India issues draft guideline on audio-visual recording norm for drug trial consent, but rule is questioned
This article was originally published in SRA
Executive Summary
India's regulators have released draft guidelines on the country's recent rule that made audio-visual recording of the informed consent process mandatory for all drug trials1,2. The rule, however, may unwittingly shrink the patient pool and potentially put off some investigators, who find themselves entrusted with add-on responsibilities, some industry experts say.