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.Ethical guidelines for biomedical research on human participants (1), published by the Indian Council of Medical Research, is the standard document adopted almost exclusively by ethics committees supervising research carried out on human participants in Indian medical institutions.As such, the guidelines have to be clear and comprehensive, and take into account the special situation prevailing in the country.At present, ethical issues in research in India do not get the attention they deserve, particularly outside major full-time research organisations.Utmost clarity is required to avoid difficulties in interpretation, or shades of opinion not intended by the ICMR.While serving as a member of the institutional ethics committee (IEC) in several institutions, I have noticed that there are several issues on which the guidelines are not clear enough, or appear misleading, or do not give adequate instructions, leaving scope for different interpretations depending on individual situations.This comment seeks to highlight such key issues.The figures in parentheses indicate the page numbers where the issues are discussed in the ICMR guidelines.