Full Text AA-94-001

BIOMEDICAL AND BEHAVIORAL RESEARCH ON ALCOHOL AND WOMEN

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

RFA:  AA-94-001

P.T. 34, II

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 health, biological,
behavioral, psychosocial, and other consequences of alcohol
consumption on women; identify risk and protective factors; and
develop more effective identification, treatment, and prevention
strategies and programs.

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 Women, 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 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 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 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 ultimately
lead to the reduction of alcohol abuse, dependence and consequences
among women.  Such research may address the etiologic factors
(including cellular and molecular mechanisms, unique neurobiological,
hormonal, and behavioral vulnerabilities), incidence, prevalence, and
natural history of alcohol-related medical consequences; identify
risk factors and markers of risk that predict development of alcohol
dependence or enhanced vulnerability to specific alcohol-induced
organ or tissue damage; examine gender differences in the interaction
of genetic, individual, and environmental factors; document barriers
to diagnosis, intervention, and treatment specific to women; and
develop and test more effective intervention strategies for the
prevention and treatment of alcohol-related problems among women
across the lifespan from childhood to old age.

Background

Fewer women than men drink and, on the whole, women who drink consume
less alcohol and have fewer alcohol-related problems than men.  Yet,
among the heaviest drinkers, women equal or surpass men in the number
of problems that result from their drinking.  The interval between
onset of drinking-related problems and entry into treatment appears
to be shorter for women.  Women are known to be more susceptible to
alcohol induced liver damage than are men--developing severe liver
disease especially alcoholic hepatitis and cirrhosis, with shorter
durations of alcohol use and lower levels of consumption.  The exact
mechanism of this enhanced susceptibility remains to be elucidated.
Gender-specific vulnerability to other alcohol-induced organ/tissue
damage also requires investigation.  Breast cancer is the second
leading cause of cancer death among women in the United States today.
Current epidemiologic evidence suggests that alcohol consumption,
even at low levels, may increase a woman's risk of breast cancer.
Further research is required in all aspects of this area.  Clearly
gender differences exist in the human body's responses to alcohol
consumption.  Alcohol research is now at the point where elucidation
of such gender differences and their implications for prevention,
intervention and treatment is needed.

Areas of Research Interest

The following list of topics is intended only to illustrate NIAAA
interests; topics not mentioned are not necessarily excluded from
consideration.  Areas include studies of the natural history,
biological mechanisms, incidence and prevalence of alcohol use,
abuse, dependence, and consequences among women and female animals,
specifically:

o  Identification of cellular and molecular mechanisms related to the
apparent increased vulnerability of women to alcohol-induced liver
damage including possible gender differences in rates of alcohol
metabolism and acetaldehyde production; differential vulnerability to
hepatic hypoxia due to lower hematocrit; possible differences in
glycoconjugate metabolism or in alcohol's effects on the integrity of
glycoproteins and glycolipids.

o  Identification of mechanisms by which alcohol contributes to the
increased risk of hemorrhagic stroke in women, including interactions
between alcohol and oral contraceptives as well as other medications,
and gender differences and mechanisms in other cardiac pathology.

o  Evaluation of the effects of acute and chronic alcohol consumption
on bone and mineral metabolism in pre- and postmenopausal women,
interaction between alcohol and hormones involved in calcium
metabolism, impact of alcohol consumption on osteoporosis in women.

o  Studies of the relationship of alcohol consumption to an increased
risk of breast cancer including mechanisms of carcinogenesis,
estrogen receptor status, hormone (endogenous and exogenous)
interactions.

o  Studies of the impact of alcohol consumption on the female
reproductive system including elucidation of the mechanisms by which
alcohol induces amenorrhea and infertility, and impact of alcohol
consumption on the maturation of the reproductive system in the
adolescent female.

o  Studies of gender-specific interactions between alcohol and other
medications, both prescription and over the counter; and developing
and testing interventions that can prevent or reduce the risk of such
interactions among women, e.g., educational strategies, counseling by
health professionals.

o  Studies of alcohol's effects on the hypothalamic/
pituitary/adrenal axis in women as well as on that of children
exposed to alcohol in utero, and the role of these effects in
alcohol-seeking behavior.

o  Studies of the relationship of gender-specific comorbidity of
psychopathology and alcoholism such as the disproportional prevalence
of depression among women alcoholics.

o  Studies of gender differences in the patterns of voluntary alcohol
intake, the extent to which they are under genetic control, the role
of hormones (including neurosteroids), and the role of
neurotransmitter and peptide systems.

o  Studies of the relationship between alcohol consumption and other
dietary components, gender differences in the utilization of alcohol
calories, the regulation of food intake and satiety in relation to
craving for alcohol and regulation of alcohol intake.

o  Studies to ascertain whether or not gender-specific alcohol
interventions improve treatment efficacy for women, determination of
barriers to identification, diagnosis, and treatment for women.

o  Development of pharmacotherapies that provide more effective
medication for women.

o  Identification of genetic or biological markers or laboratory
procedures that are specific for diagnosis of alcohol dependence or
chronic alcohol consumption in women or that show gender differences.

o  Studies to determine whether or not women are differentially
susceptible to alcoholic cardiomyopathy and possible etiologic
factors and mechanisms, other gender differences in the relationship
of alcohol to other cardiac conditions, pancreatic diseases, and
gastritis.

o  Studies utilizing modern technology such as imaging techniques to
examine gender differences in alcohol-induced organ pathology.

o  Studies of relationships between alcohol use and violence toward
women and by women; possible increased vulnerability of women with
alcohol problems to engage in violence; childhood physical/sexual
abuse as a contributory factor to alcohol dependence in women; and
the role of posttraumatic stress disorder in the development of
alcohol dependence.

o  Developing and testing interventions to prevent or reduce alcohol-
related domestic violence, child abuse, and rape by strangers, dates,
and intimates.

o  Studies of the linkage between alcohol use and unsafe sexual
practices among both adolescent and adult women, especially studies
of risk perception, risk taking and excusatory behavior in alcohol
use and HIV exposure, and studies that test possible prevention
strategies to reduce the risk of HIV exposure in the context of
alcohol use.

o  Development and testing of gender-sensitive treatment strategies,
including consideration of physiological and behavioral differences.

o  Development and testing of gender-sensitive prevention strategies
(educational and environmental) that address exposure of girls and
women to risky drinking environments and social interactions
involving alcohol, e.g., riding with drunk drivers.

o  Studies of the influence of women's roles in the workplace and
home, the impact of dual roles on their drinking behavior, and
developing and testing preventive interventions that address role-
related alcohol problems.

o  Developing and testing preventive interventions that specifically
address drinking practices and motivations of adolescent girls,
including self-image, sexuality, peer influences, sex roles, and
social deviancy.

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 should 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 301-710-0267; 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 Division of 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 application 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:

Mary C. Dufour, M.D., M.P.H.
Division of Biometry and Epidemiology
National Institute on Alcohol Abuse and Alcoholism
5600 Fishers Lane, Room 14C-26
Rockville, MD  20857
Telephone:  (301) 443-4897
FAX:  (301) 443-8614

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 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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