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"This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research. This thought-provoking book provides new perspectives on the regulation of health research by demonstrating how RECs and other regulatory actors seek to fulfil these two functions by performing a role of 'regulatory stewardship'. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application. This book is a key resource for academics and students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action"--

In this article, we consider the possible application of the European General Data Protection Regulation (GDPR) to "citizen scientist"-led health research with mobile devices. We argue that the GDPR likely does cover this activity, depending on the specific context and the territorial scope. Remaining open questions that result from our analysis lead us to call for lex specialis that would provide greater clarity and certainty regarding the processing of health data by for research purposes, including these non-traditional researchers.

Several recent data protection laws appear to afford a privileged position to scientific research, including health research. Provisions that might otherwise apply to data subjects and data controllers, including rights exercisable by data subjects against controllers, are lifted or lessened.However, when it comes to considering whether consent should serve as the lawful basis for processing data in the health research context, a fair degree of policy and regulatory divergence emerges. This divergence seems to stem from a normative link that some draw between consent as a research ethics principle and consent as a lawful basis in data protection law.We look at the EU General Data Protection Regulation (GDPR) and three national laws, either implementing the GDPR or inspired by it, to provide points of comparison: South Africa's Protection of Personal Information Act, 2013, the UK's Data Protection Act 2018, and Ireland's Health Research Regulations 2018. We supplement this analysis by considering other relevant laws and regulations governing health research in these jurisdictions.We argue that there is merit in distinguishing research ethics consent from data processing consent, to avoid what we call 'consent misconception', and come to advocate a middle-ground approach in data protection law, ie one that does not mandate consent as the lawful basis for processing personal data in health research projects—but does encourage it. This approach, we argue, achieves the best balance for protecting data subject/research participant rights and interests and promoting socially valuable 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 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.

While biobanks are established explicitly as scientific infrastructures, they are de facto political-economic ones too. Many biobanks, particularly population-based biobanks, are framed under the rubric of the bio-economy as national political-economic assets that benefit domestic business, while national populations are framed as a natural resource whose genomics, proteomics, and related biological material and national health data can be exploited. We outline how many biobanks epitomize this 'neoliberal' form of science and innovation in which research is driven by market priorities (e.g., profit, shareholder value) underpinned by state or government policies. As both scientific and political-economic infrastructures, biobanks end up entangled in an array of problems associated with market-driven science and innovation. These include: profit trumping other considerations; rentiership trumping entrepreneurship; and applied research trumping basic research. As a result, there has been a push behind new forms of 'post-neoliberal' science and innovation strategies based on principles of openness and collaboration, especially in relation to biobanks. The proliferation of biobanks and the putative transition in both scientific practice and political economy from neoliberalism to post-neoliberalism demands fresh social scientific analyses, particularly as biobanks become further established in fields such as oral health and personalized dentistry. To the best of our knowledge, this is the first analysis of biobanks with a view to what we can anticipate from biobanks and distributed post-genomics global science in the current era of oral health biomarkers.