University of Otago Wellington, Wellington, New Zealand.
Bioethics. 2019 Mar;33(3):357-366. doi: 10.1111/bioe.12551. Epub 2019 Jan 22.
This paper contends that a research ethics approach to the regulation of health data research is unhelpful in the era of population-level research and big data because it results in a primary focus on consent (meta-, broad, dynamic and/or specific consent). Two recent guidelines - the 2016 WMA Declaration of Taipei on ethical considerations regarding health databases and biobanks and the revised CIOMS International ethical guidelines for health-related research involving humans - both focus on the growing reliance on health data for research. But as research ethics documents, they remain (to varying degrees) focused on consent and individual control of data use. Many current and future uses of health data make individual consent impractical, if not impossible. Many of the risks of secondary data use apply to communities and stakeholders rather than individual data subjects. Shifting from a research ethics perspective to a public health lens brings a different set of issues into view: how are the benefits and burdens of data use distributed, how can data research empower communities, who has legitimate decision-making capacity? I propose that a public health ethics framework - based on public benefit, proportionality, equity, trust and accountability - provides more appropriate tools for assessing the ethical uses of health data. The main advantage of a public health approach for data research is that it is more likely to foster debate about power, justice and equity and to highlight the complexity of deciding when data use is in the public interest.
本文认为,在人口水平研究和大数据时代,将研究伦理方法应用于健康数据研究的监管是无益的,因为这导致主要关注同意(元同意、广泛同意、动态同意和/或具体同意)。最近的两份指南——2016 年世界医学协会关于健康数据库和生物库伦理问题的台北宣言和修订后的 CIOMS 国际人类健康相关研究伦理准则——都侧重于越来越依赖健康数据进行研究。但作为研究伦理文件,它们仍然(在不同程度上)侧重于同意和个人对数据使用的控制。许多当前和未来对健康数据的使用使得个人同意变得不切实际,如果不是不可能的话。二次数据使用的许多风险适用于社区和利益相关者,而不是个人数据主体。从研究伦理的角度转变为公共卫生视角,会带来一系列不同的问题:数据使用的利益和负担如何分配,数据研究如何为社区赋权,谁具有合法的决策能力?我提出,公共卫生伦理框架——基于公共利益、相称性、公平、信任和问责制——为评估健康数据的伦理使用提供了更合适的工具。公共卫生方法在数据研究中的主要优势在于,它更有可能促进关于权力、正义和公平的辩论,并突出决定何时数据使用符合公众利益的复杂性。