Regulatory Focus™ > News Articles > ICMR to Frame Clinical Trial Compensation Guidelines

ICMR to Frame Clinical Trial Compensation Guidelines

Posted 04 December 2011 | By

The Indian Council of Medical Research (ICMR) would lay down a framework to compensate clinical trial volunteers for injuries during clinical research programs in the country.  The move follows increasing complaints from Parliamentarians and civil society groups against the absence of a proper mechanism to compensate clinical trial victims. The proposal stipulates that all clinical trial victims be compensated, irrespective of the cause of injury and the individuals or agencies responsible. Also, the injured would have the right to claim compensation, irrespective of whether or not the injury was foreseeable/predictable. The fact that the participant had consented in writing to participate in the research would not have any bearing on the person's rights for compensation.  A draft compensation guideline, prepared by ICMR's bioethics group, an association of clinical research organisations and global research-based pharmaceutical companies, has been published by ICMR for public comments. The compensation guideline would take final shape after the 31 December deadline for comments.


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