This Program Announcement expires on February 28, 2004, unless reissued. INTERNATIONAL RESEARCH SCIENTIST DEVELOPMENT AWARD Release Date: December 1, 2000 PA NUMBER: PAR-01-025 Application Deadline: February 13 Fogarty International Center PURPOSE The International Research Scientist Development Award (IRSDA) is offered by the Fogarty International Center (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 on research relevant to stemming a major global health problem. BACKGROUND In this award the Fellow will have the opportunity to work in 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 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; and 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 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Program Announcement (PA), IRSDA, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. To be eligible for the award the applicant must: 1. Be 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 (time spent in clinical training does not count toward seven year limit); 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 mentors in the United States and in the eligible developing country who have ongoing, funded, international collaborative research in the foreign mentor’s country or region. Funding may include, but is not limited to, sources such as a National Institutes of Health (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. o The developing country mentor should be 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. o The U.S. mentor should be at a U.S. institution of higher learning or nonprofit research institution. 6. Submit a research proposal related to but not overlapping with the collaborative research project of the U.S. and foreign site mentors; 7. Candidates must justify the need for 36 months 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. 8. 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 eligible degree, 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. Candidates who have been involved in clinical training that puts them more than seven years beyond their degree may also be eligible to apply. MECHANISM OF SUPPORT This PA will use the NIH career development (K01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project 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 IRSDA offers a total of 36 funded months, which can be spread out over a maximum of five years. The award is for an intensive, mentored research experience in a clinical, field or lab setting associated with a strong research collaboration at a well-recognized research institution in a developing country. A total of at least 24 months should be at the foreign site under the joint supervision of the U.S. and foreign mentors. A period of work in the foreign country should be at least three months in length. A total of up to 12 months will be funded for work 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 may submit a competitive renewal application during the final 12 months of the award for an additional two years of funding for continuing collaborative international research studies. RESEARCH 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 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 of 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 Human Research Protections, Department of Health and Human Services 6100 Executive Boulevard, Suite 3B01, MSC 7507 Rockville, MD 20892-7507 http://www.hhs.gov/ohrp. ohrp@osophs.dhhs.gov Office of Laboratory Animal Welfare National Institutes of Health RKL1, Suite 1050, MSC 7982 6705 Rockledge Drive Bethesda, MD 20892-7982 http://grants.nih.gov/grants/olaw/olaw.htm 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 indicating 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 UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. 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 subjects 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 the following URL address: 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. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98). Applicants should use the additional instructions for preparing in Individual Research Career Award Application K series on pages IV1-IV7 in Form 398 when preparing their applications. Application kits are available at most institutional offices of sponsored research and may be obtained 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, website: http://grants.nih.gov/grants/forms.htm. The title and number of the program announcement 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 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. Total direct costs over 36 months may not exceed $300,000 prorated at a rate of $8333 direct costs per month ($6250 per month direct costs for salary and fringe benefits; $2083 per month for all other allowable direct costs). Allowable direct costs within the cap include: 1. Salary and fringe benefits for up to $75,000 per 12 months, prorated at $6250 per month, 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 five times over the duration of the project; 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. Submit a signed, typewritten original of the application, including the Checklist, and three 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) 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 PA. 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 PA 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 CSR. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the PA will be evaluated for scientific and technical merit. Peer review will be conducted by an appropriate scientific 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, all applications will 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 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 in 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 Justify the budget requests in relation to career development goals and research aims and plans. 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 PA 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 issues to: (if appropriate) 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: gschwind@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.121. Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or 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, and 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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