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"Operationalizing 'next-generation' health research regulation--what is happening in practice?" [2020] ELECD 282; in Dove, S. Edward (ed), "Regulatory Stewardship of Health Research" (Edward Elgar Publishing, 2020) 107

Book Title: Regulatory Stewardship of Health Research

Editor(s): Dove, S. Edward

Publisher: Edward Elgar Publishing

Section: Chapter 5

Section Title: Operationalizing ‘next-generation’ health research regulation—what is happening in practice?

Number of pages: 52

Abstract/Description:

I engage with the empirical data collected from the interviews and observations and, coupled with the findings from the document analysis, make sense of them through an anthropology of regulation approach. Through investigation of three main themes (the ‘black boxes’ of ethics review; regulatory connectivity; and regulators as facilitators and stewards), I explore what happens in REC meetings, consider the operationalization of ‘next-generation’ health research regulation (particularly in light of the twin aims of protection and promotion), and investigate the procedures and substance behind risk-based regulation. I do this by querying whether risk-based regulation is being practised by RECs and the HRA, and more fundamentally, by querying the nature and function of the interactions among RECs, researchers, and the HRA. Throughout, I draw on the implications of space and time in ethics review, signifying the contribution of liminality to the normative discussion to come in Chapter 6.