PREVENTING FETAL ALCOHOL SYNDROME (FAS)

Release Date:  November 18, 1998

RFA:  AA-99-002

P.T.

National Institute on Alcohol Abuse and Alcoholism
Office of Research on Women's Health

Letter of Intent Receipt Date: February 23, 1999
Application Receipt Date: March 23, 1999

THIS IS A RE-ISSUANCE OF RFA AA-99-002, WHICH WAS ORIGINALLY PUBLISHED IN THE NIH
GUIDE ON OCTOBER 8, 1998.

PURPOSE

The purpose of this Request for Applications (RFA) is to stimulate research that
develops and/or tests interventions that have the potential for preventing fetal
alcohol syndrome among human populations and thereby reducing its incidence and
prevalence.  Investigators may themselves design, develop, modify, or adapt the
interventions they plan to test; or they may take advantage of opportunities to
test or evaluate interventions that occur (or have occurred) "naturally" in
society as a whole or selected segments of it.

Investigators who design their own interventions may focus on specific dimensions
of the environment in which alcohol is distributed, sold, and consumed; on groups
and individuals at excess risk; and/or on families and significant others of
persons at risk.  In developing and implementing these interventions,
investigators are encouraged to collaborate with public and private organizations
that can help ensure that the prevention approaches are appropriate and
effective.

Naturally-occurring preventive interventions may include public, community-based,
or health-care policies that specifically attempt to reduce drinking by pregnant
women (e.g., point-of-purchase messages, counseling programs within health
maintenance organizations), strategies that attempt to reduce alcohol abuse in
general (e.g., constraints on the legal availability of alcohol), and policies
that have positive implications for preventing alcohol abuse even though they are
implemented for other reasons (e.g., taxes on beverage alcohol).

The Office of Research on Women's Health (ORWH) is interested in the effects of
high alcohol consumption on the health of women and families and, therefore,
joins with the National Institute on Alcohol Abuse and Alcoholism in co-
sponsoring this RFA.

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 activity
for setting priority areas.  This RFA is related to the priority area of alcohol
abuse reduction and alcoholism prevention.  Potential applicants may obtain a
copy of "Healthy People 2000" (Full Report:  Stock No. 170-011-00474-0 or Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal Government.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators. 

MECHANISM OF SUPPORT

Research support may be obtained through applications for a research project
grant (R01) or Investigator-Initiated Interactive Research Project Grants (IRPG). 
An IRPG requires the coordinated submission of related regular research project
grant applications (R01s) 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
applications.  Applications may be from one or several institutions.  Further
information on the IRPG mechanism is available in program announcement PA-96-001,
NIH Guide for Grants and Contracts, Vol. 24, No. 35, October 6, 1995, and from
the NIAAA program staff listed under INQUIRIES. 

FUNDS AVAILABLE

The NIAAA intends to commit $2 million in total costs and the ORWH intends to
commit approximately $100,000 in total costs for the first year of awards under
this RFA.  It is anticipated that four to six awards will be made under this RFA
in FY 1999.  This level of support is dependent on receipt of applications of
high scientific merit.  The usual policies governing grants administration and
management, including facilities and administrative costs, will apply.  Funding
beyond the first and subsequent years of the grant will be contingent upon
satisfactory progress during the preceding years and availability of funds.  The
earliest possible award date is July 1, 1999. 

RESEARCH OBJECTIVES

Background

Fetal alcohol syndrome (FAS) refers to a constellation of abnormalities that
include facial dysmorphology, growth retardation, and central nervous impairment
(neurological, cognitive, and behavioral).  The disorder occurs as the direct
result of the mother's consumption of beverage alcohol during her pregnancy. 
Estimates of FAS prevalence vary from .6 to 3 per 1000 live births in most
populations, but some communities show much higher rates (e.g., as high as 9 per
1000 live births).  FAS is arguably the most common known nongenetic cause of
mental retardation in the United States.  Two other categories of alcohol-related
birth disorders have also been defined, and together they significantly increase
the magnitude of the overall problem.  Alcohol-related birth defects (ARBD)
refers to alcohol-induced physical anomalies; and alcohol-related
neurodevelopmental disorders (ARND) refers to alcohol-induced cognitive and
behavioral problems without the characteristic facial or growth abnormalities.

For several reasons, it is impossible to estimate with reasonable certainty the
financial costs of FAS, ARBD, and ARND.  Estimates of the incidence and
prevalence of these disorders are imprecise, and the full lifetime extent of
health and other problems experienced by persons with these birth defects is
unknown.  Thus, cost estimates for the United States have varied from a low of
$75 million annually to a high of $9.7 billion.

It is, however, generally agreed that FAS, ARBD, and ARND are completely
preventable birth defects and neurodevelopmental abnormalities. According to the
Institute of Medicine (IOM) report on FAS (1996), there are two viable approaches
to its prevention:  Women should stop drinking alcohol at all phases of
pregnancy; or, alternatively, women who drink alcohol should not become pregnant
unless and until they can control their drinking.

Ordinarily, in alcohol-focused prevention research the concept of prevention does
not encompass the actual treatment of alcohol abuse and alcoholism, except when
that treatment involves brief motivational counseling or guidance/advice that
helps the recipient anticipate problematic situations and reduce personal risk. 
In the case of fetal alcohol syndrome, however, treatment for alcohol dependency
can become a vital component of a comprehensive strategy to prevent alcohol-
related birth defects.  As the IOM report states the issue, "treatment of alcohol
abuse and dependency in a pregnant woman is also prevention of FAS in her fetus." 
This concept of treatment-as-prevention is particularly important in confronting
FAS because alcohol-dependent women are most at risk of giving birth to a child
or children with FAS, and because these high-risk women appear to be relatively
unresponsive to so-called "universal" prevention strategies that target women in
general or those of child-bearing age.

NIAAA recognizes that FAS-impaired children themselves need treatment over a long
period of time to help them cope with their disorder and their social
environment, as well as to prevent future alcohol abuse among them.  However,
that aspect of prevention and treatment research is beyond the scope of this RFA. 
The purpose of this initiative is to prevent the occurrence of FAS rather than
to deal with its consequences.  There is, of course, an exception to this
exclusion.  To the extent that FAS-impaired girls and women constitute a
subpopulation who are themselves at high risk of ultimately giving birth to
alcohol-impaired children, then this subpopulation can become the target of
prevention research under this RFA.  Still, that research should be restricted
to the prevention of FAS in the next generation of offspring.

Interventions proposed for testing under this RFA should focus on the prevention
of drinking by pregnant women and women who are likely to become pregnant.  Other
Federal agencies are supporting research and demonstration projects aimed at
reducing pregnancy among abusers of alcohol and other drugs.  Because no safe
level of alcohol consumption during pregnancy has been identified, NIAAA and a
host of societies of health professionals recommend that women should completely
abstain from alcohol use during their pregnancies.  That is the ideal goal of
efforts to prevent FAS, ARBD, and ARND.  However, significant reductions in the
quantity and frequency of alcohol consumed by pregnant women can also be
considered a beneficial outcome of preventive interventions.  Thus, NIAAA defines
its mission to be the support of research that targets any drinking and
especially abusive drinking by pregnant women. 

Applications that focus only on the prevention of pregnancy among women who abuse
alcohol are not eligible for funding under this RFA; but applicants may propose
to confront the problem of FAS from simultaneous dual perspectives:  attempting
to reduce the use and abuse of alcohol by pregnant women while also encouraging
postponement of pregnancy until the abusers of alcohol are able to control their
hazardous behavior. 

Potential Prevention Strategies

FAS was first described in the medical literature approximately 30 years ago. 
Since that time, a number of efforts have been made to prevent its occurrence
among the population as a whole and among high-risk drinkers in particular.  Yet,
only a small group of scientifically-based studies have been conducted for the
purpose of informing the selection and implementation of prevention strategies. 
Moreover, it is difficult to draw convincing inferences regarding the prevention
of fetal alcohol syndrome from studies that target other forms of substance abuse
among pregnant women (such as cigarette smoking and use of crack/cocaine). 
Extrapolation must take into account differences in:  the strength of the
dependencies, deleterious effects on the fetus, legal availability of the
substances, perceptions of potential harm to the fetus among the medical
profession and the larger society, and/or measures of intervention effectiveness.

The IOM report on FAS referred to earlier emphasizes the need for a comprehensive
approach to its prevention.  However, it is rarely possible for investigators to
cover all bases within the confines of a single study, even when the research is
community based.  Scarce financial resources and the requirements of focused
state-of-the-art science constrain comprehensiveness.  Thus, applicants are
encouraged to develop and/or test a piece or integrated pieces of what will
ultimately prove to be a comprehensive approach to FAS prevention.

Options include strategies within the domains of primary, secondary, or tertiary
prevention or within the newly conceptualized domains of universal, selective,
and indicated interventions.  Primary prevention focuses on healthy persons and
seeks to avoid future problems; secondary prevention focuses on detection and
treatment of early or asymptomatic disease; and tertiary prevention attempts to
prevent the progression of the disorder and additional impairment.  The newer
typology takes into account the breadth of the target group, risk of having the
disorder, and the benefit/cost ratio of committing resources to its prevention. 
Universal approaches target entire populations or subpopulations without regard
to risk; selective strategies target subgroups known to be at higher than average
risk; and indicated interventions target persons with individual risk factors
that require more immediate intervention. 

Clues from prior studies.  Applicants are encouraged to review the literature on
interventions and strategies applicable to the prevention of alcohol-related
birth defects, particularly the approach or approaches they intend to test in
their proposed research.  In a recent working group on FAS prevention, co-
sponsored by NIAAA, ORWH and the Interagency Coordinating Committee on Fetal
Alcohol Syndrome, relevant intervention studies were discussed.  The approaches
focused on policy (environmental) changes and on changing the behavior of
individuals as individuals, through more personalized interventions that enhance
knowledge, motivation, and skills.  The following conclusions and inferences can
be drawn from the discussion of completed research specifically concerned with
FAS, ARBD, or ARND:

1.  Community-based programs that attempt to educate the public and train health
professionals and teachers about FAS can increase knowledge and concerns about
risks, and acceptance of the abstinence goal; but behavior change is more
difficult to achieve.

2.  Universal approaches are more likely to alter the behavior of light than
heavy drinkers; therefore, community-based strategies should also include
interventions tailored to the needs of relevant (e.g., pregnant) high-risk or
problem drinkers, who may require long-term case management and advocacy
programs.

3.  Screening women in health-care populations concerning their drinking behavior
can identify significantly more women at risk than would the examination of
obstetrics/gynecology (OB/Gyn) records; and data suggest that the assessment
itself may serve as a useful intervention.

4.  Studies indicate that brief interventions, counseling, and treatment for at-
risk pregnant women can reduce their drinking, maintain abstinence, and improve
health outcomes for subsequently delivered babies.  Within health maintenance
organizations (HMOs), counseling services should be located on-site, within the
OB/Gyn area, to facilitate immediate referral and reduce stigmatization.

5.  Exposure to warning labels that mention the risk of birth defects can reduce
alcohol consumption among pregnant women, at least modestly for short periods of
time; but the labels do not appear to influence the drinking behavior of older
pregnant women, those with higher parity, and/or the higher-risk drinkers. 

Other relevant options.  The list of potentially effective FAS intervention
strategies that have yet to be tested is lengthy.  Ideas are forthcoming from a
review of the whole panorama of alcohol-focused prevention research that focuses
upon environmental strategies as well as those oriented toward individuals and
includes studies of naturally occurring interventions as well as those designed
and implemented by the investigators themselves.

Historically, studies of policy approaches (such as raising the minimum legal
drinking age, lowering legally acceptable BAC levels for drinking drivers, and
increasing the taxes on beverage alcohol) have shown important preventive impacts
on alcohol abuse and related problems.  Functional equivalents for FAS prevention
could include policies that focus more specifically on deterring alcohol use by
pregnant women.  For example, certain jurisdictions require that messages
describing the risk of birth defects be posted at points of purchase.  Effects
of different types of messages and different types of server training might be
tested.  Where circumstances permit, the interventions might be designed by the
research team for testing in the "real world" or in research laboratories. 
Alternatively, it may be possible for investigators to measure the effects of new
or existing naturally-occurring policies and programs.  These policies might
include controversial attempts by courts (or tribal councils) to protect the
fetus by mandating treatment or confinement to treatment for pregnant women with
a history of alcohol abuse.  In jurisdictions where such policies have been
implemented, studies could help decision-makers understand their consequences. 
Occasional articles in the media indicate that these kinds of interventions have
been authorized in special situations, but their effects have not been
systematically evaluated.

As indicated above, various components of the health-care system (such as HMOs)
have established and implemented their own prevention policies and programs that
tend to include universal, selective, and/or indicated strategies.  In some
cases, these interventions have become integral parts of OB/Gyn care, even though
they have not been subjected to rigorous tests of their effectiveness.  Whether
such programs can be studied as "natural experiments" depends on the availability
of uncontaminated baseline data, the identification of appropriate comparison or
control groups, the ethics of denying the program to the controls, and other
scientific considerations (e.g., the frequency of focal outcomes, and clear
distinctions between the intervention being evaluated and possible confounders
associated with that particular health-care system).

Thus, there are strong reasons for applicants to develop and test interventions
that they themselves initiate and implement with the collaboration of relevant
groups, systems, and/or communities.  These interventions may focus on specific
dimensions of the environment in which alcohol is distributed, sold, and
consumed; on groups and individuals at excess risk; and/or on families and
significant others of persons at risk.  An expanding body of research indicates
that family involvement can be an important and statistically significant
prevention approach.  However, the types of family interventions that have been
tested outside the treatment domain tend to be slanted toward parental roles
(e.g., monitoring the child's behavior, setting clear and consistent rules, and
constraining the availability of alcohol).  It remains to be determined whether
parents, siblings, spouses, partners, and even children can impact on the
drinking behavior of pregnant women.

Outcome Variables

Because FAS, ARBD, and ARND are rare events, it may be difficult or impossible
to measure the extent to which these focal endpoints are affected by the
intervention of interest.  However, other outcomes such as women's drinking
behavior and indices of the baby's health (e.g., birth weight, gestational age)
may serve as proxy measures of the effectiveness of the intervention, as long as
their relationship to FAS or other alcohol-related birth disorders can be
justified.  Drinking patterns are generally assessed through self reports, which
may be inaccurate or deliberately falsified.  Thus, applicants are encouraged to
verify these reports through whatever means are possible (laboratory tests,
collaboration by significant others, etc.).

By definition, the incidence of FAS is affected by pregnant women's consumption
of alcohol.  Therefore, their drinking behavior is obviously the key mediating
variable linking a preventive intervention to FAS outcomes.  For this reason
applicants should make certain they use state-of-the-art measures of the quantity
and frequency of alcohol use and that they take into account variations in
drinking rates and other measures on the basis of gender.

Methodological Approaches

Applicants may propose to use any methodological approach that is appropriate for
their research endeavor, qualitative as well as quantitative and quasi-
experimental as well as experimental.  However, the selected approach should be
state-of-the-art for the discipline involved and should be clearly described and
justified.  Even where the principal investigator has strong methodological
skills, it may be advisable to include among the research team an expert in study
design and/or statistics.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and their
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects, unless a clear and compelling
rationale and justification is provided that inclusion is inappropriate with
respect to the health of the subjects or the purpose of the research.  This new
policy results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43). 

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 in the NIH Guide for Grants and Contracts, Volume 23,
Number 11, March 18, 1994.

Investigators also may obtain copies of the policy from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

NIH POLICY AND GUIDELINES ON THE 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 subjects research, conducted or supported by the
NIH, unless there are scientific and 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://grants.nih.gov/grants/guide/notice-files/not98-024.html

LETTER OF INTENT

Prospective applicants are asked to submit, by February 23, 1999, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title of
the RFA in response to which the application may be submitted.

Although a letter of intent is not required, is not binding, and does not enter
into the review of a subsequent application, the information that it contains
allows NIAAA staff to estimate the potential review workload and to avoid
conflict of interest in the review.

The letter of intent is to be sent to:

RFA AA-99-002
Office of Scientific Affairs 
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard, Room 409, MSC 7003 
Bethesda, MD  20892-7003 
Telephone:  (301) 443-4375 
FAX:  (301) 443-6077

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 5/95) is to be used in applying
for these grants.  These forms are available at most institutional offices of
sponsored research and from the Division of Extramural Outreach and Information,
National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD
20892-7910, telephone 301/435-0714, Email:  grantsinfo@nih.gov

The RFA label available in the PHS 398 (rev. 5/95) 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 2 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.  Non-conforming applications will be returned without being reviewed.

Submit a signed, typewritten original of the application, including the checklist
and three signed photo copies in one package to:

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

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

RFA AA-99-002 
Office of Scientific Affairs 
National Institute on Alcohol Abuse and Alcoholism 
6000 Executive Boulevard, Room 409, MSC 7003 
Bethesda, MD  20892-7003 
Rockville, MD  20852 (for express/courier service)

Applications must be received by March 23, 1999.  If an application is received
after that date, it will be returned to the applicant without review. 

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the Center for
Scientific Review (CSR) and for responsiveness by the NIAAA.  Incomplete
applications will be returned to the applicant without further consideration. 
If the application is not responsive to the RFA, CSR staff may 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 that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
the NIAAA in accordance with the review criteria stated below.  As part of the
initial merit review, a process will be used by the initial review group in which
applications receive a written critique and undergo a process in which only those
applications deemed to have the highest scientific merit, generally the top half
of the applications under review, will be discussed assigned a priority score,
and receive a second level review by the National Advisory Council on Alcohol
Abuse and Alcoholism.

Review Criteria

The goals of NIH-supported research are to advance our 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.

Significance:  Does the study address the goals of the RFA?  If the aims of the
study are achieved, how will scientific knowledge be advanced?  Will the study
advance the concepts or methods that drive this field?

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 designs?

Feasibility:  Can the design be implemented (including recruitment of subjects,
cooperation of relevant organizations, and/or collection of necessary data)?

Innovation:  Does the project employ novel concepts, approaches, theories, or
methods?

Investigator:  Are the principal investigator and key research personnel
appropriately trained and well suited to carry out this work?

Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Does the proposed research take
advantage of the unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

Budget: Is the requested budget and estimation of time to completion of the study
appropriate for the proposed research?

In addition, plans for the recruitment and retention of subjects will be
evaluated as well as the adequacy of plans to include both genders and minorities
and their subgroups and children as appropriate for the scientific goals of the
research.

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

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

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

Direct inquiries regarding applications under this RFA to:

Suzanne M. Heurtin-Roberts, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505
Bethesda, MD  20892-7003
Telephone:  (301) 443-0639
FAX:  (301) 443-8774
Email:  sheurtin@willco.niaaa.nih.gov

Joyce Rudick
Office of Research on Women's Health
National Institutes of Health
Building 1, Room 201
Bethesda, MD  20892
Telephone:  (301) 402-1770
FAX:  (301) 402-1798
Email:  jr27q@nih.gov

Direct inquiries regarding fiscal matters to:

Linda Hilley
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-0915
FAX:  (301) 443-3891
Email:  lhilley@willco.niaaa.nih.gov

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 policies and Federal
Regulations at Title 42 CFR Part 52 and 45 CFR Part 74.  This program is not
subject to the intergovernmental review requirements of Executive Order 12372 or
Health Systems Agency Review.

The PHS 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 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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