Department of Primary Health Care and General Practice, University of Otago, Wellington, New Zealand.
Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
J Med Ethics. 2018 Jun;44(6):392-396. doi: 10.1136/medethics-2017-104550. Epub 2018 Jan 22.
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.
主流观点认为，使用健康数据的研究属于观察性研究，除非可以证明获得同意是不切实际的，否则应该要求获得个人同意。但最近有人认为，公民有道德义务为研究目的共享其健康信息。在我们看来，这种义务足以扩大在没有明确的主体同意的情况下，允许使用可识别健康信息进行二次利用研究的情况。因此，对于某些研究，机构审查委员会/研究伦理委员会的审查过程不应该评估获得数据使用同意的实际情况。相反，审查过程应该侧重于评估研究的公共利益、公众参与和透明度。
