Full Text PAR-95-024

SECONDARY ANALYSIS OF ALCOHOL ABUSE PREVENTION RESEARCH DATA

NIH GUIDE, Volume 24, Number 4, February 3, 1995

PA NUMBER:  PAR-95-024

P.T. 34

Keywords: 
  Alcohol/Alcoholism 
  Disease Prevention+ 


National Institute on Alcohol Abuse and Alcoholism

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is
soliciting exploratory/developmental research grant applications to
support the secondary analysis of data relevant to the prevention of
alcohol abuse and alcoholism.  Exploratory/developmental grants for
the Secondary Analysis of Alcohol Abuse Prevention Research Data are
intended to more fully utilize currently available data sets and to
provide support for substantive exploratory or confirmatory studies
that increase knowledge in the alcohol research area.  Data used in
secondary analyses may be obtained from current or past investigator-
initiated research activities or from other archival data sets.  In
addition, research that employs new analytic techniques that
demonstrate methodological advances in the area of alcohol abuse
prevention research are of particular interest.  Grants supported
under this announcement must be limited to a two-year effort and a
maximum of $100,000 in direct costs per year.

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 program
announcement, Secondary Analysis of Alcohol Abuse Prevention Research
Data, 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. 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 REQUIREMENTS

Applications may be submitted by foreign and domestic, 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 an application for an
exploratory/developmental research grant (R21).  Grant applications
must be limited to a maximum of $100,000 in direct costs per year for
up to two years.  Annual awards will be made subject to continued
availability of funds and progress achieved.

It is estimated that in Fiscal Year 1996 approximately 8 to 10 awards
will be made under this program announcement.  However, the number of
awards will depend on the quality of applications, the availability
of funds, and program priorities at the time of award.

RESEARCH OBJECTIVES

The NIAAA wishes to promote the use of secondary analyses of data
relevant to the prevention of alcohol abuse and alcoholism where
appropriate data sets and analytic techniques are available and can
be employed.  The specific objectives of this program announcement on
the Secondary Analysis of Alcohol Abuse Prevention Research Data are
to provide support for the purpose of (a) new approaches to analysis
of current data sets that would benefit from further exploration or
(b) reanalysis of previously collected data that would provide cost
effective ways of obtaining additional insights into alcohol abuse
prevention research issues.  Grants under this program announcement
are not intended as a means to carry out ongoing data analysis,
maintenance, or distribution of data sets.

Background

Alcohol abuse prevention research projects often generate data sets
with potential usefulness that goes beyond the specific hypotheses
and questions for which the study was designed.  These data sets may
be generated by either preintervention research, which consists of a
broad spectrum of studies directly relevant to the development of
effective preventive interventions, or intervention research, that
tests single or multiple strategies for preventing or reducing
alcohol-related problems.  Both preintervention and intervention
research projects carried out over multiple years, using various
sampling designs and often specialized instruments, may yield a
wealth of additional information.  Very often these data are not
fully utilized, sometimes due to a lack of resources once a project's
funding has ended.  Reanalysis of existing data may be prompted by a
need to confirm new findings in the field or to aid in the
development of new research questions.

Efforts are already being made to increase the use of secondary
analyses in the social and behavioral sciences through access to
national data sources.  Survey and epidemiologic data on alcohol use
is available and has been used to track changing trends in alcohol
use.  However, the evolving field of alcohol abuse prevention
research continuously generates new research questions.  In some
cases, use of existing data sets may provide an expeditious and cost-
effective means of advancing knowledge.  When appropriate, secondary
data analyses may serve as an alternative approach to expensive and
time-consuming data collection projects.  For example, additional
data analyses may be particularly useful in providing information on
different age groups, genders, ethnic groups, or other special
populations of interest.  Existing data sets may be used to cross-
validate exploratory analyses in ongoing studies, to test specific
hypotheses or complex statistical models, and in special
circumstances to provide comparison groups for experimental studies.
Meta-analyses, in which effects from many studies may be compared or
combined, may also be considered a form of secondary data analysis.
Moreover, potential applicants should note that secondary analysis
may extend to all types of data such as qualitative information or
the integration of quantitative and qualitative data.

Areas of Research Interest

Applicants may choose to carry out analyses using large, nationally
representative data sets relevant to alcohol abuse prevention
research.  There are a number of such data sets that have been
collected by the Federal government, are in the public domain,
contain items relevant to alcohol use and abuse, and may not have
been fully analyzed.  Examples include many longitudinal or cross-
sectional surveys carried out by the National Center for Health
Statistics and the Centers for Disease Control and Prevention, such
as the National Health Interview Survey (NHIS) in the years 1983,
1985, 1987, 1988, 1990, and 1992-93, and The National Health and
Nutrition Examination Survey (NHANES) I and II and Follow-up.
Alternatively, applicants may of their own initiative secure access
to other large data sets not in the public domain, such as those
collected under Federal grants or sponsored by private agencies.

In general, four types of secondary analysis studies relevant to this
program announcement have been identified.  These are: (1) large
sample or multiple sample comparisons, (2) methodology development,
(3) new analysis of a current study, and (4) developmental/pilot
studies.  Several examples are given below to illustrate the types of
secondary analyses that may be considered within the scope of this
announcement.  However, the investigator is not limited by these
examples.  Proposed research should be guided by scientific
considerations and the potential benefit of the proposed analyses.

1.  Large sample or multiple sample comparisons:  In this category,
investigators may seek large archival data sets with identified
subgroups or multiple data sets for comparison with each other.  For
example, an investigator may wish to obtain two or more data sets for
the development and testing of integrated research hypotheses for
multiple cohorts, different genders, or different ethnic groups.

2.  Methodology development:  Single or multiple data sets may be
obtained to demonstrate new or improved research design, measurement,
or analytic techniques.  For example, researchers may wish to develop
new analytic techniques for longitudinal designs that take into
account transitions between alcohol and other drug use behavior over
time, or the simulation of complex systems that predict alcohol use
at an individual, group, or community level.  Measurement issues may
also be addressed for different variable and construct domains to
facilitate more accurate item equating, norming and further
validation of outcome measures, or the development of new measures.

3.  New Analysis of a current study:  This would allow the
investigator to take advantage of opportunities for additional
analyses if they are justified as a new stand alone research project
grant for secondary data analysis.  These additional analyses may be
ideal for cross-validation of results on appropriate comparison
groups and lead to improved generalizability of results.

4.  Development/Pilot Projects:  Before developing a large and
complex research grant application, an investigator may choose to
examine and pilot test hypotheses, sampling, and analytic techniques
used in similar studies.  Secondary analyses of available data sets
may provide a way to develop and pilot test a large scale study.
This approach may be particularly appropriate where little is known
in the area of the proposed research; or where the investigator needs
to pilot test the hypothesis prior to the development of a large and
complex research grant.

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) and supersedes and strengthens the previous policies
(Concerning the Inclusion of Women in Study Populations, and
Concerning the Inclusion of Minorities in Study Populations), which
have been in effect since 1990.  The new policy contains some
provisions that are substantially different from the 1990 policies.

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 reprinted
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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS
398 (rev. 9/91) and will be accepted at the standard application
deadlines as indicated in the application kit. Application kits are
available at most institutional offices of sponsored research and may
be obtained from the Office of Grants Information, Division of
Research Grants, National Institutes of Health, Westwood Building,
Room 449, Bethesda, MD 20892, telephone 301-435-0714.  The title and
number of the program announcement must be typed in Section 2a on the
face page of the application.

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

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

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS
referral guidelines.  Applications will be reviewed for scientific
and technical merit in accordance with the standard NIH peer review
procedures.  Following scientific-technical review, the applications
will receive a second-level review by the appropriate national
advisory council.

Applications that are complete and responsive to the program
announcement will be evaluated for scientific and technical merit by
an appropriate peer review group convened in accordance with the
standard NIH peer review procedures.  As part of the initial merit
review, all applications will receive a written critique and undergo
a process in which only those applications deemed to have the highest
scientific merit, generally the top half of applications under
review, will be discussed, assigned a priority score, and receive a
second level review by the appropriate national advisory council or
board.

Review Criteria

o  Scientific, technical, or medical significance and originality of
proposed research;

o  Appropriateness and adequacy of the experimental approach and
methodology proposed to carry out the research;

o  Qualifications and research experience of the Principal
Investigator and staff, particularly, but not exclusively, in the
area of the proposed research;

o  Availability of the resources necessary to perform the research;

o  Appropriateness of the proposed budget and duration in relation to
the proposed research; and

o  Adequacy of plans to include both genders and minorities and their
subgroups as appropriate for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated.

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

AWARD CRITERIA

Applications will compete for available funds with all other approved
applications assigned to the NIAAA.  The following will be considered
in making funding decisions:  quality of the proposed project as
determined by peer review, availability of funds, and program
priority.

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Kendall Bryant, Ph.D.
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 505
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-8820
FAX:  (301) 443-8774
Email:  kbryant@willco.niaaa.nih.gov

Direct inquiries regarding fiscal matters to:

Edward Ellis
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Boulevard MSC 7003
Bethesda, MD  20892-7003
Telephone:  (301) 443-4703
FAX:  (301) 443-3891
Email:  eellis@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 authorization of the
Public Health Service Act, Sections 301 and 464H and administered
under PHS grants policies and Federal Regulations 42 CFR 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.  This
is consistent with the PHS mission to protect and advance the
physical and mental health of the American people.

References

Howard, J. (1993) Alcohol Prevention Research:  Concepts, Phases, and
Tasks at Hand.  Alcohol Health and Research World, Special Focus:
Prevention of Alcohol-Related Problems. Vol 17, No 1.

Collins, R.L. and Windle, M. (In press) Secondary Data Analysis:
Advantages, Limitations, and Considerations in Substance Use
Research.  In J.E. Trimble, C. Bolek, & S. Niemcryk (Eds.),
Conducting cross-cultural drug abuse research:  Emerging strategies
and Methods.  New York, NY: Haworth

Kiecolt, K.J. & Nathan, L,E, (1985) Secondary analysis of data.
Beverly Hills, CA:  Sage

Kozlowski, L.T. Data waste:  The ethical challenge of the underdone
and unfinished.  APS Observer.  Jul/Aug 26-28, 1993.

Stewart, D.W. (1984).  Secondary research:  Information sources and
methods.  Beverly Hills, CA:  Sage.

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