Indian regulator issues guideline on filming informed consent

The office of the Drugs Controller General India (DCGI) has issued a guideline on the audio-visual recording of the informed consent process.

This guidance follows a legal judgement late in 2013 stating that “in all clinical trials, 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 confidentiality.” An administrative order confirmed that this should take place for all new subjects being enrolled in all clinical trials, with immediate effect.

The guideline reiterates the general principles of the informed consent process, and then details how audio-visual recording should be integrated. The videographer should be included as a member of the study team, and the potential participant would first need to give consent for the consent process itself to be filmed. During the filming, the identity and records of the participant should be kept confidential; the later use of any video evidence (eg, in a potential legal process) would rely on visual confirmation of identity. The draft guidance concludes with the requirement to preserve the audio-visual recording, along with other documentation, for at least 5 years after the completion/termination of the study, if it is not possible to keep it “permanently”.