of this announcement, youth is considered to
encompass childhood through early young adulthood, or approximately
the ages 2 to 21.  Specific research methodologies may be appropriate
to basic biomedical, neuroscience, and behavioral studies,
epidemiology, or prevention and treatment research.  This may include
the use of immature animals for biomedical, neuroscience, and
behavioral studies.  Studies that test interventions or seek to
advance the transfer of basic research findings toward prevention or
treatment intervention applications are encouraged.  The following
list of topics is intended only to illustrate NIAAA interests; topics
not mentioned are not necessarily excluded from consideration.

o  Strategies to Prevent or Reduce Access to Alcohol by Youth and
Change Norms Regarding Its Use

Studies may examine the institution or change in level of enforcement
of laws, regulations and policies as they affect youth access to
alcohol and the acceptability of alcohol use. This includes, but is
not limited to, price changes, sales restrictions, enforcement of
minimum drinking age, per se laws, sanctions against drunk driving,
and campus and school policies.  Interventions not involving
legislative action may be investigator-initiated or interventions may
be naturally occurring through government or community initiation.

o  Neurobiology and Physiology of Alcohol in Youth and Adolescence

Studies are needed to develop animal models of the neurobiological
mechanisms of alcohol abuse and alcoholism in the developing organism
through its adolescence.  Studies are needed utilizing immature
animals for examining the cellular and molecular mechanisms of
alcohol seeking behavior, the acute and chronic consequences of
alcohol ingestion on the immature central nervous system, on the
neuroendocrine system (neuroendocrine-neurotransmitter interactions),
effects on hormonal activation, behavioral effects, and for
controlled studies of gene-environment interactions as they relate to
patterns of adolescent drinking.

o  Risk Taking Behaviors and Decision-Making

Studies may focus on the development of attitudes and expectancies
regarding alcohol use and their relationship to behavior; judgements
of risk by youth according to age and setting, and the meaning of
risk-taking for the individual; the role of alcohol in decisions
regarding risk-taking (e.g., sexual activity; driving after
drinking); and the development of interventions that will impact
adolescent decision-making regarding alcohol use and other risk
behaviors.

o  Evolution of Risk for Alcohol Problems Across Maturational Stages
and Development of Appropriate Interventions

Studies could address the incidence and prevalence of alcohol
problems according to family history, individual, and environmental
characteristics; the identification of risk and protective factors
specific to age or maturational level; the identification of
biological, behavioral, and environmental markers of risk; behavioral
genetic models of the evolution of risk as a cumulative and dynamic
interaction of genetic heritage, individual characteristics, and
environmental factors; and development and evaluation of prevention
interventions appropriate for specific age and risk levels (e.g.,
children of alcoholics; conduct disorder).

o  Development of Appropriate Interventions

Studies are needed to determine whether assessment methodologies and
behavioral strategies developed with alcoholic adults work with
adolescents who abuse alcohol. Research topics could include
development of methodologies to detect and assess early onset
alcoholism in adolescence, evaluation of whether there are specific
opportunity points to engage adolescents in alcoholism treatment,
evaluation of potential pharmacologic interventions that may deter
the development of alcohol dependence in problem drinking youth,
further understanding the role of the family in enhancing treatment
efficacy with adolescent alcohol abusers; identification of risk
factors and the responsivity of these factors to different
intervention strategies; and the development and evaluation of
treatment interventions for alcohol-dependent youth.

o  Role of the Family in Development and Moderation of
Alcohol-Related Risk

Studies could focus on identification of mechanisms for inter- and
intra-generational transmission of norms regarding alcohol use;
development of effective interventions to strengthen the family's
protective role; identification of high-risk families, based on
individual characteristics (e.g., presence of an alcoholic family
member) or demographic variables; development of appropriate
prevention or treatment interventions for high-risk families; and the
development of family-based prevention and treatment interventions
for high risk youth.

o  Alcohol-Related Violence and Youth

Studies could address the role of alcohol use in domestic violence,
including use by victims and perpetrators; effect of experiencing or
witnessing domestic or other violence on the child's subsequent risk
for alcohol-related problems; the role of alcohol in youth
involvement in violence outside the family, including sexual
aggression and victimization; biobehavioral, individual, and social
factors mediating alcohol-related violence; and the development of
prevention and treatment interventions to reduce alcohol-related
violence and to address special alcohol-related risks of young
victims of violence.

o  Effects of Alcohol Exposure in Youth

Research is needed to assess the extent of organ damage (e.g., liver,
heart, brain, pancreas, endocrine system, immune system, digestive
tract) and on other effects of alcohol on the developing child.
Further understanding of the mechanisms by which and the level of
drinking beyond which organ damage becomes irreversible is especially
important.  Given the prevalence of drinking among adolescents,
information is needed on the long-term effects of alcohol on
fertility and reproductive capability; interactions of alcohol
exposure with neurochemical, endocrine and neuroanatomical
developmental changes (e.g., onset of puberty); the interaction of
biological effects of alcohol and individual characteristics on
alcohol-seeking behavior (e.g., role of stress and corticosteroids);
the effects of alcohol on the central nervous system, including
cognitive and motor performance; indirect effects of alcohol use on
intellectual and social development as part of a constellation of
increasing risk, including the role of alcohol use in conduct
disorder, high-risk sexual activity, future alcohol use, and other
risk taking behaviors; treatments for acute alcohol intoxication in
youth; and methodologies to identify short-term symptomatic responses
to heavy alcohol consumption.

STUDY POPULATIONS

SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING
IMPLEMENTATION OF NIH POLICIES CONCERNING
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL
RESEARCH STUDY POPULATIONS

Applications for NIH grants and cooperative agreements are required
to include both women and minorities in study populations for
clinical research, unless compelling scientific or other
justification for not including either women or minorities is
provided.  This requirement is intended to ensure that research
findings will be of benefit to all persons at risk of the disease,
disorder, or condition under study.  For the purpose of these
policies, clinical research involves human studies of etiology,
treatment, diagnosis, prevention, or epidemiology of diseases,
disorders or conditions, including but not limited to clinical
trials; and minorities include U.S. racial/ethnic minority
populations (specifically:  American Indians or Alaskan Natives,
Asian/Pacific Islanders, Blacks, and Hispanics).

NIH recognizes that it may not be feasible or appropriate in all
clinical research projects to include representation of the full
array of U.S. racial/ethnic minority populations.  However,
applicants are urged to assess carefully the feasibility of including
the broadest possible representation of minority groups.

Applications must include a description of the composition of the
proposed study population by gender and racial/ethnic group, and the
rationale for the numbers and kinds of people selected to
participate.  This information must be included in the form PHS 398
in SectionS 1-4 of the Research Plan and summarized in Section 5,
Human Subjects.

Applications must incorporate in their study design gender and/or
minority representation appropriate to the scientific objectives of
the work proposed.  If representation of women or minorities in
sufficient numbers to permit assessment of differential effects is
not feasible or is not appropriate, the reasons for this must be
explained and justified.  The rationale may relate to the purpose of
the research, the health of the subjects, or other compelling
circumstances (e.g., if in the only study population available, there
is a disproportionate representation in terms of age distribution,
risk factors, incidence/prevalence, etc., of one gender or
minority/majority group).

If the required information is not contained within the application,
the review will be deferred until it is complete.  Peer reviewers
will address specifically whether the research plan in the
application conforms to these policies.  If gender and/or minority
representation/justification are judged to be inadequate, reviewers
will consider this as a deficiency in assigning the priority score to
the application.

All applications for clinical research submitted to NIH are required
to address these policies.  NIH funding components will not award
grants that do not comply with these policies.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 9/91) is to be used
in applying for these grants.  These forms are available at most
institutional offices of sponsored research; from the Office of
Grants Information, Division of Research Grants, National Institutes
of Health, 5333 Westbard Avenue, Room 449, Bethesda, MD 20892,
telephone 301-435-0714; and from the NIAAA program administrator
listed under INQUIRIES.

The RFA label available in the PHS (rev. 9/91) application form must
be affixed to the bottom of the face page of the application.
Failure to use this label could result in delayed processing of the
application such that it may not reach the review committee in time
for review.  In addition, the RFA title and number must be typed on
line 2a of the face page of the application form and the YES box must
be marked.  Page limits and limits on size of type are strictly
enforced.  Applicants for FIRST Awards (R29) are reminded that such
applications must include three letters of reference.  Non-conforming
applications will be returned without being reviewed.

Applicants from institutions that have a General Clinical Research
Center (GCRC), funded by the NIH National Center for Research
Resources, may wish to identify the Center as a resource for
conducting the proposed research.  If so, a letter of agreement from
either the GCRC program director or Principal Investigator should be
included in the application material.

The signed original, including the checklist, and three signed,
legible copies of the completed application must be sent to:

Division of Research Grants
National Institutes of Health
Westwood Building, Room 240
Bethesda, MD  20892**

At the time of submission, two additional copies of the application
must also be sent to:

Mark Green, Ph.D.
Extramural Project Review Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard
Rockville, MD  20892
Telephone:  (301) 443-4375
FAX:  (301) 443-6077

Applications must be received by January 12, 1994.  If an application
is received after that date, it will be assigned to the next review
cycle and will compete with all investigator-initiated research grant
applications.  The Division of Research Grants (DRG) will not accept
any application in response to this RFA that is essentially the same
as one currently pending initial review, unless the applicant
withdraws the pending application.  The DRG will not accept any
application that is essentially the same as one already reviewed.
This does not preclude the submission of substantial revisions of
applications already reviewed, but such applications must include an
introduction addressing the previous critique.

REVIEW CONSIDERATIONS

The Division of Research Grants, NIH, serves as a central point for
receipt of applications for most discretionary PHS grant programs.
Upon receipt, applications will be reviewed for completeness by DRG
and responsiveness by the NIAAA.  Incomplete applications will be
returned to the applicant without further consideration.  If the
application is not responsive to the RFA, NIAAA staff will contact
the applicant to determine whether to return the application to the
applicant or submit it for review in competition with unsolicited
applications at the next review cycle.

Applications may be triaged by an NIAAA peer review group on the
basis of relative competitiveness.  The NIH will withdraw from
further competition those applications judged to be non-competitive
for award and notify the applicant Principal Investigator and
institutional official.  Those applications judged to be competitive
will undergo further scientific merit review.  Those applications
that are complete and responsive will be evaluated in accordance with
the criteria stated below for scientific/technical merit by an
appropriate peer review group convened by the NIAAA.  The second
level of review will be provided by the National Advisory Council on
Alcohol Abuse and Alcoholism.

Review Criteria

Criteria to be used in the scientific and technical merit review of
alcohol research grant applications will include:

1.  The scientific, technical, or medical significance and
originality of the proposed research.

2.  The appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research.

3.  The adequacy of the qualifications (including level of education
and training) and relevant research experience of the Principal
Investigator and key research personnel.

4.  The availability of adequate facilities, general environment for
the conduct of the proposed research, other resources, and
collaborative arrangements necessary for the research.

5.  The reasonableness of budget estimates and duration for the
proposed research.

6.  Where applicable, the adequacy of procedures to protect or
minimize effects on animal and human subjects and the environment.

7.  Conformance of the application to the NIH policy on inclusion of
women and minorities in study populations.

Research grant applications will be reviewed based on standard
criteria for scientific and technical merit for regular research
grants (R01).  The review criteria for FIRST Awards (R29) are
contained in the FIRST program announcement.

AWARD CRITERIA

Applications recommended for approval by the National Advisory
Council on Alcohol Abuse and Alcoholism will be considered for
funding on the basis of the overall scientific and technical merit of
the proposal as determined by peer review, NIAAA programmatic needs
and balance, and the availability of funds.

INQUIRIES

Potential applicants are encouraged to seek preapplication
consultation and may contact the individuals listed below for
consultation in preparing an application under this RFA.

Direct inquiries regarding programmatic issues to:

Gayle Boyd, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
5600 Fishers Lane, Room 13C-23
Rockville, MD  20857
Telephone:  (301) 443-1677
FAX:  (301) 443-9334

Direct inquiries regarding fiscal matters to:

Elsie Fleming
Office of Planning and Resource Management
National Institute on Alcohol Abuse and Alcoholism
5600 Fishers Lane, Room 16-86
Rockville, MD  20857
Telephone:  (301) 443-4703
FAX:  (301) 443-3891

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic
Assistance, No. 93.273.  Awards are made under the authorization of
the Public Health Service Act, Sections 301 and 464H, and
administered under the PHS grants policies and Federal Regulations at
Title 42 CFR Part 52, "Grants for Research Projects," and Title 45
CFR Parts 74 and 92, "Administration of Grants and 45 CFR Part 46,
"Protections of Human Subjects."  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency Review.

.

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