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

Abstract

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.

Return of individual research results from genomic research: A systematic review of stakeholder perspectives

“…Patients discuss wanting to know their results out of personal curiosity [ 48 ] or peace of mind [ 89 ], because it may provide personal health benefit [ 48 ], clinical utility [ 89 ] or actionability [ 42 , 52 ], or to inform their children of their risks [ 89 ]. A qualitative study of 25 parents highlighted that participants considered ‘actionability’ as a broad concept, encompassing aspects such as medical interventions, lifestyle modifications, education, mental preparation, and planning, including insurance, housing, and finances [ 42 ].…”

Contextual Exceptionalism After Death: An Information Ethics Approach to Post-Mortem Privacy in Health Data Research

“…Posthumous data research gives patients the opportunity to reciprocate: some authors have advocated a human right to participate in science (Vayena & Tasioulas, 2015). In our own empirical research, survivors of sudden cardiac arrest stated that "when you are dead, you are dead, but it would be nice if you can prevent other people from dying in the same way" (Bak et al, 2021). Nonetheless, research with the Acknowledgements The authors wish to thank professor Luciano Floridi for his valuable feedback throughout the writing process and on versions of the paper.…”

“…The public was similarly divided in another study where 52% supported GE (Global Alliance, 2017). In our own interviews with sudden cardiac arrest survivors, socio-economic data was regarded as more personal than DNA (Bak et al, 2021). Just like DNA sequences, 12 Embodiment is a complex term.…”

Towards trust-based governance of health data research

“…Similarly, several ESCAPE-NET researchers have told us that they believe "the trust in the researcher should be enough" for people to decide to contribute data. In a study where we interviewed SCA patients who contributed to ESCAPE-NET, we found that trust was indeed one of the key factors for people when deciding to share their personal data for research (Bak et al, 2021). This trust mainly stemmed from their positive experiences with clinicians and with the medical institution conducting the research.…”