RELEASE DATE:  January 24, 2003

PA NUMBER:  PA-03-062 (see replacement PAS-04-111)

EXPIRATION DATE: December 2005, unless reissued.

National Institute of Allergy and Infectious Diseases (NIAID)


o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Submitting an Application
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations


The National Institute of Allergy and Infectious Diseases (NIAID) encourages 
the submission of R03 applications from institutions in eligible foreign 
countries to conduct preliminary or pilot studies or to explore the 
feasibility of, and initiate the planning of, collaborative infectious 
diseases research among investigators and institutions at international sites 
where NIAID has significant investment in research and/or infrastructure (see 
below for list of NIAID programs).  These grants will serve to build 
independent research capacity by providing direct funding to investigators 
who do not currently have NIAID funded grant awards for research projects.  
The intent of these activities is to advance the development of local 
scientific expertise and to increase collaborative research partnerships at 
NIAID international sites.  Data and collaborations supported by this R03 
program should lead to submission of applications for independent research 
funding (R01s/U01s).  Collaborative projects involving investigators and 
institutions from international sites and the U.S. are particularly 


NIAID has a long-standing interest in and commitment to global health and 
international research.  Topics of interest for this program are limited to 
research on infectious diseases, including emerging infections that are of 
the greatest public health significance within the overseas country (e.g. 
tuberculosis; malaria; HIV/AIDS; sexually transmitted diseases; diarrheal, 
respiratory, and enteric diseases; viral hemorrhagic fevers; viral 
encephalitides; parasitic diseases; and vector-borne diseases).  Development 
of immunological, microbiological, biostatistical, epidemiological, and 
clinical research capacity is encouraged.  Funds may be used to support pilot 
or feasibility studies, development of preliminary data, travel and meetings 
to establish collaborations, and activities associated with writing a 
research grant proposal.  Clinical trials will not be supported under this 

NIAID's supports a number of international research programs on infectious 
diseases, including HIV/AIDS [click on any title to link to more 
information]: International Centers of Excellence in Research (ICERs), 
International Centers for Tropical Disease Research (ICTDRs),  Tuberculosis 
Research Program, Comprehensive International Program of Research on AIDS 
(CIPRA), HIV Vaccine Trials Network (HVTN), HIV Prevention Trials Network,  
The Gambia Pneumococcal Vaccine Trial, and The NIAID Global Health Research 
Plan for HIV/AIDS, Malaria, and Tuberculosis.  The IRID-NIAID program is 
intended to extend these programs by expanding the breadth of research 
supported at international sites and by providing support for young or new 
researchers.  Unlike the current programs, the IRID-NIAID program supports 
R03 grants for research, including pilot/exploratory/feasibility research.  
CIPRA R03 grants support the planning stages of large integrated research 
projects on AIDS, but do not support pilot or exploratory research projects. 
Applications that extend research programs at overseas institutions funded by 
NIAID has significant investments either through extramural research grants, 
cooperative agreements or contracts or through the Division of Intramural 
Research are particularly encouraged. 


This PA will use NIH Small (Pilot) Research Project Grant, (R03) award. The 
total requested project period for an application submitted in response to 
this PA may not exceed three years. As an applicant you will be solely 
responsible for planning, directing, and executing the proposed project. 
NIAID uses R03 grants to support small, highly innovative or pilot projects. 
Applicants for R03 grants may request up to $50,000 annual direct costs for a 
period not to exceed three (3) years. Foreign Institutions may request up to 
8% indirect costs.  Funds and time requested should be appropriate for the 
research proposed. Applicants may request travel funds, but may not request 
large equipment. R03 awards are not renewable.


Applications may be submitted by public or private research or clinical care 
institutions or organizations located in resource-constrained countries (i.e. 
countries with per capita gross national product less than US $5,000). 
Potential applicants can determine eligibility by country using the following 
table that summarizes economic information and HIV data by country:
(The HIV epidemic data is not relevant to this program.) Multiple applications
are anticipated addressing potential collaborative research activities at a
single international site or region.  


Any individual employed at an eligible foreign institution with the skills, 
knowledge, and resources necessary to carry out the proposed research is 
invited to work with their institution to develop an application for support. 
Individuals from underrepresented racial and ethnic groups as well as 
individuals with disabilities are always encouraged to apply for NIH 
programs.  Foreign investigators who currently serve as Principal 
Investigators on R01/PO1 or U01/U19 grants are not eligible to apply.  


Clinical trials will not be supported.  When clinical studies are a component 
of the research proposed, NIAID policy requires that studies be monitored 
commensurate with the degree of potential risk to study subjects and the 
complexity of the study. AN UPDATED NIAID policy was published in the NIH 
Guide on July 8, 2002 and is available at:
The full policy, including terms and conditions of award, is available at:


We encourage your inquiries concerning this PA and welcome the opportunity 
answer questions from potential applicants. Inquiries may fall into two 
areas: scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

For non-AIDS research:

Polly R. Sager, Ph.D.
Assistant Director for International Research in Infectious Diseases
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases 
Room 3110, MSC-7630
6700-B Rockledge Drive
Bethesda, MD 20892-7630
Telephone:  (301) 496-1884
Fax:  (301) 480-4528

Contact information for other DMID staff is available at:

For AIDS research: 

Dr. Rodney Hoff
Division of AIDS
National Institute of Allergy and Infectious Diseases
Room 4157, MSC-7628
6700-B Rockledge Drive
Bethesda, MD  20892-7628
Telephone:  (301) 496 6179
FAX:  (301) 493 0591

o Direct your questions about financial or grants management matters to:

Theresa Mercogliano
Division of extramural Activities
National Institute of Allergy and Infectious Diseases 
Room 2124, MSC-7614  
6700-B Rockledge Drive
Bethesda, MD 20892-7614 
Telephone:  (301) 402-5512 
FAX:  (301) 480-3780 


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). The PHS 398 is available at in an interactive 
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
Email:  Additional instructions for submitting an R03 
application, including page limitations, can be found at:

For the NIH Small Grant (R03): 

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.  NO PUBLICATIONS.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at Application 
deadlines are also indicated in the PHS 398 application kit.

SENDING AN APPLICATION TO THE NIH: 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)

APPLICATION PROCESSING: Applications must be received by or mailed before the 
receipt dates described at 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 


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 
( 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 an appropriate advisory council or board.  


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 

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. Your 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, you 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 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 

(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 

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

PROTECTIONS: 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.

INCLUSION: The adequacy of plans to include subjects from both genders, all 
racial and ethnic groups (and subgroups), and children as appropriate for the 
scientific goals of the research. Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria included in the 
section on Federal Citations, below)

BUDGET: The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.


Applications submitted in response to a PA will compete for available funds 
with all other recommended applications. The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities


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
a complete copy of the updated Guidelines are available at
_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 

The NIH maintains a policy 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 is available at

policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects. You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at and at Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see 
It is the responsibility of the applicant to provide the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research. 
Applications that do not provide this information will be returned without 

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

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.

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. Furthermore, we 
caution reviewers that their anonymity may be compromised when they directly 
access an Internet site.

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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 


This program is described in the Catalogue of Federal Domestic Assistance in 
the following citations: No. 93.855, Immunology, Allergy, and Transplantation 
Research and No. 93.856, Microbiology and Infectious Diseases Research. 
Awards are made under authorization of Sections 301 and 405 of the Public 
Health Service Act as amended (42 USC 241 and 284) 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 NIH Grants Policy Statement is available at This document includes 
general information about the grant application and review process; 
information on the terms and conditions that apply to NIH Grants and 
cooperative agreements; and a listing of pertinent offices and officials at 
the NIH.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the 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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