Our overall goal is to improve the conduct of biomedical research on human subjects in India by strengthening capacity in its system of research ethics. This Planning Grant will lay the foundation for a training grant application in 2 years' time for a training program. These efforts are coordinated through the Indian Council for Medical Research (ICMR), which is the Central Body for formulating, coordinating and promoting biomedical research in India. The specific objectives are: (1) To develop through a National Task Force a working system for program direction including Program Director and Co-Director, Advisory Committee, and International Advisory Committee; (2) To develop a centrally coordinated network of faculty among ICMR and non-ICMR Institutions to deliver this curriculum; (3) To plan development of a uniform national curriculum for bioethics for medical students, health professionals and researchers to strengthen the knowledge base in bioethics including international bioethics and research ethics; and (4) to develop a system to modify the curriculum on an ongoing basis through feedback from the Course Directors, faculty and trainees and Advisory Committees. The main rationales supporting this proposal are (1) India, one of the most populous country in the world, has a strong high-tech and pharmaceutical sector, and massive amounts of clinical trials activity; (2) Having developed the first set or contemporary research ethics guidelines in the developing world, the Indian Council of Research (ICMR) as the central body to coordinate biomedical and health research is the only body that can bring together a national program for strengthening capacity in research bioethics on account of its nidus of internal bioethics capacity, a strong regional network in bioethics through FERCAP, and strong international links in ethics. (3) The several unique and innovative features of the curriculum developed in this planning grant based on India's and ICMR's scientific strengths including a focus on Complementary and Alternative Medicine, and on Genomics Biotechnology could be used by other ethics programs in the Fogarty International Center network and beyond.
