Most developing countries do not currently have a strong community of individuals who are concerned with research ethics. To ensure that research is conducted, however, the capacity to conduct comprehensive, well-informed ethical reviews of research proposals is essential. At present, few developed and developing country institutions provide formal training in the internationally relevant aspects of bioethics, particularly those related to clinical investigations in developing countries. This proposal has two objectives: (1) To support advanced training for a cadre of developing country professionals who could assume the roles and responsibilities of bloethicists involved in ethics review of clinical trial design in the academic, laboratory, clinical or public health settings of research and clinical investigations in their countries; and (2) To provide these professionals with models and materials to enable them to conduct trainings and research projects dealing with research ethics in their countries. ? ? The proposed program will build on the present two-year Research Ethics Fellowship program, bringing in four trainees from Asia each year to begin a two-year fellowship training program. Phase I of the fellowship will be composed of a 10-month course of study, during which the trainees will be in residence at the Harvard School of Public Health. During this phase, the trainees will take four required courses, participate in a yearlong seminar and in the Program on Ethical Issues in International Health Research listserv, attend IRB meetings throughout Harvard University (including affiliated hospitals), design a short-course training program (including case study development) to be used in their country, and design a research study to be conducted in Phase II with a grant from the program. In Phase II of the fellowship, the trainees will return to their home countries for 12 months, where they will conduct the research project (dealing with an issue in research ethics) as designed during the first phase of the fellowship, and at least one short-course on research ethics (also designed during Phase I), in addition to continuing their own work and participating in their local and/or national ERB.
