Operationalising ‘publicness’ in data-intensive health research regulation: an examination of the public interest as a regulatory device

Abstract

This thesis is fundamentally concerned with revealing the complex and nuanced interrelationship between collective and individual interests in health research, and the implications of this for optimising contemporary health research regulation (HRR). This task of optimisation can be characterised as a persistent preoccupation in the heath research arena, in that consideration of these interests can be located both in foundational international instruments that have shaped the course of modern health research regulation, as well as in contemporary instruments and guidelines. Nonetheless, the nature of human health research has been transformed since the post-World War II era, which has impacted both on how health research is conducted, as well as debates about what the regulation of this endeavour ought to look like. In this way, contemporary health research constantly challenges traditional regulatory structures that are underpinned by an increasingly outdated approach to individual and collective interests that are at stake. The regulatory system struggles to keep pace and this is particularly evident in relation to data-intensive health research.

This thesis tackles these tensions head on. I propose that a new approach to HRR is required that is capable of engaging with the multiplicity of ways in which decisions about the conduct of health research might impact on our lives. More particularly, I argue that there is something about the quality of human health research that is focused on realising and promoting collective interests that builds on, but also goes beyond, the protection of individuals who contribute to that research, and that this must be reflected in the way that it is regulated. The solution I offer is the concept of ‘publicness’, as introduced and explored in this thesis. More specifically, publicness reflects the interrelationship between collective and individual interests, thereby drawing attention to the context in which this interplay takes place, as well as the implications of this relationship for HRR, both now and in the future. I identify three interlinked and overlapping facets of publicness: relationality, temporality and accountability.

The analysis in this thesis deploys the tripartite framework provided by publicness in order to scrutinise several aspects of HRR. This serves to (i) reveal new insights in relation to existing concepts in HRR, namely the public interest, social value and social licence; (ii) identify how HRR can better account for the full range of interests in play throughout the research and data lifecycle, with a focus on temporal aspects of the research endeavour and the mutability and diversity of and within publics in HRR; and (iii) offer a reconceptualisation of the public interest that is better equipped to meet the realities and challenges of the contemporary health research environment. A case study, in relation to a high-profile and disputed transfer of identifiable NHS patient data from The Royal Free NHS Foundation Trust to Google DeepMind, reintegrates the preceding analysis to the contemporary data use landscape. This illustrates how publicness helps to optimise HRR by both elucidating ‘lessons learned’, and through the identification of positive steps that can support future data-sharing initiatives to better account for publicness. In these various ways the diagnostic and normative value of publicness helps to provide a new understanding of what is at stake in health research and its regulation, and to provide a basis to move beyond what already exists in the sub-optimal HRR ecosystem.