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Rethinking Consent for Stroke Trials in Time-Sensitive Situations: Insights From the COVID-19 Pandemic.
Goyal, Mayank; Ospel, Johanna Maria; Ganesh, Aravind; Marko, Martha; Fisher, Marc.
  • Goyal M; Department of Clinical Neurosciences (M.G., J.M.O., A.G., M.M.), University of Calgary, Canada.
  • Ospel JM; Department of Radiology (M.G.), University of Calgary, Canada.
  • Ganesh A; Department of Clinical Neurosciences (M.G., J.M.O., A.G., M.M.), University of Calgary, Canada.
  • Marko M; Department of Neuroradiology, University Hospital Basel, Switzerland (J.M.O.).
  • Fisher M; Department of Clinical Neurosciences (M.G., J.M.O., A.G., M.M.), University of Calgary, Canada.
Stroke ; 52(4): 1527-1531, 2021 04.
Article in English | MEDLINE | ID: covidwho-1085244
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.
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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Randomized Controlled Trials as Topic / Stroke / Pandemics / COVID-19 / Informed Consent Subject: Randomized Controlled Trials as Topic / Stroke / Pandemics / COVID-19 / Informed Consent Type of study: Case report / Controlled clinical trial / Diagnostic study Language: English Journal: Stroke Clinical aspect: Therapy Year: 2021

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Full text: Available Collection: International databases Database: MEDLINE Document Type: Article Main subject: Randomized Controlled Trials as Topic / Stroke / Pandemics / COVID-19 / Informed Consent Subject: Randomized Controlled Trials as Topic / Stroke / Pandemics / COVID-19 / Informed Consent Type of study: Case report / Controlled clinical trial / Diagnostic study Language: English Journal: Stroke Clinical aspect: Therapy Year: 2021
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