and Human Services (HHS)
EXPIRED
SMALL RESEARCH (R03) GRANTS FOR INTERNATIONAL RESEARCH IN INFECTIOUS DISEASES AT NIAID INTERNATIONAL SITES (IRID-NIAID) 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) (http://www.niaid.nih.gov) THIS PA CONTAINS THE FOLLOWING INFORMATION 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 PURPOSE OF THIS PA 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 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 writing a research grant proposal. Clinical trials will not be supported under this program. 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. MECHANISM(S) OF SUPPORT 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. ELIGIBLE INSTITUTIONS 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: http://www.worldbank.org/aids-econ/confront/appendix/apdxtbl2a.htm (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. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS 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. SPECIAL REQUIREMENTS 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: 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 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 NIH, DHHS Room 3110, MSC-7630 6700-B Rockledge Drive Bethesda, MD 20892-7630 Telephone: (301) 496-1884 Fax: (301) 480-4528 Email: [email protected] Contact information for other DMID staff is available at: http://www.niaid.nih.gov/cgi-shl/dmid/contact.cfm 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: [email protected] 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 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. Additional instructions for submitting an R03 application, including page limitations, can be found at: http://grants.nih.gov/grants/guide/pa-files/PA-02-038.html 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 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 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 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. PEER REVIEW PROCESS 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 an appropriate 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. 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 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: 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. 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 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. 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 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. You will find this policy announcement 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://grants.nih.gov/grants/stem_cells.htm 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 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. 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 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. 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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