Full Text AA-94-004

UNDERDEVELOPED AREAS OF ALCOHOL ABUSE PREVENTION RESEARCH

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

RFA:  AA-94-004

P.T. 34

Keywords: 
  Alcohol/Alcoholism 
  Fetus 
  Injury 


National Institute on Alcohol Abuse and Alcoholism

Application Receipt Date:  January 24, 1994

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is
seeking research grant applications to stimulate studies focused on
the prevention of three types of alcohol-related problems where
prevention has received very little research attention:  Fetal
Alcohol Syndrome (FAS) and Fetal Alcohol Effects (FAE), alcohol abuse
among the elderly, and non-traffic alcohol-related injuries
(drownings, burns, falls, trauma to pedestrians, and injuries
incurred in crashes of planes, boats, and trains).  The major task is
to develop and test interventions aimed at preventing these problems
before they occur.

Usually, the intervention will be investigator-initiated and
controlled.  In natural experiments, however, investigators study the
impact of interventions that are independently initiated by others,
such as governmental bodies (e.g., warning labels).  As part of the
process of developing appropriate prevention strategies and
technologies, investigators may alternatively engage in pre-
intervention research that examines questions antecedent to the
implementation of prevention research per se.

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), Underdeveloped Areas of Alcohol Abuse
Prevention Research, 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 and 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 project 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 the 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 the awards 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, MD 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 mechanism 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 two million dollars 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

Fetal Alcohol Syndrome (FAS)/Fetal Alcohol Effects (FAE)

Background

Alcohol is a teratogen capable of damaging the developing fetus.  FAS
is a cluster of defects that includes growth retardation, central
nervous system impairment, and characteristic abnormal facial
features.  The cost of treatment, rehabilitation, and long-term care
for FAS disabilities is estimated to be $1.4 million over one
person's lifetime.  A very conservative estimate of FAS incidence in
the U.S. is 0.33 per 1000 live births.  The actual figure is
undoubtedly much larger and inclusion of more subtle alcohol-related
cognitive and behavioral birth defects (FAE) would substantially
increase the overall incidence of problematic births.  Native
Americans and African Americans show higher FAS/FAE incidence rates
than Caucasians.

It is not known whether there is a "safe" drinking threshold for
pregnant women below which the fetus will not be harmed.  Thus, NIAAA
and groups such as the American Medical Association recommend that
pregnant women completely abstain from alcohol use from conception to
delivery.

Research Areas

Preventive interventions in this area attempt to change the drinking
behavior of pregnant women.  The following research topics are
suggested:

1.  Developing and testing strategies to reach high-risk women before
they would normally seek prenatal care, generally after the first
trimester.

2.  Developing and testing strategies to heighten awareness, concern,
and action regarding FAS/FAE among vulnerable populations (e.g.,
high-risk Native American tribes, inner-city African Americans,
heavy-drinkers in their child-bearing years).  Community-wide
strategies might attempt to change drinking norms for pregnant women
and to encourage effective social controls.

3.  Developing and testing multi-strategy approaches that combine
"impersonal" media messages with more personalized sources of
influence (e.g., social networks, support groups, and health
professionals).

4.  Conducting randomized controlled trials of preventive
interventions within health-care systems, where the randomized units
might be patients, clinics, or physician practices.  Interventions
might include "anticipatory guidance" before pregnancy occurs as well
as counseling during pregnancy.

5.  Determining how sellers of alcohol might play more effective
roles in reducing drinking by pregnant women (e.g., through server
training and warning posters)

6.  Developing and testing FAS/FAE components for alcoholism
treatment programs.

Possible pre-intervention studies in this area may include:

1.  Elucidating biobehavioral factors (e.g., maternal nutrition,
hormonal changes, stress, co-drug abuse) that combined with alcohol
use may increase fetal risk and that should be taken into account in
designing preventive interventions.

2.  Developing and validating biochemical methods and markers (e.g.,
carbohydrate-deficient transferrin) to more accurately determine
alcohol intake and highest-peak BAC levels among pregnant women over
time.  Such tools can enhance assessments of risk and determinations
of the effectiveness of preventive interventions.

3.  Developing or adapting screening instruments and techniques
(e.g., self report, laboratory measures) to identify women at high-
risk for heavy alcohol use during pregnancy, and testing instrument
validity in different subpopulations.

4.  Elucidating factors that may help explain differential
vulnerability to FAS, as a means of more accurately identifying high-
risk pregnancies.

5.  Studying decision-making processes of various subgroups of
pregnant women regarding alcohol use, and their appraisals of risk to
the fetus (their estimates of the nature of fetal damage, its
severity, and likelihood).

6.  Determining whether and how health professionals who treat
pregnant women and women in the child-bearing years deal with FAS/FAE
risks.  What drinking advice and counseling is provided across
different types of practices, settings, specialties, and patient
populations?

7.  Determining which types of persons in social networks of pregnant
women and which types of messages are most likely to be influential
in preventing alcohol use/abuse during pregnancy.

Older Populations

Background

Older people are at risk for a variety of alcohol-related problems.
Both episodic and chronic drinking appear to precipitate or aggravate
a number of conditions that may be experienced in the later years
(e.g., cardiovascular disease, stroke, diabetes, cognitive loss,
falls and fractures, depression, isolation, and suicide).
Additionally, tolerance for alcohol is reduced and hazardous
interactions of alcohol with prescription and over-the-counter drugs
pose special risks for the elderly.  Epidemiologic studies indicate
that the prevalence of alcohol problems decreases with age; but the
research instruments used are often inappropriate for older
populations and alcohol abuse may go undetected.  Studies in clinical
settings suggest relatively high rates of alcohol problems.  Late-
onset alcohol abuse, especially, is not well understood.  As the
older population increases, their alcohol problems will become an
increasingly important public health issue.

Research Areas

Effective primary and secondary preventive interventions are needed
to reduce alcohol problems among the elderly. Research and
intervention approaches must consider the heterogeneity of the
population, e.g., variations in health, life style, and residence.
Prevention strategies to be tested might include:  specially-focussed
messages (e.g., concerning alcohol/medication interactions),
anticipatory guidance for persons experiencing major life transitions
(e.g., retirement or bereavement counselling), involvement of health-
care workers in detection of alcohol problems, interventions to
prevent alcohol-impaired driving and other accidents, and normative
controls in congregate-living facilities.  At risk populations might
be reached through electronic media, work sites, the hospitality
industry (e.g., server training), health care systems, social
services, and community organizations.

Pre-intervention research among the elderly is needed to provide more
accurate estimates of the prevalence of specific alcohol-related
problems; characterize drinking patterns among subgroups; establish
whether the elderly are more vulnerable to the effects of alcohol via
assessment of cognitive, neuropsychological measures; study age-
specific changes in neural function and behavior; identify etiologic,
risk, and protective factors and predictors of changes in alcohol
use; develop and/or test appropriate instruments for the early
detection of alcohol abuse; identify high risk populations,
situations, and settings as potential targets of intervention
strategies; and identify institutions, groups, and categories of
persons that can serve as resources for and facilitators of
preventive interventions.

Non-traffic Injuries

Background

In contrast to the abundant research on drinking and driving, there
are relatively few studies of the contribution of alcohol to other
types and sources of injury, such as drownings, falls, fires,
poisonings, and trauma to pedestrians and passengers of public
transport. Epidemiologic studies suggest that alcohol significantly
increases the risk of falls and burns and that a high percentage of
adult drowning victims have consumed alcohol, although it is unclear
whether the association is causal.  Many laboratory studies indicate
that alcohol consumption impairs key skills needed to operate complex
machines such as airplanes, trains, and boats, but there are  few
studies of interventions to reduce the risk of crashes in the
transportation industry.

Research Areas

Prevention of alcohol-related non-automotive injuries must rely on a
comprehensive array of interventions drawing on legislation and
enforcement, education and normative change, and engineering and
environmental approaches, all of which need scientifically-based
evaluation.  In addition, pre-intervention studies are needed to more
fully describe and better understand the role of alcohol in non-
automotive accidents and injuries.

Possible Intervention studies may include:

1.  Assessments of multifaceted community-based safety education
programs to prevent non-traffic alcohol-related injuries and deaths.
Using experimental and control communities, researchers might
implement and test community-wide programs that warn residents that
alcohol use can be a risk factor for drownings, boat accidents,
burns, and fires (particularly where alcohol abuse is associated with
smoking).

2.  Studies focused on drownings and aquatic injuries that assess the
effects of mandated BAC standards for boaters, and varying levels of
enforcement.  Drowning and injury rates might be compared across
states that do and do not have such standards, or enhanced
enforcement might serve as a test intervention.

3.  Research related to public transportation that:  (a) develops and
assesses the validity of practical "fitness for duty" tests or (b)
examines the effectiveness of work-based peer intervention
strategies, employee assistance programs (EAPs), and/or screening and
testing practices for employees.

Possible pre-intervention studies include:

1.  Case control (event-based) and general population studies to
specify the prevalence of and risk factors for alcohol related falls,
poisonings, drownings, burns, and pedestrian injuries.  Such studies
might rely on medical examiner/coroner reports or emergency room
records to assess the contribution of alcohol and to determine other
risk factors for these injuries.  BAC testing data would, of course,
enhance research validity.

2.  Epidemiologic studies of alcohol use/abuse prevalence rates by
transport mode and occupational group, and "human factor" research to
improve understanding of the performance limits and capabilities of
transportation operators, regarding their attention, vision,
perceptual judgment, information processing and overload, vehicle
control, and hangover effects.

3.  Qualitative and quantitative research on the reasons why people
drink while boating or swimming, including examination of attitudes,
perceptions of risk, and support for laws prohibiting alcohol
consumption at public beaches and pools.

Methodological Issues

Ideally, studies of the effectiveness of preventive interventions
should evaluate effects on the problem at hand (e.g., FAS,
drownings).  However, where the condition is rare or difficult to
measure, proxy indicators of the problem may serve as outcome
variables (e.g., drinking by pregnant women).  In the case of pre-
intervention research, a variety of endpoints are possible (e.g.,
awareness and perceptions of risk, outcomes of decision making
processes, identification of high-risk groups).  Any methodological
approach appropriate for the discipline involved may be used in
applications responsive to this RFA, including qualitative as well as
quantitative techniques.

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 should 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.  In such a case, 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 24, 1994.  If an application
is received after that date, it will be held for 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 the following:

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.

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:

Kendall Bryant, 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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