New audio video consent guidelines: elements for informed consent process for clinical trials in India

As per the clinical research guidelines, every adult volunteer must agree to participate in a clinical trial and proper consent must be taken for the same. As per the schedule Y, in all trials, informed, written consent, free from any physical, psychological or economic points. After highlight of the order of the Hon’ble Supreme court, CDSCO dated 19 November 2013, has made it mandatory for all clinical trials to conduct audio video (AV) recording of the informed consent process along with written consent of each trial subject. AV consent is the best mechanism intended to improve the quality of Informed Consent Process (ICP). AV consent of the informed consent process will protect both the subjects and the investigators. AV consent will also work as a safeguard for the industry as well as investigators from future litigations, media and socialists’ false claims. This article highlights the AV consent elements procedures according to present guidelines.

Author: 
Shekhar Goyal, Indra Bhadu, Dr. Akhil Kapoor and Surender Beniwal
Volume No: 
01
Issue No: 
02
Paper Number: 
0034
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