BackgroundUse of routinely collected patient data for research and service planning is an explicit policy of the UK National Health Service and UK government. Much clinical information is recorded in free-text letters, reports and notes. These text data are generally lost to research, due to the increased privacy risk compared with structured data. We conducted a citizens’ jury which asked members of the public whether their medical free-text data should be shared for research for public benefit, to inform an ethical (...) policy.MethodsEighteen citizens took part over 3 days. Jurors heard a range of expert presentations as well as arguments for and against sharing free text, and then questioned presenters and deliberated together. They answered a questionnaire on whether and how free text should be shared for research, gave reasons for and against sharing and suggestions for alleviating their concerns.ResultsJurors were in favour of sharing medical data and agreed this would benefit health research, but were more cautious about sharing free-text than structured data. They preferred processing of free text where a computer extracted information at scale. Their concerns were lack of transparency in uses of data, and privacy risks. They suggested keeping patients informed about uses of their data, and giving clear pathways to opt out of data sharing.ConclusionsInformed citizens suggested a transparent culture of research for the public benefit, and continuous improvement of technology to protect patient privacy, to mitigate their concerns regarding privacy risks of using patient text data. (shrink)

Background: Use of patients’ medical data for secondary purposes such as health research, audit, and service planning is well established in the UK. However, the governance environment, as well as public understanding about this work, have lagged behind. We aimed to systematically review the literature on UK and Irish public views of patient data used in research, critically analysing such views though an established biomedical ethics framework, to draw out potential strategies for future good practice guidance and inform ethical and (...) privacy debates. Methods: We searched three databases using terms such as patient, public, opinion, and electronic health records. Empirical studies were eligible for inclusion if they surveyed healthcare users, patients or the public in UK and Ireland and examined attitudes, opinions or beliefs about the use of patient data for medical research. Results were synthesised into broad themes using a framework analysis. Results: Out of 13,492 papers and reports screened, 20 papers or reports were eligible. While there was a widespread willingness to share patient data for research for the common good, this very rarely led to unqualified support. The public expressed two generalised concerns about the potential risks to their privacy. The first of these concerns related to a party’s competence in keeping data secure, while the second was associated with the motivation a party might have to use the data. Conclusions: The public evaluates trustworthiness of research organisations by assessing their competence in data-handling and motivation for accessing the data. Public attitudes around data-sharing exemplified several principles which are also widely accepted in biomedical ethics. This provides a framework for understanding public attitudes, which should be considered in the development in any guidance for regulators and data custodians. We propose four salient questions which decision makers should address when evaluating proposals for the secondary use of data. (shrink)

We note a range of interesting and challenging points which take forward the discourse around the ethics of sharing patient data. Of most note are criticisms of our jury recruitment and methods; questioning how we can engender trust and support from the wider, uninformed public when we only have the view of a small informed public; asking what work needs to be done to ethically transfer data from a clinical care setting to that of research; suggesting that dynamic consent with (...) opt-outs could be an avenue for allowing patients more control over the use of their medical data for research; and asking how we bridge from ‘is’ to ‘ought’. The first criticisms to be addressed focus on the recruitment and methods of our jury, raised by Carter.1 She suggests that the selection of participants, using a population distribution of responses to a data-sharing question, resulted in a jury too positively oriented to data sharing at the outset. Further, she suggests that we counted individual votes rather than allowing the jury to come to a collective position, that jurors were not asked to prioritise the common good, that we present a lack of data from the jury’s deliberations, and as a result, there is a difficulty with evaluating the reasoning and authenticity of deliberation. Regarding recruitment of our jury, our stated aim, which we acknowledge is not shared by all juries, was to achieve a sample which broadly matched what we would expect if …. (shrink)