This Program Announcement expires on October 5, 2004, unless reissued.
SECONDARY ANALYSIS OF EXISTING ALCOHOL EPIDEMIOLOGY DATA SETS
Release Date: September 25, 2001
PA NUMBER: PA-01-140 (This PA has been reissued, see PA-05-088)
National Institute on Alcohol Abuse and Alcoholism
THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. MODULAR
INSTRUCTIONS MUST BE USED FOR RESEARCH GRANT APPLICATIONS UP TO $250,000 PER
YEAR. MODULAR BUDGET INSTRUCTIONS ARE PROVIDED IN SECTION C OF THE PHS 398
(REVISION 5/2001) AVAILABLE AT
http://grants.nih.gov/grants/funding/phs398/phs398.html.
PURPOSE
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites
applications to support the secondary analysis of existing data sets with the
goal of enhancing our understanding of patterns of alcohol consumption and
the epidemiology of alcohol-related problems.
Research grants for the Secondary Analysis of Existing Alcohol
Epidemiology Data Sets are intended to provide support for studies that
more fully utilize currently available data sets to increase our
understanding of the incidence, prevalence and etiology of alcohol
related problems and disorders in the population, as well as the risk
and protective factors associated with them. Data used in secondary
analyses may be obtained from current or past investigator-initiated
research activities or from other public or private sources. Research
that employs analytic techniques which demonstrate or promote
methodological advances in alcohol-related epidemiologic research is
also of interest.
Research objectives of this program announcement include, but are not limited
to: (1) studying patterns of alcohol consumption and the distribution of
alcohol-related problems in the population as a whole and in specific sub-
populations, (2) studying risk and protective factors for alcohol-related
problems in the population as a whole and in specific subpopulations, (3)
elucidating disparities among racial/ethnic groups with respect to alcohol
consumption and alcohol-related problems, (4) understanding the natural
history, course, and short- and long-term outcomes of alcohol consumption.
HEALTHY PEOPLE 2010
The Public Health Service (PHS) is committed to achieving the health
promotion and disease prevention objectives of "Healthy People 2010," a PHS
led national activity for setting priority areas. This Program Announcement
(PA), Secondary Analysis of Existing Alcohol Epidemiology Data Sets, is
related to one or more of the priority areas. Potential applicants may obtain
a copy of "Healthy People 2010" at: http://www.health.gov/healthypeople/.
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
This PA will support research through the National Institutes of Health (NIH)
Research Project grant (R01) and the Exploratory/Developmental grant (R21)
award mechanisms. Responsibility for the planning, direction, and execution
of the proposed project will be solely that of the applicant. Applications
for research project grants (R01s) may request support for up to 5 years.
Exploratory/developmental grants (R21) are limited to 3 years and $100,000
per year in direct costs. Facilities and Administrative (F&A) costs will be
awarded based on the negotiated rate at the time of the award. Applicants
without extensive preliminary data are urged to submit applications for this
PA using the exploratory/developmental grant mechanism. More detailed
information on the R21 mechanism can be found at
http://grants.nih.gov/grants/guide/pa-files/PA-99-131.html.
Exploratory/developmental grants cannot be renewed, however, a no-cost
extension of up to one year may be granted prior to expiration of the project
period. Investigators are encouraged to seek continued support after
completing an exploratory/developmental grant project through a research
project grant (R01).
Specific application instructions have been modified to reflect "MODULAR
GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH.
Complete and detailed instructions and information on Modular Grant
applications can be found at
http://grants.nih.gov/grants/funding/modular/modular.htm.
RESEARCH OBJECTIVES
The National Institute on Alcohol Abuse and Alcoholism seeks to expand
knowledge about patterns of alcohol consumption and the epidemiology of
alcohol-related problems through the use of secondary analysis of existing
data, where appropriate data sets and analytic techniques are available. The
specific objectives of this announcement on the Secondary Analysis of
Existing Alcohol Epidemiology Data Sets are to provide support for (a)
analyzing previously collected data that would advance -- in cost effective
ways -- scientific knowledge of alcohol-related epidemiology, or (b) applying
new approaches to analyze current data sets that would benefit from further
exploration. Grants under this announcement are not intended as a means for
carrying out currently ongoing data analysis nor for the maintenance and
distribution of data sets.
BACKGROUND
Epidemiologic research projects typically generate data with potential
utility beyond the specific hypotheses and questions that they were designed
to address. Often data are not fully analyzed, especially when unexpected
research questions emerge after the end of the project’s funding period.
Analyzing such existing data sets can therefore provide a cost-effective
means to test specific hypotheses that have not been adequately examined. The
further analysis of existing research data may also be prompted by a need to
confirm new findings or to aid in the development of new research questions.
Also appropriate for secondary analyses are relevant cross-sectional and
longitudinal survey data collected by Federal, State, and local government
agencies. Secondary data analyses of these data may serve as an economical
alternative to expensive and time-consuming new data collection projects. A
few examples of such publicly available data sets are: the National
Longitudinal Alcohol Epidemiologic Survey (NLAES) conducted by NIAAA, the
National Longitudinal Survey of Youth (NLSY) conducted by the U.S. Department
of Labor, the National Adolescent Student Health Survey, a cooperative
project of the U.S. Department of Health and Human Services, Public Health
Service, Office of Disease Prevention and Health Promotion, Centers for
Disease Control and Prevention, and the National Institute on Drug Abuse, the
National Health and Nutrition Examination Survey (NHANES) conducted by the
National Center for Health Statistics (NCHS), the National Health Interview
Survey conducted by NCHS, the National Household Survey on Drug Abuse
conducted by the Substance Abuse and Mental Health Services Administration,
and the National Mortality Followback Survey conducted by NCHS.
In addition to the examination of specific research hypotheses, existing data
sets may also be used to cross-validate exploratory analyses in ongoing
studies, to test complex statistical models, and in special circumstances to
provide comparison groups for experimental studies. Meta-analysis, in which
results from multiple studies may be compared or combined, is considered to
be a form of secondary data analysis for the purpose of this program
announcement. Moreover, secondary analysis is appropriate for many types of
data, including qualitative information, and may also cover the integration
of quantitative and qualitative data.
AREAS OF RESEARCH INTEREST
Alcohol epidemiology is the study of the distribution in the population of
alcohol-related problems and disorders. Research in this area includes the
investigation of patterns of alcohol consumption and of the incidence,
prevalence and etiology of alcohol-related problems and disorders in the
population as a whole and in specific subpopulations. It also includes
studies that enhance our knowledge about risk and protective factors
(personal, environmental and genetic) for alcohol-related problems, and how
these factors may vary and/or interact in various populations and/or be
affected by other factors such as family history, education, health status,
socio-economic status and occupation.
More specifically, this general area includes, but is not limited to: (a) the
epidemiology (causes, course and outcomes) of alcohol-related problems
including alcohol use disorders among the general population and among
special populations, for example, youth, racial/ethnic groups, women and the
elderly, (b) the relationship of alcohol consumption and alcohol use
disorders to other psychiatric disorders and conditions, (c) the relationship
of alcohol consumption to the development, course, and outcomes of physical
illnesses, including heart disease, cancer, liver disease and HIV/AIDS, (d)
the study of prenatal exposure to alcohol, including the epidemiology of
fetal alcohol syndrome (FAS) and alcohol-related neurodevelopmental disorders
(ARND), and (e) the role of alcohol in intentional and non-intentional injury
and death including homicide, suicide, and vehicular and other accidents.
Applicants may conduct secondary analyses relevant to alcohol-related
epidemiology using large, nationally representative data sets or smaller,
regional or locally based data sets. As mentioned above, many data sets in
the public domain which contain items relevant to alcohol consumption and
alcohol-related problems have not been fully analyzed. Appropriate data sets
include those collected or coordinated by agencies of the Federal Government
(e.g., surveys carried out by the National Center for Health Statistics and
the Centers for Disease Control and Prevention), various State governments,
and regional or local governments. Applicants may also secure access to other
data sets that may or may not be in the public domain, such as those
collected under research grant funds, sponsored by private entities (e.g.,
philanthropic foundations, motor vehicle administrations, or commercial
businesses) or originally collected for purposes other than research (e.g.,
health care, criminal justice or insurance data).
The Alcohol Epidemiologic Data Directory is a resource document that lists
data sets of potential relevance to this announcement. It is available on
NIAAA’s website at the following address:
http://pubs.niaaa.nih.gov/publications/datasys.htm or from an NIAAA
contractor: CSR Incorporated, Suite 200, 1400 Eye Street, NW, Washington,
D.C. 20005, 202/842-7600. The information provided for each data set
includes: title, sponsoring agency, contact person, survey design/purpose,
methodology, sample size, alcohol variables, other variables and limitations.
Examples of general types of secondary analyses that may be considered within
the scope of this announcement are given below. This list is illustrative and
not exhaustive, prospective proposals need not be limited by these examples.
Scientific considerations and the potential benefit of the proposed analyses
should guide any proposed research.
o New analyses of past or current studies: Appropriate analyses include:
those which explore overarching initial hypotheses further but which are
significant enough to justify a new stand-alone analytic research project,
and those which investigate hypotheses beyond those tested in the original
study.
o Large sample or multiple sample comparisons: Investigators may use large
archival data sets with identified subgroups or multiple data sets for
comparison with one another. For example, an investigator may obtain two or
more data sets for the development and testing of integrated research
hypotheses for multiple cohorts, different genders, or different ethnic
groups.
o Methodology development: Single or multiple data sets may be used to
demonstrate new or improved research designs, measurement techniques, or
analytic approaches. For example, researchers may wish to develop new
analytic techniques for longitudinal designs that take into account
transitions in alcohol and other drug use behaviors over time, or use
existing data to undertake the simulation of complex systems for predicting
the use of alcohol or the emergence of alcohol-related problems at an
individual, group, or community level.
o Developmental Projects: Investigators might examine the feasibility of
using certain types of data records or certain kinds of data sets for
answering alcohol-related epidemiologic research questions, particularly if
these types of data have not been widely used to address alcohol-related
hypotheses. Examples include abstracting from medical encounter records, and
analyzing general health or criminal justice data.
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 are provided that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This 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
UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research," published in the NIH Guide for Grants and Contracts on
August 2, 2000
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The
revisions relate to NIH defined Phase III clinical trials and require: a) all
applications or proposals and/or protocols to provide a description of plans
to conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable, and b) all
investigators to report accrual, and to conduct and report analyses, as
appropriate, by sex/gender and/or racial/ethnic group differences.
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.
Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES. Program staff may also provide additional relevant
information concerning the policy.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS
NIH policy requires education on the protection of human subject participants
for all investigators submitting NIH proposals for research involving human
subjects. This policy announcement is found in the NIH Guide for Grants and
Contracts Announcement dated June 5, 2000, at the following website:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
URLS IN NIH GRANT APPLICATIONS OR APPENDICES
All applications and proposals for NIH funding must be self-contained within
specified page limitations. Unless otherwise specified in an NIH
solicitation, internet addresses (URLs) should not be used to provide
information necessary to the review because reviewers are under no obligation
to view the Internet sites. Reviewers are cautioned that their anonymity may
be compromised when they directly access an Internet site.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT
The Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at:
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
APPLICATION PROCEDURES
The PHS 398 research grant application instructions and forms (rev. 5/2001)
at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in
applying for these grants and will be accepted at the standard application
deadlines (http://grants.nih.gov/grants/dates.htm) as indicated in the
application kit. This version of the PHS 398 is available in an interactive,
searchable PDF format. Although applicants are strongly encouraged to begin
using the 5/2001 revision of the PHS 398 as soon as possible, the NIH will
continue to accept applications prepared using the 4/1998 revision until
January 9, 2002. Beginning January 10, 2002, however, the NIH will return
applications that are not submitted on the 5/2001 version. For further
assistance contact GrantsInfo, Telephone 301/710-0267, Email:
GrantsInfo@nih.gov.
Applicants planning to submit an investigator-initiated new (type 1),
competing continuation (type 2), competing supplement, or any amended/revised
version of the preceding grant application types requesting $500,000 or more
in direct costs for any year are advised that he or she must contact the
Institute or Center (IC) program staff before submitting the application,
i.e., as plans for the study are being developed. Furthermore, the
application must obtain agreement from the IC staff that the IC will accept
the application for consideration for award. Finally, the applicant must
identify, in a cover letter sent with the application, the staff member and
Institute or Center who agreed to accept assignment of the application.
This policy requires an applicant to obtain agreement for acceptance of both
any such application and any such subsequent amendment. Refer to the NIH
Guide for Grants and Contracts, March 20, 1998 at
http://grants.nih.gov/grants/guide/notice-files/not98-030.html
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS
The modular grant concept establishes specific modules in which direct costs
may be requested as well as a maximum level for requested budgets. Only
limited budgetary information is required under this approach. The
just-in-time concept allows applicants to submit certain information only
when there is a possibility for an award. It is anticipated that these
changes will reduce the administrative burden for the applicants, reviewers
and NIH staff. The research grant application form PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html is to be used in
applying for these grants, with modular budget instructions provided in
Section C of the application instructions. Applicants are permitted,
however, to use the 4/1998 revision of the PHS 398 for scheduled application
receipt dates until January 9, 2002. If you are preparing an application
using the 4/1998 version, please refer to the step-by-step instructions for
Modular Grants available at
http://grants.nih.gov/grants/funding/modular/modular.htm. Additional
information about Modular Grants is also available on this site.
The title and number of the program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
Submit a signed, typewritten original of the application, including the
Checklist, and five signed photocopies 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)
REVIEW CONSIDERATIONS
Applications will be assigned on the basis of established PHS referral
guidelines. Applications will be evaluated for scientific and technical merit
by an appropriate scientific 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 Advisory Council.
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 comments reviewers will be asked to discuss the following aspects
of the application 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 assigning the overall
score, weighting them as appropriate for each application. Note that the
application does not need to be strong in all categories to be judged likely
to have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
(1) Significance: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be advanced?
What will be the effect of these studies on the concepts or methods that
drive this field?
(2) 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 tactics?
(3) Innovation: Does the project employ novel concepts, approaches or
method? Are the aims original and innovative? Does the project challenge
existing paradigms or develop new methodologies or technologies?
(4) Investigator: Is the investigator appropriately trained and well-suited
to carry out this work? Is the work proposed appropriate to the experience
level of the principal investigator and other researchers (if any)?
(5) Environment: Does the scientific environment in which the work will be
done contribute to the probability of success? Do the proposed experiments
take advantage of unique features of the scientific environment or employ
useful collaborative arrangements? Is there evidence of institutional
support?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:
o The adequacy of plans to include both genders, minorities and their
subgroups, and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated.
o The reasonableness of the proposed budget and duration in relation to the
proposed research
o The adequacy of the proposed protection for humans or the environment, to
the extent they may be adversely affected by the project proposed in the
application.
o The adequacy of the proposed plan to share data, if appropriate.
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o scientific merit (as determined by peer review)
o availability of funds
o programmatic priorities.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or questions
from potential applicants is welcome. Direct inquiries regarding
programmatic issues to:
Vivian B. Faden, Ph.D.
Acting Chief, Epidemiology Branch
Division of Biometry and Epidemiology
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 514, MSC 7003
Bethesda, MD 20892-7003
Telephone: 301-594-6232
FAX: 301-443-8614
E-mail: vfaden@willco.niaaa.nih.gov
Direct inquiries regarding fiscal matters to:
Judy Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
Willco Building, Suite 504
6000 Executive Blvd., MSC 7003
Bethesda, MD 20892-7003
Telephone: 301-443-2434
FAX: (301) 443-0788
Email: jsimons@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 sections 301 and 405 of the
Public Health Service Act as amended (42 USC 241 and 284) and administered
under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts
74 and 92. 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 and contract 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, and 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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