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.