Full Text TW-92-02 INTERNATIONAL TRAINING GRANTS IN EPIDEMIOLOGY RELATED TO THE ACQUIRED IMMUNODEFICIENCY SYNDROME NIH GUIDE, Volume 21, Number 20, May 29, 1992 RFA: TW-92-02 P.T. 44 Keywords: Biomedical Research Training AIDS Epidemiology Fogarty International Center Letter of Intent Receipt Date: July 1, 1992 Application Receipt Date: September 10, 1992 PURPOSE The Fogarty International Center (FIC), National Institutes of Health (NIH), invites applications to develop international training programs in epidemiology related to Acquired Immunodeficiency Syndrome (AIDS) for foreign health scientists, clinicians, and allied health workers. This announcement is for the second five-year funding cycle for this program. Both new and competing renewal applications for this program are welcome. In the original announcement for this program in 1988, it was recognized that the role of epidemiological studies, particularly when combined with related basic, clinical, and social science disciplines such as virology, immunology, medicine, nursing, anthropology, and behavioral sciences, had been critical in understanding the natural history of AIDS, major modes of Human Immunodeficiency Virus (HIV) transmission, and risk factors for HIV infection. Studies in other countries have provided important information that complements NIH programs in such areas as characterizing the infectious agent, understanding heterosexual transmission, and documenting the effects of AIDS upon women and children. International collaboration can greatly enhance HIV/AIDS research efforts, but to be effective, research in other countries must be conducted by scientists and health professionals from these countries and endorsed by their governments. A major goal of the International Training Grants in Epidemiology Related to AIDS Program is to train scientists of other countries to deal effectively with the AIDS epidemic through epidemiologic research, clinical trials, and AIDS prevention research programs. This training program will help to (1) establish the necessary research and medical expertise needed in countries affected by HIV/AIDS and facilitate new research efforts that supplement or complement U.S. AIDS research and (2) establish cooperative relationships between U.S. and foreign research groups and support cooperation between U.S. academic research centers and foreign scientists. Collaborations established through this effort will help to facilitate standardized screening and monitoring of clinical trial subjects and prepare for the coordinated conduct of scientifically valid and ethically sound clinical trials on an international basis. Funds will be awarded to provide training in epidemiology and AIDS-related basic science in accordance with the stated objectives for individuals preparing for or involved in AIDS research and AIDS prevention research programs. Applicants are encouraged to relate training to ongoing research efforts in developing countries. 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 further enhance this program, 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), International Training Grants in Epidemiology Related to 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 described 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 International Training Grants in Epidemiology (D43) 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. U.S. investigators may request funds to support research projects in the trainees' home country that emanate from the M.S. and Ph.D. epidemiological training program. The research supported (1) must be one of the requirements in fulfillment of an M.S. or Ph.D. degree or part of advanced research training, (2) be relevant to an AIDS problem in the trainee's country, and (3) may form the basis for a long-term collaboration funded by future research grant support. The following cost categories are eligible for reimbursement under this program. It should be noted that the following stipends and allowances are maximums, and applicant institutions are encouraged to design the most cost-effective programs generally at lesser amounts: o Living allowance (stipend) comparable to trainee's professional level, but not to exceed $45,000 per annum while undergoing training in the U.S.; o Living allowance (stipend) while conducting in-country dissertation research or in-country advanced research training at a level comparable to that received by similar professionals in- country, but also not to exceed $45,000 per annum; o Tuition; o Round-trip economy class air fare between the U.S. and home country (two trips for M.S./Ph.D. candidates and advanced research trainees, one for all others); o Allowance for the grantee institution of up to $600 monthly per student to cover health insurance, scientific meetings, and incidental research expenses; o Research support of up to $15,000 per trainee to facilitate the conduct of advanced research training in the home country conducted by current and/or former trainees; the program director is expected to have projects submitted for this funding peer reviewed by the U.S. institution; o Support of up to $10,000 for in-country field research in partial fulfillment of the M.S./Ph.D training program; o Travel and per diem for the program director and faculty colleagues to provide guidance to students conducting dissertation-related field studies and/or advanced research training in their home countries; o Program director's salary (up to 25 percent of annual salary or $25,000, whichever is smaller); o Travel and per diem for faculty presenting short-term, in-country courses; o Support (travel, per diem, and pro-rated salary, up to 25 percent of annual salary or $25,000, whichever is less), to enable U.S. faculty to be involved in advanced research training activities conducted in-country; and o In keeping with the intent to maintain a flexible program, requests for administrative supplemental budget increases of up to 20 percent of funded 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 will depend upon availability of funds. Grantee institutions may request an indirect cost allowance based on eight percent of the total allowable direct costs exclusive of tuition and related fees and expenditures for equipment. The total allowable cost (direct and indirect) per grant for the first year of this five- year award may not exceed $600,000 for continuing programs and $400,000 for new starts. Applicants should assume a budget increase of four percent per year for each succeeding year. Although applicants may develop programs at or close to these limits, they are strongly encouraged to pursue the most cost-effective approaches for implementing these programs. FUNDS AVAILABLE Approximately $4,000,000 (total costs) will be allocated to this program in FY 1993, availability of funds permitting, resulting in an estimated ten awards, depending upon the quality of applications. The total (direct and indirect) cost per grant for the first year may not exceed $600,000 for continuing applications and $400,000 for new programs. RESEARCH OBJECTIVES The objectives of this program are to train scientists, particularly from developing countries, to deal effectively with the AIDS epidemic through epidemiologic research, clinical trials, and AIDS prevention research. The program is intended to support collaborative research between U.S. and foreign scientists who wish to enhance their knowledge and skills in the epidemiology, diagnosis, and treatment of HIV/AIDS and to stimulate scientists from nations affected by AIDS to cooperate and to share research knowledge in combating this global problem. This program is intended to complement ongoing AIDS research efforts of the NIH. Emphasis will be given to the development of human resources in those developing countries that are likely to be sites of HIV/AIDS-related research and field trials of anti-HIV drugs, HIV vaccines, and other interventions. Specifically, the program is designed to: o Increase expertise in epidemiology and laboratory components of AIDS-related epidemiologic research through short- and long-term training at U.S. institutions that may lead to M.S. and/or Ph.D. degrees in epidemiology; o Increase laboratory expertise of technical assistants who are engaged in epidemiological studies related to HIV/AIDS in foreign countries through in-country, short-term, didactic, and technical training; and o Expand ongoing collaborative training and epidemiological research in HIV/AIDS between U.S. and foreign scientists. Training Plan: Types of Training 1. Training in epidemiological concepts and methods and epidemiological field studies and research related to HIV/AIDS that may lead to an M.S. or Ph.D. degree for individuals with previous field research experience. The duration of training is estimated to range from about two to four years. Academic courses will be taken in the U.S.; field studies and research could be conducted in either the trainees' home country or in the U.S. 2. Training in epidemiological concepts and methods and epidemiological field studies and research related to HIV/AIDS that may lead to an M.S. degree for individuals without prior field research experience. Academic courses will be taken in the U.S.; field studies would be conducted in the trainees' home country. The duration of training is estimated to be about two years. 3. Short-term (up to three months) comprehensive courses in epidemiology, with an emphasis on AIDS, conducted in the U.S. 4. Training (about three to six months duration) in laboratory procedures and research techniques for individuals with M.S. and Ph.D. degrees conducted in the U.S. 5. In-country, practical and applied short-term training (up to three weeks) for professionals, technicians, and allied health professionals. 6. Advanced research training for selected current and/or former trainees to enable them to continue this advanced training in their home country and to participate in in-country research projects, such as clinical trials of anti-HIV drugs, HIV vaccines, and other interventions, including social and behavioral research designed to prevent the further spread of HIV/AIDS. Although applicants can plan to include such training (estimated to be about two years duration) as part of competing applications and non-competing renewals, individual appointments must be approved in advance as a reprogramming request and must be under the guidance of the program director and his/her faculty colleagues. 7. Support to enable U.S. faculty to be involved in advanced research training activities conducted in-country. Trainees Trainees shall be non-U.S. individuals who are involved in or are expected to be involved in epidemiological research related to AIDS and AIDS-prevention research activities in their home country. The following categories of individuals are eligible for training: 1. Health professionals (M.D., Ph.D., or equivalent); 2. Individuals with a bachelors or masters degree in a basic or health science; 3. Technicians and health care workers; 4. Allied health professionals such as nurses and social workers; and 5. Current or former trainees involved in advanced research training in their home countries. 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 either have well-established, in-country research efforts or a significant potential to develop such collaborative relationships as, for example, through a history of joint collaborations and/or 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 should be on HIV/AIDS, opportunistic infections, and other diseases strongly associated with AIDS (e.g., sexually transmitted diseases and tuberculosis). Applicants are required to describe training in responsible conduct of research to be part of the programs. An award will not be made unless such a description is included. 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 countries and institutions included in the program through an endorsement from the Minister of Health or other appropriate government official and from the collaborating institutions. The applicant institution must include a plan describing the recruitment and selection procedures for trainees and plans for continued collaboration with former trainees. 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 that has been approved by the Office for Protection from Research Risks. 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 Office for Protection of Research Risks, NIH, 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 Office for Protection of Research Risks. 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 brief 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 International Training Grants in Epidemiology Related to AIDS TW-92-02. 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 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. 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 will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS The DRG will review applications for completeness. Incomplete applications will be returned to the applicant without further consideration. Applications will be reviewed by FIC staff to determine responsiveness. If the application is not responsive to the RFA, it will be returned to the applicant without review. 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 applicant and institutional official. 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, that 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: September 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 The strength of the academic program in epidemiology and the depth of the faculty's experience in epidemiology and AIDS-related basic science and clinical disciplines; o The quality of teaching and research facilities and resources including those at institutions in other countries; o Previous success in training epidemiologists and in maintaining collaboration with former trainees including assisting former trainees in obtaining support for their research; o The likelihood, based on accomplishments of current and/or former trainees, that individuals selected for the proposed training will contribute meaningfully to science and health progress following return to their home countries; o Demonstrated support for domestic and international AIDS epidemiological and related research and training as evidenced by support from the NIH or other sources. Examples of such support include participation in or collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) AIDS Clinical Trials Group (ACTG), International Collaboration for AIDS Research (ICAR), AIDS Vaccine Evaluation Units (AVEU), and Preparation for AIDS Vaccine Evaluation (PAVE) programs, as well as 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/or former trainees; o Demonstrated capacity and/or potential to help support in- country clinical trials of anti-HIV drugs, HIV vaccines, and other interventions; o Capacity to provide in-country courses and workshops for indigenous technical staff and the quality of proposed technical training including training conducted by former trainees; o Demonstration of continued or of future support for the program from vernments and institutions and other non-vernmental organizations from collaborating countries; 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 anticipated date of award is on or before September 30, 1993. 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 requests for the special 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 9000 Rockville Pike 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 Awards under this program are 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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