Paper short abstract:

This paper explores UK RECs as form of hybrid 'club regulation'.

Paper long abstract:

While there is a long history of agenda setting research on the post-trial regulation of pharmaceutical products, pre-trial regulation is less well examined. Over the past few years, a growing body of work on research ethics review (a crucial aspect of pre-trial regulation) has begun to shed light on this area. The aim of this paper is, via historical and ethnographic data, to map out the broader theoretical context within which research ethics review takes place. To do so, this paper explores the nature of UK research ethics committees in the context of changes to the British regulatory state over the past 30-40 years. Drawing on the work of Michael Moran this paper argues that RECs exist as a curious hybrid between 'club regulation' (which empowers professional self-regulation and the exclusion of democratic oversight) and the 'modernist' style of regulation that succeeded it in the 1970s and 1980s. Thus while RECs are situated within a modernist context of 'governance frameworks', 'SOPs' and audit, REC decision making remains rooted in the relationship-focused, style of regulation characteristic of pre-1970s club government. This paper will examine the advantages and disadvantages of such a system, and explore its implications for broader pharmaceutical regulation.