Siriwardana Amanda, Smyth Brendan, Jardine Meg
Sydney Medical School, Faculty of Medicine & Health, University of Sydney, Sydney, New South Wales, Australia
The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia.
BMJ Open. 2025 Mar 18;15(3):e091896. doi: 10.1136/bmjopen-2024-091896.
Low-risk pragmatic clinical research such as learning health system research, quality assurance activities and comparative effectiveness studies are approaches to embedding clinical research within routine practice to generate generalisable evidence. Individual written informed consent may present a barrier to the feasibility and inclusiveness of such low-risk clinical research. Within an overarching moral and ethical framework, the form and requirements of consent vary in both clinical practice and research settings according to the context and level of risk. Within some low-risk research settings, waiver of consent may be appropriate.
We sought to describe contemporary national and international English-language guidelines pertaining to the use and oversight of waiver of consent in clinical research. We identify 14 guidelines including 1 international, 1 regional and 12 national statements, and summarise the principles in each for circumstances in which a waiver of consent is appropriate.
While complete international harmonisation of policy may be neither realistic nor necessary, there are numerous unifying concordances suggesting a broad consensus on the approach to waiver of consent research.
低风险实用临床研究，如学习健康系统研究、质量保证活动和比较效果研究，是将临床研究融入常规实践以产生可推广证据的方法。个人书面知情同意可能会对此类低风险临床研究的可行性和包容性构成障碍。在总体道德和伦理框架内，根据背景和风险水平，同意的形式和要求在临床实践和研究环境中各不相同。在一些低风险研究环境中，放弃同意可能是合适的。
我们试图描述当代有关临床研究中放弃同意的使用和监督的国家和国际英语指南。我们确定了14项指南，包括1项国际、1项区域和12项国家声明，并总结了每项声明中关于放弃同意合适情况的原则。
虽然政策完全国际化协调既不现实也无必要，但有许多统一的一致性意见，表明在放弃同意研究的方法上存在广泛共识。
