title: Not fit for purpose: the ethical guidelines of the Indian Council of Medical Research.
abstract: In 2006, the Indian Council of Medical Research (ICMR) published its 'Ethical guidelines for Biomedical Research on human participants'. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in India to conduct ethical research and thereby safeguard the interest of human subjects. Unfortunately, it is apparent that the guideline is not fit for purpose. In addition to problems with the structure and clarity of the guidelines, there are several serious omissions and contradictions in the recommendations. In this paper, we take a close look at the two key chapters and highlight some of the striking flaws in this important document. We conclude that ethics committees and national authorities should not lose sight of international ethical standards while incorporating local reality and cultural and social values, as focusing too much on the local context could compromise the safety of human subjects in biomedical research, particularly in India.
authors.forename: Priya
authors.initials: P
authors.lastname: Satalkar
authors.forename: David
authors.initials: D
authors.lastname: Shaw
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D003219:Confidentiality / Q000941:ethics*; D003466:Cultural Characteristics; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007194:India; D007258:Informed Consent / Q000941:ethics*; D028681:Moral Obligations; D011361:Professional Competence; D017150:Public Sector / Q000941:ethics; D012941:Social Responsibility; D012945:Social Values; D014838:Volunteers