• Mayank Goyal, Johanna Maria Ospel, Aravind Ganesh, Martha Marko, and Marc Fisher.
• Department of Clinical Neurosciences (M.G., J.M.O., A.G., M.M.), University of Calgary, Canada.
• Stroke. 2021 Apr 1; 52 (4): 1527-1531.

AbstractInformed 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.

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