FOGARTY INTERNATIONAL RESEARCH COLLABORATION AWARD Release Date: October 30, 1998 PA NUMBER: PAR-99-008 P.T. Fogarty International Center This Program Announcement replaces PAR-95-011, which was published in the NIH Guide, Vol. 23, No. 44, December 16, 1994. PURPOSE The Fogarty International Research Collaboration Award (FIRCA) facilitates collaborative research between U.S. biomedical scientists supported by the National Institutes of Health (NIH) and investigators in the developing world as well as in Central and Eastern Europe, and countries of the former Soviet Union (FSU). The FIRCA will extend and enhance the research interests of both the U.S. scientist and the collaborating foreign scientist and will help to increase the research capacity of the foreign scientist and institution. Awards are made to the U.S. applicant institution to support a collaborative research project that will be carried out mainly at the foreign collaborator's research site. Up to $32,000 in direct costs per year are available for up to three years. These funds may cover the purchase of supplies for the foreign collaborator's laboratory, a small stipend for the foreign investigator, and travel for the U.S. and foreign collaborators and their research associates, as justified by the needs of the collaborative research. If the foreign collaborator does not have adequate biomedical or behavioral research infrastructure support within their institution, the FIRCA will provide for the purchase of small pieces of equipment necessary to the research project. All biomedical and behavioral research topics supported by the NIH are eligible for inclusion under this program. Investigators working on topics related to human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS) or related illnesses should apply for the Fogarty International Center's HIV/AIDS and Related Illnesses Collaboration Award (AIDS-FIRCA), which is available to U.S. investigators and their collaborators in most countries of the world: see the AIDS-FIRCA announcement in the NIH guide and at the FIC web site http://www.nih.gov/fic under Research and Training Opportunities. ELIGIBILITY REQUIREMENTS For the purpose of this program, eligible countries include those in the following regions: Africa, Asia (except Japan, Singapore, South Korea and Taiwan), Central and Eastern Europe (Hungary, Poland, the Czech and Slovak Republics, Romania, Bulgaria, Albania and the countries of the former Yugoslavia), Russia and the Newly Independent States (NIS) of the FSU, Latin America and the Caribbean, the Middle East, and the Pacific Ocean Islands (except Australia and New Zealand). The U.S. scientist will apply as principal investigator with a colleague from a single laboratory or research site in an eligible country. Occasionally, scientific opportunities may arise that warrant a formal collaborative effort between the U.S. investigator and individuals from more than one country. Such applications may be considered if well-justified and only after consultation with FIC program staff. Applications may be submitted by U.S. non-profit organizations, public and private, such as universities, colleges, hospitals (including Veteran's Administration hospitals), laboratories and units of State and local governments. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. In order to be eligible for a FIRCA, the following requirements must be met: o U.S. applicants must be principal investigators or project directors on NIH research project grants (referred to as the "parent grant") that will be active and funded at the start of the proposed FIRCA budget period. Eligible mechanisms are the R01, P01, or U01 with other mechanisms from the R, P and U series considered on a case by case basis after consultation with the FIRCA program officer. Center Core Grants (P30), Shannon Awards (R55), Small Grants (R03), training grants and research contracts are among the mechanisms generally not accepted as parent grants. The parent grant must have a minimum of 12 months of funding remaining at the time of application deadline to be eligible for FIRCA funding. Grants in a no-cost extension period are not generally eligible to act as parent grants. However, for programmatic reasons they may be considered eligible with the prior approval of the FIRCA program officer. Grants in a no-cost extension period must also have sufficient funds still available at the time of application to clearly support 12 months of parent grant effort. o The FIRCA research proposal should, in general, be an extension or a new direction of the parent grant. However, the proposed research must not be already supported by the U.S. investigator's parent grant or by other sources. When well justified, the proposal may be for work that is not directly related to the aims of the parent grant. In that case the research must be clearly within the expertise and field of interest of both the U.S. and foreign collaborators, as indicated by the general area of science in the parent grant. Such proposed research should make use of unique or special resources, circumstances or environment of the foreign site and of the comparative strengths of the U.S. and foreign investigators. o The foreign collaborator must hold a position at a public or private non- profit institution that will allow him or her adequate time and provide appropriate facilities to conduct the proposed research. o There is no limit to the number of distinct FIRCA grants an applicant may be awarded over time and applicants may already be FIRCA grantees at the time of application. However, only one FIRCA application may be submitted by the same investigator per review cycle. o Applicants may apply for only one competitive renewal of a given FIRCA award, providing the above-mentioned criteria are satisfied at the time of application for the renewal. MECHANISM OF SUPPORT The FIRCA will use the NIH small research project grant (R03) mechanism. The FIRCA grant will provide up to $32,000 per year in direct costs for up to three years. All proposed expenditures must be well justified and clearly related to the research objectives of the proposed project. 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 travel directly related to the research project. Equipment requests will be considered, including computers or fax machines to facilitate both research and communication, but will require strong justification. Travel funds may be requested up to 20 percent of the total direct costs (up to $6,400) for the U.S. Principal Investigator, the foreign collaborator, and/or their colleagues or students, for visits to each other's laboratory or research site. Such visits must be directly related to the subject of the collaborative research. If well justified, up to $5,000 of the $32,000 per year, may be allocated as a stipend for the foreign collaborator (or shared with other collaborators at the foreign site who are actively involved in the proposed research). It is expected that the stipend will enable the foreign investigator(s) to better focus their efforts, and those of their lab on the collaborative research. Up to $2,000 of the $32,000 per year may be allocated for the foreign collaborator(s) to attend a scientific conference related to the scientific area of the FIRCA award. The awards will be made to U.S. institutions which will be responsible for the administration of funds. The minimum small grant project period will be for one year; the maximum will be for three years. Continuation of the FIRCA project depends upon research progress, availability of funds, and continuation of appropriate NIH support for the U.S. Principal Investigator's research. The FIRCA grant will remain active if the parent grant expires and is not renewed during the FIRCA project period, provided the Principal Investigator indicates that the FIRCA research can continue without the parent grant. The FIC accepts applications for a competing continuation of FIRCA grants on a merit basis and for one time only. Applicants may want to consider whether their collaboration has developed to the point where they can submit an R01 research grant with a foreign component. The research under the FIRCA award is expected to occur mainly at the foreign site and the major portion of the funds must be spent at the foreign site to support this research. Therefore, indirect costs will be calculated on the basis of the off-site rate of the U.S. sponsoring institution. RESEARCH OBJECTIVES An important role of the FIC is to foster discovery through the support of international cooperation across the continuum of basic, clinical and applied biomedical, behavioral and health sciences. The opportunity to collaborate internationally provides a means of access to new information and perspectives; innovative concepts and methods; emerging research technologies, and unique populations and environments. The main objective of the FIRCA program is to support collaborative research efforts between U.S. and foreign scientists. These collaborations should extend or enhance the research interests of both the U.S. Principal Investigator and the foreign co- investigator while at the same time increasing the capacity of the foreign investigator and institution for sustained and productive research and research collaborations. Protection of Research Subjects 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, including obtaining any necessary single project assurances. Applicants should 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, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20892-7507, http://www.hhs.gov/ohrp/ Information on these assurances is included in the special application instructions available from the FIC web site: http://www.nih.gov/fic under Research and Training Opportunities. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided 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 research involving human subjects, should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which were published in the Federal Register of March 28, 1994 (59 FR 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. They are also available on the web at the following URL address: http://www.nih.gov/grants/guide/notice-files/not94-105.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://www.nih.gov/grants/guide/notice-files/not98-024.html. APPLICATION PROCEDURES Special application instructions are necessary to fill out the application for the program and are available on the FIC web site: http://www.nih.gov/fic/ under Research and Training Opportunities. The application should be completed by the U.S. Principal Investigator on standard research grant application form PHS 398 (rev. 5/95). Some additional information must be provided by the foreign collaborator as described in the "Special Instructions" mentioned above. The application, along with all required supplemental information, must be submitted as a single package, by the U.S. grantee's institution. Application kits are available from most U.S. institutional offices of sponsored research and from Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: [email protected]. Application kits are also available on the NIH web site: http://www.nih.gov/grants/forms.htm. 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 marked. Submit a signed, typewritten original of the application, including the Checklist and all supplemental information as described in the "Special Instructions" mentioned above, along with four 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) IN ADDITION, one copy of the application (NOT the original) and all supplemental information should be sent to the Fogarty International Center at: FIRCA PROGRAM FOGARTY INTERNATIONAL CENTER BUILDING 31, ROOM B2C39 31 CENTER DRIVE MSC 2220 BETHESDA, MD 20892-2220 Postmark dates for completed applications are November 25, March 25, and July 25. AIDS-FIRCA applications will be accepted on the standard AIDS receipt dates indicated in the application kit. If the deadline falls on a weekend or a holiday, it is automatically extended to the following workday. REVIEW CONSIDERATIONS Applications will be assigned to the Fogarty International Center. The research proposals will be reviewed for scientific and technical merit and quality of the collaboration by an appropriate study section in the Center for Scientific Review (CSR), NIH. As part of the initial merit review, all applications will receive a written critique and undergo a process in which applications under review will be discussed and assigned a priority score. Following the scientific-technical review, the applications will receive a second level review by the Fogarty International Center Advisory Board. The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. The FIRCA program also addresses important factors associated with international collaborative research and research capacity building at the foreign research site. In the written comments, reviewers will be asked to discuss these aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of the criteria below will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major impact on the scientific field and/or capacity-building and may thus deserve a high priority score. In one 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. In another, an investigator may propose research on an important topic in a developing country with underdeveloped research infrastructure but with unique resources, environment or knowledge not readily available in the U.S. or other developed nations. Such projects may be slower to achieve their scientific goals but offer the potential for building research capacity along with significant scientific impact in the long-term. The criteria are as follows: o Significance and Innovation: scientific, technical, or medical significance and originality of proposed research. o Approach: 1) appropriateness and adequacy of the experimental approach and methodology proposed to carry out the research 2) appropriateness of the proposed collaborative effort as a format for accomplishing the stated aims. o Investigators: 1) appropriateness of the relationship of the proposed research to the research interests and expertise of the U.S. Principal Investigator and the foreign collaborator; 2) ability of the foreign collaborator to undertake and direct the foreign research efforts. o Research Capacity Building: potential of the collaboration to enhance the research capability of the foreign collaborator and the foreign site. Does the research constitute a substantial scientific endeavor for the foreign collaborator, including creative and scientific input to the research proposal? The foreign site and investigator should not be used merely to gather biological samples (clinical, plants etc), or behavioral data (interviews, surveys, etc.) unless a strong and compelling scientific rationale for such use can be presented. In all cases, the foreign investigator should be actively involved in analyzing and interpreting the data. o 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 and of the collaborative arrangements? Is there evidence of institutional support? Are the resources necessary to perform the research available or obtainable? After the priority score has been determined, in accordance with NIH policy, all applications will also be reviewed with respect to the following criteria: o The appropriateness of the proposed budget and duration in relation to the proposed research. o The adequacy of plans to include both genders, children, and minorities and their subgroups as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The adequacy of the proposed protection of humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. AWARD CRITERIA Applications will compete for available funds with all other approved applications assigned to the Fogarty International Center. The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review, o availability of funds, and o program priority, which may include regional balance of the foreign sites. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Kathleen Michels Division of International Research and Training Fogarty International Center Building 31, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: [email protected] Direct inquiries regarding grants management and fiscal matters to: Ms. Heidi Bishop Fogarty International Center Building 31, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-7613 FAX: (301) 402-0779 Email: [email protected] 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. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-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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