Literature DB >> 33588599

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

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


  2 in total

1.  Brief Consent Methods Enable Rapid Enrollment in Acute Stroke Trial: Results From the TICH-2 Randomized Controlled Trial.

Authors:  Zhe Kang Law; Jason P Appleton; Polly Scutt; Ian Roberts; Rustam Al-Shahi Salman; Timothy J England; David J Werring; Thompson Robinson; Kailash Krishnan; Robert A Dineen; Ann Charlotte Laska; Philippe A Lyrer; Juan Jose Egea-Guerrero; Michal Karlinski; Hanne Christensen; Christine Roffe; Daniel Bereczki; Serefnur Ozturk; Jegan Thanabalan; Ronan Collins; Maia Beridze; Alfonso Ciccone; Lelia Duley; Angela Shone; Philip M Bath; Nikola Sprigg
Journal:  Stroke       Date:  2021-12-01       Impact factor: 7.914

2.  Rethinking informed consent in the time of COVID-19: An exploratory survey.

Authors:  Evelien De Sutter; Teodora Lalova-Spinks; Pascal Borry; Peggy Valcke; Els Kindt; Anastassia Negrouk; Griet Verhenneman; Jean-Jacques Derèze; Ruth Storme; Isabelle Huys
Journal:  Front Med (Lausanne)       Date:  2022-09-27
  2 in total

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