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

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health research constantly challenges traditional regulatory structures that are underpinned by an increasingly outdated approach to individual and collective interests that are at stake.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

The medicolegal landscape through the lens of COVID-19:time for reform

The COVID-19 pandemic has brought out the best of the health and social care workforce globally, as acknowledged by the public. But the clapping has now stopped. Over 50,000 people who tested positive for coronavirus in the UK have died, a tragic figure that is more than double the UK Government's early ‘best case scenario’ estimate. Each death represents a life lost too soon, leaving behind grieving family and friends. At the same time, doctors and other healthcare professionals are exhausted and anxious, fearing both the implications of a second wave, and possible repercussions from decisions made under the strain of the pandemic.There has been polarised debate around whether doctors should be granted immunity from civil and criminal negligence claims and regulatory proceedings arising from treatment provided during COVID-19.1,2 Here, we argue that this focus on temporary statutory immunity is a distraction from pre-existing concerns that several aspects of the current medicolegal system are not fit for purpose – for doctors or for patients. Areas where there is no ‘quick fix’ include: the need for reform of the clinical negligence system; concerns in relation to regulatory proceedings; and the potential for BAME (black, Asian, and minority ethnic) doctors (and patients) to be disproportionately impacted in both areas. These issues are critical, since they each have a direct impact on multiple stakeholders, including on those who deliver and receive healthcare. However, there has been a tendency for these to be considered from single-minded viewpoints; accordingly, we aim in this paper to provide a more holistic view. Rather than pursuing immunity legislation, we say that the time is right for more comprehensive action, including an independent Public Inquiry to scrutinise these issues, taking into account all of the interests engaged (Figure 1)

The medicolegal landscape through the lens of COVID-19:time for reform

The COVID-19 pandemic has brought out the best of the health and social care workforce globally, as acknowledged by the public. But the clapping has now stopped. Over 50,000 people who tested positive for coronavirus in the UK have died, a tragic figure that is more than double the UK Government's early ‘best case scenario’ estimate. Each death represents a life lost too soon, leaving behind grieving family and friends. At the same time, doctors and other healthcare professionals are exhausted and anxious, fearing both the implications of a second wave, and possible repercussions from decisions made under the strain of the pandemic.There has been polarised debate around whether doctors should be granted immunity from civil and criminal negligence claims and regulatory proceedings arising from treatment provided during COVID-19.1,2 Here, we argue that this focus on temporary statutory immunity is a distraction from pre-existing concerns that several aspects of the current medicolegal system are not fit for purpose – for doctors or for patients. Areas where there is no ‘quick fix’ include: the need for reform of the clinical negligence system; concerns in relation to regulatory proceedings; and the potential for BAME (black, Asian, and minority ethnic) doctors (and patients) to be disproportionately impacted in both areas. These issues are critical, since they each have a direct impact on multiple stakeholders, including on those who deliver and receive healthcare. However, there has been a tendency for these to be considered from single-minded viewpoints; accordingly, we aim in this paper to provide a more holistic view. Rather than pursuing immunity legislation, we say that the time is right for more comprehensive action, including an independent Public Inquiry to scrutinise these issues, taking into account all of the interests engaged (Figure 1)

Beyond categorisation:Refining the relationship between subjects and objects in health research regulation

In this article, we argue that the relationship between ‘subject’ and ‘object’ is poorly understood in health research regulation (HRR), and that it is a fallacy to suppose that they can operate in separate, fixed silos. By seeking to perpetuate this fallacy, HRR risks, among other things, objectifying persons by paying insufficient attention to human subjectivity, and the experiences and interests related to being involved in research. We deploy the anthropological concept of liminality – concerned with processes of transformation and change over time – to emphasise the enduring connectedness between subject and object in these contexts. By these means, we posit that regulatory frameworks based on processual regulation can better recognise and encompass the fluidity and significance of these relationships, and so ground more securely the moral legitimacy and social licence for human health research