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• W2556566498 endingPage "20160130" @default.
• W2556566498 startingPage "20160130" @default.
• W2556566498 abstract "Advances in data science allow for sophisticated analysis of increasingly large datasets. In the medical context, large volumes of data collected for healthcare purposes are contained in electronic health records (EHRs). The real-life character and sheer amount of data contained in them make EHRs an attractive resource for public health and biomedical research. However, medical records contain sensitive information that could be misused by third parties. Medical confidentiality and respect for patients' privacy and autonomy protect patient data, barring access to health records unless consent is given by the data subject. This creates a situation in which much of the beneficial records-based research is prevented from being used or is seriously undermined, because the refusal of consent by some patients introduces a systematic deviation, known as selection bias, from a representative sample of the general population, thus distorting research findings. Although research exemptions for the requirement of informed consent exist, they are rarely used in practice due to concerns over liability and a general culture of caution. In this paper, we argue that the problem of research access to sensitive data can be understood as a tension between the medical duties of confidentiality and beneficence. We attempt to show that the requirement of informed consent is not appropriate for all kinds of records-based research by distinguishing studies involving minimal risk from those that feature moderate or greater risks. We argue that the duty of easy rescue-the principle that persons should benefit others when this can be done at no or minimal risk to themselves-grounds the removal of consent requirements for minimally risky records-based research. Drawing on this discussion, we propose a risk-adapted framework for the facilitation of ethical uses of health data for the benefit of society.This article is part of the themed issue 'The ethical impact of data science'." @default.
• W2556566498 created "2016-11-30" @default.
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• W2556566498 creator A5057523747 @default.
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• W2556566498 date "2016-12-28" @default.
• W2556566498 modified "2023-10-16" @default.
• W2556566498 title "Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue" @default.
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• W2556566498 doi "https://doi.org/10.1098/rsta.2016.0130" @default.
• W2556566498 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/5124071" @default.
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