Abstract
BackgroundConsent 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.MethodsWe 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.ResultsSudden 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.ConclusionsSudden 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.
Highlights
Introduction of the interviewers and stating of their credentials Personal conversation to build rapport
The use of large-scale patient data is necessary for acute conditions like sudden cardiac arrest (SCA) that have a diversity of causes and are often the first expression of underlying disease [15]
Interview guide and procedure Based on practical experience and previous literature research [16], we developed an interview topic guide which was used for this study and to evaluate patients’ experiences with consent for the AmsteRdam REsuscitation STudies (ARREST) project (Additional file 1)
Summary
Introduction of the interviewers and stating of their credentials Personal conversation to build rapport. Health data research may bring about group-level ethical issues relating to stigma and unfair discrimination [7, 8] In this context, genomic data are often seen as sensitive, since they are almost by definition personally identifiable and may reveal information about blood relatives [9,10,11,12]. The GDPR defines genetic, biometric and other health-related data as a special category of data (together with “personal data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, [...] or data concerning a natural person’s sex life or sexual orientation” [Article 9]) Processing of these types of sensitive data is in principle prohibited, but one may appeal to exceptions such as informed consent or public interest. Disease-specific biobanks and registries are needed to obtain sufficiently large numbers of samples, and because the clinical data needed for this research (e.g., ambulance ECGs) are usually not collected routinely
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