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India
The Indian Government, as per the order of Supreme Court of India, made
audio-video (AV) recording of the informed consent mandatory for all clinical
trials in 2013. The recording also included the procedure of providing information
to the subject and his/her understanding on such consent. The identity and
records of the trial subjects were to be kept confidential. The immediate effect of
this regulation was a decline in the number of clinical trials conducted in India.
With concerns rising among global clinical research organizations (CROs) in the
feasibility of conducting trials in India, in July 2015, the Indian Government
modified the AV recording norms. The AV consent was made mandatory only
for trials involving vulnerable population, or is done for a new chemical or
molecular entity. Instead of the audiovisual recording, audio recording of the
consent was made mandatory for clinical trials of anti-HIV and anti-leprosy
drugs.