@article{13e19f3eecd349fb8ca3b9d07245ca22,
title = "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{\textquoteright} data. However, there was general support for the disclosure of potentially relevant post-mortem genetic findings to relatives. Conclusions: Sudden cardiac arrest patients{\textquoteright} 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{\textquoteright} 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.",
keywords = "Big data, Biobanking, Death, ESCAPE-NET, Emergency medicine, Health registries, Informed consent, Research ethics",
author = "Bak, {Marieke A.R.} and Rens Veeken and Blom, {Marieke T.} and Tan, {Hanno L.} and Willems, {Dick L.}",
note = "Funding Information: This work has received funding from the European Union{\textquoteright}s Horizon 2020 research and innovation programme under acronym ESCAPE-NET, registered under grant agreement No. 733381, and the COST Action PARQ (grant agreement No CA19137) supported by COST (European Cooperation in Science and Technology). Funding Information: We performed a qualitative, semi-structured interview study in the Netherlands with patients who survived SCA and with their next-of-kin. The study was funded by a EU Horizon 2020 grant which had no role in the design or execution of the research. Our methodological orientation was one of empirical ethics [] and we based our interview topics on previous literature research []. Patients who were interviewed had donated their data to the ARREST (AmsteRdam REesuscitation STudies) research project. This project, part of the European ESCAPE-NET consortium, is an ongoing registry that investigates causes and treatment of out-of-hospital SCA [, ]. Data for ARREST are collected through various data sources in the {\textquoteleft}chain of care{\textquoteright} such as ambulance services and hospitals. These sources provide information about pre-hospital treatment (resuscitation by citizen rescuers or ambulance personnel), in-hospital treatment and diagnosis, patients{\textquoteright} medical history and medication use, name and date of birth, (pseudo-anonymised) socio-economic data like household income, and biosamples including DNA from residual materials that were obtained for the sake of routine clinical care (blood, intubation tubes). Some data are collected without prospective consent, because they need to be saved quickly (e.g., ambulance ECGs will otherwise be overwritten). For other data, surviving patients are approached to ask for opt-in consent, three months or more after the resuscitation. Contact is initiated with a letter from the ambulance service after which, unless they opt out from being contacted, patients are approached with consent documentation by ARREST researchers. Until deferred consent has been obtained, the data are not used for the ARREST study. For genetic data, a separate consent option is provided. In the year 2016, a total of 1126 patients were eligible for ARREST (one-fifth alive at discharge). Of the survivors, 67% consented while 9% declined to give consent and the remainder were not reachable. Funding Information: The authors wish to thank all interview participants for their time and input. We also thank the ARREST research group, specifically Dr Ruud Koster, and researchers at the AMC department of General Practice and the section of Medical Ethics for their insightful comments during discussions on our research proposal and findings; in particular, we thank Kasper Kruithof for his thorough reading of the manuscript. Lastly, we thank Ivana Bogicevic for her suggestions and literature recommendations and Dr Corrette Ploem for her expert advice about the themes discussed in this article. Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
month = dec,
day = "1",
doi = "https://doi.org/10.1186/s12910-021-00576-9",
language = "English",
volume = "22",
journal = "BMC medical ethics",
issn = "1472-6939",
publisher = "BioMed Central",
number = "1",
}