Implementation of audio-visual recording of informed consent in India

  • As per Hon’ble Supreme Court order, the union health ministry has made mandatory the audio-visual recording of informed consent process of each subject who participates in the clinical trials in the country. This is applicable to the new subjects to be enrolled in all clinical trials including global clinical trials.
  • In view of the above, audio-visual recording of the informed consent process for new subjects to be enrolled in the trial has been already implemented in India. To maintaining level of transparency in clinical trials in the country it is in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required to be done while adhering to the principles of confidentially. Such audio-visual recording and related documentation would be preserved.