PAS-04-111: NIAID INTERNATIONAL RESEARCH IN INFECTIOUS DISEASES (IRID) R03 PROGRAM

Department of Health
and Human Services (HHS)

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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.

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