THE INTERNATIONAL BIOETHICS EDUCATION AND CAREER DEVELOPMENT AWARD Release Date: March 13, 2000 RFA: TW-00-008 Fogarty International Center Letter of Intent Receipt Date: April 7, 2000 Application Receipt Date: May 5, 2000 PURPOSE The Fogarty International Center (FIC) in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Nursing Research (NINR), the National Institute of Child Health and Human Development (NICHD), the National Heart Lung and Blood Institute (NHLBI), the National Institute on Drug Abuse (NIDA), the National Institute of General Medical Sciences (NIGMS), the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), and the National Center for Complementary and Alternative Medicine (NCCAM)invites applications from nonprofit, private or public, domestic or international, educational and research institutions to develop or expand on current graduate curricula in international bioethics related to performing research in low- and middle-income nations. The curricula will provide a core set of advanced study courses that primarily focus on the internationally relevant aspects of the ethical, legal and social principles guiding the responsible conduct of research in developing countries, particularly on scientific integrity and the protection of the interests of research participants. Support will be provided for advanced multi-disciplinary training for developing country health professionals working at institutions conducting biomedical, behavioral or public health research involving human and animal subjects as well as ethicists or philosophers from developing countries with no prior experience in biomedical/clinical research. Support may also be included for the development and implementation of intensive short courses designed specifically for individuals directly involved in human subjects research ethical review and in conducting clinical trials in developing countries. This RFA contributes to the FIC’s initiative to strengthen research bioethics training for individuals from the developing world. The FIC recognizes that highly trained individuals from a number of disciplines are needed in order to provide guidance to the research community on ethical questions that arise during the conduct of transcultural research. This RFA is intended to stimulate the development of new didactic programs in relevant issues in international bioethics at institutions that either do not currently offer such programs or at institutions with existing didactic programs in international bioethics to support or expand their programs to include a major focus on issues relevant to developing countries. It is expected that such high- quality, didactic training for career development of individuals from developing countries will strengthen bioethical expertise at the trainees host institutions as well as within national governments and international bodies. Trainees may also subsequently pursue culturally relevant studies on ethical practice in biomedical and behavioral research. The goal of this initiative is to increase the cadre of developing country biomedical and behavioral scientists, clinical investigators, nurses and other health professionals and relevant academics and to provide them with state-of-the-art knowledge of ethical considerations, concepts and methods in research involving human and animal subjects. Upon completion of their training, developing country participants supported by this RFA are expected to return to independent and productive careers, including training and consultation and/or research in bioethics within their home institutions. 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 Request for Applications (RFA), International Bioethics Education and Career Development Award, is related to the priority area of human resource development. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Institution: Applications may be submitted by nonprofit public or private, international and domestic, non-Federal organizations, such as medical schools or schools of public health, or from comparable institutions of higher education, or research institutions that have strong, well-established graduate bioethics and/or ethics research training programs. The applicant institution must have a faculty that is active in ethics research, as evidenced by current research support and research publications. Applicant institutions should have a substantial biomedical and clinical research portfolio including faculty conducting significant biomedical or behavioral research in developing countries. An institution may submit only one application. Applicants are encouraged to develop consortia with other U.S. or international institutions to enhance the depth of their faculty and participant pool, or to improve the quality of the educational experience. Participants: Developing country candidates for international bioethics training will be selected by the applicant institutions. Since ethics is a multidisciplinary field, it is expected that trainees supported in each training program will represent diverse academic backgrounds. Trainees may include post-doctoral behavioral or biomedical scientists, physicians, dentists, nurses, midwives, ethics review committee members, hospital directors and health policy-makers as well as ethicists or philosophers with no prior experience in biomedical/clinical research from the developing world. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) education project grant (R25) award mechanism that limits facilities and administrative (F & A) costs to eight percent. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA cannot exceed four years. Continued support during this period depends on satisfactory performance as judged by annual progress reports, site visits, meetings with program directors, career progress of trainees and the development of institutional capacity for international bioethics related training. Although the intent of this RFA is for long-term capacity development in research bioethics, at this time, the FIC has not determined whether this solicitation will be continued beyond the present RFA. The FIC will conduct a program evaluation by the end of the third year that will assist the NIH in determining whether to reissue the RFA. If, by the end of the third year of the award, the FIC has not announced its intent to reissue the RFA, incumbents should contact program staff for instruction as to how to proceed. The applicant organization must provide the necessary management for the transfer of funds and materials to the consortial institutions. Allowable Costs All budget items related to trainee participation in the program should be itemized on the PHS Form 398 NRSA substitute budget pages OO and PP. All budget items related to faculty participation in the program should be itemized on the PHS Form 398 budget pages DD and EE. Allowable costs requested for training at international institutions should follow the guidelines specified for U.S. institutions. Stipend/Salary/Consultant Fees Program Director: The program director may receive salary and fringe benefits compensation for 10-25% professional effort devoted to the international bioethics curriculum and training program creation during the first year of the award. The compensation for the program director must not exceed the actual institutional salary rates. Salary must not exceed the annual salary cap level (currently $141,300 plus fringe benefits) from federal sources (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-011.html). (Use 398 form page DD.) Faculty: Faculty at the applicant institution who provide critical design, development, implementation and refinement of essential components of the international bioethics curriculum or extended long- term training or conduct collaborative research with the trainees may receive salary and fringe benefits. The total amount of salary and fringe benefits requested for all applicant faculty, including the program director in the second and subsequent years of the award, may not exceed 20% of direct costs in the budget. The responsibilities and time commitment for faculty receiving salary should be thoroughly described. (Use 398 form page DD.) o Faculty from consortia institutions involved in curriculum development and training, invited speakers and consultants who provide essential programmatic functions may receive consultant fees not to exceed $2,000 per year, in accordance with the applicant’s institutional policies. No more than ten percent of the direct costs in the budget may be used for consultant fees. The teaching responsibilities and time commitment for faculty receiving consultant fees should be thoroughly described. (Use 398 form page DD.) o Developing country trainees may be paid a stipend comparable to their professional experience similar to other equivalent trainees at the U.S. institution but not exceeding $45,000 per year in accordance with the U.S. institutional policies while involved in long-term training in the U.S. Applicants may wish to refer to the NRSA stipend levels as a guide. These are described on the web site http://www.nih.gov/fic/opportunities/index.html. (Use 398 form substitute page OO.) o Up to ten percent direct costs may be used to provide salary and fringe benefits for clerical support staff for the program at the U.S. institution. The responsibilities and time commitment for personnel receiving salary support should be thoroughly described. (Use 398 form page DD.) Tuition, Fees and Insurance o Funds for tuition, academic fees and self-only medical insurance for developing country trainees at the applicant and consortia institutions may be requested. Programs are encouraged to seek cost sharing arrangements with the participating institutions in order to provide reduced tuition for long-term trainees and tuition-free short courses. (Use 398 form substitute page OO.) Trainee Travel o Funds may be requested for one round trip economy class airfare per year on U.S. carriers (to the maximum extent possible) and local ground transportation for each long-term developing country trainee to travel to the applicant institution and return to their home country. Funds may also be requested for developing country trainees to participate in short courses or attend bioethics conferences. (Use 398 form substitute page OO.) o Funds may be requested for per diem and lodging for developing country trainees to participate in short courses or attend bioethics conferences. (Use 398 form substitute page OO.) Faculty Travel o Funds may be requested for round trip economy airfare year on U.S. carriers (to the maximum extent possible) per diem and lodging for consortia faculty participants to travel to the applicant institutions and U.S. or developing country sites of short courses. (Use 398 form page DD.) o Funds should be requested for airfare, per diem and lodging for two days comparable to U.S. government rates (http://www.gsa.gov/Portal/gsa/ep/contentView.do?contentId=17943&contentType=GSA_BASIC) for the Program Director, foreign co-PIs, if appropriate, and selected trainees to attend an annual bioethics network meeting in the Washington, D.C. area. (Use 398 form page DD.) Training related expenses o Funds to support curriculum development related costs at the applicant institution (such as books, printed materials, audiovisual materials, computer software, etc.) as well as administrative expenses (such as photocopying, long distance phone and shipping costs, etc.) may be requested. (Use 398 form substitute page OO.) o No more than 20% of total direct costs per year may be requested to support intensive short courses. o Reentry grants for trainees may be requested for the first year. The amount of salary support at the home institution for returning trainees may not exceed 20% of their full-time salary. FUNDS AVAILABLE FIC and partners have committed approximately $1,600,00 in FY 2000 to fund an estimated five to six new grants in response to this RFA. An applicant may request a project period of up to four years and a budget for total costs of up to $300,000 per year maximum (including eight percent F & A costs). Facilities and administrative costs are not allowed at international institutions. Because the nature and scope of the curriculum development and training proposed may vary, it is anticipated that the size of each award will also vary. 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 OBJECTIVES Educational Objectives Background: This initiative is intended to attract talented individuals in developing countries to the challenges of transcultural bioethics and to equip them with the critical skills that are needed to enable them to provide expertise and leadership to their institutions, national governments and international bodies and potentially, to pursue culturally relevant studies on ethical practice in biomedical and behavioral research. Few developing country institutions provide formal training in bioethics. Few U.S. advanced bioethics training programs focus in depth on the internationally relevant aspects of bioethics, particularly those related to clinical investigations in developing countries. While other NIH programs support some short-term training courses in research bioethics, only a few trainees are from the developing world. Few developing country health professionals conducting laboratory or clinical investigations have received extensive formal training in the principles of bioethics, the primary rules and codes of ethical research, ethical experimentation on vertebrate animals, the components of informed consent in transcultural settings, decision-making related to collaborative agreements between host and sponsors of clinical research, elements of study design that affect the ethical conduct of clinical trials, or interventions that should be provided to study participants. Therefore the specific objectives of this initiative are: 1) To improve the quality of international ethics training by supporting the development of didactic courses in fundamental areas needed to provide skills for teaching and research related to bioethics and the conduct of medical research in developing countries. 2) To support advanced training for a cadre of developing country professionals who could assume the roles and responsibilities of bioethicists involved in ethics review or clinical trial design in the academic, laboratory, clinical or public health settings of research and clinical investigations in their countries. A) Program: This award provides support for up to four years to allow institutions to develop a comprehensive ethics curriculum with a focus on the ethics of conducting research in developing countries and to train a cohort of developing country participants. Applications may be submitted from educational and research institutions that do not currently provide such a didactic program, as well as to those that propose to expand well-established international ethics training programs. Applicants must provide a detailed description of the proposed program including courses offered, frequency of classes, selection criteria for participants entering the program, and target goal of enrollment into the program. If planned activities include short courses, applicants should provide detailed descriptions of well- justified, specifically targeted, intensive curricula designed for individuals directly involved in human subjects research ethical review or in conducting clinical trials in developing countries. B) Program Director: The award will support the Principal Investigator/Program Director to manage, coordinate and evaluate and, with associated faculty, to design, develop, implement and refine as needed, an international bioethics curriculum. The Program Director should possess the international bioethics expertise, leadership and administrative capabilities required to create an interdisciplinary didactic program. He or she should be currently engaged in ethics research as well as in the mentoring of new investigators. A minimum of 10-25% of the program director’s professional effort is required during the first year. C) Faculty: Sufficient numbers of faculty should be involved in the proposed curriculum development and training who have a record of providing the type of instruction required under this award. Faculty trained in ethics, philosophy, clinical research and public health are recommended. Faculty should also be accomplished investigators and graduate training mentors. The proposed faculty should be actively engaged in the design and conduct of bioethical research, and also have demonstrated a successful record in obtaining peer reviewed Federal and non-Federal funding for such activities. The capability of the participating faculty to develop advanced curricula, instruct and fully train individuals to pursue careers in international bioethics must be documented. The training faculty are encouraged to consult with at least one individual from a developing country with expertise in conducting research or who is familiar with ethics review procedures in their home country. Training faculty should also include individuals with experience in the design of biomedical (including clinical) or behavioral research in developing countries. The percent of faculty effort planned for course development, instruction and mentoring trainees should be described. D) Curriculum: The curriculum should be designed to provide a maximum of two years, master’s degree level graduate training but could also accommodate non-degree seeking participants with other professional degrees and different levels of experience in bioethics. The core curriculum developed should ideally be case-based. It may include an array of bioethics-related topics of general interest such as the history and principles of human and animal subjects research, ethical perspectives on the use of human biological materials in research, the ethics of designing clinical research protocols and ethical considerations in performing research in vulnerable populations with an emphasis on transcultural research. Other topics may include international codes and guidelines, informed consent, collaborative agreements between host and sponsor countries, the role of ethics review committees in the developing world and in cross-cultural research and ethnographic research. The curriculum should include training in the methodology to pursue culturally relevant studies on ethical theory and practice in biomedical and behavioral research. The scope and format for presenting the core curriculum can be flexible to meet the perceived needs of the trainees and faculty. The program may also include advanced, specialized courses in ethics related to epidemiology, public health, human rights, justice and economics. The detailed description of the content of proposed courses and the potential benefit to developing country trainees should be included in the training plan. The curriculum developed must begin to be offered to trainees within one year of the award and should be initiated during the first year of support, if feasible E) Training: The award provides support for up to two years and no less than 12 months of advanced bioethics training for developing country trainees. In addition, institutions may propose providing support for appropriate candidates to earn a master"s degree in a relevant area - e.g., public health research bioethics, clinical research. The proposed program should also have the flexibility to accommodate participants with different levels of experience. Individuals selected for training should demonstrate a high level of interest and the potential to pursue culturally relevant studies on ethical practice in biomedical and behavioral research or the potential to become leaders and provide expertise to their host institutions, national governments and international bodies. Applicants should describe how the proposed training will advance the career development of prospective trainees. Candidates selected for training should document that they can return to a position in their country of origin that will permit them to pursue an independent and productive career that includes training, consultation and/or research on bioethics. Grantees are encouraged to include plans for enabling the trainees to develop and sustain bioethics programs on return to their home country. Applicants are encouraged to select candidates associated with supported international research efforts. Plans for recruiting and the process and criteria for selecting participants to enter the program and the countries to be involved should be described. Applicants should describe the criteria for selecting particular developing countries or developing country institutions for recruiting trainees. Applicants should describe how participants from diverse professional backgrounds (postdoctoral behavioral and biomedical scientists, physicians, nurses, midwives, ethics review committee members, hospital directors and health policy- makers as well as ethicists or philosophers with no prior experience in biomedical/clinical research) will be recruited and selected as participants in both long-and short-term training. A faculty mentor with appropriate research and training experience in ethical issues related to biomedical research must be identified for each potential candidate. Trainees cannot receive concurrent salary support from any other PHS sources while being supported by this award and must be willing to commit at least 75% of their full-time professional effort to training activities for the entire period of support. F) Environment: The institution should develop an innovative, multidisciplinary program to maximize the available research and educational resources. The opportunities for trainees to participate in research and other activities related to the institution’s clinical research portfolio and with faculty conducting significant biomedical or behavioral research in developing countries should be described in detail. The opportunities for trainees to participate in activities through consortia established with other U.S. or international institutions to enhance the depth of their faculty or to improve the quality of the educational experience should be described. Applicant institutions must describe the pool of trainees and their career development that previously received bioethics training in existing programs. SPECIAL REQUIREMENTS 1) Advisory Committee: The Program Director must establish an Advisory Committee for this program to provide ongoing assessment and monitoring. Bioethics divisions in the School of Public Health, Medicine or Nursing, as well as members of institutional ethics review committees and developing country representatives should be represented on the committee. The committee"s responsibilities might include recruitment and selection of faculty, selecting trainees, evaluating trainee progress, and monitoring and evaluation of the overall effectiveness of the didactic program and suggesting revisions as needed. A detailed description should be provided of the committee"s composition, function, and organizational structure. 2) Evaluation: A plan must be provided for the evaluation of the curriculum developed and training provided. Benchmarks should be specified as well as detailed plans and procedures to identify, analyze and report results to the FIC program staff. 3) Dissemination: Grantees will be encouraged to share educational tools and curricula and to make them publicly accessible. 4) Trainee Tracking System: Applicants should describe their plan to track the short- and long-term impact of research bioethics training on their trainees. Awardees will be required to implement a system to track and document the long-term impact of this training program on: (1) the careers of all trainees, (2) the research capacity at the collaborating developing country institution of trainees, (3) positions trainees assume upon completion of training, (4) the contributions of trainees to future NIH-supported and other international research and intervention trial efforts. Examples of training impact include: how training enabled participants to assume more responsible positions upon returning home, how collaborations with former trainees resulted in the funding of collaborative research projects for which trainees were either Principal Investigators or co-Investigators, and publications of research results authored by trainees supported by this program. During the first year after the awards are made, program staff at the FIC will work with grantees to standardize tracking systems among programs for annual progress reporting based on the ideas presented in their applications and experience with similar programs. It is expected that the standardized tracking system developed will be implemented in all programs. The impact of training resulting from each program will be an important criteria considered in determining whether this RFA will be recompeted. 5) Program Directors will attend an annual meeting of all directors supported by this RFA in Washington, D.C. organized by the FIC. 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. LETTER OF INTENT Prospective applicants are asked to submit, by April 7, 2000, a letter of intent that includes a descriptive title of the proposed program, the name, address, telephone and fax numbers, and E-mail address of the Program Director, the identities of other key personnel, the participating institutions and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not affect the review of the application submitted, the information that it contains permits the NIH to estimate the potential application review workload and avoid conflict of interest during the review of applications. The letter of intent is to be sent to the program staff listed under INQUIRIES by the letter of intent receipt date listed in the heading of this RFA. APPLICATION PROCEDURES It is strongly recommended that prospective applicants contact the staff person listed under INQUIRIES early in the planning phase of the application. Such contact will help ensure that applications are responsive to the overall intent of this award. The grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. Additional instructions for submitting a training program application can be found on pages V-1 to V-8 in the instructions for form PHS 398. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. The RFA label available in the PHS 398 (rev. 4/98) 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 two of the face page of the application form and the YES box must be marked. The sample RFA label available at: http://grants.nih.gov/grants/funding/phs398/labels.pdf has been modified to allow for this change. Please note this is in pdf format. Submit a signed, typewritten original of the application, including the Checklist, and four signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, one additional copies of the application should be sent to: Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center Building 31, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Applications will be reviewed for completeness by the CSR and responsiveness by FIC. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive will be evaluated for scientific and technical merit by a peer review group convened by CSR in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique. Applications may undergo a streamlined review process. In this process, 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 and training are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed curricula and training will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. Significance 1. The need for the specific international bioethics curriculum and training proposed to fill specific gaps in expertise for perspective developing country trainees. 2. The expected public health contributions to the trainees developing country institution, national government or an international institution related to the proposed curriculum and training. 3. The demonstrated capacity or potential to achieve independent and sustainable developing country capacity in bioethics through the proposed curriculum and training efforts. Approach 1. The clarity and feasibility of the curriculum development and training objectives. 2. Adequacy of the program plan to achieve the proposed curriculum development and training objectives including: o Quality and content of the proposed courses and other didactic components of the training curriculum. o A trainee recruiting, application and selection process that captures the most qualified individuals with a variety of professional backgrounds from developing countries who could most benefit from the training proposed including the potential impact of training on their developing country institution. (The proposed qualifications of potential candidates should be well described in terms of academic status and previous accomplishments and/or experience in bioethics.) o A process for matching trainees to appropriate mentors or instructors, new skills to be acquired and participation in research related ethical design and review activities. o Balance in the proposed curriculum to provide a breadth of knowledge in international bioethics related to either academic based laboratory, clinical or public health studies while providing focused training to fill recognized gaps in expertise. o If short courses are proposed, the adequacy of the mixture of long and short-term training opportunities within the program as a means to achieve the overall objectives stated. o Provision of training in related skills such as bioethics research methodology, technical writing, statistical methods, good clinical practice, medical informatics, English as a second language (if necessary). o Process for periodic evaluation and revision of curriculum developed. o Process for periodic evaluation of trainee progress including academic achievement, assistance with common trainee problems and mentorship for successful trainee participation in research related ethical design or review activities. o Adequacy of the methods to monitor the long-term impact of the training experience on the subsequent careers of the trainees and capacity for ethical review of research in the trainees home countries. o Adequacy of plans to include an adequate representation of women among the developing country trainees. Innovation o Innovation in the international bioethics curriculum designed for developing country trainees. o Innovation in strategies for training participants to become actively involved in the ethical design and review of laboratory, clinical or public health research or intervention trials conducted at their home countries. o Creativity of plans to include modern information technology training to facilitate trainee access to electronic information resources, distance learning and collaborative interaction. Investigators o Qualifications of the program director to lead and other faculty to participate in the proposed curriculum development and training program. (The bioethics research experience and training accomplishments should be included in addition to Biographical Sketch and Other Support forms for each faculty participant.) o The extent and effectiveness of previous efforts made by applicants in developing bioethics-training programs to support biomedical and behavioral research efforts. Environment The adequacy of the teaching facilities and other training resources including possible research related opportunities and the overall training environment at the applicant and consortia institutions. In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed plan to share data. Schedule Letter of Intent Receipt Date: April 7, 2000 Application Receipt Date: May 5, 2000 Peer Review Date: June/July 2000 Council Review: September 2000 Earliest Anticipated Start Date: September 29, 2000 AWARD CRITERIA In addition to the outcome of the initial scientific peer review, the following may also be considered in making funding decisions: o The extent to which proposed training programs support and complement other FIC or NIH efforts in international bioethics. o The availability of funds. o Program balance among critical research and public health training areas of emphasis. o The geographic distribution among proposed trainees included in applications under consideration, including the need for a given program to work with trainees from a specific country. INQUIRIES Written and telephone inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Barbara Sina, Ph.D. Division of International Training and Research Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 402-9467 FAX: (301) 402-0779 E-mail: barbara_sina@nih.gov Direct inquiries regarding fiscal matters to: Ms. Susan Bettendorf Grants Management Specialist Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-7614 FAX: (301) 402-0779 E-mail: susan_bettendorf@nih.gov AUTHORITY AND REGULATIONS Awards are made under authorization of Sections 301 and 405 and Title IV, Part A, (42 USC 241, 284 and 287) of the Public Health Services Act, as amended, and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92s. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or to Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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