To safeguard the interests of patients participating in clinical trials, their informed consent will soon have to be audio-visually recorded. The move will ensure unsuspecting patients are not recruited without adequate information and counselling about the pros and cons of a drug trial.

The Drug Technical Advisory Board (DTAB) that advises the Centre on scientific matters recently gave its nod for incorporating the change and making it a law.

“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 said. “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 Centre last year informed the Supreme Court that as many as 2,644 people died during the clinical trials of 475 new drugs on humans between 2005 and 2012. Serious adverse events of deaths during the clinical trials were 2,644, of which 80 deaths were directly attributable to the clinical trials, said the Centre.

The numbers forced the government to bring in more regulation, such as digital consent-taking.

The official said that necessary steps to include the proposal in the drugs and cosmetics rules had also been initiated. The law says an investigator is supposed to counsel and explain every detail that the trial may entail before seeking the patient’s signature.

“In reality, those indulging in unethical clinical trials just lure the patients and make them sign the documents,” Dr Anand Rai of Clinical Trial Victims Help Group said. “There have been cases when doctors have recruited 150 children to participate in a trial within three hours. Here, it is anyone’s guess how much counselling was done.”

He said most trial sites do not even have counsellors.

The stakeholders are divided on whether digital consent will cleanse or further push the industry into a crisis. The once-blooming medical research field that was clocking a 30% growth has plummeted to registering just about 262 trials last year and six till January this year.

“It is a positive step but may pose logistic challenges when it comes to community research involving lakhs,” said thoracic surgeon Dr CS Pramesh from the Tata Memorial Hospital in Parel.

Industry insiders say they have other regulations related to compensation or delayed approvals to deal with first.

“It actually should not be very difficult,” Dr Vandana Gupta, representative of V care foundation, a support group for cancer patients, said. “The investigator can simply do the recording when he or she is counselling the patient.”