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Not Fit for Purpose: The Ethical Guidelines of the Indian C ouncil of M edical R esearch
Author(s) -
Satalkar Priya,
Shaw David
Publication year - 2015
Publication title -
developing world bioethics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.398
H-Index - 27
eISSN - 1471-8847
pISSN - 1471-8731
DOI - 10.1111/dewb.12036
Subject(s) - context (archaeology) , clarity , ethical standards , compromise , guideline , psychology , engineering ethics , political science , law , paleontology , biochemistry , chemistry , engineering , biology
In 2006, the Indian C ouncil of M edical R esearch ( ICMR ) published its ‘Ethical guidelines for B iomedical R esearch on human participants’. The intention was to translate international ethical standards into locally and culturally appropriate norms and values to help biomedical researchers in I ndia 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 I ndia.