Not Fit for Purpose: The Ethical Guidelines of the Indian Council of Medical Research

Developing World Bioethics 15 (1):40-47 (2015)

David M. Shaw
University of Basel
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
Keywords research ethics  clinical trials  Bioethics  guidelines  India  patient protection
Categories (categorize this paper)
DOI 10.1111/dewb.12036
Edit this record
Mark as duplicate
Export citation
Find it on Scholar
Request removal from index
Revision history

Download options

Our Archive

Upload a copy of this paper     Check publisher's policy     Papers currently archived: 46,373
Through your library

References found in this work BETA

Ethicovigilance in Clinical Trials.David Shaw & Alex McMahon - 2013 - Bioethics 27 (9):508-513.

Add more references

Citations of this work BETA

No citations found.

Add more citations

Similar books and articles


Added to PP index

Total views
27 ( #343,935 of 2,286,141 )

Recent downloads (6 months)
3 ( #413,317 of 2,286,141 )

How can I increase my downloads?


My notes

Sign in to use this feature