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Article

30 Jan 2014

Author:
Dhananjay Mahapatra,Times News Network

Video-recording of consent for clinical trials driving away subjects

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The new draft protocol for clinical trials of drugs, on the lines suggested by the Supreme Court, is making it difficult for global drug manufacturers to find subjects for testing new chemical compositions...The protocol has made it mandatory for companies intending to conduct human trials of drugs to video-record the free consent of patients to be part of the trial. It also mandates them to inform patients about the possible adverse health effects of the drug, which is under clinical trial. ..This is because most patients, taken as subjects for clinical trials in India, suffer from terminal diseases and they do not want to reveal it on camera, despite the protocol providing for complete secrecy of the video-recorded consent obtaining process.

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