Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders’ attitudes

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; pp. 411 - 15
• Main Authors: Fitzpatrick, Aran, Wood, Fiona, Shepherd, Victoria
• Format: Journal Article
• Language: English
• Published: London BioMed Central 16.05.2022; BioMed Central Ltd; BMC
• Subjects: Adult; Attitude of Health Personnel; Attitudes; Biomedicine; Clinical trials; Coronaviruses; COVID-19; Critical care; Emergency medicine; Ethics Committees, Research; Health Sciences; Humans; ICU; Informed Consent; Informed consent (Medical law); Intensive care; ITU; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Methods; Patients; Pulmonary arteries; Recruitment method; Recruitment strategy; Research Design; Research ethics; Review; Software; Stakeholders; Statistics for Life Sciences; Systematic review; United Kingdom; United Kingdom > UK; Intensive care; Recruitment strategy; Critical care; Recruitment method; Systematic review; ICU; ITU
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06304-x

Background Patients with acute conditions often lack the capacity to provide informed consent, and narrow therapeutic windows mean there is no time to seek consent from surrogates prior to treatment being commenced. One method to enable the inclusion of this study population in emergency research is through recruitment without prior consent, often known as ‘deferred consent’. However, empirical studies have shown a large disparity in stakeholders’ opinions regarding this enrolment method. This systematic review aimed to understand different stakeholder groups’ attitudes to deferred consent, particularly in relation to the context in which deferred consent might occur. Methods Databases including MEDLINE, EMCare, PsychINFO, Scopus, and HMIC were searched from 1996 to January 2021. Eligible studies focussed on deferred consent processes for adults only, in the English language, and reported empirical primary research. Studies of all designs were included. Relevant data were extracted and thematically coded using a narrative approach to ‘tell a story’ of the findings. Results Twenty-seven studies were included in the narrative synthesis. The majority examined patient views ( n = 19). Data from the members of the public ( n = 5) and health care professionals ( n =5) were also reported. Four overarching themes were identified: level of acceptability of deferred consent, research-related factors influencing acceptability, personal characteristics influencing views on deferred consent, and data use after refusal of consent or participant death. Conclusions This review indicates that the use of deferred consent would be most acceptable to stakeholders during low-risk emergency research with a narrow therapeutic window and where there is potential for patients to benefit from their inclusion. While the use of narrative synthesis allowed assessment of the included studies, heterogeneous outcome measures meant that variations in study results could not be reliably attributed to the different trial characteristics. Future research should aim to develop guidance for research ethics committees when reviewing trials using deferred consent in emergency research and investigate more fully the views of healthcare professionals which to date have been explored less than patients and members of the public. Trial registration PROSPERO CRD42020223623