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26 Aug 2013

NHRC Consults Indian Health Ministry on Clinical Trial Guidelines

The National Human Rights Commission (NHRC) is seeking consultation from the Indian Union Health Ministry on a set of new clinical trial guidelines it has prepared.

In a written document it explains that an expert committee at NHRC suggests further clarity on compensation, risks involved and setting up ethics committee in all institutions undertaking studies on human subjects.

It also specified that standard operation procedures should be written down and followed in all clinical trials and that there should be an effective mechanism for monitoring the implementation of these.

Better information should also be given to patients, including details of all risks involved as per the current knowledge, their rights for compensation in case of injury or death and access to medical care before, during and in a specified period after the study.

These measures are designed to provide a strict framework for clinical trials in the country and to improve current health and safety procedures.

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