Full Text TW-92-03 SPECIAL INTERNATIONAL POSTDOCTORAL RESEARCH PROGRAM IN THE ACQUIRED IMMUNODEFICIENCY SYNDROME NIH GUIDE, Volume 21, Number 20, May 29, 1992 RFA: TW-92-03 P.T. 44 Keywords: Biomedical Research Training AIDS Epidemiology Diagnosis, Medical Disease Prevention+ Treatment, Medical+ Fogarty International Center Letter of Intent Receipt Date: July 1, 1992 Application Receipt Date: September 10, 1992 PURPOSE The Fogarty International Center (FIC) invites applications to develop multi-disciplinary postdoctoral fellowship programs in Acquired Immunodeficiency Syndrome (AIDS) research for foreign and U.S. scientists. Funds will be awarded to encourage basic and population-based research in all biomedical and behavioral disciplines related to AIDS. This announcement is for the second five-year funding cycle for this program. Both new and competing applications for this program are welcome. According to the World Health Organization, over 160 nations from all continents have reported AIDS cases in their countries. Research into this disease has been significant. The causative agent, the human immunodeficiency virus (HIV) has been identified; the virus has been shown to severely impair the immune system and the central nervous system. The associated risk factors and major modes of transmission are known. The epidemiologic patterns and modes of transmission have been shown to vary between men and women and among countries. Until the disease can be prevented, cures are found, or an effective vaccine is developed, AIDS will continue to be an increasingly global public health problem. International cooperation is important in understanding and preventing HIV infection/AIDS. It is in this context that the FIC, NIH, is inviting a recompetition for the Special International Postdoctoral Research Program in AIDS. In February 1992, the FIC completed a comprehensive review of the overall program to date. The basic rationale for the program as originally designed was reaffirmed and a number of useful recommendations were made to enhance this program further, the most relevant of which have been incorporated into this announcement. The major changes for the second five-year funding cycle include a shift in emphasis from short- to long-term training and greater emphasis on advanced research training of former and future trainees in-country under continued guidance of the program director and his/her faculty colleagues. Applicants are encouraged to develop training programs that facilitate the conduct of future international vaccine and drug trials in an ethical and equitable manner. This program will continue to emphasize trainees from, and training activities in, the developing countries of Africa, Latin America and the Caribbean, Asia and the Pacific region. The program will also accommodate trainees from, and training activities in, countries of Central and Eastern Europe and the former Soviet Union. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2OOO," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Special International Postdoctoral Research Program in AIDS, is related to the priority of HIV infections. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0) or "Healthy People 2000" (Summary Report: Stock No. 017-001-0473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone (202) 783-3238. ELIGIBILITY REQUIREMENTS Eligible institutions must be a U.S., non-profit, private or public institution capable of meeting the objectives in this RFA. Only one application will be allowed under this program from each U.S. institution. MECHANISM OF SUPPORT Grants will be made as institutional research fellowship (T22) awards for a total project period of five years. Continued support depends on satisfactory performance as judged by annual progress reports, during site visits, and meetings of program directors. Continued support will be based on the satisfactory performance of the grantee as judged by program progress described in annual reports and during periodic site visits and meetings of program directors. Each appointee will receive a stipend not to exceed $3,750 per month and expenses to cover round-trip economy-class air fare; the host institution will receive an allowance of up to $600 monthly per person to cover health insurance, travel to domestic scientific meetings, and incidental research expenses. It should be noted that the above stipends and allowances are maximums, and applicant institutions are encouraged to design the most cost-effective programs generally at lesser amounts. Grantee institutions may request (1) an indirect cost allowance based on eight percent of the total allowable direct cost, and (2) reimbursement of the program director's time and effort, not to exceed 25 percent of annual salary or $25,000 whichever is smaller. The total cost per grant (direct plus indirect) for the first year may not exceed $300,000 for continuing programs and $200,000 for new starts. Applicants should assume a budget increase of four percent per year for each succeeding year. While applicants may develop programs at or close to these limits, as noted above, they are strongly encouraged to pursue the most cost-effective approaches for implementing these programs. It is expected that successful applicants will attract additional funds to support the AIDS research efforts of current and former appointees. In keeping with the intent to maintain a flexible program, requests for administrative supplemental budget increases of up to 20 percent of budget levels in a given budget year for the expansion of prior- approved activities will be allowed to meet special needs and take advantage of unusual opportunities. Such requests will be reviewed by program staff, and support depends upon availability of funds. The intent is to award up to four grants for the first year of the second five-year funding cycle. The number of grants awarded, however, will depend upon the quality of the approved grant applications and the availability of funds. Only one T22 application will be allowed under this program from each U.S. institution. The anticipated date of award is July 1993. FUNDS AVAILABLE Approximately $1,000,000 (total costs) will be allocated to this program in FY 1993, availability of funds permitting, resulting in an estimated four awards, depending upon the quality of applications. The total (direct and indirect) cost per grant for the first year may not exceed $300,000 for continuing and $200,000 for new programs. RESEARCH OBJECTIVES The objectives of this special institutional research fellowship program are (1) to support collaborative research between U.S. and foreign scientists who wish to enhance their knowledge and skills in the epidemiology, diagnosis, prevention, and treatment of HIV/AIDS and (2) to stimulate scientists from nations affected by AIDS to cooperate and to share research knowledge in combatting this global problem. It is expected that the program director will be a recognized scientist in AIDS research, interested in both the basic and clinical aspects of the syndrome, and able to attract as preceptors basic and clinical scientists in his or her institution who have expertise in AIDS. Under this award the program director will make training appointments varying from 3-24 months to foreign and U.S. scientists. Scientists who are appointed must have an earned doctoral degree (M.D., Ph.D., D.V.M., D.D.S.) or the equivalent in a health science field, be actively engaged in AIDS research, not be employed by a for-profit institution, and if foreign, must have a permanent position in his/her home institution. Postdoctoral scientists at all career levels are eligible for appointment. It is expected that appointments will cover the range of scientific disciplines related to HIV/AIDS research. U.S. scientists from the grantee institution will be limited to collaborative study in foreign institutions only. The U.S. appointees must have a letter of invitation from the foreign hosts accepting the fellows and committing the resources of the foreign institutions to the research effort. Foreign scientists will generally conduct their research at the awardee institution although appointments for in-country advanced research training under the guidance of participating faculty are allowable, but with individual appointments in this category to be approved in advance as a reprogramming request; each appointee will be assigned to a preceptor from among the participating faculty. Up to 60 person-months of appointments will be permitted each budget year. Types of Training o Postdoctoral research training conducted for 3-24 months in duration at U.S. institutions for foreign scientists. Postdoctoral scientists (e.g., M.D.s, Ph.D.s) at all career levels are eligible for appointment. Training includes basic and clinical research in all biomedical and behavioral disciplines related to HIV/AIDS and is meant to enhance knowledge and skills in the epidemiology, diagnosis, prevention, and treatment of HIV/AIDS. o Postdoctoral research training conducted at foreign institutions for U.S. scientists varying from 3-24 months duration. Scientists at all postdoctoral career levels are eligible for appointment to this type of training. o Advanced in-country research training conducted at foreign institutions for selected, highly qualified foreign scientists under the guidance of participating U.S. faculty, varying from 3-24 months duration. Individuals who had completed initial training at U.S. institutions are potentially eligible for appointments in this category. SPECIAL REQUIREMENTS The primary effort of the program should be directed toward developing countries and selected other countries that have, or are likely to have, population groups with a significant incidence of HIV/AIDS. Countries in Central and Eastern Europe and the former Soviet Union are eligible to participate as are countries in Asia and the Pacific Region from which the greatest number of future HIV infections and AIDS cases are expected to occur. The majority of candidates for training will be selected from those developing countries where the program director and colleagues have well-established collaborations as, for example, through in-country research efforts and/or a history of joint publications. This does not preclude establishing collaborative arrangements in countries or areas where HIV/AIDS has not yet developed epidemic proportions. Trainees from developed countries may be allowed into the program only under special, well-justified circumstances and with prior approval by the FIC as a reprogramming request to meet special training needs. The program's focus must be on HIV/AIDS, opportunistic infections, and other diseases strongly associated with AIDS (e.g., sexually transmitted diseases and tuberculosis). Emphasis will be given to the development of human resources in those developing countries that are likely to be hosts for HIV/AIDS-related research and field trials of anti-HIV drugs, HIV vaccines, and other interventions. Applicants are required to describe training in the responsible conduct of research to be part of the programs. An award will not be made unless such a description is included. The application must include a plan describing the selection procedures for appointees. It is expected that appointees will include: (1) U.S. and foreign scientists, (2) junior-, mid-, and senior-level scientists, (3) scientists from those countries where AIDS has been identified as a current or future public health problem, and (4) scientists whose research in AIDS will benefit from this research experience. Before any funds can be expended from this award, the grantee institution must show evidence of approval for collaborative research between the U.S. and foreign institutions and/or from the foreign government through an endorsement from the Minister of Health or other appropriate government official. STUDY POPULATIONS While the majority of support for training-related research may be derived from sources other than in this award, prospective awardees are expected to comply with NIH policy concerning study populations in the conduct of training-related research. Protection of Human Subjects Although in most cases the primary support for training-related research and associated assurances of protection for human subjects will be covered through other funding mechanisms, the program directors are responsible to assure that all training-related research supported under this program meets applicable NIH requirements. Applicant institutions are reminded that adequate protection for human subjects in international collaborative research is an essential requirement for the NIH. Awardee institutions, each subordinate entity to the awardee, and each performance site, whether institutions or independent investigators, must agree that the rights and welfare of human subjects involved in research under this award shall be protected in accordance with 45 CFR 46. As a condition of award, not as a condition of application, applicants and affiliated performance sites are required to designate an institutional review board and possess an applicable assurance of compliance which has been approved by the Office for Protection from Research Risks (OPRR) of the NIH. Applicants will be notified if additional information is required on this matter. Protection of Vertebrate Animals Although in most cases the primary support for training-related research and associated assurances of protection for vertebrate animals will be covered through other funding mechanisms, the program directors are responsible to assure that all training-related research supported under this program meets applicable NIH requirements. The applicant organization must either have on file with the OPRR an approved Animal Welfare Assurance or the applicant organization must comply with PHS policy regarding the care and use of animals by establishing an institutional animal care and use committee (IACUC) and submitting an Animal Welfare Assurance and verification of IACUC approval when requested to do so by the OPRR. LETTER OF INTENT Prospective applicants are requested to submit a letter of intent, by July 1, 1992, that includes the number and title of this RFA, a title of the training program, the names of the program director and other key participating faculty, if known, and the identity of the U.S. and foreign countries and institutions involved in the collaboration. Although a letter of intent is not required, is not binding, and does not enter into the review of subsequent applications, the information that it contains is helpful in planning for the review of applications. It allows FIC staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Dr. Sherry Dupere Scientific Review Administrator Fogarty International Center National Institutes of Health Building 31, Room B2C32 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-2516 FAX: (301) 402-2056 For overnight or courier service letters are to be sent to the same address. APPLICATION PROCEDURES Special instructions are essential for completion of an application. These instructions are available from Dr. Bridbord at the address listed under "INQUIRIES". The research grant application form PHS 398 (rev. 9/91) is to be used in applying for this grant. These forms are available at most U.S. institutional business offices and from the Office of Grants Inquiries, Division of Research Grants, National Institutes of Health, 5333 Westbard Avenue, Room 449, Bethesda MD 20892, telephone (301) 496-7441 The RFA label available in the form PHS 398 must be affixed at the bottom of the face page of the original signed application. Failure to use this label could result in delayed processing of the application such that it may not reach the committee in time for review. To ensure the identification of the application with this RFA, mark "Yes" in item 2a of the face page of the application and type "Special International Postdoctoral Research Program in AIDS, TW-92-03". Submit a signed, typewritten original application, including the Checklist, and three signed, exact, single-sided photocopies, in one single package to: Application Receipt Office Division of Research Grants National Institutes of Health Westwood Building, Room 240 Bethesda, MD 20892** At the same time, to ensure that the application will be included in this expedited review, two complete copies of the application must be sent directly to: Dr. Sherry Dupere Scientific Review Administrator Fogarty International Center National Institutes of Health Building 31, Room B2C32 9000 Rockville Pike Bethesda, MD 20892 Telephone: (301) 496-2516 FAX: (301) 402-2056 If sending the application by overnight mail or courier service to Dr. Sherry Dupere, send the application to the above address. Applications must be received by September 10, 1992. If an application is received after that date, it will be returned to the applicant without review. The Division of Research Grants (DRG) will not accept any application in response to this announcement that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The DRG also will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revision of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed by DRG staff for completeness and FIC staff for responsiveness. Incomplete applications will be returned to the applicant without further consideration. If the application is not responsive to the RFA, it will be returned to the applicant. Those applications that are complete and responsive may be subjected to triage by an FIC peer review group to determine scientific merit relative to the other applications received in response to this RFA. The NIH reserves the right to withdraw from competition those applications judged as non-competitive and will so notify the applicants. Those applications judged to be competitive for award will be further reviewed for scientific and technical merit by the review committee convened by the FIC during November 1992. The final level of review will be provided by the Fogarty International Center Advisory Board in February 1993 which will provide advice to the Director, FIC, who will make the final funding decisions. Timetable Letter of Intent Receipt Date: July 1, 1992 Application Receipt Date: September 10, 1992 Review for Scientific Merit: November 1992 Review by the FIC Advisory Board: February 1993 Anticipated Award Date: July 1993 The following criteria apply to new applicant institutions and those seeking a competitive renewal. Factors to be considered in the scientific evaluation of each application include: The likelihood that the applicant institution can meet the objectives stated in this RFA and specifically: o Quality of research objectives and program design; o Qualifications of the participating faculty including depth of experience in basic and clinical disciplines related to HIV/AIDS research; o Relevance of the fellowship appointments to the U.S. and any collaborating foreign institutions' AIDS research programs; o Quality of facilities and resources including access to a significant population of HIV-infected individuals; o Ability of the faculty to attract, foster, and maintain international collaborations including accomplishments of current and/or former trainees following return to their home countries; o Level of support for domestic and international AIDS research and training from the NIH and other sources. Examples of such support include participation in or collaboration with the National Institute of Allergy and Infectious Diseases, AIDS Clinical Treatments Group (ACTG), International Collaboration for AIDS Research (ICAR), AIDS Vaccine Evaluations Clinics (AVEU), and Preparation for AIDS Vaccine Evaluation (PAVE) programs, and support from or collaboration with the National Cancer Institute; o Demonstrated capacity and/or potential to provide in-country advanced research training, that involves support for the research and appropriate guidance, for selected, highly qualified current and former trainees; o Demonstrated capacity and/or potential to prepare trainees for participation in in-country clinical trials of anti-HIV drugs, HIV vaccines, and other interventions; o Qualifications of the proposed collaborating in-country institutions; and o Demonstrated capacity and/or potential to coordinate program activities with related efforts of other FIC programs, other Federal agencies, and international organizations. AWARD CRITERIA The following will be considered in making funding decisions: o quality of the proposed project as determined by peer review; o cost-effectiveness of programs; o availability of funds; o program balance among critical research training areas of emphasis such as, but not limited to, preparation for future trials of anti-HIV drugs, HIV vaccines, and other interventions; and o geographic distribution among countries included in applications under consideration. INQUIRIES Prospective applicants are strongly encouraged to discuss their applications, including proposed collaborating countries and institutions with FIC program staff (see below) before submitting formal applications. All programmatic and scientific inquiries, including any requests for modified instructions to prepare applications, are to be directed to: Kenneth Bridbord, M.D. Chief, International Studies Branch Fogarty International Center National Institutes of Health Building 31, Room B2C32 Bethesda, MD 20892 Telephone: (301) 496-2516 FAX: (301) 402-2056 Inquiries related to the review of these applications may be directed to: Dr. Sherry Dupere Scientific Review Administrator Fogarty International Center National Institutes of Health Building 31, Room B2C32 Bethesda, MD 20892 Telephone: (301) 496-2516 FAX: (301) 402-2056 Inquiries regarding fiscal matters may be addressed to: Mrs. Silvia Mandes Grants Management Officer International Research and Awards Branch Fogarty International Center National Institutes of Health Building 31, Room B2C39 Bethesda, MD 20892 Telephone: (301) 496-1653 FAX: (301) 402-0779 AUTHORITY AND REGULATIONS This program of the John E. Fogarty International Center for Advanced Study in the Health Sciences is identified in the Catalog of Federal Domestic Assistance, No. 93.154. Awards will be made under the authority of the Public Health Service Act, Section 307 (42 USC 242l) and administered under PHS grants policies and Federal regulations, most specifically 42 CFR part 61. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. .
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