NIH Guide: SECONDARY ANALYSIS OF EXISTING HEALTH SERVICES DATA SETS

This Program Announcement expires 3 years from the Release Date shown
directly below.

SECONDARY ANALYSIS OF EXISTING HEALTH SERVICES DATA SETS

Release Date: May 24, 2000

PA NUMBER: PA-00-100

National Institute on Alcohol Abuse and Alcoholism

THIS PROGRAM ANNOUNCEMENT (PA) USES "MODULAR GRANT" AND "JUST-IN-TIME"
CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION
INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO
THIS PA.

PURPOSE

The National Institute on Alcohol Abuse and Alcoholism (NIAAA) invites
applications to support the secondary analysis of existing data sets relevant
to developing a knowledge base to improve the delivery of services for
alcohol-related problems, including both treatment and preventive
interventions. This program announcement replaces and supersedes PA-97-066 of
the same title.

Research grants for the Secondary Analysis of Existing Health Services Data
Sets are intended to more fully utilize currently available data sets and to
provide support for studies that increase knowledge related to improving the
availability, accessibility, delivery, quality, effectiveness, cost-
effectiveness, and outcomes of alcohol-related treatment and prevention
services. Data used in secondary analyses may be obtained from current or
past investigator-initiated research activities or from other archival data
sets from public or private sources. Of particular interest is research that
employs analytic techniques that demonstrate or promote methodological
advances in the area of alcohol-related health services research.

Research objectives of this program announcement include, but are not limited
to, six major areas: (1) determining the effects of various financing and
reimbursement mechanisms on alcohol-related health care program availability,
accessibility, delivery, organization, content, quality, and outcomes; (2)
assessing sources of variation in access to, and utilization of, treatment
and prevention interventions for alcohol-related problems; (3) examining the
possible impact of managed care on alcohol treatment and prevention services;
(4) identifying organizational and managerial factors that influence the
delivery of treatment and prevention services for alcohol-related problems,
either within or across regions, populations, and settings; (5) evaluating
the cost, cost-effectiveness, cost-benefit, and cost-utility of alcohol-
related treatment and prevention services; and (6) identifying and assessing
the effectiveness and outcomes of alcohol-related treatment and preventive
services.

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 Health Services 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

Research support may be obtained through applications for a research project
grant (R01) or an exploratory/developmental grant (R21). Applications for
R01s may request support for up to 5 years. 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
https://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).

Applicants who anticipate submitting an application under this PA should
contact the program staff listed under INQUIRIES or the NIAAA Home Page at
http://www.niaaa.nih.gov for additional information.

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
https://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

The National Institute on Alcohol Abuse and Alcoholism seeks to promote the
use of secondary analyses of data in the expansion of knowledge to improve
the delivery of services for alcohol-related problems where appropriate data
sets and analytic techniques are available. The specific objectives of this
announcement on the Secondary Analysis of Existing Health Services Data Sets
are to provide support for (a) analyzing previously collected data that would
advance -- in cost effective ways -- scientific knowledge of alcohol-related
health services issues 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 to carry out currently ongoing data
analysis or for the maintenance and distribution of data sets.

BACKGROUND

Biomedical research in general, and health services research in particular,
typically generate data sets with potential utility beyond the specific
hypotheses and questions for which a particular study was designed. Often
these data are not fully analyzed, especially when unexpected research
questions emerge subsequent to the close of the original funding period.
Existing data sets can provide an expeditious and cost-effective means of
testing specific hypotheses that have not yet been examined adequately. In
addition, the analysis of existing research data may be prompted by a need to
confirm new findings in the field or to aid in the development of new
research questions.

Other data sets, including survey and epidemiologic data as well as health
care utilization, cost, and insurance claims data, are compiled by Federal,
State, and local government agencies, or by private entities such as
insurance companies, Health Maintenance Organizations, other third-party
payers, and large to mid-size corporations. While such data sets may not have
been intended initially for use within a research context, they are
potentially rich sources of information that can illuminate a wide range of
research questions and policy-relevant topics. When appropriate, secondary
data analyses may serve as an economical alternative to expensive and time-
consuming data collection projects.

Beyond the examination of specific research hypotheses, existing data sets
may 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-analyses, in which results
from multiple studies may be compared or combined, are considered to be a
form of secondary data analysis for the purposes of this program
announcement. Moreover, potential applicants should note that secondary
analysis may be appropriate to all types of data, including qualitative
information, and also covers the integration of quantitative and qualitative
data.

AREAS OF RESEARCH INTEREST

Health services research is defined as "research endeavors that study the
impact of the organization, financing and management of health services on
the quality, cost, access to and outcomes of care" (P.L. 101-321, Section
409). Health services research also is concerned with assessing the
effectiveness of health services in everyday practice.

For the purposes of this announcement, this includes: (a) the impact of
health services and the effects of organizational and financing arrangements
in "real world" clinical settings on the quality and outcomes of care
provided to patients with alcohol abuse and alcoholism or with medical
problems consequent to alcoholism; and (b) the impact of prevention services
on the demand for and utilization of alcohol-related services, as well as the
financing, organization, management, implementation, cost, and utilization of
the prevention services themselves. As directed by legislation (P.L. 103-43),
health services research, for the purposes of this announcement, does not
include studies of the efficacy of preventive, diagnostic, and treatment
modalities.

Applicants may choose to carry out analyses relevant to alcohol-related
health services research using large, nationally representative data sets or
smaller, regional, and locally based data sets. A number of such data sets
exist in the public domain, which contain items relevant to alcohol use and
abuse and may not have been fully analyzed. Two resource documents which
list data sets that may be of potential interest to health services
researchers are readily available from NIAAA:

(1) Inventory of Databases for Health Services Research on Alcohol Treatment
and Prevention, which lists publicly- and privately-supported data sets
containing information on the utilization, cost, financing, management,
organization, or effectiveness of alcohol treatment or prevention services
(copies may be obtained from the NIAAA Health Services Research Branch, 6000
Executive Boulevard, MSC 7003, Bethesda, MD 20892-7003; 301/443-0786); and

(2) Alcohol Epidemiologic Data Directory, which identifies national-scope and
special population data sets that are available for expanded epidemiologic
study (copies may be obtained from CSR Incorporated, Suite 200, 1400 Eye
Street, NW, Washington, D.C. 20005; 202/842-7600).

Other examples include data sets 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,
Medicaid and Medicare data compiled by the Health Care Financing
Administration), various State governments, and regional or local
governments. Applicants may 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, Health
Maintenance Organizations, or commercial businesses) or originally collected
for purposes other than research (e.g., health care or insurance data).

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.

New analyses of a current (or past) study: Investigators may wish to take
advantage of opportunities for additional analyses if they are justified as a
new stand-alone research project grant for secondary data analysis.
Additional analyses are ideal for investigating additional hypotheses beyond
those tested in the original study.

Large sample or multiple sample comparisons: 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.

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 behaviors over time, or the simulation of
complex systems that predict use of alcohol treatment 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. The development of improved techniques to
measure the costs, cost-effectiveness, or cost-benefits of alcohol treatment
and prevention services is encouraged under this announcement.

Developmental Projects: Investigators may be interested in examining the
feasibility of using certain types of data records or certain kinds of data
sets for answering alcohol-related health services research questions,
especially if the proposed analyses previously have not been widely used on
those types of records or data sets. Examples include abstracting from
medical encounter records, accessing insurance claims and reimbursement data,
and analyzing epidemiological or general health 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
"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, Vol.
23, No. 11, March 18, 1994 and is available on the web at the following URL
address: https://grants.nih.gov/grants/guide/notice-files/not94-100.html

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: https://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.

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.

APPLICATION PROCEDURES

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) 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 Division of
Extramural Outreach and Information Resources, National Institutes of Health,
6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email: GrantsInfo@nih.gov. Applications are also available at:
https://grants.nih.gov/grants/forms.htm.

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
https://grants.nih.gov/grants/guide/notice-files/not98-030.html

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, reviewer's and Institute
staff. The research grant application form PHS 398 (rev. 4/98) is to be used
in applying for these grants, with the modifications noted below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up
to a total direct cost request of $250,000 per year for R01 applications and
up to a total direct cost request of $100,000 per year for R21 applications.
The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:

PHS 398

o FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs
(in $25,000 increments up to a maximum of $250,000 for R01 applications and a
maximum of $100,000 for R21 applications) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period. Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.

o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398. It is not required and will not be accepted with the
application.

o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398. It is not required
and will not be accepted with the application.

o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative
page. (See https://grants.nih.gov/grants/funding/modular/modular.htm for
sample pages.) At the top of the page, enter the total direct costs requested
for each year. This is not a Form page.

o Under Personnel, list key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should
be provided. However, the applicant should use the NIH appropriation language
salary cap and the NIH policy for graduate student compensation in developing
the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct
plus facilities and administrative) for each year, each rounded to the
nearest $1,000. List the individuals/ organizations with whom consortium or
contractual arrangements have been made, the percent effort of key personnel,
and the role on the project. Indicate whether the collaborating institution
is foreign or domestic. The total cost for a consortium/contractual
arrangement is included in the overall requested modular direct cost amount.
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a
specific role in the proposed project, as well as to evaluate the overall
qualifications of the research team. A biographical sketch is required for
all key personnel, following the instructions below. No more than three pages
may be used for each person. A sample biographical sketch may be viewed at:
https://grants.nih.gov/grants/funding/modular/modular.htm.

o Complete the educational block at the top of the form page.
o List position(s) and any honors;
o Provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years.
o List selected peer-reviewed publications, with full citations.

o CHECKLIST - This page should be completed and submitted with the
application. If the F&A rate agreement has been established, indicate the
type of agreement and the date. All appropriate exclusions must be applied in
the calculation of the F&A costs for the initial budget period and all future
budget years.

o The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information
is necessary following the initial review.

Applications not conforming to these guidelines will be considered
unresponsive to this PA and will be returned without further review.

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 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 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.

o The reasonableness of the proposed budget and duration in relation to the
proposed research.

o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.

Additional consideration pertinent to the review of Exploratory/Developmental
Grant (R21) applications:

- Pilot/feasibility studies may contain little or no preliminary data. Review
should focus on whether the rationale for the study is well developed and
whether the proposed research is likely to generate data that will lead to a
regular research project grant or full-scale clinical trial. Adequate
justification for the proposed work may be provided through literature
citations, data from other sources, or investigator-generated data.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications assigned to the Institute. The following will be considered in
making funding decisions: scientific merit 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:

Harold I. Perl, Ph.D.
Health Services Research Branch
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 505, MSC 7003
Bethesda, MD 20892-7003
Telephone: 301-443-0788
FAX: 301-443-8774
E-mail: hperl@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, Maryland 20892-7003
Telephone: 301-443-4703
FAX: 301-443-3891
E-mail: 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,
Title IV, Part A (Public Law 78-410), as amended by Public Law 99-158, 42 USC
241, 285 and 290) 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, 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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