NEI CLINICAL STUDY PLANNING GRANT (R21)

Release Date:  January 27, 2000

PA NUMBER:  PAR-00-051 (This PA has been reissued, see PAR-05-115)

National Eye Institute

THIS PA USES THE "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

This Program Announcement (PA) replaces the "National Eye Institute Clinical 
Trial Planning Grant", which was last revised in September, 1989.

The National Eye Institute (NEI) supports large-scale clinical research 
projects, including randomized clinical trials and epidemiologic studies.  At 
the time of submission, applications requesting support for these activities 
are expected to provide detailed information regarding the study"s rationale, 
design, analytic techniques, protocols and procedures, facilities and 
environment, organizational structure, and collaborative arrangements.  This 
information is best conveyed in a well-documented Manual of Procedures (MOP), 
the development of which represents a costly and time-consuming activity.  The 
Clinical Study Planning Grant, providing up to $100,000 annual Direct Costs 
for up to two years, is an NEI support mechanism designed to facilitate 
activities central to the refinement of the study"s protocol and procedures 
and the development of a detailed MOP.

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 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 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.  Foreign institutions are not eligible for NEI 
Clinical Study Planning Grants.  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) R21 
Exploratory/Development Grant award mechanism.  Responsibility for the 
planning, direction, and execution of the proposed project will be solely that 
of the applicant.  The total project period for an application submitted in 
response to this PA may not exceed two years, and the annual Direct Costs may 
not exceed $100,000 per year.  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 Clinical Study Planning Grant provides support for the development of a 
comprehensive research protocol for a large-scale clinical trial or 
epidemiologic study.  This grant provides early peer review of the proposed 
clinical study in terms of its rationale, design, organizational structure and 
implementation plan.  The planning grant is used to support the development of 
a detailed MOP and can include preliminary studies to refine study procedures 
or to document recruitment potential.

Prospective applicants should note that funding of a Clinical Study Planning 
Grant does not guarantee or imply funding for any subsequent competitive 
application for the support of a full-scale study.

Applicants should consider the relevance of their proposed research 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:  
http://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: 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.

APPLICATION PROCEDURES

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 
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.  Applications 
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 301/435-0714, 
email: GrantsInfo@nih.gov .

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 http://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:  
http://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. 

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 four 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, one additional copy of the application should be 
sent to:

Andrew P. Mariani, Ph.D.
Chief, Scientific Review Branch
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 
standard NIH peer review procedures.  As part of the initial merit review, all 
applications will be discussed and assigned a priority score.  All 
applications also receive a second level review by the National Advisory Eye 
Council.

Review Criteria

Applications will be evaluated in accordance with standard NIH peer review 
criteria and procedures.  Special emphasis will be placed on the rationale of 
the proposed study in terms of relevance, importance, timeliness, and 
generalizability.  Other factors to be considered in assessing the merit of 
the application will include:

Significance:  Relationship of the proposed project with the NEI"s published 
priorities as set forth in "Vision Research--A National Plan:  1999-2003".

Approach:  Appropriateness and rigor of the proposed study design, in 
particular the selection of primary and secondary outcomes of interest, 
discussion of statistical issues, enumeration of possible study limitations or 
biases and plans for dealing with them, detailed description of and timetable 
for activities to take place during the planning grant period.

Innovation:  Discussion of novel or creative aspects of the proposed project’s 
focus, design or implementation, including plans for recruiting and retaining 
eligible study participants.

Investigator:  Expertise, leadership, and experience of the proposed 
investigative team in conducting collaborative clinical research.

Environment:  Methods of communication to promote interaction among proposed 
investigative team members, organizational resources, e.g. level of effort, 
use of equipment and financial support, available to the investigative team to 
augment NEI funds in developing a detailed, clinical study protocol.

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.

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 concerning this PA 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
Executive Plaza South, Suite 350
6120 EXECUTIVE BLVD, MSC 7164
BETHESDA, MD 20892-7164
Telephone: (301) 496-5983
FAX:  (301) 402-0528
Email:  mfcotch@nei.nih.gov
deverett@nei.nih.gov
kurinij@nei.nih.gov 

Direct inquiries regarding fiscal matters to:

William W. Darby
Grants Management Officer
Division of Extramural Research
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
Email:  wwd@nei.nih.gov

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, a 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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