Proactive role for ethics committees

Rashmi Kadam

DOI: 10.20529/IJME.2012.072


Abstract

The study conducted by Shetty et al on the experiences of an ethics committee (EC) in developing an oversight mechanism is indeed an eye opener . The study has identified some crucial areas where good clinical practice (GCP) guidelines have been violated at investigator sites. These would probably have gone unnoticed had the EC not intervened. The authors have rightly argued that the current procedure followed by ECs to maintain oversight through passive monitoring needs to be changed

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