Clinical research continues to remain at the top of the news, courtesy of the Supreme Court of India. Through a series of judgments delivered on an ongoing litigation, the apex judiciary has directed the drug regulatory body to get its act together to build more accountability and transparency into clinical research carried out across the country.

The writ petition, filed by an NGO,  alleged that lack of adequate checks and balances for drug experiments involving people have led to the loss of hundreds of lives as well as countless cases of serious adverse reactions over the years.

Spurred by the court’s quest for a review of all trial approvals granted a year ago, the health ministry started closing the gaps through legislation and amendments to existing regulations. The reform-spree has left the clinical research scene most hectic.

In the latest order, the regulator has made audio-visual recording mandatory for the informed consent process while recruiting patients for studies. The petitioners pointed out that norms related to obtaining informed consent are not usually followed in most trials and investigators either take it lightly or take advantage of the process due to inefficient enforcement of regulations. Circumventing this crucial aspect of clinical research, many CROs virtually make “ignorant patients mere guinea pigs.”

The ministry has decided that “for all clinical trials, in addition to the requirement of obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent, is also required to be done while adhering to the principle of confidentiality,” according to the health minister, citing the court order. The new requirement will appy to new subjects to be enrolled in all clinical trials, including global studies.

Too Hasty?
Despite the fact that filming of informed consent process is not common among clinical researchers worldwide, some Indian CROs have already been trying to implement the procedure as a safeguard (see this column in the June 2012 issue of Contract Pharma). The recorded proof would provide them an edge when contested in a clinical research ecosystem that is highly sensitive and sensationalized, the CROs contended.

While welcoming the order as a positive step towards bringing in more transparency in clinical studies, CROs contend that adherence to the requirement of A/V recording of informed consent process of trial subjects, with immediate effect, would be difficult as the order is ”too hasty and hazy.”

Besides lacking a timeline, there are other hurdles with implementing the rule, say CROs. The biggest is overcoming the practical impediments of the whole process of explaining and obtaining the informed A/V consent from critically ill patients without breaching their confidentiality. Phase III trials are mostly run in public hospitals.

“Sometimes the informed consent can be a lengthy process in itself, involving multiple sittings with the patient. And it’s supposed to be taken privately and confidentially. But it looks all too hazy, how one can maintain that level of confidentiality in front of a camera crew and in a public surrounding,” said a chief investigator from a Mumbai-based CRO.

Confusion Reigns
Equally challenging is the task of convincing ailing patients about the requirement, especially in cases where religious taboos and certain cultural practices forbid one from being filmed.

Meanwhile, CROs running field studies doubt the scope and applicability of the new law. The notification says “all clinical trials,” but in the case of large field studies, A/V recording of informed consent is not always practical, they opined.

CROs would like to clear the air. They want the regulator to spell out the specifics by publishing necessary guidelines and SOPs for A/V recording. At the moment, most are unsure about the requirement and are looking for answers about the nature of recording, the sort of equipment to be employed, the procedure for preserving the video clips, how the data should be submitted, etc., all the while “adhering to the principles of confidentiality.”

Clinical trials in India are very much in the public glare. Media scrutiny and a number of court cases stand testimony to this. Therefore, it is important to salvage the reputation of the growing industry before it gets irreparably damaged by bad press. From this standpoint, the regulatory body is fully justified in plugging any loopholes and getting the system streamlined.

No serious player will question the regulator’s motive in bringing in systems. But sketchy orders that leave more questions than answers can only bring forth inconsistencies and escalate the confusion, CROs said. CP