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探讨临床试验中电子知情同意伦理问题。

Towards an understanding of the ethics of electronic consent in clinical trials.

机构信息

Ethox Centre, Oxford Population Health, University of Oxford, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.

Clinical Trial Service Unit, Oxford Population Health, University of Oxford, Richard Doll Building, Old Road Campus, Roosevelt Drive, Oxford, OX3 7LF, UK.

出版信息

Trials. 2024 Aug 16;25(1):545. doi: 10.1186/s13063-024-08330-3.

Abstract

There are good practical reasons to use electronic consent (e-consent) in randomised trials, especially when conducting large-scale clinical trials to answer population-level health research questions. However, determining ethical reasons for e-consent is not so clear and depends on a proper understanding of what e-consent means when used in clinical trials and its ethical significance. Here we focus on four features of ethical significance which give rise to a range of ethical considerations relating to e-consent and merit further focused ethics research.

摘要

使用电子知情同意(e-consent)在随机试验中具有良好的实际意义,特别是在进行大规模临床试验以回答人群健康研究问题时。然而,确定使用电子知情同意的伦理理由并不那么明确,并且取决于对在临床试验中使用的电子知情同意的含义及其伦理意义的正确理解。在这里,我们重点关注具有伦理意义的四个特征,这些特征引发了与电子知情同意相关的一系列伦理考虑因素,值得进一步进行重点伦理学研究。

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