Liminality of NHS research ethics committees: navigating participant protection and research promotion across regulatory spaces
Item statusRestricted Access
Embargo end date04/07/2019
Dove IV, Edward Stellwagen
NHS research ethics committees (RECs) serve as the gatekeepers of health research involving human participants. They have the power to decide, through a regulatory ‘event licensing’ system, whether or not any given proposed research study is ethical and therefore appropriate to undertake. RECs have several regulatory functions. Their primary function has been to protect the interests of research participants and minimise risk of harm to them. Yet RECs, and other actors connected to them, also provide stewardship for the promotion of ethical and socially valuable research. While this latter function traditionally has been seen as secondary, the ‘function hierarchy’ is increasingly blurred in regulation. Regulatory bodies charged with managing RECs now emphasise that the functions of RECs are to both protect the interests of research participants, and also promote ethical research that is of potential benefit to participants, science, and society. Though the UK has held in some of its previous regulations (broadly defined) that RECs equally function to facilitate (ethical) health research, I argue that the ‘research promotionist’ ideology has moved ‘up the ladder’ in the regulation of RECs and in the regulation of health research, all the way to implementation in law, specifically in the Care Act 2014, and in the regulatory bodies charged with overseeing health research, namely the Health Research Authority. This thesis therefore asks: what impact does this ostensibly twinned regulatory objective then have on the substantive and procedural workings of RECs? I invoke a novel ‘anthropology of regulation’ as an original methodological contribution, which enables me to study empirically the nature of regulation and the experiences of actors within a regulatory space (or spaces), and the ways in which they themselves are affected by regulation. Anthropology of regulation structures my overall empirical inquiry to query how RECs, with a classic primary mandate to protect research participants, now interact with regulatory bodies charged with promoting health research and reducing perceived regulatory barriers. I further query what this changing environment might do to the bond of research and ethics as seen through REC processes of ethical deliberation and decision-making, by invoking the original concept of ‘regulatory stewardship’. I argue that regulatory stewardship is a critical, but hitherto invisible, component of health research regulation, and requires fuller recognition and better integration into the effective functioning of regulatory oversight of research involving human participants.
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