The lived experience of law in medical practice and research is typified by intricate, sometimes complex and often mundane (perhaps even ritualistic) procedural requirements. While some scholars have been content thus to limit the normativity of law, Graeme reminds us that law is interconnected with ethics and that its distinctiveness may be better understood as process, particularly in boundary or liminal spaces where the roles of ethics and law are blurred. This processual conception of law is in turn a component of governance regimes that he depicts as ‘Ethics+’. He argues that ethics is always a necessary component of a robust and defensible regime of health research that is rooted in the core values and principles at stake while concurrently enabling adaptation and accommodation. Law as an ‘Ethics+’ governance regime embraces uncertainty and the liminal nature of the health research journey, while admitting value-based objectives that can act as foci for stakeholders. The chapter shows the bright beacon dimension of Graeme’s legacy, which points the way to a rich, non-formalistic account of law – not simply as law in action or law on the books but as law subsisting in-between.

A ubiquitous issue in medical law is how to strike the balance between affording individuals freedom and keeping communities safe. Legislators strive to do this by examining existing practices (constantly fluctuating due to evidence and experience) and anticipating future ones (notoriously difficult); it is a sophisticated exercise in the context of medicine because of the field’s proximity to science and innovation. The ingrained culture of self-regulation and professional ethos-based governance also obscures practices and emerging trends in a way that frustrates appropriate public debate and timely legislator intervention. This creates a trigger for explosive decompression of public opinion where practices are no longer socially acceptable (or, indeed, never were) and where emerging biomedical practices are poorly communicated or implemented. The resulting scandals create a social legacy which drives the political context of subsequent legislation. This chapter looks at two such events – the Alder Hey organ retention scandal and the care.data controversy – and analyses the legacy they created for the future regulation of the use of human tissues and data for biomedical research.

In recent times, biomedical research has begun to tap into larger-than-ever collections of different data types. As a consequence, the notion of health data – data that are of relevance for health-related research or for clinical purposes – is expanding to include a variety of non-clinical data, as well as data provided by research participants themselves through commercially available products such as smartphones and fitness bands. To date, most scholarship and policy on these issues has focused on privacy and data protection. Less attention has been paid to addressing other aspects of the wicked challenges posed by big data health research and even less work has been geared towards the development of novel governance frameworks.  In this chapter, we make the case for adaptive and principle-based governance of big data research. We outline six principles of adaptive governance for big data research and propose key factors for their implementation into effective governance structures and processes.

Across most jurisdictions today, researchers who propose to involve humans must first submit an application form to one or several committees of experts, who then assess the ethics of the proposed research. As a result of central role in determining the bounds of ethical research, Research Ethics Committees have been subject to sustained scrutiny. The cumulative charge is that research ethics review by committees promotes a wicked combination of inexpert review, inconsistent opinions, duplicative work, mission creep and heavy-handed regulation of health research. This chapter places this charge at the focal point. In what follows, I chart the process of research ethics review with a view towards arguing that RECs have become regulatory entities in their own right and very much are a form of social control of science. As I detail, while RECs are far from perfect in terms of regulatory design and performance, they do perform, at least in principle, a valuable role in helping to steward research projects towards an ethical endpoint. This chapter also offers a critique of existing work and suggests some future directions for both the regulatory design of research ethics review and also researching the field itself.

Global health emergencies (GHEs) are situations of heightened and widespread health crisis, that usually require the attention and mobilisation of actors and institutions beyond national borders. Conducting research in such contexts is both ethically imperative and requires particular ethical and regulatory scrutiny. While global health emergency research (GHER) serves a crucial function of learning how to improve care and services for individuals, it is difficult to fully capture the range of ethical considerations that arise, let alone provide a one-size-fits-all solution to such question. Using illustrations drawn from research projects conducted during GHEs, in this chapter we discuss key ethical issues and governance implications of GHER, beyond those traditionally associated with biomedical research, and explore the future direction of oversight for GHER. After setting out the complex context of GHER, we illustrate the various ethical issues associated with research and in justifying research, including considerations related to context, social value and engagement with the affected communities. Finally, we explore some of the new orientations and lenses in the governance of GHER through recent guidelines and developing practices.

In Singapore, genome editing techniques may be applied in research but not for therapeutic (or clinical) purposes. Broadly speaking, the legal, regulatory and ethical provisions that apply to genome editing are drawn from five (at times overlapping) regulatory regimes: (i) research involving human embryos and stem cells; (ii) research involving assisted reproduction centers (and assisted reproduction services); (iii) research involving non-human animals; (iv) human biomedical research other than clinical trials; and (v) clinical trials. A human embryo may be created solely for the purposes of research (to study a genome editing technique, for instance), provided certain conditions are met and requisite approvals are obtained. Any such research should not extend beyond fourteen days from the time that the embryo was created. These requirements apply mutatis mutandis to the use of genome editing techniques to modify the genome of human oocytes and embryos. Owing to a moratorium that has been imposed, human germline genetic modification is not allowed in the clinical setting. However, it is less clear if such procedures could be applied in a clinical trial. This chapter provides an analysis of the regulatory framework and its application, as well as how it is expected to change in the foreseeable future.