Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road.

This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has challenged the concept of 'broad consent', which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR 'research condition' provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper.

'Leading by Science' through Covid-19: the NHS Data Store & Automated Decision-Making.

The UK government announced in March 2020 that it would create an NHS Covid-19 'Data Store' from information routinely collected as part of the health service. This 'Store' would use a number of sources of population data to provide a 'single source of truth' about the spread of the coronavirus in England. The initiative illustrates the difficulty of relying on automated processing when making healthcare decisions under the General Data Protection Regulation (GDPR). The end-product of the store, a number of 'dashboards' for decision-makers, was intended to include models and simulations developed through artificial intelligence. Decisions made on the basis of these dashboards would be significant, even (it was suggested) to the point of diverting patients and critical resources between hospitals based on their predictions. How these models will be developed, and externally validated, remains unclear. This is an issue if they are intended to be used for decisions which will affect patients so directly and acutely. We have (by default) a right under the GDPR not to be subject to significant decisions based solely on automated decision-making. It is not obvious, at present, whether resource allocation within the NHS could take place in reliance on this automated modelling. The recent A Level debacle illustrates, in the context of education, the risks of basing life-changing decisions on the national application of a single equation. It is worth considering the potential consequences for the health service if the NHS Data Store is used for resource planning as part of the Covid-19 response.