"Charting a framework for regulatory stewardship" [2020] ELECD 283; in Dove, S. Edward (ed), "Regulatory Stewardship of Health Research" (Edward Elgar Publishing, 2020) 159

Book Title: Regulatory Stewardship of Health Research

Editor(s): Dove, S. Edward

Publisher: Edward Elgar Publishing

Section: Chapter 6

Section Title: Charting a framework for regulatory stewardship

Number of pages: 22

Abstract/Description:

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’.