“Giving something back”: A systematic review and ethical enquiry of public opinions on the use of patient data for research in the United Kingdom and the Republic of Ireland

Abstract

Use of medical data for secondary purposes such as health Background research, audit, and service planning is well established in the UK. However, the governance environment, as well as public opinion and understanding about this work, have lagged behind. We aimed to systematically review the literature on UK and Irish public opinions of medical data use in research, critically analysing such opinions though an established biomedical ethics framework, to draw out potential strategies for future good practice guidance and inform ethical and privacy debates.: We searched three databases using terms such as patient, public, Methods opinion, and electronic health records. Empirical studies were eligible for inclusion if they surveyed healthcare users, patients or the wider 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.: Out of 13,492 papers and reports screened, 20 papers or reports Results were eligible. While there was a widespread willingness to share EHRs for research for the common good, this very rarely led to unqualified support. The public expressed two generalised concerns through a variety of hypothetical examples. 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.: The public evaluates trustworthiness of research organisations Conclusions 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 data guardians should address when evaluating proposals for the secondary use of data.

Gathering data for decisions: best practice use of primary care electronic records for research

“…Internationally, public opinion on the appropriate use of EMRs for purposes other than providing direct clinical care is mixed . A systematic review of public opinion on the use of patient data for research in the UK and the Republic of Ireland was undertaken after the 2013 introduction, public backlash and 2016 closure of NHS England's care.data program.…”

“…Ultimately, this led to the downfall of the project, scepticism and closer scrutiny of future ventures of a similar nature . The reviewers found that although consumers generally had little knowledge about secondary uses of data from EMRs, when it was explained, many were willing to share their data for the “common good” subject to safeguards . In New Zealand, public opinion has been found to be similar .…”

“…In New Zealand, public opinion has been found to be similar . Overall, public willingness to share data is qualified by concerns about data de‐identification and privacy, issues of trust (or distrust) relating to who can access the data, the amount of transparency regarding secondary use, security controls, and the ability to retain control over who can access data and for what purpose . Emerging from the research are best practice principles for the appropriate use of health data for research (Box 2).…”

Our data, our society, our health: A vision for inclusive and transparent health data science in the United Kingdom and beyond

“…There are several important barriers in terms of gaining public trust for researchers to access health records on a large scale. Whilst there is good evidence that the public support the secondary use of routine data, previous highly public cases (eg, care.data scheme to centralise primary care records in England and Google use of Royal Free data to develop artificial intelligence algorithms) place this public support and trust at risk. Furthermore, wider misuse of data (eg, the use of personal information from Facebook to target election campaigning) and the increasing monetisation of data and advice (eg, pharmaceutical company donations to patient advocacy groups in the United States), risk reducing public trust for all complex data (re)use.…”

AI in Cardiac Imaging: A UK-Based Perspective on Addressing the Ethical, Social, and Political Challenges

“…Being open reduces the sense that a system or process has been captured by a particular organization or body that may not have the system's users' best interests at heart (58,59). Moreover, openness allows the organization to demonstrate its competence in data handling, and to share its motivations for doing so; both these factors have also been found to be important determinants of readiness to engage by a systematic review (60). In order to address the requirements for openness and transparency in clinical trials involving AI algorithms, an international project is underway that aims to develop AI extensions to the existing CONSORT and SPIRIT checklists and guidance documents (61).…”