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 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. (shrink)

The phenomenon of the New Genetics raises complex social problems, particularly those of privacy. This book offers ethical and legal perspectives on the questions of a right to know and not to know genetic information from the standpoint of individuals, their relatives, employers, insurers and the state. Graeme Laurie provides a unique definition of privacy, including a concept of property rights in the person, and argues for stronger legal protection of privacy in the shadow of developments in human genetics. He (...) challenges the role and the limits of established principles in medical law and ethics, including respect for patient autonomy and confidentiality. This book will interest lawyers, philosophers and doctors concerned both with genetic information and issues of privacy; it will also interest genetic counsellors, researchers, and policy makers worldwide for its practical stance on dilemmas in modern genetic medicine. (shrink)

The right not to know is a contested matter. This can be because the inversion of the normal framing of entitlement to information about one's own health is thought to be illogical and inconsistent with self-authorship and/or because the very idea of claiming a right not to know information is an inappropriate appeal to the discourse of rights that places impossible responsibilities on others. Notwithstanding, there has been a sustained increase in this kind of appeal in recent years fueled in (...) large part by the rise and rise of the importance of personal autonomy in health care ethics, and by domestic and international health law. The right not to know has been acknowledged in at least two important international legal instruments. For example, the UNESCO Universal Declaration on the Human Genome and Human Rights, Article 5c provides: “The right of every individual to decide whether or not to be informed of the results of genetic examination and the resulting consequences should be respected.”. (shrink)

This article argues for the importance of conceptual clarity in the debate about the so-called right not to know. This is vital both at the theoretical and the practical level. It is suggested that, unlike many formulations and attempts to give effect to this right, what is at stake is not merely an aspect of personal autonomy and therefore cannot and should not be reduced only to a question of individual choice. Rather, it is argued that the core interests that (...) can be protected by the right not to know are better conceived of as privacy interests rather than autonomy interests. This not only helps us to understand what is in play but also informs regulatory, professional, and legal responses to handling information and taking decisions about whether or not to disclose information to persons about themselves. The practical implications of this conceptualization are explored in the context of feedback policies in health-related research. (shrink)

This article investigates a high-profile and ongoing dilemma for healthcare professionals, namely whether the existence of a duty of care to genetic relatives of a patient is a help or a hindrance in deciding what to do in cases where a patient’s genetic information may have relevance to the health of the patient’s family members. The English case ABC v St George’s Healthcare NHS Trust and others considered if a duty of confidentiality owed to the patient and a putative duty (...) of care to the patient’s close relatives could coexist in this context. This article examines whether embracing the concept of coexisting duties could enable HCPs to respect duties in line with their clinical judgement, thereby providing legal support and clarity to professionals to allow them to provide the best possible genetics service to both the patient and their family. We argue that these dual duties, framed as a novel, composite duty to consider the interests of genetic relatives, could allow HCPs to exercise and act on their professional judgements about the relative value of information to family members, without fears of liability for negligence or breach of confidence. (shrink)

Despite the growing importance of ‘social value’ as a central feature of research ethics, the term remains both conceptually vague and to a certain extent operationally rigid. And yet, perhaps because the rhetorical appeal of social value appears immediate and self-evident, the concept has not been put to rigorous investigation in terms of its definition, strength, function, and scope. In this article, we discuss how the anthropological concept of liminality can illuminate social value and differentiate and reconfigure its variegated approaches. (...) Employing liminality as a heuristic encourages a reassessment of how we understand the mobilization of ‘social value’ in bioethics. We argue that social value as seen through the lens of liminality can provide greater clarity of its function and scope for health research. Building on calls to understand social value as a dynamic, rather than a static, concept, we emphasize the need to appraise social value iteratively throughout the entire research as something that transforms over multiple times and across multiple spaces occupied by a range of actors. (shrink)

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 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 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. (shrink)

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 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. (shrink)

As the sustained and devastating extent of the coronavirus disease 2019 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 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. (shrink)

Re-consent in research, the asking for a new consent if there is a change in protocol or to confirm the expectations of participants in case of change, is an under-explored issue. There is little clarity as to what changes should trigger re-consent and what impact a re-consent exercise has on participants and the research project. This article examines applicable policy statements and literature for the prevailing arguments for and against re-consent in relation to longitudinal cohort studies, tissue banks and biobanks. (...) Examples of re-consent exercises are presented, triggers and non-triggers for re-consent discussed and the conflicting attitudes of commentators, participants and researchers highlighted. We acknowledge current practice and argue for a greater emphasis on ‘responsive autonomy,’ that goes beyond a one-time consent and encourages greater communication between the parties involved. A balance is needed between respecting participants' wishes on how they want their data and samples used and enabling effective research to proceed. (shrink)

Without trust there is no credible human health research (HHR). This article accepts this truism and addresses a crucial question that arises: how can trust continually be promoted in an ever-changing and uncertain HHR environment? The article analyses long-standing mechanisms that are designed to elicit trust—such as consent, anonymization, and transparency—and argues that these are best understood as trust represented by proxies of trustworthiness, i.e., regulatory attempts to convey the trustworthiness of the HHR system and/or its actors. Often, such proxies (...) are assumed to operate as markers that trust exists or, at least, has not been lost. But, since trust can neither be “built” nor “secured,” this is a precarious assumption. Worryingly, there is no existing theoretical account of how to understand and evaluate these proxies of trustworthiness as part of a trusted HHR ecosystem. To remedy this, the paper argues for a radical reimagining of trust and trustworthiness as performative acts that ought to be understood in relation to each other and by reference to the common values at stake. It is shown that proxies of trustworthiness are the operational tools used to perform trustworthiness. It advocates for a values-based approach to understanding the relationship between trust and trustworthiness. This establishes a strong basis for an evaluative framework for proxies of trustworthiness, i.e., to determine how to perform trustworthiness well. Five common proxies in HHR are scrutinized from a values perspective. The contribution is to provide a far-reaching normative and practical framework by which existing and future proxies of trustworthiness can be identified, assessed, maintained, or replaced in rapidly changing HHR regulatory ecosystems where trust itself is crucial to the success of the entire HHR enterprise. (shrink)

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. (shrink)

Biomedical research increasingly relies on long-term studies involving use and re-use of biological samples and data stored in large repositories or “biobanks” over lengthy periods, often raising questions about whether and when a re-consenting process should be activated. We sought to investigate the views on re-consent of participants in a longitudinal biobank. We conducted a qualitative study involving interviews with 24 people who were participating in a longitudinal biobank. Their views were elicited using a semi-structured interview schedule and scenarios based (...) on a hypothetical biobank. Data analysis was based on the constant comparative method. What participants identified as requiring new consent was not a straightforward matter predictable by algorithms about the scope of the consent, but instead was contingent. They assessed whether proposed new research implied a fundamental alteration in the underlying character of the biobank and whether specific projects were within the scope of the original consent. What mattered most to them was that the cooperative bargain into which they had entered was maintained in good faith. They saw re-consent as one important safeguard in this bargain. In determining what required re-consent, they deployed two logics. First, they used a logic of boundaries, where they sought to detect any possible rupture with their existing framework of cooperation. Second, they used a logic of risk, where they assessed proposed research for any potential threats for them personally or the research endeavour. When they judged that a need for re-consent had been activated, participants saw the process as way of re-actualising and renewing the cooperative bargain. Participants’ perceptions of research as a process of mutual co-operation between volunteer and researcher were fundamental to their views on consent. Consenting arrangements for biobanks should respect the cooperative values that are important to participants, recognise the two logics used by research volunteers, and avoid rigidity. Agility may be favoured by tiered consent combined with strong oversight mechanisms; this approach requires evaluation. (shrink)

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 anonymisation 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. (shrink)

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. (shrink)