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I explain the research approach, theoretical underpinnings, and analytical concepts that drive the empirical investigation. I show how regulatory theory provides a solid but ultimately insufficient foundation on its own for the empirical investigation that informs this book. I argue that there is a need for an empirically grounded discussion of regulatory practice. I propose an anthropology of regulation that contributes to socio-legal studies by drawing explicit attention to processes, passages, and change. I further draw on the anthropological concept of liminality, which serves as a sensitizing concept in addition to concepts provided by regulatory theory. Together with regulatory theory, liminality helps us to better understand the nature of transformations of actors within the regulatory space, the form of regulation in this space, as well as the behaviours and experiences of actors as they go through processes of change.

This chapter unpacks further the ability of actors within the health research regulatory space to serve as ‘regulatory stewards’, but it does so from a normative angle. I propose a model of what a regulatory framework for health research oversight ought to look like were it to incorporate the findings from the empirical investigation. This would include explicit endorsement of regulatory stewardship and a charting of how protection and promotion can and should work together. I offer a proposal for a more processual regulatory framework that enables regulatory stewards to assist in accommodating potential harms and maximizing research outcomes, and that creates a regulatory space within which there is more room for regulators to protect and promote, including room to ‘experiment’ in working through these principles together with other actors. As part of this regulatory stewardship model are key components that I term ‘regulatory conversations’ (building on the insightful work of Julia Black) and ‘regulatory flexibility’.

This chapter queries whether the practices of RECs, specifically RECs within the National Health Services of the UK, align with their recently established regulatory mandate. In particular, it explores a shift from a protectionist model that has been seen by some as paternalistic, with regulators disproportionately focusing on research risks in comparison to research benefits, to a more broadly facilitative model, undergirded by law, that could be called ‘next-generation’ in that it seeks to foster an environment that both protects research participants and also facilitates responsible health research through proportionate, risk-based regulation and coordinated alignment of ethics review and other regulatory processes. This chapter raises the (empirically orientated) question of whether the roles and practices of RECs are shifting in compliance with this next-generation regulation.

This chapter reflects on the data, discussion, and regulatory stewardship framework presented; reflects on how this work contributes to broader scholarship and understandings of regulation, law, and theory in the health research context; and proposes future directions for regulation of health research and research in this area.

The introduction sets out the aims of the book, the driving empirical research questions, and provides a roadmap for the book (i.e. a chapter-by-chapter summary).

In this chapter, I trace the regulatory development of RECs and health research regulation within the UK, with a view to demonstrating both the growth of health research regulation and the increasingly central role that RECs play in regulating health research. While, to a certain degree, research promotion has always been embedded in the regulatory techniques of RECs, it has not until now been instantiated in law with the creation of the HRA and rules promulgated under the Care Act 2014. The subsequent and fundamental research question to explore is whether this instantiation of research promotion in law has a (hitherto absent) trickle-down effect that impacts the day-to-day practices of RECs, and if so, how, or indeed, whether the law is only now coming to reflect an everyday practice that has long existed.

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.