Consent in Canadian-Led Critical Care Research During the COVID-19 Pandemic: A Scoping Review

Abstract

ABSTRACTIntroductionDespite the importance of critical care research during the SARS-CoV-2 pandemic, several pandemic-related factors made the process of obtaining prior written informed consent for research infeasible. To overcome these challenges, research studies utilized alternate informed consent models suggested by available guidance.ObjectiveTo describe the consent models used in Canadian intensive care unit (ICU) and pediatric ICU (PICU) studies during the COVID-19 pandemic.Data SourcesWe searched MEDLINE, EMBASE, CENTRAL,clinicaltrials.gov, and medRxiv from 01-Jan-2020 to 28-Apr-2023 using Medical Subject Headings and keywords related to the setting (ICU, PICU), study design (e.g., RCT) and study region (i.e., Canada). We included Canadian-led studies that were enrolling during the SARS-CoV-2 and reported on consent. Two independent reviewers reviewed titles/abstracts and full text articles for inclusion.ResultsWe included 13 studies from adult (n=12, 92.3%) and pediatric (n=1, 7.7%) populations. Some study authors reported that informed (n=3/13, 23.1%) or a priori (n=2/13, 15.4%) consent was obtained, without further details. Study authors also reported using written informed (n=4/13, 30.8%), deferred (n=3/13, 23.1%), verbal/waived/assent (each n=2/13, 15.4%), or that ethics approval was not necessary which means consent was not required (n=1/13, 7.7%). Five studies (n=5/13, 38.5%) used multiple consent models: a priori/deferred (n=2/5, 40%), written/verbal (n=2/5, 40%), or waived/assent (n=1/5, 20%).ConclusionThis scoping review underscores the importance of transparent reporting of or modifications to trial procedures during crises, such as the COVID-19 pandemic. Improved reporting practices and exploration of alternate consent models, including electronic consent, are crucial for advancing critical care trials beyond the pandemic and preparing for future health emergencies.