The emerging regulatory landscape addressing autonomous systems (AS) is underpinned by the notion that such systems be trustworthy. What individuals and groups need to determine a system as worthy of trust has consequently attracted research from a range of disciplines, although important questions remain. These include how to ensure trustworthiness in a way that is sensitive to individual histories and contexts, as well as if, and how, emerging regulatory frameworks can adequately secure the trustworthiness of AS. This article reports the socio-legal analysis of four focus groups with publics and professionals exploring whether answerability can help develop trustworthy AS in health, finance, and the public sector. It finds that answerability is beneficial in some contexts, and that to find AS trustworthy, individuals often need answers about future actions and how organisational values are embedded within a system. It also reveals pressing issues demanding attention for meaningful regulation of such systems, including dissonances between what publics and professionals identify as ‘harm’ where AS are deployed, and a significant lack of clarity about the expectations of regulatory bodies in the UK. The article discusses the implications of these findings for the developing but rapidly setting regulatory landscape in the UK and EU.

The proliferation of autonomous and semi-autonomous systems (AS) poses important and pressing regulatory challenges. Underpinning these is the recognition that many different stakeholders will need to trust systems to ensure their effective adoption and implementation. However, research on stakeholder perspectives is lacking, and assessing trustworthiness is difficult due to 'responsibility gaps' where it is unclear where responsibility for harms arising from AS ought to lie. Bridging these gaps is important because holding one another responsible is how social trust is maintained, and trust is vital to unlocking the promise that AS hold. This article considers how the concept of answerability could provide a useful framework for boosting the trustworthiness of AS. We present findings from a series of stakeholder interviews identifying what answers different stakeholders need to trust AS in health, finance, and government applications, and consider the implications of our research for current proposals for regulating AS in the United Kingdom and the European Union.

The decades-old debate over so-called ‘responsibility gaps’ in intelligent systems has recently been reinvigorated by rapid advances in machine learning techniques that are delivering many of the capabilities of machine autonomy that Matthias [1] originally anticipated. The emerging capabilities of intelligent learning systems highlight and exacerbate existing challenges with meaningful human control of, and accountability for, the actions and effects of such systems. The related challenge of human ‘answerability’ for system actions and harms has come into focus in recent literature on responsibility gaps [2, 3]. We describe a proposed interdisciplinary approach to designing for answerability in autonomous systems, grounded in an instrumentalist framework of ‘responsible agency cultivation’ drawn from moral philosophy and cognitive sciences as well as empirical results from structured interviews and focus groups in the application domains of health, finance and government. We outline a prototype dialogue agent informed by these emerging results and designed to help bridge the structural gaps in organisations that typically impede the human agents responsible for an autonomous sociotechnical system from answering to vulnerable patients of responsibility.

This chapter considers the meaning and role of interdisciplinary approaches to research and teaching in medical law and ethics, itself an inherently interdisciplinary field. It notes that formidable challenges persist, however, especially when navigating methodological and conceptual differences across disciplines, and operating outwith a disciplinary 'home'. The chapter looks at how complementary strands of diverse specialisms can come together to create the constellation of critical tools needed to address contemporary legal, regulatory and ethical challenges in medicine, health care and the biosciences. In the three case studies, the authors examine the contribution of multi- and interdisciplinary approaches to pedagogy, critical scholarship and the production of practical research outputs, and how these have informed and influenced their own work, with and alongside that of Graeme Laurie. Throughout, the discussions highlight the myriad ways that his research and teaching exemplify the openness of spirit and the intellectual curiosity required to engage meaningfully in interdisciplinarity.

In this chapter I consider some important implications of adopting rules, principles and supplementary guidance-based approaches to the regulation and governance of health research. This is a topic that has not yet received sufficient attention given how impactful different regulatory approaches can be on health research. I suggest that each approach has strengths and limitations to be factored in when considering how we shape health research practices. I argue that while principles-based approaches can be well-suited to typically complex health research landscapes, additional guidance is often required. I explore why this is so, highlighting in particular the added value of best practice and noting that incorporating additional guidance within regulatory approaches demands its own important considerations, which are laid out in the final section.

The first ever interdisciplinary handbook in the field, this vital resource offers wide-ranging analysis of health research regulation. The chapters confront gaps between documented law and research in practice, and draw on legal, ethical and social theories about what counts as robust research regulation to make recommendations for future directions. The Handbook provides an account and analysis of current regulatory tools - such as consent to participation in research and the anonymization of data to protection participants' privacy - as well as commentary on the roles of the actors and stakeholders who are involved in human health research and its regulation. Drawing on a range of international examples of research using patient data, tissue and other human materials, the collective contribution of the volume is to explore current challenges in delivering good medical research for the public good and to provide insights on how to design better regulatory approaches. This title is also available as Open Access on Cambridge Core.

Quality deliberation is essential for societies to address the challenges presented by the coronavirus pandemic effectively and legitimately. Critics of deliberative and participatory democracy are highly skeptical that most citizens can engage with such complex issues in good circumstances and these are far from ideal circumstances. The need for rapid action and decision-making is a challenge for inclusivity and quality of deliberation. Additionally, policy responses to the virus need to be even more co-ordinated than usual, which intensifies their complexity. The digitalisation of the public sphere may be seen as a further challenge to deliberating. Furthermore, these are stressful and emotional times, making a considered judgement on these issues potentially challenging. We employ a modified version of the Discourse Quality Index to assess the deliberative quality in two facilitated synchronous digital platforms to consider aspects of data use in light of COVID 19. Our study is the first to perform a comprehensive, systematic and in-depth analysis of the deliberative capacity of citizens in a pandemic. Our evidence indicates that deliberation can be resilient in a crisis. The findings will have relevance to those interested in pandemic democracy, deliberative democracy in a crisis, data use and digital public spheres.

The global coronavirus pandemic has clearly demonstrated the great urgency to collect and use patient data effectively to understand, track and manage the spread of Covid-19. The value of patient data in this pandemic is undeniable, however considerations around how - and by whom - such data should be collected, accessed and used, and for what purposes, remain to be fully debated and resolved. Who decides, and how such decisions are made remain unclear. We argue that public engagement and deliberation are essential for good governance and are key to establish and maintain a legitimate social licence for data practices around Covid-19.

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.

In bioethics, the contrast between normative and empirical approaches has commonly been aligned with disciplinary differences: bioethics defines itself as a form of normative inquiry, while empiric...

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.

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.

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.

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.

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