Future of Indian clinical trials: Moving forward from hyped potential to human protection

A Retrospective Study of Ethics Committee Monitoring Checklists of the Audiovisual Consent Process: An Ethical Perspective

“…In the same context, on October 21, 2013, a directive from the Supreme Court of India was issued that mandated audiovisual (AV) recording of the informed consent process for all clinical trials. The National Regulatory Body for Indian Pharmaceuticals and Medical Devices, Central Drugs Standard Control Organization (CDSCO), together with the Drugs Technical Advisory Board (DTAB) then issued an order on November 19, 2013, stating that AV recording of the informed consent process (in addition to obtaining written informed consent) must be conducted for each study participant for all clinical trials [ 1 , 2 ]. The original order was subsequently modified, making AV consent legally binding only in cases of vulnerable populations involved in research on new chemical entities.…”

Ethics committees: Challenge of evidence-based accreditation

“…It would be advisable for ECs to develop a bill of rights for the subjects such as the US National Institutes of Health the Clinical Center Patients' Bill of Rights. [ 5 6 ] It would be essential for the EC to create awareness among research subjects about their rights by displaying the bill of rights in a multilingual poster, to review Informed Consent Process documentation and audio-visual recording, and active monitoring of the subject recruitment procedures.…”