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

Introduction Despite 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. Objective To describe the consent models used in Canadian intensive care unit (ICU) and pediatric ICU (PICU) studies during the COVID-19 pandemic. Data Sources We searched MEDLINE, EMBASE, CENTRAL, [clinicaltrials.gov][1], 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. Results We 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%). Conclusion This 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. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Protocols ### Funding Statement This study did not receive any funding ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors [1]: http://clinicaltrials.gov