Fail to Prepare and you Prepare to Fail: the Human Rights Consequences of the UK Government's Inaction during the COVID-19 Pandemic.

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 governmental inaction that 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.

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.

Cross-Sectoral Big Data: The Application of an Ethics Framework for Big Data in Health and Research.

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.

An Ethics Framework for Big Data in Health and 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.