Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University Singapore, Singapore.
Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University Singapore, Singapore
J Med Ethics. 2020 Sep;46(9):610-616. doi: 10.1136/medethics-2020-106152. Epub 2020 May 6.
The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is judged to be of particular value. However, several different terms are used to refer to this value (including public interest, public benefit, public good and social value), indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term 'public interest' best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. 'Public interest' contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided (1) Those projects have social value, broadly defined. (2) Data are de-identified. (3) Data are kept secure. (4) Businesses are not able to access the data for profit.
对健康数据的需求不断增长；为二次研究获得特定同意变得越来越不切实际；以及降低数据有效匿名化的能力。在这种情况下，政府、临床医生和研究界必须证明他们能够成为健康数据的负责任管理者。IRB 和 REC 处于这一过程的核心，因为在许多司法管辖区，当研究被认为具有特殊价值时，它们有能力授予同意豁免。然而，有几个不同的术语被用来指代这种价值（包括公共利益、公共利益、公共利益和社会价值），这表明在没有同意的情况下，为研究获取健康数据的适当测试方面缺乏概念上的清晰性。在本文中，我们做了三件事。首先，我们描述了与同意豁免相关的公共利益术语方面的当前混乱和不稳定。其次，我们基于清晰性、透明度和一致性的理由主张术语的统一。第三，我们认为“公共利益”一词最好地反映了为同意豁免辩护所需的规范性工作，因为它是竞争术语中最广泛的。“公共利益”包含了研究的积极和消极影响，以及福利、正义和权利考虑。在提出这一论点时，我们解释了同意豁免的规范性基础，并为进一步讨论在何种具体情况下可以说某项研究符合公共利益提供了一个起点。益普索·莫里研究公司的研究发现：……公众将广泛支持为研究项目进行行政数据链接，前提是：（1）这些项目具有广泛定义的社会价值。（2）数据已去识别。（3）数据安全。（4）企业不能为了盈利而获取数据。
