Protecting and promoting: Can regulatory stewardship lead the way in health research? A roundtable discussion at Edinburgh Law School – 29 March 2019

Edward Dove

On 29^th March 2019, a roundtable of research ethics committee (REC) members, research managers, regulators, patient advocates, and scholars was convened at Edinburgh Law School to discuss “regulatory stewardship”, a potentially novel regulatory model of health research oversight that could improve regulatory interactions among different stakeholders.

The roundtable partially built on recent empirical research I conducted on the roles and practices of NHS RECs in light of recently implemented health research regulation that explicitly seeks to promote health research in the UK, in part by streamlining regulation itself. It was unclear to me how these recent regulatory changes, stressing efficiency and maximisation of UK competitiveness for health research and maximisation of return from investment in the UK, might affect the substantive and procedural workings of RECs. It was also unknown whether or how the modification of research regulation at the level of legal architecture to promote research—seen, for example, in the Care Act 2014 and in the mandate of the Health Research Authority (HRA)—might ‘trickle down’ to the day-to-day practices of RECs.

The research findings from that empirical investigation can serve as a basis for further assessments of the relationship between regulatory actors and health research, thereby opening the potential to inform policy decisions and policy reform. Indeed, a key aim of this roundtable was to consider a reimagining of ‘regulatory spaces’ in health research to optimise their effectiveness in delivering productive regulation. Core questions included:

• How might participant protection and research promotion work together in a regulatory framework, if at all?
• Is there a need for a deliberative space within which RECs can both negotiate the risks relevant to a research application and also work with researchers to get to a point where the application can be deemed ethically acceptable?
• What range of actors needs to be involved, with which responsibilities, and towards which ends?
• How might a regulatory deliberative space be protected to capture and promote the fluid, processual nature of REC deliberations and effective health research regulation? 

Research from the University of Edinburgh’s Liminal Spaces Project suggests that regulatory stewardship involves different actors—RECs and others involved in the regulation of health research—helping researchers and sponsors navigate complex regulatory pathways and work through the thresholds of regulatory approvals. Collective responsibility, as a component of regulatory stewardship, requires relevant actors to work together to design and conduct research that is ethical and socially and scientifically valuable and that ultimately aims to improve human health. This can only be accomplished if a framework delineates how and when regulators and regulatees should communicate with one another and makes clear who has what responsibility and role to be played (if any) at each stage in the research lifecycle.

To this end, in this roundtable we considered whether a regulatory framework for health research could identify different kinds of stewards with distinct roles, such as state stewards, institutional stewards, operational stewards and ethics stewards. If so, seen in this way, the example of the REC would serve as an illustration of a potentially much wider contribution to policy, regulation, law, and theory in the health research context. 

Using hexagon shapes to thematically group responses to several high-level questions posed to them (see the photo below), roundtable participants helped identify the key challenges and opportunities associated with regulatory stewardship. For example, several participants commented on the difficulty in teasing out the conceptual and practical difference between stewardship and gatekeeping, and considered whether there are aspects of health research regulation that can be researched more in-depth to see whether stewardship is observed or can be implemented as a pilot project. Participants also discussed the link between stewardship and proportionality: stewardship is partially about streamlining regulatory pathways, helping to avoid researchers and sponsors and getting bogged down in unnecessary paperwork or duplicative processes.

Overall, participants were enthused by the day-long discussion and the potentially beneficial impact of regulatory stewardship in health research. The immediate next step for our roundtable group is to construct a short policy brief that will chart the ways in which regulatory stewardship might be implemented in health research. Once finalised, as with the forthcoming roundtable report, it will be publicly disseminated on the Mason Institute website.

The roundtable participants acknowledge and thank Wellcome for funding the roundtable through a Senior Investigator Award entitled “Confronting the Liminal Spaces of Health Research Regulation” (Award No: WT103360MA), and the College of Arts, Humanities and Social Sciences at the University of Edinburgh for supporting the roundtable through funding from a Knowledge Exchange and Impact Grant.