Under constant attack from the Supreme Court for lax clinical trial norms, the Drug Controller General of India (DCGI) has finally issued draft guidelines on the audio-visual recording of informed consent process in the clinical trials to make the system more transparent.
As per guidelines, before seeking an individual’s consent to participate in clinical trial, the investigator must provide the individual with the all the information in a simple language to be recorded through audio-visual means. According to an official from the DCGI, the guidelines aim to make the clinical trial process more friendly to the volunteers participating in the clinical trials.
As per guidelines, if a participant is not able to give informed consent, for instance if he or she suffers from severe mental illness or disability or is unconsicious, the information will have to be provided to the legally acceptable representative (lAR). “If the subject or his/her legally acceptable representative is unable to read/write then an impartial witness (IW) should be present during the entire informed consent process,” as per guidelines.
Also, the audio visual recording of informed consent process and other related documents should be preserved safely after the completion/termination of the study for at least a period of five years if it is not possible to maintain the same permanently.
The draft guidelines further says that “during the audio-visual recording of informed consent process, the identity and records of the trial subjects has to be kept confidential and that no details about identity of said subjects, which would result in the disclosure of their identity, are disclosed without valid scientific and legal reasons which may be essential for the purposes of therapeutics or other interventions…”
In order to maintain the confidentiality, the videographer should be engaged as part of the study team. Prior to initiation of the study, the Investigator should define and allocate the activities of audio-video recording of informed consent process to the respective identified person as videographer. The Investigator shall maintain the details of the person to whom he has delegated the duties of audio video recording.
The DCGI move follows the Supreme Court order a few months back directing the Government to issue regulations mandating videotaped informed consent of all participants in any clinical trial conducted on Indian soil, as well as additional cost-benefit analyses of potential drugs before trials can proceed.