RFA-TW-98-004: ACTIONS FOR BUILDING CAPACITY IN SUPPORT OF ICIDR PROGRAM

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ACTIONS FOR BUILDING CAPACITY IN SUPPORT OF ICIDR PROGRAM Release Date: May 8, 1998 RFA: TW-98-004 P.T. Fogarty International Center Letter of Intent Receipt Date: August 7, 1998 Application Receipt Date: September 15, 1998 PURPOSE The Fogarty International Center (FIC) invites applications for Actions For Building Capacity (ABC), a research training program issued jointly with, and closely related to, the NIAID"s International Collaborations in Infectious Disease Research (ICIDR) program (RFA AI-98-009). The ABC research training program will be supported by FIC through funding applications in response to this RFA (TW-98-004). Since the ABC is in direct support of the ICIDR, ABC awards will only be made to awardees of ICIDR grants. NOTE: Investigators may apply for: (1) an ICIDR award (in response to RFA AI- 98-009) or (2) BOTH an ICIDR award (in response to RFA AI-98-009) and an ICIDR- RELATED ACTIONS FOR BUILDING CAPACITY award (in response to this RFA). Independent applications for this ABC RFA will not be accepted. The purpose of this FIC training program, Actions for Building Capacity, is to stimulate high quality training and to support current and future collaborative training-related research on infectious diseases that are predominately endemic in or impact upon people living in tropical countries. The intent of the ABC program is to provide training opportunities for foreign investigators which will build research capacity and strengthen foreign and U.S. cooperation on tropical infectious diseases. Integration of the ABC and the ICIDR enhances the purposes of both the ICIDR and the ABC. The ABC will support training experiences for foreign scientists in the context of ICIDR priority research areas (see RFA AI-98-009). There are three objectives: 1) to increase expertise of scientists in developing countries in infectious disease-related biomedical, control and prevention research, 2) to expand ongoing collaborative training in infectious disease research and biomedical research between U.S. and foreign scientists, and 3) establish or strengthen infectious disease research, treatment and control centers of excellence in the home countries of trainees. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA is related to the priority area(s) of immunization and infectious diseases. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800). ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private institutions, such as universities, colleges, hospitals, laboratories, etc. All applicants for the FIC ABC grant must also apply for the NIAID"s ICIDR cooperative agreement. The proposed PI for the NIAID ICIDR must also be the proposed PI for the FIC ABC. While for-profit organizations may apply, they are strongly encouraged to develop linkages with academic institutions to be able to offer the full range of training opportunities included in the FIC ABC. Racial/ethnic minority individuals and women are encouraged to apply as Principal Investigators. The U.S. grantee institution is responsible for developing an affiliations(s) with an established institution (e.g. university, research institute, federal or state health department, hospital) in the host country. No ABC award will be made unless the applicant is successful in receiving an ICIDR award. NIAID may make ICIDR awards without ABC awards. MECHANISM OF SUPPORT Awards will be made under the international training grants (D43), which limits indirect costs to eight percent. Fogarty will make awards to selected top training applications. These awards will only be made to ICIDR recipients. The total project period for an ABC application submitted in response to this RFA may not exceed five years. At this time, the FIC has not determined whether and how this solicitation will be continued beyond the present RFA. FIC, with NIAID, will conduct a program evaluation by the end of the fourth year of the ABC. The results will assist in determining the re-issuance of the RFA. If, by the end of the fourth year of the award, the FIC has not announced their intent, due to budget uncertainties or other reasons, to reissue the RFA, incumbents should contact program staff before preparing a recompeting application to seek advice on the most appropriate method of application submission. FIC, with NIAID, anticipate conducting a program evaluation early in the fourth year of the program as part of the decision-process on whether to reissue this RFA. The applicant organization"s administrative support (including that available through the companion ICIDR award) must provide the necessary management for the transfer of funds and material to the off-site component. Indirect costs will not be paid on any expense incurred by the foreign institution(s). Travel, salaries, and fringe benefits will be subject to the applicant institution"s rules and regulations. Grants will be made as D43 training grant awards for a project period of up to five years. Continued support during this period depends on satisfactory performance of both the NIAID ICIDR and FIC ABC as judged by: annual progress reports, site visits and meetings of program directors, career progress of trainees (e.g., positions occupied, first author publications, presentations, research undertaken and research awards received), and development of national capacity for infectious disease related research, control and prevention, including the establishment or strengthening of model infectious disease centers of excellence in the home countries of trainees. Assessment of performance will be made jointly by FIC and NIAID. Special program reviews will be conducted by the FIC and NIAID. FUNDS AVAILABLE Approximately $500,000 is anticipated for support of this program in FY 1999. Awards under this Fogarty capacity building program will only be made to successful ICIDR applicants. The maximum allowable support for the first year is $54,000 ($50,000 direct costs plus 8% = $4,000). A budget of approximately $100,000 may be requested for years 02 to 05. Depending on the availability of funds for support of ABC in the future, FIC will consider this requested increase when making future-year awards. RESEARCH OBJECTIVES Scope of Training Training Objectives A. The integration of the FIC Actions for Building Capacity (ABC) program and the NIAID ICIDR will facilitate training of foreign scientists in the context of ICIDR research priority areas and facilitate sustainable collaborative research between the U.S. and foreign countries. The establishment and strengthening of scientific linkages between U.S. and foreign investigators stimulates self- sufficiency of the collaborating foreign institution and enhances the scientific infrastructure for additional international collaborative arrangements. The linkage of the ICIDR research and the ABC training programs is responsive to the recommendations of the Committee on International Science, Engineering and Technology Working Group on Emerging and Re-emerging Infectious Diseases which specifically recommends the following actions by the U.S. government: "Encouraging and assisting other countries to make infectious diseases detection and control a national priority, and, preserving existing U.S. Government activities that enhance other countries abilities to prevent and control emerging and re-emerging health threats." (As printed in Infectious Disease A Global Health Threat, Report of the National Science and Technology Council Committee on International Science, Engineering, and Technology Working Group on Emerging and Re-emerging Infectious Diseases. September 1995.) B. Specific Objectives: Training Plan: The training plan should include U.S.-based, long-term (usually a minimum of two years) training leading to an advanced degree or to provide postdoctoral training. The ABC will promote and facilitate training courses targeted toward specific needs, such as learning laboratory techniques and transfer of medical informatics, biotechnology and other methods required to support infectious disease research efforts in the home countries of the trainees involved in the ICIDR research projects. When a specific scientific course is given by one ABC program it is expected that this course will be open to trainees of other ABC award institutions. Training activities will be coordinated, facilitated and monitored by a training advisory group comprised of ABC PI"s, major foreign collaborators and the FIC and NIAID program officers or their designees. C. Types of Training: 1. Pre-doctoral training in infectious disease-related and biomedical research disciplines, and data management and analysis in support of that research, which may lead to an M.S. or Ph.D. or equivalent degree for individuals with or without previous field research experience. A masters or Ph.D. degree must be in support of the ICIDR research. The duration of training is estimated to range from about two to four years. In general, academic courses will be taken at the U.S. ICIDR institution. Field studies and research could be conducted in the U.S. but, to the extent possible, should occur in the trainees" home country in the context of the ICIDR project. Active involvement in on-going research and prevention projects is vital for a successful research and/or public health training experience. Innovative ways to involve trainees in ICIDR research projects conducted in their home countries is encouraged. 2. Postdoctoral research experiences, generally of two years duration for foreign health scientists. 3. Training of up to four weeks (or more if needed) in focused research methodologies, such as molecular epidemiology, immunologic technologies and clinical trial design. It is anticipated that at least one such course will be given each year, preferentially in a host country. 4. Training of about three to six months duration conducted in the U.S. in laboratory procedures and research techniques for example, development of pilot biomedical studies for individuals with M.S. and M.D. or Ph.D. degrees. D. Trainees: Trainees shall be individuals who are, or are expected to be, involved in infectious diseases biomedical research activities in their home country. The following categories of foreign individuals are eligible for training: 1. Health professionals (M.D., D.D.S./D.M.D., Ph.D., or equivalent). 2. Professionals with a bachelors or masters degree in a basic or health science. 3. Medical technicians and health care workers (short courses). 4. Allied health professionals such as behavioral scientists, nurses and social workers (short courses). 5. Current or former FIC trainees involved in advanced research training in their home countries. SPECIAL REQUIREMENTS Each awardee will have a U.S. Principal Investigator (PI) and a Major Foreign Collaborator (MFC). The PI and MFC will be responsible for the overall conduct of the ABC. Training Advisory Group. The ICIDR Executive Committee will establish a Training Advisory Group (TAG) to coordinate and facilitate training activities (See RFA AI-98-009). The ABC PI and MFC will be predominantly responsible for progress made by the trainees. The TAG will include ABC PIs (who will also be ICIDR PIs), the MFC for each ABC, the Fogarty Program Officer or designee and the NIAID Program Officer or designee. The TAG will have responsibility for reviewing, coordinating, and facilitating training plans (and in-country training courses) tied to research supported under the ICIDR, and for enhancing the progress of trainees. Training in Responsible Conduct of Research. Applicants are required to include training in responsible conduct of research as a part of the program. An award will not be made unless a description of such training is included. Recruitment and Selection Plan. The applicant institution must include a plan describing the recruitment and selection procedures for trainees, a detailed description of peer review for training-related and advanced in-country research (re-entry grants), and plans for continued collaboration with former trainees. Degree candidates must meet all entrance requirements of the U.S. degree granting institution. The grant applications should clarify and completely specify: (a) criteria and procedures for the selection of trainees as, for example, by a committee composed of U.S. and foreign investigators at participating institution(s) and (b) a mechanism for internal peer review of applications to support in-country research projects. Tracking System For Long Term Impact. As part of their obligations under this program, awardees are required to design and implement a system to fully track and document the long-term impact of this training program on: (1) the careers of current and former trainees, (2) research capacity in the home institution of trainees, (3) types of positions the proposed trainees may assume upon completion of training, (4) the contributions to future NIH international infectious disease prevention and clinical research efforts, and (5) the establishment or strengthening of infectious disease research centers of excellence in the home countries of trainees. Examples of such impact include how training received under the program has allowed participants to assume more responsible positions upon returning home, how continuing collaborations with former trainees resulted in the funding of infectious disease prevention or collaborative research projects for which trainees were either principal investigators or co- investigators, and publications in which trainees were first authors and which were based upon support under this program. Coordination and Collaboration. Coordination and collaboration of the ABC Program with other FIC award programs and affiliated institutions, especially when operating within the same country, will be of benefit to all partners. The coordination of activities among training sites will be facilitated by the FIC, in conjunction with NIAID, and will include organization of joint meetings to be held during international and regional scientific or public health meetings. Program applicants are strongly encouraged to include plans, if possible for coordination and collaboration with other FIC training programs: these include the FIC AIDS International Training and Research Program (AITRP), the International Training and Research Program in Emerging Infectious Diseases (ITREID) the International Training and Research Program in Environmental and Occupational Health (ITREOH), the International Training and Research Program in Population and Health, the International Cooperative Biodiversity Groups Program, the Minority International Research Training Program (infectious disease related activities), the newly established Medical Informatics Program and with other NIH-sponsored programs when working in common countries and/or regions. Given the increased emphasis on infectious disease research training and research globally, FIC will also facilitate coordination and collaboration with other government agencies (e.g., CDC, USAID, DoD, etc.) and with bilateral and multilateral international organizations, including the World Health Organization (WHO), Pan American Health Organization (PAHO), and in-country projects funded by NIAID. Allowable Costs The following cost categories are allowable and serve only as a guide under the training portion considering the limited amount of funds available particularly for the first year. A. Stipend and Salary 1. Living allowance (stipend) comparable to trainee"s professional level, in accordance with grantee institutional policies but not to exceed $35,000 per annum while undergoing training in the U.S., 2. Living allowance (stipend) while conducting in-country dissertation research or in-country advanced research training (re-entry grants) at a level comparable to that received by similar professionals in-country, in accordance with grantee institutional policies, but also not to exceed $35,000 per annum, 3. Stipend support (not to exceed $35,000 per year) for foreign and (with prior FIC approval) for U.S. postdoctoral researchers, 4. In general, for the purposes of this award U.S.-based faculty would not be supported in the first year of this program. It is expected that the companion ICIDR would support U.S. faculty participation in research training activities conducted in-country. In years 2-5, resources permitting, support (pro-rated salary, up to 10 percent of annual salary or $10,000, whichever is less) could be considered, to enable U.S. faculty to be involved in advanced research training activities conducted in-country, B. Travel 1. Round trip economy class air fare between the U.S. and home country (during the five years, two trips for M.S./Ph.D. candidates and advanced research trainees, one for all others), 2. 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, 3. Travel and per diem for faculty presenting short-term, in-country courses, 4. Travel for participation in networking and program coordination meetings. C. Tuition Tuition, not to exceed 20% of total direct costs. Exceptions to this policy require prior approval from the FIC. D. Training Related Expenses 1. Allowance for the grantee institution of up to $600 monthly per student to cover health insurance, scientific meetings, and incidental research expenses, 2. Support of up to $7,500 for in-country field research in partial fulfillment of the M.S./Ph.D. training program, 3. Research support of up to $10,000 per trainee to facilitate the conduct of advanced research training (re-entry grants) in the home country conducted by current and/or former FIC program trainees, the program director is expected to have projects submitted for this funding peer reviewed by the U.S. institution in accordance with plans outlined in the grant application. 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 sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided that inclusion is inappropriate with respect to the health of the subjects of 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 has been published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994. Investigations carried out under the ABC will be in accordance with U.S. government guidelines, including obtaining any required single project assurances (and possibly multiple project assurances) from the NIH Office for Protection from Research Risks. Investigators may obtain copies of these documents from Dr. Joel Breman (listed under INQUIRIES). LETTER OF INTENT Prospective applicants are asked to submit, by August 7, 1998, a letter of intent that includes a descriptive title of the overall proposed research, the name, address and telephone number of the Principal Investigator, the country(ies) and possible institutions to which the U.S. institution will be linked, and the number and title of this RFA. Although the letter of intent is not required, is not binding, does not commit the sender to submit an application, and does not enter into the review of subsequent applications, the information that it contains allows NIH staff to estimate the potential review workload and to avoid conflict of interest in the review. The letter of intent is to be sent to Dr. Joel Breman with a copy to Dr. Hortencia Hornbeak at the addresses listed under INQUIRIES. APPLICATION PROCEDURES Applications are to be submitted on the standard research grant application form PHS 398 (rev. 5/95), using the instructions for Institutional National Research Service Awards on page V-1. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone (301) 710-0267, email: grantsinfo@nih.gov For purposes of identification and processing, item 2 on the face page of the application must be marked "YES" and the RFA number "TW-98-004" and the words "ACTIONS FOR BUILDING CAPACITY" must be entered on the face page. Applications must be received by September 15, 1998. The RFA label available in the application form PHS 398 must be affixed to the bottom of the face page. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. Submit a signed, typewritten original of the application, including the checklist, and three signed, exact, single-sided 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) At the time of submission, two additional exact copies of the grant application and all five sets of any appendix material must be sent to Dr. Hornbeak at the address listed under INQUIRIES. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review (CSR) and for responsiveness by FIC staff, those judged to be incomplete will be returned to the applicant without review. Those considered to be non-responsive will be returned without review. NIAID will conduct the initial scientific review on behalf of the FIC, as part of the overall review of the ICIDR and ABC applications. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a peer review group convened by the NIAID in accordance with the review criteria stated below. As part of the initial merit review, all applications will be discussed, assigned a priority score and receive a written critique as well as receive a second level review by the FIC Advisory Board. Review Criteria Applicants for an ABC training award must also have applied for an ICIDR research award. The scientific evaluation of each application will include assessment of the linkage between proposed training and the research defined in the ICIDR application. Evidence of support for the ABC from collaborating institutions and host governments must be submitted with the application. A. Significance 1. The expected public health and scientific contributions of the proposed activity, 2. The demonstrated capacity and/or potential to achieve sustained research and training efforts, and to build clinical and operational research and public health capacity within a country. B. Approach 1. Balance in the proposed training program to provide breadth of training opportunities in the field of academic-based, infectious diseases-related training in biomedical and clinical sciences and prevention research, 2. The mix of long- and short-term training to achieve the goals of this RFA, including focused efforts to build long-term biomedical, clinical and operational research and public health capacity at a model infectious disease center of excellence within a collaborating country, 3. Adequacy of proposed procedures and criteria for 1) recruitment, review and selection of trainees, and 2) peer review of research and infectious disease control and prevention projects, 4. Adequacy of plans to include an adequate representation of women among foreign trainees. C. Innovation 1. Plans for trainees to become involved in infectious diseases-research, control and prevention projects conducted in their home countries, and 2. Adequacy and creativity of plans including use of the modern information technology to facilitate access to scientific information, distance learning, coordination and research collaboration. D. Investigator(s) 1. Qualifications of the program director to lead and the named faculty to participate in the proposed training and research program, 2. Active research support of the program director and participating faculty. E. Environment 1. The strength of resources and training environment in-country as evidenced by 1) the quality of teaching and the in-country research facilities and other resources, 2) the availability of high-quality candidates chosen on the basis of merit, and 3) past history of success of former trainees returning to their home countries and their continued involvement in the program, for example, the participation of past trainees in advanced in-country research and as faculty and mentors for new trainees, and 2. Training environment in the U.S., including the institutional commitment, the caliber of preceptors, the quality of teaching and research facilities and resources. F. The initial review group will also examine the adequacy of the process for providing for the protection of human and animal subjects and the safety of the research environment, and plans to include training in responsible conduct of research and training in the operation of IRBs, data and safety monitoring boards and community advisory boards as a part of the program. IRBs in the home countries of trainees will be responsible for determining the adequacy of inclusion of women and minorities in research involving human subjects in their countries. AWARD CRITERIA The following will be considered in making funding decisions: Whether NIAID plans to make a companion ICIDR award and: 1. the extent and effectiveness of efforts made by applicants in developing biomedical and prevention research training programs necessary to support infectious diseases-research and biomedical research efforts in the home countries of trainees including efforts made to focus resources to build long- term clinical research, operational research and public health capacity at a model infectious diseases center in the home country of trainees, 2. cost-effectiveness of programs, 3. efforts made to collaborate with other NIH ICDs, CDC, and USAID programs and institutions and with other organizations, 4. the extent to which proposed training programs support and complement other NIH international infectious diseases research efforts, 5. availability of funds including the capability to expand (at least double) training and capacity building efforts should additional resources become available for this purpose from FIC or other sources, 6. program balance among critical research and public health training areas of emphasis such as, but not limited to, U.S. academic training, and 7. geographic distribution among countries included in applications under consideration, including the need for a given program to work in a specific country. Before any funds can be expended from this award, the grantee institution must show evidence of approval for collaborative research and training 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 as well as from the collaborating institutions. INQUIRIES Written and telephone inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding ABC programmatic (training scope and eligibility) issues to: Joel G. Breman, M.D., D.T.P.H. Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: jbreman@nih.gov Direct inquiries regarding review issues and special instructions for application preparation, and mail two copies of the application and all five sets of appendices to: Hortencia Hornbeak, Ph.D. Division of Extramural Activities National Institute of Allergy and Infectious Diseases 6003 Executive Boulevard, Room 3C16 Bethesda, MD 20892 Telephone: (301) 496-7291 FAX: (301) 402-2638 Email: hhornbeak@mercury.niaid.nih.gov Direct inquiries regarding ABC fiscal matters to: Ms. Silvia Mandes Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: silvia_mandes@nih.gov Schedule Letter of Intent Receipt Date: August 7, 1998 Application Receipt Date: September 15, 1998 Scientific Review Date: February 1999 FIC Advisory Board: May 18, 1999 Earliest Award Date: June 1999 AUTHORITY AND REGULATIONS 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 to Health Systems Agency review. The PHS strongly encourages all grant and contract 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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