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• W2892353835 abstract "Sudden cardiac arrest (SCA) accounts for half of all cardiac deaths in Europe. In recent years, large-scale SCA registries have been set up to enable observational studies into risk factors and the effect of treatment approaches. The increasing scale and variety of data sources, coupled with the implementation of a new European data protection legal framework, causes researchers to struggle with how to handle these ‘big data’. Data protection in the SCA setting is especially complex since patients become at least temporarily incapacitated, and are thus unable to provide prospective informed consent, and because the majority of patients do not survive. A narrative review employing a systematic literature search was conducted to thematically analyse ethical aspects of non-interventional emergency medicine and critical care research. Although the identified issues may apply to a wider patient population, we describe them within the context of SCA research. Potential harms were found to include: privacy breaches, genetic discrimination and issues associated with the disclosure of individual findings, study design and application of research results. Measures proposed to mitigate harms were: alternative informed consent models including deferred or waived consent and data governance approaches promoting data security, responsible sharing and public engagement. The themes identified in this study may serve as a basis for a much-needed ethical framework regarding research with data from patients with acute and critical illness such as SCA." @default.
• W2892353835 created "2018-09-27" @default.
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• W2892353835 date "2018-09-13" @default.
• W2892353835 modified "2023-10-16" @default.
• W2892353835 title "Ethical aspects of sudden cardiac arrest research using observational data: a narrative review" @default.
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• W2892353835 doi "https://doi.org/10.1186/s13054-018-2153-3" @default.
• W2892353835 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/6136218" @default.
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• W2892353835 hasPublicationYear "2018" @default.
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