NEI SMALL RESEARCH GRANTS FOR DATA ANALYSIS (R03)

Release Date:  October 4, 1999

PA NUMBER:  PAR-99-170

National Eye Institute

THIS PA USES THE "MODULAR GRANT" CONCEPT.  IT INCLUDES DETAILED MODIFICATIONS
TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING
APPLICATIONS IN RESPONSE TO THIS PA.

PURPOSE

This Program Announcement (PA) replaces PA-92-13, which was published in the
NIH Guide for Grants and Contracts, Vol. 20, No. 4, October 25, 1991.

The purpose of the National Eye Institute (NEI) Small Research Grants for Data
Analysis (R03) is to provide limited support, up to $100,000 annual Direct
Costs for two years, for meritorious research projects that involve secondary
data analyses using existing database resources.

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 PA, NEI Small Research Grants for
Data Analysis (R03), is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2000" at
http://odphp.osophs.dhhs.gov/pubs/hp2000

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 use the National Institutes of Health (NIH) Small Research Grant
(R03) award mechanism.  Responsibility for the planning, direction, and
execution of the proposed project will be solely that of the applicant. 
Applicants may request up to $100,000 direct costs per year.  Salary support
for the Principal Investigator may be requested with strong justification. 
Equipment is generally not allowed.  New data collection activities will not
be supported.  The total project period for an application submitted in
response to this PA may not exceed two years.

Specific application instructions have been modified to reflect "MODULAR
GRANT" streamlining efforts being examined by the NIH.  Complete and detailed
instructions and information of Modular Grant applications can be found at
https://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

The NEI supports an extensive portfolio of clinical trials and large-scale
epidemiologic research projects wherein numerous data collection activities
are required to meet each project's specific aims.  The resultant wealth of
data generated by these studies often provides unique, cost-effect
opportunities to investigate additional research questions or develop new
analytical approaches secondary to a project's originally intended purpose.
The Small Research Grants for Data Analysis (R03) program is designed to
provide investigators with the support necessary to conduct such secondary
data analyses utilizing existing database resources.  Applications may be
related to, but must be distinct from, the specific aims of the original data
collection.  This mechanism may be used to develop new statistical
methodologies or to test new hypotheses using existing data.  Hypothesis-
generating research will be considered only if carefully described and
justified.

Secondary analyses of data derived from NEI-supported studies are of highest
programmatic interest, although the grants can be used to support analyses of
data derived from other sources.  Applicants should consider the relevance of
their proposed analyses to NEI programs and priorities as described in "Vision
Research--A National Plan:  1999-2003" which is available at
http://www.nei.nih.gov

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 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 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.

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: [email protected]

Supplemental Guidelines

o  Face Page:
Item 2,  Check "Yes" and enter "NEI Small Research Grants for Data Analysis".
Item 6,  A maximum of two years of support may be requested.

o  Research Plan:
Specific Aims,  Do not exceed one-half page.
Background and Significance,  Do not exceed one page.
Progress Report,  Not generally applicable.  If data from preliminary studies
are available, the report should not exceed one page.
Research Design and Methods,  Do not exceed five pages, with a maximum of two
pages devoted to a description of the data set(s) proposed for analysis, to
allow an evaluation of the quality and extent of the data available.

o  Literature Cited:  Do not exceed one page

o  Consortium/Contractual Arrangements:  Do not exceed one and one-half pages. 
Documentation of access to the data should be provided in this section.

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.  It is
anticipated that these changes will reduce the administrative burden for the
applicants, reviewers 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 $100,000 per year.  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 $100,000) 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  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.

o  Consortium/Contractual Costs:  Provide an estimate of Total Costs (Direct
plus F&A Costs) 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 their 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.

o  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

- Complete the educational block at the top of the form page
- list position(s) and any honors
- provide information, including overall goals and responsibilities, on
research projects ongoing or completed during the last three years
- 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.

Submit a signed, typewritten original of the application, including the
Checklist, and three 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)

At the time of submission, two additional signed copies of the application,
INCLUDING ANY APPENDICES, must be sent to:

Andrew P. Mariani, Ph.D.
Chief, Scientific Review Branch
National Eye Institute
Executive Plaza South, Suite 350
6120 EXECUTIVE BLVD, MSC 7164
BETHESDA MD  20892-7164

REVIEW CONSIDERATIONS

Applications will be evaluated for scientific and technical merit by an
appropriate scientific review group convened by the NEI in accordance with the
review criteria stated below, and receive a second level review by the
National Advisory Eye 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, animals or the
environment, to the extent they may be adversely affected by the project 
proposed in the application.

Additional scientific/technical merit criteria specific to the objectives of
this PA include:

o  The adequacy of the data set for testing the stated hypothesis.

o  Documentation that the Principal Investigator will have access to the data
to be analyzed.

o  Demonstration that the investigator(s) have an understanding of the extent
and limits of the data base, and how these factors may affect the proposed
research.

AWARD CRITERIA

Applications will compete for available funds with all other recommended
applications.  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:

Mary Frances Cotch, Ph.D.
Donald F. Everett, M.A. or
Natalie Kurinij, Ph.D.:
Collaborative Clinical Research
National Eye Institute
6120 Executive Boulevard, Suite 350, MSC 7164
Bethesda, MD  20892-7164
Telephone:  (301) 496-5983
FAX:  (301) 402-0528
Email:  [email protected]
Email:  [email protected]
Email:  [email protected]

For grants administration information, applicants should contact:

Grants Management Officer
National Eye Institute
Executive Plaza South, Suite 350
6120 EXECUTIVE BLVD, MSC 7164
BETHESDA MD  20892-7164
Telephone:  (301) 496-5884
FAX:  (301) 496-9997

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.867.  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 and 285) 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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