INTERNATIONAL RESEARCH SCIENTIST DEVELOPMENT AWARDS FOR U.S. POSTDOCTORAL SCIENTISTS Release Date: March 30, 1999 RFA: TW-99-004 P.T. Fogarty International Center Letter of Intent Receipt Date: April 23, 1999 Application Receipt Date: May 21, 1999 PURPOSE The International Research Scientist Development Award is offered by the Fogarty International Center to support basic research, behavioral and clinical scientists who are committed to a career in international health research and would benefit from an additional period of mentored research as part of a strong, established collaboration between a U.S. sponsor and leading scientists at a developing country center of scientific excellence. The specific research training may be new to the candidate or in an area that would demonstrably enhance the candidate's pursuit of a career focussing on international research pertinent to health in developing countries. Applications are encouraged to address one of the global health research priorities defined by the World Health Organization (http://www.who.ch) which include both infectious and chronic/degenerative conditions and mental health disorders. It is expected that following this experience, the candidate will be able to pursue an independent and productive international research career involving ongoing collaboration with developing country scientists to more effectively pursue research relevant to stemming a major global health problem. The International Research Scientist Development Award offers 3 years of intensive research experience for U.S. postdoctoral biomedical, clinical or behavioral scientists in the formative stage of their careers to extend their research experience to laboratories or other research settings in developing countries. The award funds postdoctoral research for two years under the joint mentorship of the U.S. and on site foreign sponsor and a total of 12 months (whenever most appropriate for the project) at the U.S. institution under the U.S. sponsor's mentorship in order to support the transitions between foreign and U.S. institutions. Grantees who are promoted to junior faculty status upon return to the U.S. with a clear institutional commitment to their long term career development may submit a competitive renewal application during the third year of the award for an additional two years of funding for continuing collaborative international research studies. In this award young scientists will have the opportunity to establish a direct collaboration with an established foreign scientist at a center of scientific excellence and maintain a scientific base with a U.S. investigator who is involved in collaborative research at a developing country institution where the applicant will work. It is expected that these awards will serve to forge working relationships between state of the art scientists who are potential future heads of basic, clinical and behavioral health research programs in the U.S. and established researchers in developing countries that will lead to ongoing collaborations in studying health problems of mutual interest. Candidates must justify the need for a three year period of mentored research training including research experience at the foreign site. The applicant must be able to show that the proposed period of support will substantially enhance his/her career and/or will allow the pursuit of a novel or promising approach to a particular developing country health research problem. Candidates who have interrupted their careers because of illness or family commitments may apply if they can clearly demonstrate the potential for productive independent research and the need for an additional period of mentored research experience in order to accomplish an effective scientific reentry. Similarly, underrepresented minority junior faculty members at institutions with a substantial minority enrollment who wish to enhance their research skills through a supervised research experience may also apply. This research scientist development award program is part of a long-term Fogarty International Center strategy to support centers of research excellence in developing countries that address global health research priorities. This support is envisioned to: -Attract new research talent to and enhance the multi-disciplinary synergy among the research collaborators at the U.S. and foreign sites; -Leverage existing research and training support for developing country scientists and U.S. scientists committed to international research; -Support the coalescence of the critical, sustainable components necessary to move developing country institutions with significant potential to new levels of research excellence; -Stimulate a more effective translation of the results of research on global health problems into practical public health actions; Overall, this strategy seeks to reduce health disparities between developed and developing countries and between population groups within countries. 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 Request for Applications (RFA), International Research Scientist Development Awards For U.S. Postdoctoral Scientists, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS To be eligible for the award the applicant must be: 1. A U.S. citizen or non-citizen national or lawfully admitted for permanent residence and in possession of an Alien Registration Receipt Card (I-151 or I- 551) or some other verification of legal admissions as a permanent resident. Non-citizen nationals are usually born in areas that are not states but are under U.S. sovereignty, jurisdiction or administration. Individuals on temporary or student visas are not eligible; 2. Hold a doctoral or medical degree or the equivalent in a health science field; 3. Have earned the relevant degree within seven years of the application receipt date (not including clinical training); 4. Have demonstrated a commitment and competence in international health research as well as the potential to engage in independent and productive basic biomedical, behavioral or epidemiological/clinical research in the period following the award; 5. Have a sponsor in an internationally recognized developing country research institution addressing one or more of that country's major health problems. Eligible countries include those in the following regions subject to U.S. State Department travel restrictions: Africa, Asia (except Japan, Singapore, South Korea and Taiwan), Central and Eastern Europe, Latin America and the Caribbean, the Middle East (except Israel) and the Pacific Ocean Islands (except Australia and New Zealand). Applications to work in institutions in sub-Saharan Africa are especially encouraged; 6. Have a U.S. sponsor/mentor at an institution of higher learning or nonprofit research institution with ongoing collaborative research funding (such as a NIH R01 grant with a foreign component, World Health Organization grant, Burroughs- Wellcome Foundation grant or other international agency funding) or who is a member of a productive international collaborative research team at the foreign site where the candidate will work; 7. Submit a research proposal related to but not overlapping with the collaborative research project of the U.S. and foreign site sponsors; 8. Applications must be submitted on behalf of the candidate by a U.S. non- federal, public or private, institution of higher education or academic medical centers affiliated with such institutions; 9. Members of underrepresented minorities in the U.S., women and persons with disabilities are especially encouraged to apply. MECHANISM OF SUPPORT This RFA will use the NIH career development (K01) award mechanism. Planning, direction and execution of the project proposed will be the responsibility of the candidate, her/his mentor at the foreign site and her/his mentor U.S. sponsor on behalf of the applicant institution. The project period should be for three years (two years at the foreign site institution and a total of twelve months at the U.S. institution, whenever most appropriate for the project). Competing renewal applications may be submitted during the third year of the award for two additional years of funding for continuing collaborative international research studies by grantees promoted to junior faculty status with demonstrable commitment of the U.S. institution to the individual's career development. This RFA will be used to solicit applications for peer review once in FY 1999. Based on an assessment of the success of this pilot effort, this award may be offered as part of an ongoing program announcement (PA) in FY 2001. Each award, during the initial three years, must not exceed a total of $70,000 per year direct costs. All awards are anticipated to be made before September 30, 1999 although awardees may delay activating their fellowship (no later than September 1, 2000) for compelling reasons with prior Fogarty International Center approval. Allowable costs include: 1. Salary and fringe benefits for up to $50,000 equivalent to a full time, 12 month staff appointment based on the level of experience of the candidate (i.e. comparable to other staff members of equivalent qualifications, rank and responsibilities in the U.S. sponsor's department). The institution may supplement the NIH contribution to the candidate's salary up to a level that is consistent with the institution's salary scale. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of the award. Fogarty International Center will consider a well justified request for an administrative supplement up to $20,000 during the third year of the award for candidates promoted to junior faculty status upon return to the U.S. institution in order to bring the salary to a level more consistent to the institution's scale for that status; 2. Round trip economy class airfare (on a U.S. carrier) and necessary ground transportation for the candidate to the foreign site up to once per year with sufficient justification; 3. Excess baggage allowance; 4. Supplemental health insurance costs of up to $50 per month during time abroad; 5. Allowance to cover the costs of relevant journal subscriptions, computer time, materials, supplies, small equipment and technical support salary at the foreign site, in-country travel required for research and travel to scientific meetings up to maximum of $20,000 per year; 6. Language training if justified; 7. Roundtrip economy airfare, supplemental health insurance up to $50 per month abroad and supplemental living allowance of $150 per month for each dependent accompanying the awardee for six months or more abroad; 8. Indirect costs of 8% applied to allowable direct costs. FUNDS AVAILABLE The Fogarty International Center intends to commit approximately $500,000 to fund approximately seven to eight awards of up to $70,000 each in FY 1999. Although the financial plans of the Fogarty International Center provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. RESEARCH AND TRAINING OBJECTIVES The International Research Scientist Development Award provides opportunities for U.S. postdoctoral biomedical, epidemiological/clinical and behavioral scientists with cutting edge technical training who are committed to careers in international health research to obtain unique scientific experiences and international perspectives gained through conducting research in a developing country environment. The award supports direct collaboration between junior U.S. scientists and established developing country mentors on research projects of mutual interest in the context of an ongoing relationship between the U.S. sponsor's institution and the foreign site institution. The award is specifically designed to facilitate the candidate's transition between the U.S. and foreign institutions and to enhance subsequent pursuit of an independent research career. In the long term, it is expected that these awards will serve to forge relationships between a new generation of U.S. scientists and established scientists in developing countries that will lead to ongoing collaborations to address global health problems and to reduce global health disparities. The Fogarty International Center recognizes that there will be significant differences in the U.S. and foreign institutional environments, applicants, U.S. sponsor and foreign mentor backgrounds and approaches to international research collaboration among applications. Therefore, applicants should define their specific research and training goals, methods to achieve these goals, and specific measurable objectives to assess their proposed project with reference to the overall goals described above. SPECIAL REQUIREMENTS Evaluation A progress report will be required from the candidate, U.S. sponsor and foreign mentor prior to the end of each budget year. The submission of progress reports via electronic mail is encouraged. Recipients may be contacted periodically after the completion of the award for updates on the progress of their careers including their employment history, publications, receipt of research grants or contracts, honors and awards, professional activities and achievements and other information required for an evaluation of the impact of the program. Protection of Research Subjects Applicable provisions for the protection of research subjects and laboratory animals must be met in both domestic and foreign institutions, 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 the Protection from Research Risks, National Institutes of Health, 6100 Executive Boulevard, MSC 7507, Rockville, MD 20892-7507 (http://www.hhs.gov/ohrp/). 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, clinical 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 Guideline for Inclusion of Women and Minorities as subjects in Clinical Research" which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts Vol.23 No.11, March 18, 1994, available on the web at: https://grants.nih.gov/grants/guide/notice-files/not94-100.html. For international research, the frame of reference for inclusion of minorities in research is whether the participants would be considered to be minorities in the U.S. population. 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 subject 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: https://grants.nih.gov/grants/guide/notice-files/not98-024.html. Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research, the name, address, email address, telephone and fax number of the candidate, U.S. sponsor and foreign mentor, the participating U.S. and foreign institutions and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding and does not enter into the review of a subsequent application, the information that it contains allows the Fogarty International staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to the program staff listed under INQUIRIES by the receipt date listed in the heading of this RFA. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Applicants should use the additional instructions for preparing an Individual Research Career Awards Application "K" series on pages V1-V7 in Form 398 when preparing their applications. These forms are available at most institutional offices of sponsored research and from the 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: GrantsInfo@nih.gov. The RFA label available in the PHS 398 application form must be affixed to the bottom of the face page of the application. 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. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The application must address the following issues: Candidate -Establish the candidate's commitment to a career in international biomedical, clinical or behavioral research addressing a major global health problem; -Establish the candidate's potential to develop into a successful independent investigator; -Summarize the candidate's immediate and long term career objectives, explaining how the award will contribute to their attainment. Three sealed letters of recommendation from senior research scientists addressing the candidate's potential for an international research career must be included as part of the application. One of the three letters should be from the applicant's thesis advisor, research supervisor, chief of staff or department head. Letters should not be submitted from either the U.S. or foreign sponsor. Career Development Plan -Describe the candidate's career development plan. The plan should incorporate consideration of the candidate's goals and prior experience. It should delineate a systematic approach to obtain the necessary basic biomedical or behavioral science background and research experience to launch an independent international research career addressing a major global health problem; -Candidates must describe evidence of previous training or plans to receive instruction in the responsible conduct of research in an international context. The topics included, format, frequency and duration of instruction as well as the amount and nature of faculty participation should be detailed. No award will be made if an application lacks this component. Research Plan Describe the research plan as outlined in form PHS 398 and the use of a basic science or clinical approach to a biomedical or behavioral problem including the Specific Aims, Background and Significance, Progress Report/Preliminary Studies, Research Design and Methods sections. It should include a schedule of planned activities at the U.S and foreign sites during the award period. U.S. and Foreign Mentor Statements The application must include information from the U.S. and foreign mentors including their research qualifications and previous experience as research supervisors. The application must also include a description of the nature and extent of supervision that will occur at each institution during the proposed award period. U.S. and Foreign Institutional Commitments The sponsoring U.S. institution and foreign performance site institution must document the extent and quality of the research environment relevant to the candidate's research focus including faculty and staff capable of productive collaboration with the candidate, seminars and opportunities for interactions with other research groups and scientists and available research facilities and equipment. The U.S sponsoring institution also must provide a statement of commitment to the candidate's development into a productive, independent investigator. Budget Budget requests must be provided according to the instructions for form PHS 398. Each item must be specified by one of the categories in the form and justified by an accompanying explanation of need. Submit a signed, typewritten original of the application, including the Checklist and 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) At the time of submission, one additional copies of the application must be sent to: Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center Building 31, Room B2C39 31 Center Drive MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: barbara_sina@nih.gov Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of an application already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the Center for Scientific Review and responsiveness by the Fogarty International Center. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for educational and scientific merit of the proposed training by an appropriate peer review group convened by the Center for Scientific Review in accordance with the review criteria stated below. As part of the initial merit review, the peer review group will discuss all applications, assign a priority score and provide a written critique that will be sent to the applicants. Applications then receive a second level of review by the Fogarty International Center Advisory Board before funding decisions will be made. Review Criteria The goals of NIH supported research are to advance our understanding of biological systems, improve the control of disease and enhance health. In their written and oral comments, reviewers will be asked to discuss the following 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 these criteria will be addressed and considered in assigning the overall score, weighing 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 and thus deserve a high priority score. The following specific review criteria will be applied: Candidate -Commitment to an independent international research career including potential to contribute to knowledge that will address a major global health problem; -Potential to develop (or evidence of the capacity to develop) as an independent investigator pursuing international research; -Quality and relevance of prior scientific training and experience including record of previous research support and publications; Career Development Plan -Likelihood that the plan will contribute substantially to the scientific development of the candidate, the achievement of scientific independence and ongoing involvement in collaborative international research; -Appropriateness of the research plan to the career goals of the candidate; -Appropriateness of the plan to increase conceptual and theoretical knowledge in the research area proposed; -Consistency of the career development plan with the candidate's prior research and academic experience and the stated career goals; -Clarity of the goals and scope of the plan and the need for the proposed research experience at the foreign site; -Quality of the previous or proposed training in the responsible conduct of research in an international context. Research Plan -Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan; -Scientific and technical merit of the research question, design and methodology judged in the context of the candidate's previous training and experience; -Relevance of the proposed research to a major global health problem; -Relevance of the proposed research to the candidate's career objectives; -If appropriate, adequacy of plans to include children, both genders and minorities and their subgroups as human subjects in proposed studies in the context of the goals of the research. Recruitment and retention of subjects will also be evaluated. U.S. and Foreign Mentors -Appropriateness of each mentor's research qualifications for the proposed project; -The extent of the commitment of each mentor to supervising and guiding the candidate throughout the award period; -Adequacy of each mentor's previous experience in fostering the development of independent researchers highlighting persons involved international research; -Adequacy of each mentor's research productivity and grant support related to the proposed project. U.S. and Foreign Institutional Environment and Commitment -U.S. and foreign institution's commitment to the scientific development of the candidate and assurances that the institution intends the candidate to be an integral part of its research program; -Adequacy of the research facilities at each institution; -Adequacy of the training opportunities and quality of the environment for scientific and professional development at each institution. A history of the success of former participants after training should be included; -A detailed description of overall research funding at the foreign institution (government, non-governmental and international sources) as well as funding specific for the proposed research area should be included to support its status as an existing or potential center of research excellence. Budget Justification of the budget requests in relation to career development goals and research aims and plans. Schedule Letter of Intent Receipt Date: April 23, 1999 Application Receipt Date: May 21, 1999 Peer Review Date: July 1999 Advisory Board: September 1999 Earliest Anticipated Start Date: September 30, 1999 AWARD CRITERIA The criteria that will be used to make the award decisions include the scientific, technical and educational merit of the application as determined by peer review, the likelihood that the proposal will contribute to the achievement of the Fogarty International Center's objectives and the availability of funds. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center Building 31 Room B2C39 31 Center Drive MSC2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1653 FAX: (301) 402-0779 Email: barbara_sina@nih.gov Direct Inquiries regarding fiscal matters to: Ms. Heidi Bishop Division of International Training and Research Fogarty International Center Building 31 Room B2C39 31 Center Drive MSC2220 Bethesda, MD 20892-2220 Telephone: (301) 496-7613 FAX: (301) 402-0779 Email: heidi_bishop@nih.gov AUTHORITY AND REGULATIONS The International Research Scientist Development Awards are made under the authority of Title III, Section 301 of the Public Health Service Act (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 described in the Catalog of Federal Domestic Assistance No. 93.121 and 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 portions 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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