| Literature DB >> 33588599 |
Mayank Goyal1,2, Johanna Maria Ospel1,3, Aravind Ganesh1, Martha Marko1,4, Marc Fisher5.
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.Entities:
Keywords: clinical trial; informed consent; ischemic stroke; stroke; workload
Mesh:
Year: 2021 PMID: 33588599 DOI: 10.1161/STROKEAHA.120.031976
Source DB: PubMed Journal: Stroke ISSN: 0039-2499 Impact factor: 7.914