NEI SMALL GRANTS FOR PILOT RESEARCH (R03)

Release Date:  October 26, 2000 (See termination per NOT-EY-05-001)

PA NUMBER:  PAR-01-007

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

The National Eye Institute (NEI) announces a program of small grants (R03) 
for support of pilot research.  These R03 projects should focus on research 
that is particularly innovative and/or potentially of high impact to vision 
research.  High impact research involves feasibility studies in which the 
technological, methodological, or theoretical approach to a problem lacks an 
historical precedent or sufficient preliminary data, but whose successful 
outcome would have a major effect on a scientific area.  The application must 
develop new research relevant to the NEI mission in retinal diseases, corneal 
diseases, lens and cataract research, glaucoma, strabismus, amblyopia, visual 
processing, low vision and its rehabilitation, visual health services 
research, or collaborative clinical vision research.

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), NEI SMALL RESEARCH GRANTS FOR PILOT RESEARCH (R03), 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.  Participation in the program by investigators at minority 
institutions is strongly encouraged.

This NEI small grant support is for pilot research for new projects only, 
competing continuation applications will not be accepted.  Submission of an 
application under this PA precludes concurrent submission of any other Public 
Health Service application containing substantially the same research 
proposal.  In addition, these R03 awards may not be used to supplement 
research projects currently supported by Federal or non-Federal funds, or to 
provide interim support of projects under review by the Public Health 
Service.

To be eligible for this award, the proposed Principal Investigator must be an 
independent researcher.  New investigators are eligible, but they must be 
independent of a mentor and have strong institutional support.  Small grant 
support may not be requested for thesis or dissertation research.  
Investigators who have questions about eligibility should contact one of the 
officials listed under INQUIRIES.

MECHANISM OF SUPPORT

This PA will use the NIH small grant (R03) 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 three years.  The budget may 
be submitted for direct costs up to four modules of $25,000 each ($100,000 
direct costs per year).  These grants may not be renewed.

Replacement of the Principal Investigator on this award is not permitted.

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

Background

The NEI supports laboratory and clinical research aimed at increasing our 
understanding of the eye and visual system in health and disease.  NEI-funded 
research seeks to develop the most appropriate and effective means of 
prevention, treatment, and rehabilitation of visual disorders and to promote 
visual health through the timely dissemination of research findings and 
information.

The goal of this small grants program is to provide flexibility for 
initiating preliminary, short-term studies, thus allowing new ideas to be 
investigated in a more expeditious manner without stringent requirements for 
preliminary data.  Such support is needed to encourage experienced 
investigators as well as new investigators to pursue new approaches, 
underdeveloped topics, or more risky avenues of research.  If successful, 
these awards should lead to significant scientific advances in vision 
research.

Research Goals and Scope

The purpose of this PA is to support studies that have the potential for 
leading to a technological, methodological, or conceptual breakthrough or 
major contribution in laboratory and/or clinical biomedical and behavioral 
vision science.  This research may involve: 1) pilot testing of novel 
experimental hypotheses, 2) design-driven development of new or novel 
techniques or technologies, and/or 3) acquisition of a body of data that has 
potentially high-impact on vision research.  This program solicits projects 
relevant to the mission of all NEI program areas:  retinal diseases, corneal 
diseases, lens and cataract research, glaucoma, strabismus, amblyopia, and 
visual processing, and low vision and its rehabilitation.  "Vision Research, 
a National Plan:  1999-2003", articulates NEI"s current research needs, 
opportunities, and priorities.  It 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 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.

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

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.

The PHS 398 grant application form (rev. 4/98) is to be used to submit the 
R03 grant at the standard application deadlines indicated in the application 
kit.  The form may be downloaded from the NIH web site at 
http://grants.nih.gov/grants/forms.htm.  Application kits are also 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.

BUDGET INSTRUCTIONS

R03 Modular Grant applications will request Direct Costs in $25,000 modules, 
up to a Total Direct Cost request of $100,000 per year, with the 
modifications made to the standard PHS 398 application instructions described 
below:

PHS 398

o FACE PAGE - The title, "NEI Small Grants for Pilot Research (R03)" and 
number of this PA must be typed on line two of the face page and the YES box 
must be marked.  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 all 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 OTHER SUPPORT -- Do not complete this section.  It is not required and will 
not be accepted with the application.

o RESEARCH PLAN -- Items a - d of the Research Plan (Specific Aims, 
Background and Significance, Preliminary Studies (not required), and Research 
Design and Methods) may not exceed a total of ten pages.  Detailed 
descriptions of protocols for the proposed involvement of human subjects 
and/or vertebrate animals, literature cited, consortium/contractual 
arrangements and consultant letters are not included in the ten-page limit.

Describe the particularly innovative/high impact aspects of the proposed 
study in an introductory paragraph at the beginning of the research plan.  
Include a description of how the outcome of this project would provide a 
foundation for important new vision research.  Label this paragraph, 
"Justification as Innovative/High Impact Research." 

For revised applications, an introduction (not to exceed one page) in 
addition to the Research Plan is required.  This introduction should respond 
to the comments and concerns of the Initial Review Group delineated in the 
summary statement.

o APPENDIX -- Appendix material will be limited to color/glossy figures and 
tables.

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 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 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
Bethesda, MD  20817 (for express/courier service)

REVIEW CONSIDERATIONS

Applications will be reviewed by the Center for Scientific Review (CSR) for 
completeness. NEI staff will carry out an administrative review of all 
submissions.  Applications that lack the introductory justification, are 
incomplete, do not conform to the required format, or exceed the ten-page 
limit will not be reviewed and will be returned to the investigator.  

Applications will be evaluated for scientific and technical merit in 
accordance with the standard NIH procedures by an appropriate scientific 
review group convened by the NEI.  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 and 
assigned a priority score.  All applications also 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.

(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?  Will a successful outcome from this pilot study lead 
directly to more extensive studies that would likely advance the field of 
vision research?

(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?  Will the 
project generate a new body of data that provides a foundation for important 
new research directions?

(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)?  Is the 
Principal Investigator an independent researcher?

(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 considerations pertinent to the review of these NEI Small Grants 
for Pilot Research (R03) applications:

o  Because the research plan is limited to ten pages, these R03 small grant 
applications may not have the same level of detail or extensive discussion 
normally found in a regular R01 research project grant application.  Review 
emphasis will be placed on the conceptual framework and general approach to 
the problem, with less emphasis on methodological details.

o  Since pilot/feasibility studies may not include preliminary data, the 
review will 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 additional studies that could potentially be funded as a regular research 
project grant (R01).

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:

Richard S. Fisher, Ph.D.
Division of Extramural Research
National Eye Institute
Executive Plaza South, Suite 350
6120 Executive Blvd, MSC 7164
Bethesda, MD  20892-7164

Telephone:  (301) 496-5301
FAX:  (301) 402-0528
Email:  rf75s@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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

			Department of Health and Human Services (HHS)
NIH... Turning Discovery Into Health®