Charting a framework for regulatory stewardship

In the previous chapter, I examined the ways in which certain actors in health research—particularly RECs—are affected by regulation, and similarly, the ways in which they can affect regulation. The findings revealed that research ethics review is an essential component of health research regulation and the ethics review system overall appears to be operating relatively smoothly, at least in comparison to previous decades. At the same time, though, the evidence suggests that several regulatory components can be refined. In this chapter, I unpack further the significance of the liminality of RECs and the ability of actors within the health research regulatory space to serve as ‘regulatory stewards’. I do so by taking up the normative dimension of anthropology of regulation, suggesting a model of what a regulatory framework for health research oversight ought to look like if it were to incorporate the findings from this empirical investigation. This would include explicit endorsement of regulatory stewardship and a charting of how protection and promotion can and should work together in regulatory design and practice. This proposed framework has application at two levels, which can be seen as both top-down and bottom-up: (1) the government and managing regulators (e.g. Department of Health and Social Care, HRA), and (2) RECs and regulatees (e.g. researchers, sponsors, institutions). As the evidence in Chapter 5 indicates, RECs are embedded in multiple overlapping, interconnecting regulatory spaces, yet their roles and the roles of other actors are not always manifest in regulation. Further, the conversations between regulators, namely between RECs and the HRA, can be sporadic and at times less effective as compared to the conversations between regulators and regulatees (here, being RECs and researchers). This can cause disconnected spaces to appear within a given regulatory space where hazards may occur. A reformulated framework could work to improve regulatory conversations between actors, provide ongoing