This Program Announcement expires on January 3, 2005, unless reissued.

NIAID INVESTIGATOR-INITIATED SMALL RESEARCH (R03) GRANTS

Release Date:  December 17, 2001

PA NUMBER:  PA-02-038 (see Notice of Inactivation, NOT-AI-03-029)

National Institute of Allergy and Infectious Diseases
 (http://www.niaid.nih.gov)

THIS PROGRAM ANNOUNCEMENT 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

This announcement redefines the National Institute of Allergy and 
Infectious Diseases (NIAID) Small Grant (R03) mechanism and extends its 
use to unsolicited applications in addition to its use in individual 
Requests for Applications (RFA) and Program Announcements (PA). The R03 
award supports small research projects that can be carried out in a 
short period of time, with limited resources. The characteristics, 
requirements, preparation, and review criteria for the small grant 
application are described below. 

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) is related to one or more of the priority areas.  
Potential applicants may obtain "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.

Small grant support is for new projects only; competing continuation 
applications will not be accepted.  Small grant support may not be used 
for thesis or dissertation research.  

MECHANISM OF SUPPORT

This program 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 two years. Support may be requested for up to $50,000 
(direct costs) per year.  These grants may not be renewed.

Specific application instructions have been modified to reflect 
"MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts that have been 
adopted by the NIH for applications requesting up to $250,000 per year.  
Complete and detailed instructions and information on Modular Grant 
applications have been incorporated into the PHS 398 (rev. 5/2001).  
Additional information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

RESEARCH OBJECTIVES

Background

NIAID has used the R03 mechanism for many years to support research 
within the scope of individual RFAs and PAs, but has not accepted 
unsolicited investigator-initiated applications. The announcement is 
intended to introduce a more broadly defined small grant mechanism.

Scope

The common characteristic of the small grant is a requirement for 
minimal funding for a limited period of time.  Examples of the types of 
projects that NIAID will support with the R03 include the following:  

o  Pilot or feasibility studies
o  Small, self-contained research projects
o  Research at small colleges without well-developed research 
traditions
o  Emergency research support (e.g., in disaster situations)
o  Unexpected research opportunities
o  Projects by investigators changing fields/changing research 
direction
o  Innovative research
o  Development of new research technology

In addition, NIAID will continue to use the R03 for additional specific 
purposes announced in NIH Guide Notices, RFAs, and PAs. Investigators 
with projects that may qualify for the R03 mechanism should contact the 
NIAID to determine whether the project's aims are within the mission of 
NIAID. Staff will provide guidance on the suitability of the R03 
mechanism for individual projects.  Staff contact information is 
provided under INQUIRIES, below.

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 sub-populations must be included in all NIH-supported 
clinical research projects unless a clear and compelling justification 
is provided indicating 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 clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.  
The amended policy incorporates: the use of an NIH 
definition of clinical research; updated racial and ethnic categories 
in compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must 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) 
investigators must report annual accrual and progress in conducting 
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," published in the 
NIH Guide for Grants and Contracts, March 6, 1998, and available on the 
Internet at:  http://grants.nih.gov/grants/guide/notice-files/not98-024.html. 

REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

All investigators proposing research involving human subjects should 
read the NIH policy on education in the protection of human research 
participants now required for all investigators, published in the NIH 
Guide for Grants and Contracts, June 5, 2000 (Revised August 25, 2000), 
and available on the Internet at:  
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

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 must 
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 format. Although applicants are 
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:  [email protected].

Application Instructions

The following instructions are to be used in conjunction with the 
information accompanying application form PHS 398 (rev. 5/2001); they 
refer only to selected items in the application form.  All PHS 398 
requirements should be followed, with the exception of those items 
affected by the following instructions.  Applications not conforming to 
the requested format will be returned to the applicant without review.

o 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.    

For the NIH Small Grant (R03), Modular Grant applications will request 
direct costs in $25,000 modules, up to a total direct cost request of 
$50,000 for up to two years.  

o Research Plan

Items a - d of the Research Plan (Specific Aims, Background and 
Significance, Preliminary Studies, and Research Design and Methods) may 
not exceed a total of 10 pages.  Please note that a Progress Report is 
not needed; competing continuation applications will be not accepted 
for an R03.

o Appendix

Appendix material may only include color and/or glossy pictures with 
descriptions. 

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)

All grant applications submitted to CSR must come via United States 
Postal Service or a recognized delivery/courier service.  Individuals 
may not personally deliver packages to Rockledge.  For further 
information please see 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

Applications must be received by or mailed before the receipt dates 
described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR 
will not accept any application in response to this PA that is 
essentially the same as one currently pending initial review unless the 
applicant withdraws the pending application.  The CSR will not accept 
any application that is essentially the same as one already reviewed.  
This does not preclude the submission of a substantial revision of an 
application already reviewed, but such application must include an 
Introduction addressing the previous critique.

REVIEW CONSIDERATIONS 

Applications will be reviewed for completeness by the Center for 
Scientifif Review.  Incomplete applications will be returned to the 
applicant without further consideration.

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.  An appropriate scientific review 
group convened in accordance with the standard NIH peer review 
procedures (http://www.csr.nih.gov/refrev.htm) will evaluate 
applications for scientific and technical merit.  

As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a selection 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
o Receive a second level review by the appropriate national advisory 
council or board

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 your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  

 (1) SIGNIFICANCE:  Does your study address an important problem? If the 
aims of your application are achieved, how do they advance scientific 
knowledge?  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?  Do you acknowledge potential problem areas and 
consider alternative tactics?

 (3) INNOVATION:  Does your project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does your project 
challenge existing paradigms or develop new methodologies or 
technologies?

 (4) INVESTIGATOR: Are you appropriately trained and well suited to 
carry out this work?  Is the work proposed appropriate to your 
experience level as the principal investigator and to that of other 
researchers (if any)?

 (5) ENVIRONMENT:  Does the scientific environment in which your 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?

ADDITIONAL REVIEW CRITERIA 

The R03 "small grant" is a mechanism for supporting discrete, well-
defined projects that can realistically be expected to be completed in 
two years and that require only a modest level of funding.  Because the 
research plan is limited to 10 pages, a small grant application will 
not have the same level of detail or extensive discussion found in an 
R01 application.  Accordingly, reviewers should evaluate the conceptual 
framework and general approach to the problem, placing less emphasis on 
methodological details and certain indicators traditionally used in 
evaluating the scientific merit of R01 applications (e.g., hypothesis-
driven design, supportive preliminary data. 

In accordance with NIH policy, all applications also will 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 also 
will 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, and 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 priorities.

INQUIRIES 

Written and telephone inquiries concerning this program announcement 
are encouraged, especially during the planning phase of the 
application.  Below is a listing of NIAID contacts for the small grant 
(R03) program:

Carl W. Dieffenbach, Ph.D. 
Division of AIDS
National Institute of Allergy and Infectious Diseases 
Room Number 4133 MSC-7626
6700-B Rockledge Drive
Bethesda, MD  20892-7626 
Telephone:  (301) 496-0637 
FAX:  (301) 402-3211 
Email:  [email protected]

Irene B. Glowinski, Ph.D.
Chief
Office of Scientific Coordination and Program Operations
Division of Microbiology and Infectious Disease
National Institute of Allergy and Infectious Diseases
6700 B Rockledge, Room 3145
Bethesda, MD  20892-7630
Telephone:  301-496-1884
FAX:  301-480-4528
Email:  [email protected]

Alison Deckhut Ph.D.
Program Officer
Division of Allergy, Immunology and Transplantation, NIAID
Basic Immunology Branch
6700-B Rockledge Drive Rm. 5138
Bethesda, MD  20892-7640
Telephone:  301-496-7551 
FAX:  301-402-2571 
Email:  [email protected]

AUTHORITY AND REGULATIONS

This program is supported under authorization of the Public Health 
Service Act, Sec. 301(c), Public Law 78-410, as amended. The Catalogue 
of Federal Domestic Assistance Citations are No. 93.855, Immunology, 
Allergy, and Transplantation Research, and No. 93.856, Microbiology and 
Infectious Disease Research. Awards will be administered under PHS 
grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 
74. This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems 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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