Wednesday, November 28, 2012

Video recording consent processes in India

As mentioned before on this blog, India has become a magnet for global clinical trials as well as for research ethics controversies. The potential in India for fast, cheap biomedical research with drug-naive populations is great, and since India is a fast-growing economy, you can throw the attractions of local expertise and decent clinical infrastructure into the mix. However, many participants in the trials may be illiterate, unfamiliar with scientific concepts, unhealthy and poor. This situation puts a great deal of pressure on regulatory bodies and research ethics committees: it is up to them to keep studies from being exploitative and harm-causing. They must ensure the responsible conduct of research between powerful pharmaceutical companies on the one hand, and the destitute sick on the other. If the last few years is any indication, they are struggling to meet this formidable challenge.

This is the background for a new regulatory safeguard being proposed by India's Drug Technical Advisory Board (DTAB) for clinical trials: video recording of the consent process. The proposed change to the regulations would have language like: "An audio/video recording to the informed consent process of the individual subject including the procedure of providing information to the subject and his understood consent shall be maintained by the investigator for the record." Some Indian observers, concerned about the ethical problems with local trials, support this proposal. But there are some reasons to be skeptical.

What is the rationale for recording? When it comes to the use of recording as a form of data collection, researchers are routinely asked for justifications. The reason is that recording (especially the visual part) involves collection of a major identifier, i.e. the participant's face. Since recording adds a piece of identifying information which then has to be covered by confidentiality protections, researchers are advised only to record what is essential to conduct the research. So why record consent? One answer could be to document the process for reasons of quality control. With a recording, you could see/hear how the research study was presented to the prospective participant. The obvious limitation is that the recording might not capture what the participant actually understood, and (unless we are talking about the self-protection of research institutions) that is the ethical point. Another possibility is that the requirement to record has a deterrent effect: if the researchers know they are on camera, then they will be on their best behavior. This sounds intuitively plausible, though to my knowledge there have been no studies to support the claim of a deterrent effect, and the researchers (due to inadequate training) might not know what best behavior would be anyway, and fail to be deterred. Another drawback of the regulation is the burden of work it would add to research ethics committees, to the extent that they are charged with reviewing/monitoring the recorded consent processes. Another consideration is that the regulation seems to unduly privilege the informed consent process: if we are concerned about the ethics of such trials, and recording is supposed to help, why not record the recruitment process, the study visits, and other procedures that could compromise the well-being of the participant?

If this proposal is taken up, it will constitute a kind of regulatory experiment, interesting to observe from afar.

Hat tip: Louise Winstanly, IntraHealth

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