RFA-TW-02-008: THE INTERNATIONAL BIOETHICS EDUCATION AND CAREER DEVELOPMENT AWARD

Department of Health
and Human Services (HHS)

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THE INTERNATIONAL BIOETHICS EDUCATION AND CAREER DEVELOPMENT AWARD Release Date: August 6, 2001 RFA: RFA-TW-02-008 Fogarty International Center (http://www.nih.gov/fic) National Institute of General Medical Sciences (http://www.nigms.nih.gov/) National Institute of Environmental Health Sciences (http://www.niehs.nih.gov/) National Center for Complementary and Alternative Medicine (http://nccam.nih.gov/) National Institute of Dental and Craniofacial Research (http://www.nidr.nih.gov/) Letter of Intent Receipt Date: September 7, 2001 Application Receipt Date: January 11, 2002 PURPOSE The Fogarty International Center (FIC), in partnership with the National Institute of General Medical Sciences, the National Institute of Environmental Sciences, the National Center for Complementary and Alternative Medicine and the National Institute of Dental and Craniofacial Research, invites applications from nonprofit, private or public, domestic or international, educational and research institutions to develop or expand current graduate curricula and training opportunities in international bioethics related to performing research on acute and chronic diseases in low- and middle-income nations. Applicant institutions can request up to four years support to create full curriculum development and training programs, or up to two years support for curriculum development alone in preparation to apply for full training program support in the future. The proposed curricula should 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 multi-disciplinary training for developing country health professionals working at institutions conducting biomedical, behavioral or public health research involving human subjects, and for ethicists or philosophers from developing countries with an interest in biomedical/clinical research. Appropriate training may included advanced degree and non-degree associated course work and practicums. 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 developing countries. 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 research in settings where cultural differences may be relevant. This RFA is intended to stimulate the development of new instructional programs in relevant aspects of international bioethics at institutions that do not currently offer such programs or to expand existing instructional programs in international bioethics to include a major focus on issues relevant to developing countries. It is expected that such advanced training will enhance the career development of individuals from developing countries as well as strengthen bioethical expertise at the trainees host institutions. Trainees may also be supported to pursue culturally relevant studies on ethical practice in biomedical and behavioral research as part of their training. 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 with state-of-the-art knowledge of ethical considerations, concepts and methods in research involving human subjects. Upon completion of their training, developing country participants supported by this RFA are expected to pursue independent and productive careers, including expert 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 or domestic, non-Federal organizations, such as health professional schools or comparable higher education or research institutions that have strong, well-established graduate ethics training programs. The applicant institution must have a faculty that is active in international ethics research, as evidenced by current research support and research publications. Applicant institutions should also have a substantial biomedical and clinical research portfolio including faculty conducting significant biomedical or behavioral research involving human subjects in developing countries. An institution may submit only one application and only one new or existing program will be supported at an institution. Applicants are encouraged to develop consortia with other U.S. or international institutions to enhance the depth of their faculty and participant pool, and to improve the quality of the training provided. 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, traditional medicine practitioners, ethics review committee members, hospital directors and health policy-makers as well as ethicists or philosophers with an interest 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. F&A costs up to eight percent can be requested in applications submitted by foreign institutions or for a subcontract to a foreign institution. Please see the web site http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-028.html for more information on the F&A costs allowed for foreign institutions and international organizations. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The applicant organization must provide the necessary management for the transfer of funds and materials to the consortial institutions. The total project period for an application for a full curriculum development and training program submitted in response to this RFA cannot exceed four years. The total project period for an application for a curriculum development award without formal developing country training opportunities can not exceed two 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. Allowable Costs All expenses related to trainee participation in the program should be itemized on the PHS Form 398 (NRSA substitute budget pages OO and PP) in the categories listed in the RFA. All expenses related to faculty participation in the program should be itemized on the PHS Form 398 budget pages DD and EE in the categories listed in the RFA. Total training expenses should be identified on PHS Form 398 (NRSA substitute page DD) under the Other category. Developmental proposal budgets may include costs for curriculum and faculty development but not for trainee related expenses. 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 up to 25% professional effort devoted to the international bioethics curriculum and training program creation during the first year of the award. Salary must not exceed the annual salary cap level (currently $161,200 plus fringe benefits) from federal sources (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-01-013.html). (Use PHS 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 faculty, including the program director in the second and subsequent years of the award, may not exceed $56,000 for full curriculum and training program application budgets. The total amount of salary and fringe benefits requested for all faculty, including the program director in the second year, for a curriculum development alone award without formal developing country training may not exceed $9,250. The responsibilities and time commitment for faculty receiving salary should be thoroughly described. (Use PHS 398 form page DD.) o Faculty from consortia institutions involved in curriculum development and training, and invited speakers and consultants who provide essential programmatic functions may receive consultant fees not to exceed $2,000 per faculty member 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 PHS 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 grantee institution but not exceeding $45,000 per year in accordance with the grantee institutional policies while involved in long-term training. 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 PHS 398 form substitute page OO.) o Up to $28,000 may be requested in the budget of full curriculum and training program applications to provide salary and fringe benefits for support staff for the program at the grantee institution. Up to $4,625 may be requested in the budget of applications for the curriculum development alone without developing country training awards to provide salary and fringe benefits for support staff for the program at the grantee institution. The responsibilities and time commitment for personnel receiving salary support should be thoroughly described. (Use PHS 398 form page DD.) Tuition, Fees and Insurance o Funds for tuition, academic fees and self-only or family medical insurance for developing country trainees at the applicant and consortia institutions may be requested. (Use PHS 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 be requested for appropriate per diem and lodging for developing country trainees to participate in short courses or attend bioethics conferences. (Use PHS 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 sites of short courses once per year. (Use PHS 398 form page DD.) o Funds should be requested for airfare, per diem and lodging for two-three 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 PHS 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 PHS 398 form substitute page OO.) o No more than $56,000 per year may be requested to support intensive short courses in full curriculum and training program application budgets. o One time, one-year project support of up to $10,000 may be requested for trainees when returning to their home country institutions. The amount of salary support at the home institution for returning trainees may not exceed 20% of their full-time salary. The application should describe in detail how proposals for reentry projects monitored by appropriate faculty will be selected by a competitive peer review process examining merit and potential impact in the trainee’s home country. FUNDS AVAILABLE FIC and partners have committed approximately $1,500,000 in FY 2002 to fund an estimated 6 new training program awards and 3 developmental program awards in response to this RFA. A full curriculum development and training program applicant may request a project period of up to four years and a budget for total costs (which includes eight percent F & A costs) of up to $250,000 per year maximum. A curriculum development alone program without developing country training applicant may request a project period of up to two years and a budget for total costs (which includes eight percent F & A costs) of up to $25,000 per year maximum. The National Institute of Dental and Craniofacial Research will provide supplements to grantee institutions to cover the training related costs for oral health professionals or researchers per year up to a total of $200,000 per year. 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. TRAINING OBJECTIVES 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. Curriculum development awards provide up to two years support for curriculum and faculty development alone in preparation for offering full training programs in the future. Applications may be submitted from educational and research institutions that do not currently provide such a instructional program, as well as to those that propose to expand well-established international ethics training programs to include developing country participation. Background: Few developing country institutions provide formal training in bioethics, and few developed country programs for advanced bioethics training focus in depth on the internationally relevant aspects of bioethics, particularly those related to clinical investigations and traditional medical interventions 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. In addition, few developing country health professionals conducting laboratory or clinical investigations have received extensive training in the principles of bioethics, codes and legal aspects of ethical research, ethical experimentation on vertebrate animals, informed consent, 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. This initiative is intended to involve talented, interested individuals in developing countries in the challenges of culturally relevant bioethics. Proposed training programs should equip them with the critical skills that are needed 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. The specific objectives are: 1) To improve the quality of international ethics training by supporting the development of courses in fundamental areas needed to provide skills for teaching and research related to bioethics and the conduct of research on acute and chronic diseases in developing countries. 2) To support appropriate advanced training for a cadre of developing country professionals who could assume the expert roles and leadership responsibilities when involved in ethics review or clinical trials and epidemiological studies involving academic, laboratory, clinical or public health settings of research and clinical investigations in their countries. A) Program: The applicant must provide an explicit set of goals/objectives for the proposed program that address the specific needs for bioethics training in the developing countries or regions of origin for prospective trainees. 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 the program 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 the administrative capabilities required to create an interdisciplinary instructional program. He or she should be currently engaged in international 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, law, clinical research and public health are recommended. Faculty should also be accomplished research 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 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. Applicants are encouraged to include senior faculty from developing countries with expertise in conducting research involving human subjects or who participates in ethics review procedures in their home countries as program consultants or training faculty. Training faculty should also include individuals from the grantee or consortium institutions with experience in the design of biomedical (including clinical) or behavioral research involving human subjects 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 may also accommodate shorter term training for non-degree seeking participants with other professional degrees and different levels of experience in bioethics. The core curriculum developed 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 culturally relevant research. Other topics may include international codes, laws and guidelines, informed consent, intellectual property, 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 may include training in the methodology used in culturally relevant studies of 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 human genetics, epidemiology, public health, traditional medical practice, 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 through an appropriate combination of instructional and practical experiences at the grantee, consortium or home country institutions. 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 become leaders and provide expertise to their host institutions, national governments and international bodies and possibly, pursue culturally relevant studies on ethical practice in biomedical and behavioral research. Applicants should describe how the proposed training will advance the career development of prospective trainees. Candidates selected for training should document in their applications to the grantee program 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 already involved with international research efforts involving human subjects. 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, traditional medicine practitioners, ethics review committee members, hospital directors and health policy-makers as well as ethicists or philosophers with an interest 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 or behavioral research must be identified for each potential long-term trainee. 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. Members of bioethics divisions in the School of Public Health, Medicine or Nursing, as well as members of institutional ethics review committees should be considered for such committees. Committees should include representatives of potential trainee countries or regions. 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 instructional 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 are encouraged to share educational tools and curricula and to make them publicly accessible. 4) Trainee Tracking System: Applicants should describe their plan to monitor 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 affects research bioethics training, review or policies at the home institution, 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 evaluation 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 evaluation approach 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 organized by the FIC of all directors and selected trainees supported by this RFA in the Washington D.C. area. Applicants should allow for these travel expenses in their proposed budgets. 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 requires 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 throuh 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., 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 RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the applicant should 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. LETTER OF INTENT Prospective applicants are asked to submit 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 names, titles and institutions 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 by the letter of intent receipt date listed in the heading of this RFA to the program staff listed under INQUIRIES. APPLICATION PROCEDURES The PHS 398 research grant application instructions and forms (rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html are to be used in applying for these grants. This version of the PHS 398 is available in an interactive, searchable PDF format. The NIH will return applications that are not submitted on the 5/2001 version. For further assistance contact GrantsInfo, Telephone 301/710-0267, Email: GrantsInfo@nih.gov. 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 RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. Submit a signed, typewritten original of the application, including the Checklist, and five 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) 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. 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 ethical 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 training 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 prospective developing country trainees. 2. The expected contributions of the proposed international bioethics curriculum and training to developing country institutions, national governments or an international institutions. 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 Strong and appropriate courses and overall curriculum that provides balance and breadth in all critical areas while providing focussed training opportunities to fill recognized gaps in trainee expertise; o If short courses or non-degree training 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 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 The process for determining appropriate trainee skill development plans, ethical research or review participation and mentorship; o Appropriate assessment and enhancement of background skills needed by each trainee in areas such as bioethics research methodology, technical writing, statistical methods, clinical practice, medical informatics and 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 and mentoring activities; o 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 Plans to include an adequate representation of women and ethnic minorities in the home countries among the developing country trainees. Innovation o Innovation in the international bioethics curriculum designed for developing country trainees; o Innovation in training participants for active involvement 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 applicant’s record and experience 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: September 7, 2001 Application Receipt Date: January 11, 2002 Peer Review Date: March-April 2002 Council Review: May 21, 2002 Earliest Anticipated Start Date: June 1, 2002 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. INQUIRIES Written and telephone inquiries concerning this RFA are strongly encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. FIC will hold a workshop for prospective applicants associated with the Global Forum on Bioethics in Research in the Gambia November 8-10, 2001. All potential applicants who wish to attend the workshop should submit a letter of intent to apply for the RFA by the deadline stated above expressing this interest in order to obtain information about the workshop. Support will be available for a limited number of potential developing country applicants to attend the workshop. All documents distributed at this workshop and a summary of questions and answers regarding this RFA raised at the workshop will be posted on the FIC website (http://www.nih.gov/fic/programs/bioethics.html) subsequent to the workshop. Direct inquiries regarding the workshop and other 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: Mr. Bruce Butrum Grants Management Officer Fogarty International Center 31 Center Drive, Room B2C39, MSC 2220 Bethesda, MD 20892-2220 Telephone: (301) 496-1670 FAX: (301) 594-1211 E-mail: butrumb@mail.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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