Rethinking Consent for Stroke Trials in Time-Sensitive Situations: Insights From the COVID-19 Pandemic.
Stroke
; 52(4): 1527-1531, 2021 04.
Article
em En
| MEDLINE
| ID: mdl-33588599
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Acidente Vascular Cerebral
/
Pandemias
/
COVID-19
/
Consentimento Livre e Esclarecido
Tipo de estudo:
Clinical_trials
/
Diagnostic_studies
Limite:
Aged
/
Humans
/
Male
Idioma:
En
Revista:
Stroke
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Canadá