The Indian Society for Clinical Research (ISCR), a professional body representing the interests of clinical research professionals in the country, has expressed concern over the haste with which the union health ministry has introduced the audio-visual recording of informed consent in clinical trails without the requisite clarity and an appreciation of the logistical issues in its implementation.

Fully supporting the need for a more robust and regulated environment for the conduct of clinical trials in India ensuring the practice of the highest standards of ethics and quality, the ISCR asked the regulators to provide more clarity and address concerns of stakeholders to ensure that an important step taken to safeguard the interests of patients does not act as a deterrent to stakeholders.

Expressing concern over the hasty introduction, an ISCR spokesperson said that lack of guidance and direction on operational and logistical issues of managing the audio-visual recording process like kind of equipment to be used, where and how information should be stored, etc could leave room for ambiguity and inconsistencies in execution.

There is lack of clarity about what studies the health ministry order is applicable to. 'All clinical trials' is a term that includes all kinds of studies, including field studies, where there are practical challenges in audio-visual recording. More clarity is required on how confidentiality of patients should be protected and maintained in an ‘audio-visual’ context and what processes need to be followed in instances where, due to religious and socio-cultural reasons, patients may not want to be videographed which is a reality in a country like India, the ISCR spokesperson said.

Most importantly, the order states that audio-visual recording of informed consent will be applicable with immediate effect to all clinical trials where new patients are recruited which implies that it is mandated for ongoing trials as well. This will be a setback to ongoing trials as sites require time to procure equipment, train their teams in using them and provide storage areas for the recordings. Providing a window for implementation would have ensured that ongoing trials are not impacted even as sites invest in the requisite infrastructure to implement the new order.

Over the last few years, three areas where there have been issues raised about the conduct of clinical research and which have been most misunderstood amongst the public at large are the informed consent process; making the distinction between death of a patient in a clinical trial and death of a patient due to a clinical trial; and compensation payouts. Audio-visual recording of informed consent will go a long way in providing documented proof of informed consent, particularly where contested, and to that extent ISCR is fully supportive of audio-visual recording of informed consent, the ISCR spokesperson further added.