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关于分享实用临床试验汇总结果的伦理考量。

Ethical considerations for sharing aggregate results from pragmatic clinical trials.

作者信息

Morain Stephanie R, Brickler Abigail, Ali Joseph, O'Rourke Patricia Pearl, Spector-Bagdady Kayte, Wilfond Benjamin, Rahimzadeh Vasiliki, Propes Caleigh, Mehl Kayla, Wendler David

机构信息

Johns Hopkins Berman Institute of Bioethics, Baltimore, MD, USA.

Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.

出版信息

Clin Trials. 2025 Apr;22(2):248-254. doi: 10.1177/17407745241290782. Epub 2024 Nov 25.

Abstract

A growing literature has explored the ethical obligations and current practices related to sharing aggregate results with research participants. However, no prior work has examined these issues in the context of pragmatic clinical trials. Several characteristics of pragmatic clinical trials may complicate both the ethics and the logistics of sharing aggregate results. Among these characteristics include that pragmatic clinical trials may affect the rights, welfare, and interests of not only patient-subjects but also clinicians, meaning that results may be owed to a broader range of groups than typically considered in other research contexts. In addition, some pragmatic clinical trials are conducted under a waiver of informed consent, meaning sharing results may alert participants that they were enrolled without their consent. This article explores the ethical dimensions that can inform decision-making about sharing aggregate results from pragmatic clinical trials, and provides recommendations for that sharing. A central insight is that healthcare institutions-as key partners for the conduct of pragmatic clinical trials-must also be key partners in decision-making about sharing aggregate pragmatic clinical trial results. We conclude with insights for future research.

摘要

越来越多的文献探讨了与向研究参与者分享汇总结果相关的伦理义务和当前做法。然而,此前尚无研究在务实临床试验的背景下审视这些问题。务实临床试验的几个特征可能会使分享汇总结果的伦理和后勤工作变得复杂。这些特征包括务实临床试验不仅可能影响患者受试者的权利、福利和利益,还可能影响临床医生的权利、福利和利益,这意味着结果可能应告知比其他研究背景中通常考虑的范围更广的群体。此外,一些务实临床试验是在放弃知情同意的情况下进行的,这意味着分享结果可能会提醒参与者他们是在未经同意的情况下被纳入试验的。本文探讨了可为务实临床试验汇总结果分享决策提供参考的伦理层面,并为这种分享提供建议。一个核心观点是,医疗机构作为开展务实临床试验的关键合作伙伴,也必须成为务实临床试验汇总结果分享决策的关键合作伙伴。我们最后提出了对未来研究的见解。

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