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.

Social license for the use of big data in the COVID-19 era.

Strategies to enable the reopening of businesses and schools in countries emerging from social-distancing measures revolve around knowledge of who has COVID-19 or is displaying recognized symptoms, the people with whom they have had physical contact, and which groups are most likely to experience adverse outcomes. Efforts to clarify these issues are drawing on the collection and use of large datasets about peoples' movements and their health. In this Comment, we outline the importance of earning social license for public approval of big data initiatives, and specify principles of data law and data governance practices that can promote social license. We provide illustrative examples from the United States, Canada, and the United Kingdom.

Segmenting communities as public health strategy: a view from the social sciences and humanities.

On the 5th of May 2020, a group of modellers, epidemiologists and biomedical scientists from the University of Edinburgh proposed a "segmenting and shielding" approach to easing the lockdown in the UK over the coming months. Their proposal, which has been submitted to the government and since been discussed in the media, offers what appears to be a pragmatic solution out of the current lockdown. The approach identifies segments of the population as at-risk groups and outlines ways in which these remain shielded, while 'healthy' segments would be allowed to return to some kind of normality, gradually, over several weeks. This proposal highlights how narrowly conceived scientific responses may result in unintended consequences and repeat harmful public health practices. As an interdisciplinary group of researchers from the humanities and social sciences at the University of Edinburgh, we respond to this proposal and highlight how ethics, history, medical sociology and anthropology - as well as disability studies and decolonial approaches - offer critical engagement with such responses, and call for more creative and inclusive responses to public health crises.

Co-production and Managing Uncertainty in Health Research Regulation: A Delphi Study.

European and international regulation of human health research is typified by a morass of interconnecting laws, diverse and divergent ethical frameworks, and national and transnational standards. There is also a tendency for legislators to regulate in silos-that is, in discrete fields of scientific activity without due regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the stakeholders-researchers and regulators alike-who attempt to navigate these landscapes. This Delphi study was undertaken in order to provide the first interdisciplinary and crosscutting analysis of health research regulation, as it is experienced by such stakeholders in the UK context. As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration, and even co-production, of processes involved in health research regulation. On the basis of this research, we offer insights about how health research regulation can become a matter with which a wider range of stakeholders-including researchers, regulators, publics and research sponsors-can engage. The evidence supports the normative claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principle-based regimes that allow researchers, regulators and publics to co-produce regulatory systems serving core principles. By unpacking thorny concepts and practices at the heart of health research regulation-including the public interest and public engagement-our results have the potential to situate and breathe life into them. The results also demonstrate that while proportionality is well-recognised as a crucial element of flexible regulatory systems, more must be done to operationalise this as an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. This is required if we are to move beyond proportionality as a mere risk-management tool. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators, nor does it necessarily produce the best research. Embracing uncertainty-both as a human practice and a regulatory objective-may represent the brighter future for health research.

Regulating for uncertainty: bridging blurred boundaries in medical innovation, research and treatment.

This paper explores the blurred conceptual boundaries between 'practice/treatment', 'research' and 'medical innovation' in order to inform what these mean - and can mean - for regulation of these fields of enquiry. These terms are constantly employed within the sphere of health and human health research regulation, but there is a lack of clarity and consistency in the ways in which the activities are categorised. This gives rise to confusion and can negatively impact treatment/research and innovation. I argue that it is not only timely but also necessary to revisit our current conceptualisations of these key activities, with a particular emphasis on medical innovation. The proposal is to reimagine regulatory landscapes - including regulation - in more holistic terms that reflect the processes that transgress these categories and to understand better the blurred boundaries that exist between them. I suggest that the anthropological concept of liminality is particularly helpful in developing more holistic understandings of medical innovation that reflect the processes and relationships that exist. Importantly, it provides us with a new conceptualisation of medical innovation as a shared space where both practice/treatment and research can co-exist.

Research and Global Health Emergencies: On the Essential Role of Best Practice.

This article addresses an important, overlooked regulatory challenge during global health emergencies (GHEs). It provides novel insights into how, and why, best practice can support decision makers in interpreting and implementing key guidance on conducting research during GHEs. The ability to conduct research before, during and after such events is crucial. The recent West-African Ebola outbreaks and the Zika virus have highlighted considerable room for improvement in meeting the imperative to research and rapidly develop effective therapies. A means of effectively capturing these experiences and folding them into future decision-making is lacking; the need for effective practical translational measures remains. The challenge for the research community lies in extracting meaningful action-guiding content from pre-existing guidelines-which draw upon practical examples of guidelines 'in action'-that assist in determining how to act in a particular (future) situation. Insights are provided into the role of best practice as a means to do so; such examples can provide invaluable support to decision makers in interpreting high-level guidance; overarching guidelines retain their necessary level of generality and flexibility, whilst corresponding best practice examples-which incorporate important lessons learned-illustrate how such guidelines can be interpreted at a practical level.

Charting Regulatory Stewardship in Health Research: Making the Invisible Visible.

This section focuses on the ethical, legal, social, and policy questions arising from research involving human and animal subjects.

Data Safe Havens and Trust: Toward a Common Understanding of Trusted Research Platforms for Governing Secure and Ethical Health Research.

In parallel with the advances in big data-driven clinical research, the data safe haven concept has evolved over the last decade. It has led to the development of a framework to support the secure handling of health care information used for clinical research that balances compliance with legal and regulatory controls and ethical requirements while engaging with the public as a partner in its governance. We describe the evolution of 4 separately developed clinical research platforms into services throughout the United Kingdom-wide Farr Institute and their common deployment features in practice. The Farr Institute is a case study from which we propose a common definition of data safe havens as trusted platforms for clinical academic research. We use this common definition to discuss the challenges and dilemmas faced by the clinical academic research community, to help promote a consistent understanding of them and how they might best be handled in practice. We conclude by questioning whether the common definition represents a safe and trustworthy model for conducting clinical research that can stand the test of time and ongoing technical advances while paying heed to evolving public and professional concerns.

The promotion of data sharing in pharmacoepidemiology.

This article addresses the role of pharmacoepidemiology in patient safety and the crucial role of data sharing in ensuring that such activities occur. Against the backdrop of proposed reforms of European data protection legislation, it considers whether the current legislative landscape adequately facilitates this essential data sharing. It is argued that rather than maximising and promoting the benefits of such activities by facilitating data sharing, current and proposed legislative landscapes hamper these vital activities. The article posits that current and proposed data protection approaches to pharmacoepidemiology--and more broadly, re-uses of data--should be reoriented towards enabling these important safety enhancing activities. Two potential solutions are offered: 1) a dedicated working party on data reuse for health research and 2) the introduction of new, dedicated legislation.

Towards Principles-Based Approaches to Governance of Health-related Research using Personal Data.

Technological advances in the quality, availability and linkage potential of health data for research make the need to develop robust and effective information governance mechanisms more pressing than ever before; they also lead us to question the utility of governance devices used hitherto such as consent and anonymisation. This article assesses and advocates a principles-based approach, contrasting this with traditional rule-based approaches, and proposes a model of principled proportionate governance. It is suggested that the approach not only serves as the basis for good governance in contemporary data linkage but also that it provides a platform to assess legal reforms such as the draft Data Protection Regulation.

Delivering proportionate governance in the era of eHealth: Making linkage and privacy work together.

This article advances a principled proportionate governance model (PPGM) that overcomes key impediments to using health records for research. Despite increasing initiatives for maximising benefits of data linkage, significant challenges remain, including a culture of caution around data sharing and linkage, failure to make use of flexibilities within the law and failure to incorporate intelligent iterative design. The article identifies key issues for consideration and posits a flexible and accessible governance model that provides a robust and efficient means of paying due regard to both privacy and the public interests in research. We argue that proportionate governance based on clear guiding principles accurately gauges risks associated with data uses and assigns safeguards accordingly. This requires a clear articulation of roles and responsibilities at all levels of decision-making and effective training for researchers and data custodians. Accordingly, the PPGM encourages and supports defensible judgements about data linkage in the public interest.