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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 – in order 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.

As the sustained and devastating extent of the coronavirus disease 2019 (COVID-19) pandemic becomes apparent, a key focus of public scrutiny in the UK has centred on the novel legal and regulatory measures introduced in response to the virus. When those measures were first implemented in March 2020 by the UK Government, it was thought that human rights obligations would limit excesses of governmental action and that the public had more to fear from unwarranted intrusion into civil liberties. However, within the first year of the pandemic’s devastation in the UK, a different picture has emerged: rather than through action, it is governmentalinactionthat has given rise to greater human rights concerns. The UK Government has been roundly criticized for its inadequate response, including missteps in decision-making, delayed implementation and poor enforcement of lockdown measures, abandonment of testing, shortages of critical resources and inadequate test and trace methods. In this article, we analyse the UK Government’s missteps and compare them with published international guidance; we also contrast the UK’s decisions with those taken by several other countries (including the devolved administrations within the UK) to understand how its actions and inactions have contributed to unfavourable outcomes. Using an analytical perspective that demonstrates how human rights are both a protection from the power of the state and a requirement that governmental powers are used to protect the lives, health and wellbeing of citizens, we argue that the UK Government’s failure to exercise their powers competently allowed the virus to spread without ensuring the country had the means to manage a high case load. This abject failure has led to one of the highest rates of deaths per capita worldwide. We offer several lessons that can be learnt from this unfortunate, but preventable, situation.

The delivery of good outcomes from human health research is entirely dependent on the proper functioning of the attendant regulatory systems. This article focuses on the processes of regulation themselves, and how these might be better understood, so that regulators and other stakeholders have a strong normative basis upon which to pursue the regulatory objective of achieving outcomes with maximum social value. The argument is made that the concept of ‘processual regulation’—which promotes a whole systems approach to regulation—can assist greatly in the design, implementation, and review of human health research. This moves beyond the current often-fragmented approach to regulation towards a joined-up, reflective, and responsive system that has fitness-for-purpose at its core.

This article explores the social imaginary in the context of data ownership and the (non-)delivery of the data sharing revolution in biomedicine. We contribute to this Special Issue’s broad definition of an imaginary—as the shared (or, here, divergent) stakeholder views on the hopes, promises and expectations to be engendered through technoscientific development—by developing a method and paradigm of ‘competing narratives’. Despite multiple initiatives to encourage health data sharing, and a strong ‘open access’ agenda, the data sharing revolution is not yet delivered. Ownership is persistently (though inconsistently) presented as a barrier to data sharing. However, existing literature does not reveal how far appeals to ownership are part of the problem. This paper reports original, interdisciplinary research asking: in health research, in what ways, if at all, do notions of ownership (broadly conceived) of health-related data impact on sharing practices? Doctrinal and empirical research methods are used to expose evidence of drivers behind appeals to ownership in health data sharing. The findings speak to how funders and data custodians can better tailor existing and potential data sharing initiatives to perspectives and behaviors. The concept of ‘my data’ is important: notions of reward, opportunity, control, and safeguarding establish legitimate, potentially competing ‘ownership’ interests in data. In particular, this research raises questions about the long-term effectiveness of an open access ideology that ignores these subtleties. In conclusion we find power in the social imaginary of ownership with respect to biomedical data; however, that power emerges and is enacted in unexpected ways by multiple actors within the ecosystem, often driven by competing narratives about what is at stake. Importantly, formal legal property-type appeals to ownership appear to have far less power in the narratives about data than the ethical and social concerns that underpin responsible biomedical research.

Ethical decision-making frameworks assist in identifying the issues at stake in a particular setting and thinking through, in a methodical manner, the ethical issues that require consideration as well as the values that need to be considered and promoted. Decisions made about the use, sharing, and re-use of big data are complex and laden with values. This paper sets out an Ethics Framework for Big Data in Health and Research developed by a working group convened by the Science, Health and Policy-relevant Ethics in Singapore (SHAPES) Initiative. It presents the aim and rationale for this framework supported by the underlying ethical concerns that relate to all health and research contexts. It also describes a set of substantive and procedural values that can be weighed up in addressing these concerns, and a step-by-step process for identifying, considering, and resolving the ethical issues arising from big data uses in health and research. This Framework is subsequently applied in the papers published in this Special Issue. These papers each address one of six domains where big data is currently employed: openness in big data and data repositories, precision medicine and big data, real-world data to generate evidence about healthcare interventions, AI-assisted decision-making in healthcare, public-private partnerships in healthcare and research, and cross-sectoral big data. Published version The development of the Framework and its application to the six Domain papers was funded and supported by the Singapore National Medical Research Council Research, Innovation and Enterprise 2020 Grant.

Discussion of uses of biomedical data often proceeds on the assumption that the data are generated and shared solely or largely within the health sector. However, this assumption must be challenged because increasingly large amounts of health and well-being data are being gathered and deployed in cross-sectoral contexts such as social media and through the internet of (medical) things and wearable devices. Cross-sectoral sharing of data thus refers to the generation, use and linkage of biomedical data beyond the health sector. This paper considers the challenges that arise from this phenomenon. If we are to benefit fully, it is important to consider which ethical values are at stake and to reflect on ways to resolve emerging ethical issues across ecosystems where values, laws and cultures might be quite distinct. In considering such issues, this paper applies the deliberative balancing approach of the Ethics Framework for Big Data in Health and Research (Xafis et al. 2019) to the domain of cross-sectoral big data. Please refer to that article for more information on how this framework is to be used, including a full explanation of the key values involved and the balancing approach used in the case study at the end.

This final chapter of the Cambridge Handbook of Health Research Regulation revisits the question posed in the Introduction to the volume: What could a Learning Health Research Regulation System look like? The discussion is set against the background of debates about the nature of an effective learning healthcare system,1 building on the frequently expressed view that any distinction between systems of healthcare and health research should be collapsed or at the very least minimised as far as possible. The analysis draws on many of the contributions in this volume about how health research regulation can be improved, and makes an argument that a framework can be developed around a Learning Health Research Regulation System (LHRRS). Central to this argument is the view that successful implementation of an LHRRS requires full integration of insights from bioethics, law, social sciences and the humanities to complement and support the effective delivery of health and social value from advances in biomedicine, as well as full engagement with those who regulate, areregulated, and are affected by regulation.

The principal objective of this volume is to provide the first-ever integrated, multidisciplinary and cross-cutting analysis of health research regulation, drawing on experiences and expertise from across the globe. The book confronts the gaps between documented law and regulation in action; it demonstrates the relevance and value of ethical and social theories to good governance in research, and it seeks to capture and capitalise on lessons learned from research practice. This chapter provides an account of the changing landscape of health research regulation since the millennium, exposing themes and issues that become the focus of the subsequent sections and chapters of the book. Together, the contributions lay the foundation for the development of a Learning Health Research Regulation System, and the potential elements of such a system are explored in the Afterword.

Background Several jurisdictions, including Singapore, Australia, New Zealand and most recently Ireland, have a public interest or public good criterion for granting waivers of consent in biomedical research using secondary health data or tissue. However, the concept of the public interest is not well defined in this context, which creates difficulties for institutions, institutional review boards (IRBs) and regulators trying to implement the criterion. Main text This paper clarifies how the public interest criterion can be defensibly deployed. We first explain the ethical basis for requiring waivers to only be granted to studies meeting the public interest criterion, then explore how further criteria may be set to determine the extent to which a given study can legitimately claim to be in the public interest. We propose an approach that does not attempt to measure magnitude of benefit directly, but rather takes into account metrics that are more straightforward to apply. To ensure consistent and justifiable interpretation, research institutions and IRBs should also incorporate procedural features such as transparency and public engagement in determining which studies satisfy the public interest requirement. Conclusion The requirement of public interest for consent waivers in secondary biomedical research should be guided by well-defined criteria for systematic evaluation. Such a criteria and its application need to be periodically subject to intra-committee and intra-institution review, reflection, deliberation and amendment.

This article re-examines and fundamentally re-assesses the symbiotic relationship between law and ethics in the governance and regulation of biobanks as a global phenomenon. Set against the two decades of experience of set-up, management and most recently granting access to biobanks to promote advances in human health, it is argued that the boundaries—and so the legitimacy—of the respective roles of ethics and law have become blurred and, potentially, blunted. The caricature of law as a tool of command and control—resulting in compliance culture—is well recognised in regulation studies, but parallels with this can now also be seen within certain ethical regimes pertaining to biobanks and human health research more generally. At the same time, the ethical content of certain legal responses to biobanks can be lacking, as some legal systems seek to regulate biobanking in inflexible and unreflective ways that potentially undermine the entire enterprise. This can result in a net failure to capture adequately particular features of biobanking that make this field so potentially rich in terms of ultimate social value and human benefit. The argument is made that the interconnected, yet distinct, nature of the contributions of law and ethics must be better understood in this setting. The central message is unapologetically sceptical about the role of law in regulating biobanking, except when we see law as process. Rather, the position is advanced that more work is required to develop governance regimes that are ‘Ethics+’ : that is, rooted in the core values and principles at stake while able to adapt and accommodate the inevitable changing landscape of biobank research and practice. While ethics are always a necessary component of a robust and defensible regimes of health research, the notion of Ethics+ directs our attention to processes in which ethical discourse and engagement can be optimised to respond to particular features of biobanks and their operation.

John Kenyon Mason (19 December 1919-26 January 2017), CBE, MD, LLD, FRCPath, DMJ, FRCPE, FRSE, and known as Ken Mason to us all, was Regius Professor of Forensic Medicine at the University of Edinburgh from 1973-1985 and thereafter Emeritus Professor of Forensic Medicine and Honorary Fellow in the School of Law at the University of Edinburgh. A formal obituary to Professor Mason is published in the Scotsman (http://www.scotsman.com/news/obituaries/obituary-professor-ken-mason-medical-jurisprudence-pioneer-1-4357181). We offer some personal tributes to our friend and colleague.

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. Electronic supplementary material The online version of this article (10.1007/s10728-019-00383-9) contains supplementary material, which is available to authorized users.

This chapter examines the question of the limits set on our right to control our bodies or parts thereof. This debate has centred on the very important issue of our relationship with our body, and the status of the body, which has most recently been shaped by ideas of property. The chapter considers three aspects of that debate: property in material taken from living persons; property in material taken from cadavers; and the granting of intellectual property rights in human material.

This chapter discusses ethical and legal aspects of mental health and its management. It covers the evolution of mental health law, paternalism and capacity, and the treatment framework, which includes standards for informal treatment and compulsory treatment, and safeguards of liberty. It also addresses a range of issues from the human rights perspective, and mental disorders and criminality, as well as civil liability.

This chapter discusses ethical and legal aspects of euthanasia and assisted dying. It first examines the non-voluntary termination of life, covering the relationship between medical treatment and assistance in dying as a matter of failure to treat, and the philosophical concept of ‘double effect’. The chapter then discusses activity and passivity in assisted dying; dying as an expression of patient autonomy; suicide and assisted suicide; physician-assisted suicide; and assisted dying in practice.

This chapter discusses: the nature of the duty of care in the action for wrongful pregnancy; legal action for wrongful birth; wrongful (or diminished) life actions; and wrongful injury to the fetus and feticide.

This chapter begins with a discussion of concepts of death. It considers the mostly philosophical arguments against the use of the term ‘brain death’ as applied to the person and then explains the medico-legal effects of applying brainstem death criteria. The chapter also discusses post-mortem pregnancy.

This chapter examines a range of ethico-legal issues as the impact on children. The focus is one consent of mature minors, and the limits therefore, and also on the range of rights and responsibilities relating to children concerning protection of the ir personal data. The chapter then discusses ethical and legal aspects of non-therapeutic research on children; therapeutic research on children; foetal research and experimentation; and embryos and embryonic stem cell research.

This chapter discusses ethical and legal aspects of biomedical research. After highlighting the evolution and acceleration of rule-making in this setting, it differentiates between research and experimentation, and articulates a core regulatory concept, namely risk. It then covers ethical codes and legal instruments in human biomedical research, research ethics committees, randomised controlled trials, and experimental treatment, paying particular attention to informed consent and research involving people lacking capacity. It also addresses the unethical researcher, compensation for personal injury in research, research involving human tissue and personal data, and new approaches to research governance.

This chapter begins with a discussion of the concept of medical futility. It examines cases dealing with selective non-treatment of the newborn and selective non-treatment in infancy. The chapter argues that while concepts such as ‘futility’ and ‘best interests’ have strong normative appeal, the search for objectivity in their application may itself be a futile exercise. The reality is that decision-makers are involved in a value-laden process, and this is no less true when the decision is taken in a court rather than at the patient’s bedside. The chapter then considers the issue of end of life, examining cases of patients in a permanent vegetative state and those in a minimally conscious state.

This chapter discusses some of the ethical and legal issues associated with the very difficult practice of treating the elderly, grounding the discussion in the tension between autonomy and paternalism. It is emphasised that this complex and fragmented field is still undergoing significant regulatory changes as a result of the Care Act 2014, the Social Services and Well-being (Wales) Act 2014, and the Public Bodies (Joint Working) (Scotland) Act 2014. It also covers the elder incapax and dying from old age.

This chapter discusses ethical and legal aspects of the global distribution of medical resources; the allocation of national resources; and medical treatment of the individual. It argues that so long as decisions are made taking into account fundamental moral values and principles of equity, impartiality, and fairness, and provided the bases for decision making are flexible in relation to the times, then the underlying system is just and is likely to yield just results.

This chapter discusses ethical and legal aspects of controlling fertility and birth. It addresses the highly contested concept of personhood, as well as contraception, contragestation, sterilisation, and termination of pregnancy, and the increasing use of conscientious objection by care givers.

This chapter discusses ethical and legal aspects of organ transplantation. After reviewing the technical criteria—or biological hurdles—associated with transplantation, and the two primary types of transplantation (i.e., homotransplantation and xenotransplantation), it explores the regulatory framework and types of donors in the living donor context, and the same for the cadaveric donor. It also looks briefly at neonates and foetal donors, donations for the aged, and reconstructive transplants.

The commitment of massive resources – financial, social, organisational, and human – drives developments in biomedicine. Fundamental transformations in the generation and application of knowledge are challenging our understandings and experiences of health, illness, and disease as well as the organisation of research and care. Coupled with the accelerated pace of change, it is pressing that we build authentic collaborations across and between the biomedical sciences, humanities and social sciences, and wider society. It is only in this way that we can ask and answer the penetrating questions that will shape improvements in human health now and in the decades ahead. We delineate the need for such commitments across five key areas of human and societal experience that impact on and are impacted by developments in biomedicine: disease; bodies; global movements and institutions; law; and, science-society engagements. Interactions between ideas, researchers, and communities across and within these domains can provide a way into creating the new knowledges, methods, and partnerships we believe are essential if the promises of biomedicine are to be realised.

In June 2016, the University of Edinburgh hosted the 13th World Congress (IAB2016) of the International Association of Bioethics (IAB). It is critical both to reflect on the event past and to consider how we might keep future events relevant and to adequately bridge the periods in-between. In other words, how do we generate and maintain legacy and help to keep communities consistently engaged over time? This brief article undertakes these functions by reflecting on some of the lessons learned from IAB2016 in the hope that it will prove useful to future IAB Congress organizers (and indeed other international conference organizers).

Starting in West Africa and with a fatality rate exceeding 50%, the Ebola epidemic is projected to infect some 20,000 people before running its course and has already infected many health-care workers. Responses to the outbreak have included refusals by local health workers to examine patients and collect samples (for fear of infection and the unavailability of proper personal protective equipment) and assaults on health officials and

This article examines the Brexit process through the anthropological lens of liminality. As a concept that explains the impact of change and transformation on human experience, it is argued that liminality is an especially valuable perspective to understand better the phenomenon of Brexit, particularly as to how this might impact on the regulation of human health research. A central feature of liminality is its attention to process; that is, the identification of milestone thresholds within a series of events involving change. More particularly, liminality has a degree of predictive power about certain influencing factors on transformational processes and their outcomes. In this regard, the pivotal role of law is subjected to close scrutiny in the period leading up to March 29, 2018: one year before the so-called Brexit Day. The European Union (EU) (Notification of Withdrawal) Act 2017 was the threshold trigger for the Brexit process, while the EU Withdrawal Bill 2017–2019 has as its objective the shepherding through of the United Kingdom in its departure from the EU. The argument is made that these events are liminal moments in European legal and human history; moreover, lessons from history are used to identify the specific implications for human health research as an area of human activity that will be profoundly impacted by the Brexit process. This analysis also provides a means to reflect on the broader implications of what a disruptive process such as Brexit means for law generally.

ObjectivesIt is widely acknowledged that breaches and misuses of health-related data can have serious implications and consequently they often carry penalties. However, harm due to the omission of health data usage, or data non use, is a subject that lacks attention. A better understanding of this other side of the coin is required before it can be addressed effectively. ApproachThis article uses an international case study approach to explore why data non use is difficult to ascertain, the sources and types of health-related data non-use, its implications for citizens and society and some of the reasons it occurs. It does this by focussing on issues with clinical care records, research data and governance frameworks and associated examples of non-use. ResultsThe non-use of health-related data is a complex issue with multiple sources and reasons contributing to it. Instances of data non-use can be associated with harm, but taken together they describe a trail of data non-use, and this may complicate and compound its impacts. Actual evidence of data non-use is sparse and harm due to data non use is difficult to prove. But although it can be nebulous, it is a real problem with largely unquantifiable consequences. There is ample indirect evidence that health data non-use is implicated in the deaths of many thousands of people and potentially £billions in financial burdens to societies.ConclusionThe most effective initiatives to address specific contexts of data non-use will be those that are cognisant of the multiple aspects to this complex issue, in order to move towards socially responsible reuse of data becoming the norm to save lives and resources.

As various stakeholders in biomedical research and clinical practice laudably move toward a data sharing culture, challenges arise. In particular, privacy and data privacy regulation play a large role in defining the proper contours of global data sharing. In this chapter, we outline the practices and benefits of genomic and clinical data sharing; the dimensions of privacy and data privacy regulation that challenge data sharing; and the ways in which one organization, the Global Alliance for Genomics and Health, is addressing these challenges.

Introduction It is widely acknowledged that breaches and misuses of health-related data can have serious implications and consequently they often carry penalties. However, harm due to the omission of health data usage, or data non-use, is a subject that lacks attention. A better understanding of this ‘other side of the coin’ is required before it can be addressed effectively. Approach This article uses an international case study approach to explore why data non-use is difficult to ascertain, the sources and types of health-related data non-use, its implications for citizens and society and some of the reasons it occurs. It does this by focussing on issues with clinical care records, research data and governance frameworks and associated examples of non-use. Results and discussion The non-use of health-related data is a complex issue with multiple explanations. Individual instances of data non-use can be associated with harm, but taken together, they can describe a trail of data non-use that may complicate and compound its impacts. There is ample indirect evidence that health data non-use is implicated in the deaths of many thousands of people and potentially £billions in financial burdens to societies. Conclusions Harm due to the non-use of health data is difficult to attribute unequivocally and actual proven evidence is sparse. Although it can be elusive, it is nevertheless a real problem with widespread and serious, if largely unquantifiable, consequences. The most effective initiatives to address specific contexts of data non-use will be those that: firstly, understand the pertinent sources, types and reasons for data non‐use in a given domain in order to meet the challenges and create appropriate incentives and repercussions; and secondly, are cognisant of the multiple aspects to this complex issue in other domains to keep benefits and limitations in perspective, to move steadily towards socially responsible reuse of data becoming the norm to save lives and resources.