RFA-TW-00-005: INTERNATIONAL RESEARCH SCIENTIST DEVELOPMENT AWARD

Department of Health
and Human Services (HHS)

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INTERNATIONAL RESEARCH SCIENTIST DEVELOPMENT AWARD Release Date: December 21, 1999 RFA: TW-00-005 Fogarty International Center Letter of Intent Receipt Date: February 18, 2000 Application Receipt Date: March 29, 2000 PURPOSE The International Research Scientist Development Award (IRSDA) is offered by the FIC for U.S. postdoctoral biomedical scientists, in the formative stages of their careers, who seek an opportunity to continue research in, or extend their research experience into, developing countries. It provides the successful candidate with a period of mentored research as part of a strong, established collaboration between a U.S. sponsor and leading developing country scientist at an internationally recognized research institution. 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. Background In this award the Fellow will have the opportunity to establish a direct collaboration with an established foreign scientist and maintain a scientific base with a U.S. investigator who is involved in collaborative research at the developing country institution where the applicant will work. It is expected that these awards will serve to forge working relationships between outstanding U.S. scientists, early in their careers, who are potential future heads of basic, clinical and behavioral/social health research programs in the U.S., and established, developing country researchers, to study global health problems of mutual interest. The IRSDA is part of a long-term Fogarty International Center (FIC) strategy to support centers of research excellence in developing countries that address global health research priorities. This support is envisioned to: o Attract new research talent to and enhance the multi-disciplinary synergy among the research collaborators at the U.S. and foreign sites, o Leverage existing research and training support for developing country scientists and U.S. scientists committed to international research, o Support the coalescence of the critical, sustainable components necessary to move developing country institutions with significant potential to new levels of research excellence, o 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 Award, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://odphp.osophs.dhhs.gov/pubs/hp2000. 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, dental 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 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 mentor 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), Russia and countries of the Former Soviet Union, 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. mentor at an institution of higher learning or nonprofit research institution with ongoing, funded, international collaborative research with the foreign mentor in that scientist"s country or region. Funding may include (but is not limited to) sources such as a NIH R01 grant with a foreign component, Fogarty International Research Collaboration Award, World Health Organization grant, Burroughs-Wellcome Foundation grant or other international agency funding. 7. Submit a research proposal related to but not overlapping with the collaborative research project of the U.S. and foreign site mentors, 8. 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. 9. Applications must be submitted on behalf of the candidate by the U.S. mentor"s institution, which must be a U.S. non- federal, public or private, institution of higher education (or academic medical centers affiliated with such institutions). The applicant need not already be at the U.S. mentor"s institution at the time of application, but it is expected that the U.S. component of the project will be carried out by the Fellow at the U.S. mentor"s institution. 9. Candidates who are more than seven years beyond the Ph.D., but who have interrupted their careers because of illness or family commitments, may also apply. They must 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 re-entry. 10. Minorities, women, and individuals with disabilities are 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 U.S. mentor on behalf of the applicant institution. The project period should be for three years (at least two years at the foreign site institution and a maximum 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 obtaining tenure-track faculty status at a U.S. institution. This RFA will be used to solicit applications for peer review once, in FY2000. 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. FUNDS AVAILABLE The FIC intends to commit approximately $500,000 to fund approximately seven to eight awards of up to $70,000 each in FY 2000. Although the financial plans of the FIC 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 IRSDA provides international research opportunities (in eligible developing countries) for U.S. postdoctoral biomedical, epidemiological/clinical and behavioral scientists, with cutting edge technical training, and who are committed to careers in international health research. The award supports direct collaboration between the U.S. scientist and established developing country sponsor on a research project of mutual interest in the context of an ongoing relationship between the U.S. and foreign sponsors. 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. It is expected that such ongoing collaborations will work to address global health problems and to reduce global health disparities. The IRSDA offers three years of intensive, mentored research experience in a clinical, field or lab setting associated with a strong research collaboration at a well-recognized research institution in developing countries. At least two years should be at the foreign site under the joint supervision of the U.S. and foreign mentors. A total of up to 12 months (whenever most appropriate for the project) may be spent at the U.S. institution under the U.S. mentor"s supervision in order to support the transitions between foreign and U.S. institutions. Grantees, who obtain a tenure-track faculty position at any U.S. institution, upon return to the U.S., 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. The specific research training may be new to the candidate or an extension of the candidate"s prior research, but should focus on international research areas 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, but are not limited to, infectious diseases, chronic/degenerative conditions and mental health disorders. Basic, behavioral/social and clinical biomedical research will be supported in clinical, field or laboratory settings. The FIC 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 enable assessment their proposed project with reference to the overall goals described above. SPECIAL REQUIREMENTS Evaluation 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: http://grants.nih.gov/grants/guide/notice-files/not94-100.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e. individuals under the age of 21) must be included in all human 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: http://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 this RFA. 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 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 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 IV1-IV7 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 or at the website: http://grants.nih.gov/grants/forms.htm. 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 RFA number must be typed on the label as well. The sample RFA label is available at the following URL: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Please note that this is in a pdf format. The application must address the following issues: Candidate o Establish the candidate"s commitment to a career in international biomedical, clinical or behavioral research addressing a major global health problem, o Establish the candidate"s potential to develop into a successful independent investigator, o Summarize the candidate"s immediate and long-term career objectives, explaining how the award will contribute to their attainment. o Letters of recommendation. 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 of recommendation should not be submitted from either the U.S. or foreign sponsor. Career Development Plan o Describe the candidate"s career development plan. The plan should incorporate a detailed description of Ph.D. and other previous research experiences as well as an explanation of long-term career goals of the applicant and role of this award in achieving them including future foreign collaboration. 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. Training in Responsible Conduct of Research o Candidates must describe evidence of previous training or plans to receive instruction in the responsible conduct of research in an international context. The topics of, 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 o 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 an annual schedule of planned activities at the U.S and foreign sites during the award period. The research plan should serve as a justification for conducting research abroad and provide a clear description of the relationship between the proposed research and current research efforts at U.S. and foreign labs. U.S. and Foreign Mentor Statements o The application must include information from the U.S. and foreign mentors including their research qualifications and previous experience and record in supervising research training (number of Ph.D. and post- docs mentored and their current career status). Both U.S. and foreign mentors should submit Biographical Sketches, Other Support and Resources Forms. The application must also include a detailed plan for the supervision of the Fellow, by both mentors, at each institution, during the proposed award period. U.S. and Foreign Institutional Commitments o The extent and quality of the research environment, relevant to the candidate"s research focus, should be described for the U.S. and foreign institutions. The research environment includes 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. o A detailed description of overall research funding at the foreign institution (government, non-governmental and international sources), specific for the proposed research area, should be included to support its status as an existing or potential center of research excellence. Budget Budget requests must be provided according to instructions in form PHS 398 as modified by the Just-In-Time Procedures instituted in 1996 (NIH Guide for Grants and Contracts, Vol. 25, No. 10, March 29, 1996 and as modified in Vol. 25, Number 16, May 17, 1996), including information on the mentor"s pending and current research support, as stipulated. No detailed budget is required. However, total direct costs for all years must be provided in addition to the name, role on project and percent effort. In addition, Other Support information for the applicant is not required as part of the initial application. However, Other Support information is required for the mentor and co-mentor. If there is a possibility for an award, necessary budget and Other Support information for the applicant will be requested by FIC staff following the initial review. 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 by September 29, 2000. Allowable direct costs (within the $70,000 cap) 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. The FIC will consider a request for an administrative supplement, up to $20,000, during the third year of the award, for candidates who obtain a tenure-track faculty position upon return to the U.S., in order to bring the salary to a level more consistent to the institution"s scale for that status, 2. Travel Costs: 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, Roundtrip economy airfare for each dependent accompanying the awardee for six months or more abroad, Excess baggage allowance, 3. Health insurance and Living Allowance: May cover health insurance costs of up to $50 per month, for the candidate and each dependent, during the time abroad, and allow a supplemental living allowance of $150 per month for each dependent accompanying the awardee for six months or more abroad, 4. Research Development Support: These funds may be used for the following expenses: (a) tuition, fees, and books related to career development, (b) research expenses, such as supplies, equipment and technical personnel, (c) in-country travel required for research, research meetings or training, (d) statistical and computational services (including personnel and computer time (e) Language training. All expenses must be directly related to the proposed research career development program. Facilities and Administrative costs of eight percent are applied to allowable direct costs. Submission of Application Submit a signed, typewritten original and three (3) signed copies of the application, including the Checklist in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 20817 (for express/courier service) Send two (2) copies and appendices to Dr. Madelon Halula (listed in INQUIRIES below). 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. 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 Applications will be reviewed for completeness by the CSR. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete, and responsive to the RFA, will be evaluated for scientific and technical merit. Peer review will be conducted by a peer review group convened by the National Institute of Allergy and Infectious Diseases (NIAID) in accordance with the standard NIH peer review procedures. As part of the initial merit review, a process will be used by the initial review group in which applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the FIC Advisory Board. Review Criteria The goals of NIH supported research are to advance our understanding of biological systems, improve the control of disease and enhance health. The following specific review criteria will be applied: Candidate o Commitment to an independent international research career including potential to contribute to knowledge that will address a major global health problem, o Potential to develop (or evidence of the capacity to develop) as an independent investigator pursuing international research, o Quality and relevance of prior scientific training and experience including detailed description of previous research, record of previous research support and publications, Career Development Plan o 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, o Appropriateness of the research plan to the career goals of the candidate, o Appropriateness of the plan to increase conceptual and theoretical knowledge in the research area proposed, o Consistency of the career development plan with the candidate"s prior research and academic experience and the stated career goals, o Clarity of the goals and scope of the plan and the need for the proposed research experience at the foreign site, o Adequacy of the proposed training for responsible conduct of research in an international context. Research Plan o Usefulness of the research plan as a vehicle for enhancing existing research skills as described in the career development plan, o Scientific and technical merit of the research question, design and methodology judged in the context of the candidate"s previous training and experience, o Relevance of the proposed research to a major global health problem, o Relevance of the proposed research to the candidate"s career objectives, U.S. and Foreign Mentors o Appropriateness of U.S. and foreign mentors research and training qualifications for the proposed project, o The extent of the commitment of each mentor to supervising and guiding the candidate throughout the award period, o Adequacy of each mentor"s previous experience in fostering the development of independent researchers highlighting persons involved international research, o Adequacy of each mentor"s research productivity and grant support related to the proposed project. U.S. and Foreign Institutional Environment o Adequacy of the research facilities at the U.S. and foreign institutions, o Adequacy of the training opportunities and quality of the environment for scientific and professional development at the U.S. and foreign institutions. Budget Justification of the budget requests in relation to career development goals and research aims and plans. Schedule Letter of Intent Receipt Date: February 18, 2000 Application Receipt Date: March 29, 2000 Peer Review Date: June/July 2000 Advisory Board: September 2000 Earliest Anticipated Start Date: September 29, 2000 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 FIC"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: Kathleen Michels, 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: IRSDA@nih.gov Direct inquiries regarding review matters to: Madelon Halula, Ph.D. Scientific Review Program NIAID DEA 6700-B Rockledge Blvd Room 2217 Bethesda, MD 20817 (Fed Ex) or Bethesda, MD 20992-7616 (US mail) Telephone: 301 402-2636 FAX: 301 402-2638 (fax) Email: mh30x@nih.gov Direct inquiries regarding fiscal matters to: Ms. Lee Ann Gschwind Division of International Training and Research Fogarty International Center Building 31 Room B2C39 31 Center Drive MSC2220 Bethesda, MD 20892-2220 Telephone: (301) 402-7335 FAX: (301) 402-0779 Email: Leeann_Gscwhind@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 is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and promote the non-use of all tobacco products. In addition, public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any 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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