EXPIRED
This Program Announcement expires on February 14, 2002 unless reissued. INTERNATIONAL RESEARCH SCIENTIST DEVELOPMENT AWARD (IRSDA) Release Date: December 20, 2001 PA NUMBER: PAR-02-041 (see replacement PAR-04-058) Application Deadline: February 13 Fogarty International Center (FIC) (http://www.nih.gov/fic) PURPOSE The International Research Scientist Development Award (IRSDA) is offered by the Fogarty International Center (FIC). This program is for U.S. postdoctoral biomedical and behavioral 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 a 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 international research career, involving ongoing collaboration with developing country scientists, on research to reduce the impact of a major global health challenge. Background 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 global health research and enhance multi- disciplinary synergy among the research collaborators at the U.S. and foreign site, 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. With IRSDA support, the Investigator will have the opportunity to work directly with an established foreign scientist in the developing world and maintain a scientific base with a U.S. investigator who is involved in collaborative research at the developing country institution in which the applicant will work. It is expected that these awards will serve to forge collaborative relationships between established, developing country researchers and outstanding U.S. junior scientists, who are potential future heads of basic, clinical and behavioral/social health research programs in the U.S.. Collaborations are expected to lead to advances that will reduce the impact of global health problems and narrow the gap in health disparities between developed and developing 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), the International Research Scientist Development Award (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 non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, and units of state and local governments. 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 admission 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. Applicants who already have a faculty position need a letter of support from their institution which shows they will be granted the required minimum time off from clinical and teaching duties to conduct research at the foreign site for the required time. At least 24 months must be spent at the foreign site over the entire project period with four months or more at the foreign site each year. 3. Have earned the relevant degree within seven years of the application receipt date. Any exemptions must be pre-approved by FIC staff on a case by case basis. o Time spent in clinical or other biomedical-related but non-research training (such as policy training), or time spent obtaining another degree (e.g. M.P.H.), does not count toward the seven-year limit. o 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. 4. Have demonstrated a commitment and competence in health research as well as the potential to engage in independent and productive 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 where the proposed research will be performed. o The U.S. mentor must be at a U.S. institution of higher learning or non- profit research institution. o The developing country mentor must 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: 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 for work in institutions in sub-Saharan Africa are especially encouraged. Awards may be delayed or denied by any State Department restrictions in effect at the time of award. o The two mentors for the IRSDA applicant must be funded to collaborate with each other on a relevant research program or project. 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 U.S. or international agency funding. If the proposed mentors had a funded collaboration for a significant period of time but the funding will have ended by the time of the award, please contact FIC staff to determine eligibility. 6. Submit a research proposal related to but not overlapping with the collaborative research project of the U.S. and foreign site mentors, 7. Be able to spend four months or more of each year in mentored research training at the foreign site and a total of at least 24 months over the entire project period. 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-profit, 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. Any exemptions must be pre-approved by FIC staff. 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, who are committed to careers in international health research. The award supports direct collaboration between the U.S. scientist and an established developing country sponsor on a research project of mutual interest in the context of an ongoing, funded, research 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 international 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 global health concerns. Applicants are encouraged to consult 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, trauma/injury and mental health disorders, all of which can pose an increasing global burden in the coming decades. 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 clearly define specific research and training goals, methods to achieve these goals, and specific measurable objectives to enable assessment of the proposed project, with reference to the overall goals described above. SPECIAL REQUIREMENTS Candidates must be able to spend four months or more of each year in mentored research training at the foreign site so that not less than 24 months is spent at the foreign site over the entire project period. 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. MECHANISM OF SUPPORT This PA will use the NIH career development (K01) award mechanism (general K01 guidelines may be found at: http://grants.nih.gov/grants/guide/pa-files/PA-00-019.html). The IRSDA will provide direct costs for salary for the principal investigator up to $75,000 (based on the actual salary scale at his/her U.S. institution) and applicable fringe benefits, plus an additional $20,000 for travel and research development support each year for up to four 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. IRSDA grantees who obtain a tenure-track faculty position at any U.S. institution may submit a competitive renewal application at the same direct cost level described above. At institutions or in departments where tenure- track positions are not available, the institution must demonstrate a comparable commitment to the candidate at the assistant professor level or above. In such cases, consultation with the IRSDA program officer is required. The renewal may be for a three-year period and should be a continuation or extension of the research collaboration begun under the original K01. Although additional training may be justified, the focus in the renewal should be on research. As stipulated in the original K01 application, most of the proposed research should take place at the foreign site and the grantee is expected to spend as much time there as possible. However, unlike the original competitive application, no minimum time period at the foreign site will be specified. Responsibility for the planning, direction, and execution of the proposed project will be that of the candidate, her/his mentor at the foreign site and her/his U.S. mentor on behalf of the applicant institution. Facilities and administrative (F & A) costs of eight percent should be used for IRSDA applications. PROVISIONS OF THE AWARD 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. For the original K01 application, 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. o For renewal applications, a letter from the applicant"s U.S. institution must be submitted indicating commitment to provide the candidate with the necessary support and time, free from clinical and teaching duties, to continue the international work proposed in the application. 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, 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 research activities at the U.S. and foreign sites during that 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. o For renewal applications, describe progress made under the original K01 and how the research proposed in the renewal continues or extends the original research. U.S. and Foreign Mentor Statements o The applications must include information from the U.S. and foreign mentors including their funded research collaboration and 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 the 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-government 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 o Budget requests must be provided according to instructions in form PHS 398 (rev. 5/2001) Allowable Costs: 1. Salary and fringe benefits for up to $75,000 per year (based on the actual salary scale at the U.S. institution). 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. 2. Research Development Support: These funds may be used for expenses such as: (a) tuition, fees, and books related to career development, (b) research expenses, such as supplies, equipment and technical personnel, (c) language training, (d) statistical and computational services (including personnel and computer time, (e) in-country travel required for research, research meetings or training, round trip economy class airfare (on a U.S. carrier) and necessary ground transportation for the candidate to and from the foreign site over the duration of the project, roundtrip economy airfare for each dependent accompanying the awardee for four months or more abroad, 3. Ancillary Personnel Support: Salary for mentors, secretarial and administrative assistance, etc., is not allowed. 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. Concurrent Applications IRSDA applications may not be submitted or awarded concurrently with other NIH applications, such as the Independent Scientist Award, Mentored Clinical Scientist Development Award, Academic Award, Research Project Grant, or Mentored Patient-Oriented Research Career Development Award. Subsequent Applications for NIH Research Support Subsequent to receiving the K01 Award, incumbents are encouraged to apply for independent research support (e.g., R01, etc.). K01 recipients who are successful in obtaining NIH research grant support may not receive salary support from the research grant for the duration of the award except under certain circumstances and with prior FIC approval. After the conclusion or termination of the award, salary support should transfer to the research grant. K01 recipients who apply for research grant support are encouraged to include salary and all other research needs in the research grant application for the period following completion of the K01. Alternatively, recipients of research grant awards may terminate the K01 prior to the start of the research grant. 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 clinical research projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research, updated racial and ethnic categories in compliance with the new OMB standards, clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398, and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must 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) investigators must report annual accrual and progress in conducting 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. REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS NIH policy required education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is found in the NIH Guide for Grants and Contracts Announcement dated June 5, 2000, at the following website: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html must be used in applying for these grants (http://grants.nih.gov/grants/dates.htm). This version of the PHS 398 is available in an interactive, searchable format. Beginning January 10, 2002, the NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: [email protected]. Applicants should use the additional instructions for preparing an Individual Research Career Development Award Application "K" series on pages IV1-IV7 in Form 398 when preparing their applications. The title and number of the program announcement must be typed on line two of the face page and the YES box must be marked. Submit a signed, typewritten original of the application, including the Checklist, three sealed letters of recommendation, 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 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 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 may 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 research and training in 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 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 plan with the candidate"s prior training, 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 and training experience at the foreign site, o Adequacy of the proposed training for responsible conduct of research in an international context, o Clear description of the roles of the U.S. and foreign mentors in the training and research planned. 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" ongoing funded collaborative research and their other 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 o Justify the budget requests in relation to career development goals and research aims and plans. AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific, technical and educational merit (as determined by peer review) o availability of funds o the likelihood that the proposal will contribute to the achievement of FIC"s objectives. 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: Dr. Kathleen Michels 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: [email protected] Or to: Julie Marquardt Division of International Training and Research Fogarty International Center Building 31, Room B2C39 Bethesda, MD 20892-2220 Telephone: 301-496-1653 Fax: 301-402-0779 Email: [email protected] Direct inquiries regarding review issues to: Madelon Halula, Ph.D. Scientific Review Program NIAID DEA 6700-B Rockledge Blvd., Room 2217, MSC 7616 Bethesda, MD 20892-7616 Bethesda, MD 20817 (express/courier service) Telephone: 301-402-2636 Fax: 301-402-2638 Email: [email protected] Direct inquiries regarding fiscal matters to: Bruce Butrum Grants Management Office Fogarty International Center Building 31, Room B2C29 31 Center Drive, MSC 2220 Bethesda, MD 20892-2220 Telephone: 301-451-6830 Fax: 301-594-1211 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.989. 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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