Views on consent approaches used in emergency and critical care research: a rapid, systematic review.

backgroundObtaining informed consent can be challenging in emergency and critical care research due to the acute and severe nature of the patient's condition. However, such research is urgently needed to inform practice and optimise patient outcomes. While alternative consent approaches have been commonly used, opinions may vary, particularly among diverse and underserved patient groups and in the context of the recent COVID-19 pandemic. The objective of this review was to assess views of alternative consent methods in emergency and critical care research.

methodsWe conducted a rapid systematic review to understand diverse opinions of alternative consent models used in emergency and critical care research with searches of MEDLINE, EMBASE, PsycINFO, Web of Science and CENTRAL carried out to July 31, 2024. We included quantitative and qualitative studies and summarised findings using narrative synthesis. We specifically investigated underserved groups and consent in the pandemic setting.

resultsFrom 9974 citations, we screened 289 full-text articles, and included 145 eligible studies from 26 countries. Consent methods included prospective informed consent, deferred consent, surrogate decision maker consent, healthcare professional consent and waived consent. Groups represented included previous trial participants, relatives of trial participants, patients, members of the general public, healthcare providers, researchers, site staff, and research ethics committees. It was recognised that prospective informed consent from the patient is not possible in all scenarios. In general, alternative consent models were acceptable, with emphasis on the inclusion of the patient and relatives in the decision-making process whenever possible. Acceptability of alternative consent models was influenced by previous research participation, experience of critical or emergency illness, perceived risk of participation, and invasiveness of the intervention. Study staff highlighted potential limitations of some alternative consent models, such as unavailability of relatives. Pandemic studies showed an increased need for alternative consent methods, and greater preparedness and engagement with ethics committees to facilitate implementation. Sub-analysis evaluating the views of underserved groups did not show consensus, and accommodations were largely not reported.

conclusionAlternative consent models used for emergency, critical care and pandemic research including deferred consent, relative/surrogate decision maker consent, and physician consent were generally acceptable.

trial registrationPROSPERO CRD42023408305 (April 19, 2023).