Consent and the ethical duty to participate in health data research
Consent and the ethical duty to participate in health data research
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DOI：
10.1136/medethics-2017-104550
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发表时间：
2018-06-01
影响因子：
4.1
通讯作者：
Schaefer, G. Owen
中科院分区：
文献类型：
--
作者：
Ballantyne, Angela;Schaefer, G. Owen
主流观点认为，使用健康数据的研究是观察性研究，应该要求个人同意，除非能证明获得同意是不切实际的。但最近有观点认为，出于研究目的，公民有道德义务分享他们的健康信息。在我们看来，这一义务是扩大情况的充分理由，在没有明确的受试者同意的情况下，允许使用可识别的健康信息的二次使用研究。因此，对于一些研究，机构审查委员会/研究伦理委员会的审查程序不应评估获得数据使用同意的实用性。相反，审查过程应侧重于评估研究的公共利益、公众参与和透明度。
The predominant view is that a study using health data is observational research and should require individual consent unless it can be shown that gaining consent is impractical. But recent arguments have been made that citizens have an ethical obligation to share their health information for research purposes. In our view, this obligation is sufficient ground to expand the circumstances where secondary use research with identifiable health information is permitted without explicit subject consent. As such, for some studies the Institutional Review Board/Research Ethics Committee review process should not assess the practicality of gaining consent for data use. Instead the review process should focus on assessing the public good of the research, public engagement and transparency.