Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue.
Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue.
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DOI：
10.1098/rsta.2016.0130
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发表时间：
2016-12-28
期刊：
影响因子：
--
通讯作者：
Sahakian BJ
中科院分区：
文献类型：
--
作者：
Porsdam Mann S;Savulescu J;Sahakian BJ
数据科学的进步允许对越来越大的数据集进行复杂的分析。在医疗背景下，为医疗保健目的收集的大量数据包含在电子健康记录（EHR）中。其中包含的真实生活特征和大量数据使EHR成为公共卫生和生物医学研究的有吸引力的资源。然而，医疗记录包含可能被第三方滥用的敏感信息。医疗保密和尊重病人的隐私和自主权保护病人的数据，禁止访问健康记录，除非得到数据主体的同意。这就造成了一种情况，即许多有益的基于记录的研究被阻止使用或受到严重破坏，因为一些患者拒绝同意引入了一种系统性偏差，称为选择偏差，偏离了一般人群的代表性样本，从而扭曲了研究结果。虽然存在对知情同意要求的研究豁免，但由于对责任的担忧和普遍的谨慎文化，这些豁免很少在实践中使用。在本文中，我们认为，研究访问敏感数据的问题可以被理解为保密和有益的医疗义务之间的紧张关系。我们试图表明，知情同意的要求是不适合所有类型的记录为基础的研究，区分研究涉及的风险最小的那些中度或更大的风险。我们认为，义务容易救援的原则，即人应该造福他人时，这可以做到在没有或最小的风险，以自己的理由，同意要求最低风险的记录为基础的研究删除。基于这一讨论，我们提出了一个风险适应框架，以促进健康数据的道德使用，造福社会。本文是主题问题“数据科学的伦理影响”的一部分。
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’.
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