NIAID INTERNATIONAL RESEARCH IN INFECTIOUS DISEASES (IRID) R03 PROGRAM

RELEASE DATE:  June 17, 2004

PA NUMBER:  PAS-04-111

EXPIRATION DATE: June 15, 2006

Update:
June 15, 2006 (RFA-AI-06-041) -  This PAS has been reissued as RFA-AI-06-041

Department of Health and Human Services (DHHS)
 (http://www.hhs.gov/)

PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
 (http://www.nih.gov/)

COMPONENT OF PARTICIPATING ORGANIZATION: 
National Institute of Allergy and Infectious Diseases (NIAID)
 (http://www.niaid.nih.gov)

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research

RECEIPT DATES:  Standard receipt dates (http://grants.nih.gov/grants/dates.htm)

THIS PA CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanism 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 Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA 

This Program Announcement replaces PA-03-062, SMALL RESEARCH (R03) GRANTS FOR 
INTERNATIONAL RESEARCH IN INFECTIOUS DISEASES AT NIAID INTERNATIONAL SITES 
(IRID-NIAID) (http://grants.nih.gov/grants/guide/pa-files/PA-03-062.html) that 
appeared in the NIH Guide on January 24, 2003.

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. 

Collaborative projects involving investigators and institutions from 
international sites and the U.S. are particularly encouraged.  

RESEARCH OBJECTIVES

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 developing research 
programs and grant applications. Clinical trials will not be supported under 
this program. Studies may be proposed on any aspect of infectious diseases 
(except clinical trials), including but not limited to:  the epidemiology, 
pathogenesis, immunopathogenesis of infectious diseases; epidemiologic studies 
to define the incidence, clinical presentations, and outcomes of diseases; 
identification of resistance patterns; characterization of susceptible cohorts 
for a particular pathogens; pilot and feasibility studies in preparation for 
larger studies.  

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) 
(http://www.niaid.nih.gov/dmid/icer/default.htm); International Centers for 
Tropical Disease Research (ICTDRs) (http://www.niaid.nih.gov/ictdr/default.htm); 
Tuberculosis Research Program; Comprehensive International Program of Research 
on AIDS (CIPRA) (http://www.niaid.nih.gov/daids/cipra); HIV Vaccine Trials 
Network (HVTN) (http://www.hvtn.org); HIV Prevention Trials Network 
(http://www.hptn.org/index.htm); The Gambia Pneumococcal Vaccine Trial 
(http://www.niaid.nih.gov/dmid/gambia/study.htm); and The NIAID Global Health 
Research Plan for HIV/AIDS, Malaria, and Tuberculosis 
(http://www.niaid.nih.gov/publications/globalhealth/global.pdf).  

This IRID 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. This program supports R03 grants for research, including 
pilot/exploratory/feasibility research. CIPRA R03 grants support the planning 
stages research projects on AIDS, but do not support pilot or exploratory 
research projects. Applications from institutions from eligible countries where 
NIAID has significant investments through extramural research grants, 
cooperative agreements or contracts or through programs of the NIAID Division of 
Intramural Research are particularly encouraged.  However, NIAID funding is not 
a requirement. 

MECHANISM(S) OF SUPPORT

This PA will use the 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 for an R03. The applicant 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.  NIAID intends to commit approximately 
$1 million annually in FY 2005 to FY2007 to fund 20 new grants in response to 
this PA. 

This PA uses just-in-time concepts.  It also uses the modular budgeting as well 
as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if the 
investigator is submitting an application with direct costs in each year of 
$250,000 or less, use the modular budget format.  Otherwise follow the 
instructions for non-modular budget research grant applications.  This program 
does not require cost sharing as defined in the current NIH Grants Policy 
Statement at http://grants2.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.  

ELIGIBLE INSTITUTIONS 

Applications may be submitted by institutions or organizations located in 
resource-constrained countries (i.e. countries with per capita gross national 
income (GNI) less than US $5,000 for 2002, or the most recent year for which 
data are available.  Potential applicants can determine eligibility by selecting 
the relevant country using the following site World Bank, Data and Statistics, 
Data by Country:  http://www.worldbank.org/data/countrydata/countrydata.html.  
Select the country from “Select a Group or Country”; “GNI, per capita” is found 
under the “Economy” section.

The applicant may submit (an) application(s) if their institution has any of the 
following characteristics: 

o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, and 
laboratories
o Units of Foreign National, State and local governments
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual 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/P01 or U01/U19 grants are not eligible to apply.

SPECIAL REQUIREMENTS 

Clinical trials will not be supported.  When clinical studies or trials 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: 
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full 
policy, including terms and conditions of award, is available at: 
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf).

WHERE TO SEND INQUIRIES

Inquiries concerning this PA are encouraged. Inquiries may fall into two areas: 
scientific/research and financial or grants management issues.

o Direct questions about scientific/research issues to:

For non-AIDS research:

Dr. Polly R. Sager
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 6005, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 496-1884
FAX: (301)480-4528
Email: ps31g@nih.gov 

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
Email: cipra@niaid.nih.gov 

o Direct questions about financial or grants management matters to:

Donna Sullivan
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 2232, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 594-6361
Email: DSullivan@niaid.nih.gov  

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a DUN and 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal 
Identifier when applying for Federal grants or cooperative agreements. The DUNS 
number can be obtained by calling (866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 
of the face page of the PHS 398 form. The PHS 398 document is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html  in an interactive 
format. For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
Email: GrantsInfo@nih.gov.

The title and number of this program announcement must be typed on line 2 of the 
face page of the application form and the YES box must be checked.

SUPPLEMENTAL INSTRUCTIONS FOR R03 APPLICATIONS:

Please use the following guidelines for preparation of an R03 application in 
response to this PA:

1) The description (abstract) must include a brief explanation of the proposed 
activity, and how it is consistent with the exploratory/development nature of 
the R03 mechanism as described in this notice.

2) Although preliminary data are neither expected nor required for an R03 
application, they may be included.

3) Sections a-d of the Research Plan may not exceed 10 pages, including tables 
and figures.

4) Appendix materials should be limited, as is consistent with the exploratory 
nature of the R03 mechanism, and should not be used to circumvent the page limit 
for the research plan. Copies of appendix material will only be provided to the 
primary reviewers of the application and will not be reproduced for wider 
distribution. The following materials may be included in the appendix:

o Up to five publications, including manuscripts accepted for publication, 
abstracts, patents, or other printed materials directly relevant to the project. 
These may be stapled as sets.  

o Surveys, questionnaires, data collection instruments, and clinical protocols. 
These may be stapled as sets.

o Original glossy photographs or color images of gels, micrographs, etc., 
provided that a photocopy (may be reduced in size) is also included within the 
10-page limit of items a-d of the research plan.

Include five collated sets of all appendix material, in the same package with 
the application, following all copies of the application. Identify each item 
with the name of the principal investigator. Appendices should not be attached 
to individual copies of the application.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which are 
available at http://grants.nih.gov/grants/dates.htm. 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 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)

APPLICATION PROCESSING: Applications must be received by or mailed before the 
receipt dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The NIH 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 NIH 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 unfunded version of an application already reviewed, 
but such application must include an Introduction addressing the previous 
critique.

Although there is no immediate acknowledgement of the receipt of an application, 
applicants are generally notified of the review and funding assignment within 8 
weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of established 
PHS referral guidelines. Appropriate scientific review groups 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 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 written critique
o Receive a second level review by an 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 evaluate the application in order 
to judge the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals. The scientific review group will address 
and consider each of the following criteria in assigning the application’s 
overall score, weighting them as appropriate for each application.

o Significance
o Approach
o Innovation
o Investigator
o Environment

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.

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?

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?

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

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)?

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?

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation in 
the proposed research will be assessed. (See criteria included in the section on 
Federal Citations, below) 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 
will be assessed. Plans for the recruitment and retention of subjects will also 
be evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be 
used in the project, the five items described under Section f of the PHS 398 
research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL REVIEW CONSIDERATIONS

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

AWARD CRITERIA

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

REQUIRED FEDERAL CITATIONS

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against these 
risks, the potential benefits of the research to the subjects and others, and 
the importance of the knowledge gained or to be gained. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm 

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: 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:  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. 

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 
http://grants.nih.gov/grants/funding/children/children.htm.

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy 
requires education on the protection of human subject participants for all 
investigators submitting NIH proposals for research involving human subjects. 
This policy announcement is in the NIH Guide for Grants and Contracts 
Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research on 
hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It 
is the responsibility of the applicant to provide, in the project description 
and elsewhere in the application as appropriate, 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 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to the 
“Standards for Privacy of Individually Identifiable Health Information”, the 
“Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal regulation 
under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 
that governs the protection of individually identifiable health information, and 
is administered and enforced by the DHHS Office for Civil Rights (OCR). 

Decisions about applicability and implementation of the Privacy Rule reside with 
the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a 
complete Regulation Text and a set of decision tools on “Am I a covered entity?” 
Information on the impact of the HIPAA Privacy Rule on NIH processes involving 
the review, funding, and progress monitoring of grants, cooperative agreements, 
and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.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. 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 http://www.health.gov/healthypeople.
 
AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic Assistance at 
http://www.cfda.gov/ 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 
http://grants.nih.gov/grants/policy/policy.htm. 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.  All awards are subject 
to the terms and conditions, cost principles, and other considerations described 
in the NIH Grants Policy Statement.

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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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