Newspapers in India are reporting that the country’s Drug Technical Advisory Board (DTAB) has been having detailed meetings regarding the use of audio-visual recordings to document informed consent to take part in a clinical trial. The Times of India reported that the DTAB had given “its nod for incorporating the change and making it a law” while the Pune Mirror suggested that the mandate would be introduced “soon”.
“Digital consent, as much as it will safeguard the interest of a patient, will also make the process of counselling more transparent,” a senior government official told the Times of India. “This will ensure that no one is blindly made to sign some papers. More importantly, it will show how much the participants are informed about the possibility of failure or side effects.”
The idea initially arose to combat suggestions that patients were taking part in clinical trials without being adequate informed, let alone given the opportunity to consent, with at least one Indian CRO having its activity suspended while claims were investigated.
This is a topic that I wrote about in CRfocus almost a year ago, and which caused something of a furore on discussion boards such as LinkedIn. This piece explores some of the logistical issues that the Indian law-makers will need to consider, but concludes that, whilst filming informed consent “would not of itself make a well-performed consent process any better, it would make it more difficult to get away with conducting the process badly.”