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Background: Observational studies using large-scale databases and biobanks help improve prevention and treatment of sudden cardiac arrest (SCA) but the lack of guidance on data protection issues in this setting may harm patients’ rights and the research enterprise itself. This qualitative study explored the ethical aspects of observational SCA research, as well as solutions. Methods: European experts in SCA research, medical ethics and health law reflected on this topic through semi-structured interviews (N = 29) and a virtual roundtable conference (N = 18). The ESCAPE-NET project served as a discussion case. Findings were coded and thematically analysed. Results: The first theme concerned the potential benefits and harms (at individual and group level) of observational data-based SCA studies and included the following sub-themes: societal value, scientific validity, data privacy, disclosure of genetic findings, stigma and discrimination, and medicalisation of sudden death. The second theme involved governance through ‘privacy by design’, ‘privacy by policy’ and associated regulation and oversight. Sub-themes were: de-identification of data, informed consent (broad and deferred), ethics review, and harmonisation. Conclusions: Researchers and scientific societies should be aware that ethico-legal issues may arise during data-driven studies in SCA and other emergencies. These can be mitigated by combining technical data protection safeguards with appropriate informed consent policies and proportional ethics oversight. To ensure responsible conduct of data research in emergency medicine, we recommend the establishment of ‘codes of conduct’ which should be developed in interdisciplinary groups and together with patient representatives.

Abstract Background With advances in sequencing technologies, increasing numbers of people are being informed about a genetic disease identified in their family. In current practice, probands (the first person in a family in whom a genetic predisposition is identified) are asked to inform at-risk relatives about the diagnosis. However, previous research has shown that relatives are sometimes not informed due to barriers such as family conflicts. Research on family communication in genetic diseases aims to explore the difficulties encountered in informing relatives and to identify ways to support probands in this. Main body Research on family communication may also reveal that participants did not inform their relatives about the risk of a serious genetic condition, even when preventive and treatment options are available. Researchers may then face a dilemma: Do they need to warn at-risk relatives about the finding? Or do they keep silent due to prior confidentiality agreements with study participants? Conclusions We believe that the absolute confidence promised to research participants outweighs the interests of their relatives, even though it can be claimed that relatives at risk of a genetic disease do, in principle, have a right to know information collected about their health. Not respecting confidentiality agreements could cause distrust between researchers and research participants and possibly harm the relationship between probands and relatives. Relatives' health interests can still be taken into account without jeopardizing participant trust, by considering alternative scenarios, including sharing general study findings on the barriers participants experience with their healthcare professionals and by offering participants psychosocial support for family communication.