Should free-text data in electronic medical records be shared for research? A citizens’ jury study in the UK

Ford, Elizabeth; Oswald, Malcolm; Hassan, Lamiece; Bozentko, Kyle; Nenadić, Goran; Cassell, Jackie A

doi:10.1136/medethics-2019-105472

Cited by 47 publications

(48 citation statements)

References 47 publications

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“…Notably, the opt-out is only a meaningful way of ensuring individual autonomy if transparency of data usage, and stakeholder inclusion, is guaranteed. This combination (opt-out plus full transparency) is also the public’s preferred approach 53, 54 , and is thus vital for maximising public trust, and securing a social licence, for any initiative. One example of operationalising a transparent patient opt out was launched by the NHS in the UK in May 2018.…”

Section: Discussionmentioning

confidence: 99%

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

2019

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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

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Section: Discussionmentioning

confidence: 99%

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

2019

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“…Biobanking participants generally have limited understanding of the aspects of research included in consent forms, and the level of understanding depends on contextual and demographic factors such as education [ 49 ]. A recent deliberative study showed that better informed persons are more supportive of sharing data for health research [ 50 ]. As such, improving research participants’ knowledge on data protection processes (e.g., through public engagement, increased transparency or more extensive consent procedures) might enhance autonomy but also improve patient trust.…”

Section: Discussionmentioning

confidence: 99%

Health data research on sudden cardiac arrest: perspectives of survivors and their next-of-kin

et al. 2021

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Background Consent for data research in acute and critical care is complex as patients become at least temporarily incapacitated or die. Existing guidelines and regulations in the European Union are of limited help and there is a lack of literature about the use of data from this vulnerable group. To aid the creation of a patient-centred framework for responsible data research in the acute setting, we explored views of patients and next-of-kin about the collection, storage, sharing and use of genetic and health-related data for observational research. Methods We conducted qualitative interviews (n = 19) with Dutch sudden cardiac arrest survivors who donated clinical and socio-economic data and genetic samples to research. We also interviewed their next-of-kin. Topics were informed by ethics literature and we used scenario-sketches to aid discussion of complex issues. Results Sudden cardiac arrest survivors displayed limited awareness of their involvement in health data research and of the content of their given consent. We found that preferences regarding disclosure of clinically actionable genetic findings could change over time. When data collection and use were limited to the medical realm, patients trusted researchers to handle data responsibly without concern for privacy or other risks. There was no consensus as to whether deferred consent should be explicitly asked from survivors. If consent is asked, this would ideally be done a few months after the event when cognitive capacities have been regained. Views were divided about the need to obtain proxy consent for research with deceased patients’ data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives. Conclusions Sudden cardiac arrest patients’ donation of data for research was grounded in trust in medicine overall, blurring the boundary between research and care. Our findings also highlight questions about the acceptability of a one-time consent and about responsibilities of patients, researchers and ethics committees. Finally, further normative investigation is needed regarding the (continued) use of participants’ data after death, which is of particular importance in this setting. Our findings are thought to be of relevance for other acute and life-threatening illnesses as well.

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“…Furthermore, patients should be involved as key stakeholders throughout all stages of the research process. The public also expects that researchers are committed to a culture of continuous improvement of methods for coding, anonymizing, processing, and safeguarding clinical free-text data [ 15 ].…”

Section: Discussionmentioning

confidence: 99%

“…Participants were recruited via advertisements on the Healtex website. The workshop was attended by 44 people and included outlines of the TexGov study aims, the findings of a previous citizens’ jury on using clinical free-text data for research [ 15 ], and data protection. These were followed by presentations from the NLP community on their approaches to working with clinical free-text data, during which the audience was asked to write down the topics to discuss in more detail.…”

Section: Methodsmentioning

confidence: 99%

Toward the Development of Data Governance Standards for Using Clinical Free-Text Data in Health Research: Position Paper

Jones¹,

Ford²,

Lea³

et al. 2020

J Med Internet Res

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Background Clinical free-text data (eg, outpatient letters or nursing notes) represent a vast, untapped source of rich information that, if more accessible for research, would clarify and supplement information coded in structured data fields. Data usually need to be deidentified or anonymized before they can be reused for research, but there is a lack of established guidelines to govern effective deidentification and use of free-text information and avoid damaging data utility as a by-product. Objective This study aimed to develop recommendations for the creation of data governance standards to integrate with existing frameworks for personal data use, to enable free-text data to be used safely for research for patient and public benefit. Methods We outlined data protection legislation and regulations relating to the United Kingdom for context and conducted a rapid literature review and UK-based case studies to explore data governance models used in working with free-text data. We also engaged with stakeholders, including text-mining researchers and the general public, to explore perceived barriers and solutions in working with clinical free-text. Results We proposed a set of recommendations, including the need for authoritative guidance on data governance for the reuse of free-text data, to ensure public transparency in data flows and uses, to treat deidentified free-text data as potentially identifiable with use limited to accredited data safe havens, and to commit to a culture of continuous improvement to understand the relationships between the efficacy of deidentification and reidentification risks, so this can be communicated to all stakeholders. Conclusions By drawing together the findings of a combination of activities, we present a position paper to contribute to the development of data governance standards for the reuse of clinical free-text data for secondary purposes. While working in accordance with existing data governance frameworks, there is a need for further work to take forward the recommendations we have proposed, with commitment and investment, to assure and expand the safe reuse of clinical free-text data for public benefit.

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Should free-text data in electronic medical records be shared for research? A citizens’ jury study in the UK

Cited by 47 publications

References 47 publications

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

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

Health data research on sudden cardiac arrest: perspectives of survivors and their next-of-kin

Toward the Development of Data Governance Standards for Using Clinical Free-Text Data in Health Research: Position Paper

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