ICMR's ethical guidelines for biomedical research on human participants: need for clarification.

The "Ethical guidelines for biomedical research on human participants" prepared by the Indian Council of Medical Research in 2006 came as a welcome step in the process of regulation of research on human subjects, since clear cut Indian guidelines were absent earlier. The guidelines have been accepted as the standard operating manual by Institutional Ethics Committees (IEC) in India. However, over a period of time, it has become obvious that the guidelines lack clarity in certain areas and require to be revised in the light of experiences of members in the IECs. Some of these problems with the ICMR guidelines have been highlighted in this paper to press for revision of the manual in the light of these experiences.