HIV, AIDS AND RELATED ILLNESSES COLLABORATION AWARD NIH GUIDE, Volume 23, Number 3, January 21, 1994 PAR NUMBER: PAR-94-029 P.T. 34, 48 Keywords: AIDS Fogarty International Center PURPOSE The Fogarty International Center (FIC) is expanding its AIDS International Research and Training Program to provide small individual research grants for collaboration between U.S. and foreign scientists in any country, consistent with U.S. foreign policy considerations. Support is available for research on human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), and for research related to AIDS. Up to $20,000 per year for a maximum of three years is available for U.S. investigators and their foreign collaborators to conduct research mainly at the foreign site. U.S. investigators holding currently active NIH grants for research related to HIV infections, AIDS, and other related health problems are eligible to apply with their foreign collaborator for the AIDS Fogarty International Research Collaboration Award (AIDS-FIRCA). Grants will provide funds to the foreign collaborator, through the U.S. grantee institution, for supplies at the foreign institution; for expenses incurred at the U.S. institution to support the collaboration; and for research-related travel and subsistence expenses for both the U.S. and foreign investigators. If the foreign collaborator is in a developing country, applicants may also request funds for small pieces of equipment necessary to the AIDS-FIRCA project at the foreign site. For the purpose of this program, developing countries are considered to include those in the following regions: Africa, Asia (except Hong Kong, Japan, Singapore, South Korea and Taiwan), Central and Eastern Europe, Latin America, the Middle East (except Israel and the Persian Gulf states), and the Pacific Ocean Islands (except Australia and New Zealand). ELIGIBILITY To be eligible for the AIDS-FIRCA program, the following conditions must be met: o The proposed U.S. Principal Investigator must be the Principal Investigator (Project Director) of an NIH-sponsored AIDS or AIDS-related research grant project (R, P, or U01 series) that will be active and funded during the proposed grant award period (up to three years). Under exceptional circumstances, after consultation with program officials, some research contracts (N01 series) may be eligible "parent" funding for the AIDS-FIRCA. On submission of an application, at least 19 months of active research support must remain on the listed parent grant. Investigators may request the full three years of support in the FIRCA application in cases where less than three future years remain on the parent grant, presuming that the renewal application will be submitted and awarded. o The foreign collaborator must hold a position at an institution in a foreign country that will allow him or her adequate time and provide appropriate facilities to conduct the proposed research. o The application must demonstrate that the award will enhance the scientific contributions of both the U.S. and foreign scientists and will enhance or expand the contribution of the NIH-sponsored research project (parent grant). MECHANISM OF SUPPORT The small grants (R03) will provide up to $20,000 per year in direct costs for up to three years. Funds may be used for materials and supplies necessary to conduct the collaborative research in the foreign scientist's research laboratory or site, and for costs related to the AIDS-FIRCA project at the U.S. institution. Equipment requests are limited to items for use in the AIDS-FIRCA project at foreign institutions in developing countries. Travel and subsistence-related expenses may be requested for the U.S. Principal Investigator, the foreign collaborator, and/or their colleagues for visits directly related to the subject of the collaborative research. All proposed expenditures must be well justified and clearly related to the research objectives of the proposed project. Applicants should request support to conduct research not already being supported by the U.S. investigator's parent grant; however, the research application must be an extension of or related to the research project currently funded by the NIH. The awards will be made to U.S. institutions, which will be responsible for the expenditures. The minimum FIRCA project period will be for one year, the maximum will be for three years, and depends on the continuation of appropriate NIH support of the Principal Investigator's AIDS-related research. If the related NIH research project (parent) grant expires in less than three years' time it may, upon renewal, reestablish eligibility for a continuation of the AIDS- FIRCA award for the full award period. Since the research supported under this award is mainly to occur at the foreign site, indirect costs will be calculated on the basis of the off-site rate of the U.S. sponsoring institution. RESEARCH OBJECTIVES The main objective of this AIDS-FIRCA program is to facilitate unique and highly promising collaborative basic and applied research efforts between U.S. and foreign scientists that will both expand and enhance the HIV- and AIDS-related NIH-supported research program of the U.S. Principal Investigator and benefit the scientific interests of the collaborating foreign scientist. All areas of research directly and indirectly related to HIV infection and AIDS are eligible for consideration. Examples of topics include, but are not limited to: o Research related to the development of HIV/AIDS vaccines; o Research on antiviral and other interventions for HIV/AIDS; o Research on HIV and infection by the virus; o Research on other retroviruses related to HIV; o Studies of maternal/pediatric HIV infections; o Cofactors involved in HIV infection; o Studies on the spread of HIV infection and AIDS into new locales; o The natural history of HIV infection; o Research on opportunistic infections and other disorders that result from immunosuppression by the AIDS virus; o Studies of emerging/reemerging microbes and diseases linked to factors known or suspected to relate to the spread of HIV; and o Research on the social and behavioral factors that affect HIV risk and transmission. Applicants should be aware that applicable provisions for protection of human research subjects and laboratory animals must be met in both domestic and foreign settings. See Title 45 CFR, Part 46, for information concerning the Department of Health and Human Services regulations for the protection of human subjects and the PHS Policy on Humane Care and Use of Laboratory Animals. These are available from the Office for Protection from Research Risks, National Institutes of Health, Building 31, Room 5B59, Bethesda, MD 20892. Information on these assurances is included in the special application instructions available from FIC (address below). STUDY POPULATIONS SPECIAL INSTRUCTIONS TO APPLICANTS REGARDING IMPLEMENTATION OF NIH POLICIES CONCERNING INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH STUDY POPULATIONS NIH policy is that applicants for NIH clinical research grants and cooperative agreements are required to include minorities and women in study populations so that research findings can be of benefit to all persons at risk of the disease, disorder or condition under study; special emphasis must be placed on the need for inclusion of minorities and women in studies of diseases, disorders and conditions which disproportionately affect them. This policy is intended to apply to males and females of all ages. If women or minorities are excluded or inadequately represented in clinical research, particularly in proposed population-based studies, a clear compelling rationale must be provided. FIRCA applicants should employ these principles in the design of studies and the selection of subjects or materials relative to the local population, and include a statement indicating the relationship of the design to the U.S. population. The composition of the proposed study population must be described in terms of gender and racial/ethnic group. In addition, gender and racial/ethnic issues should be addressed in developing a research design and sample size appropriate for the scientific objectives of the study. This information must be included in the form PHS 398 (rev. 9/91) in Sections 1-4 of the Research Plan AND summarized in Section 5, Human Subjects. Applicants are urged to assess carefully the feasibility of including the broadest possible representation of minority groups. However, NIH recognizes that it may not be feasible or appropriate in all research projects to include representation of the full array of United States racial/ethnic minority populations (i.e., Native Americans (including American Indians or Alaskan Natives), Asian/Pacific Islanders, Blacks, Hispanics). The rationale for studies on single minority population groups must be provided. For the purpose of this policy, clinical research is defined as human biomedical and behavioral studies of etiology, epidemiology, prevention (and preventive strategies), diagnosis, or treatment of diseases, disorders or conditions, including but not limited to clinical trials. The usual NIH policies concerning research on human subjects also apply. Basic research or clinical studies in which human tissues cannot be identified or linked to individuals are excluded. However, every effort should be made to include human tissues from women and racial/ethnic minorities when it is important to apply the results of the study broadly, and this should be addressed by applicants. If the required information is not contained within the application, the review will be deferred until the information is provided. Peer reviewers will address specifically whether the research plan in the application conforms to these policies. If the representation of women or minorities in a study design is inadequate to answer the scientific question(s) AND the justification for the selected study population is inadequate, it will be considered a scientific weakness or deficiency in the study design and will be reflected in assigning the priority score to the application. All applications for clinical research submitted to NIH are required to address these policies. NIH funding components will not award grants or cooperative agreements that do not comply with these policies. APPLICATION PROCEDURES Applications must be submitted by the U.S. Principal Investigator on standard form PHS 398 (rev. 9/91), which is available from most U.S. institutional offices of sponsored research and from the Office of Grants Information, Division of Research Grants, National Institutes of Health, Bethesda, MD 20892, telephone (301) 710-0267. Special application instructions are required and are available from FIC program staff listed under INQUIRIES. All budget item requests must be fully justified. The application consists of a portion to be completed by the U.S. Principal Investigator and a separate portion to be completed by the foreign collaborator. Both portions of this application must be submitted as a single package by the U.S. grantee institution. Receipt dates for completed applications are October 1, February 1, and June 1. If the deadline falls on a weekend or a holiday, it is automatically extended to the following workday. REVIEW CONSIDERATIONS Applications will be assigned for review to, and awards made by, the Fogarty International Center, utilizing the customary NIH peer review process. Scientific and technical merit are evaluated by a Fogarty International Center initial review group. Second level review is provided by the Fogarty International Center Advisory Board. AWARD CRITERIA Award decisions are made by the Director, FIC, and are based on the scientific merit of the applications, program policy considerations, and the availability of funds. Awards are announced as soon as possible following each Advisory Board meeting. INQUIRIES Written and telephone inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Mirilee Pearl International Research and Awards Branch Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 FAX: (301) 402-0779 Direct inquiries regarding grants management and fiscal matters to: Ms. Silvia Mandes Grants Management Office Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 FAX: (301) 402-0779 AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.934. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. .
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