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重新思考时间敏感情况下的中风试验中的同意问题:COVID-19 大流行带来的启示。

Rethinking Consent for Stroke Trials in Time-Sensitive Situations: Insights From the COVID-19 Pandemic.

机构信息

Department of Clinical Neurosciences (M.G., J.M.O., A.G., M.M.), University of Calgary, Canada.

Department of Radiology (M.G.), University of Calgary, Canada.

出版信息

Stroke. 2021 Apr;52(4):1527-1531. doi: 10.1161/STROKEAHA.120.031976. Epub 2021 Feb 16.

Abstract

Informed consent is a key concept to ensure patient autonomy in clinical trials and routine care. The coronavirus disease 2019 (COVID-19) pandemic has complicated informed consent processes, due to physical distancing precautions and increased physician workload. As such, obtaining timely and adequate patient consent has become a bottleneck for many clinical trials. However, this challenging situation might also present an opportunity to rethink and reappraise our approach to consent in clinical trials. This viewpoint discusses the challenges related to informed consent during the COVID-19 pandemic, whether it could be acceptable to alter current consent processes under these circumstances, and outlines a possible framework with predefined criteria and a system of checks and balances that could allow for alterations of existing consent processes to maximize patient benefit under exceptional circumstances such as the COVID-19 pandemic without undermining patient autonomy.

摘要

知情同意是确保临床试验和常规护理中患者自主权的一个关键概念。由于身体距离防范措施和医生工作量的增加,2019 年冠状病毒病(COVID-19)大流行使知情同意过程变得复杂。因此,及时获得充分的患者同意已成为许多临床试验的瓶颈。然而,这种具有挑战性的情况也可能为我们重新思考和评估临床试验中的同意方式提供了机会。本观点讨论了 COVID-19 大流行期间知情同意方面的挑战,在这种情况下,是否可以接受改变当前的同意程序,并概述了一个可能的框架,其中包含预设标准和制衡系统,可允许在 COVID-19 等特殊情况下修改现有的同意程序,以最大限度地使患者受益,同时又不损害患者自主权。

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