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

Fitzpatrick, Aran, Wood, Fiona ORCID: https://orcid.org/0000-0001-7397-4074 and Shepherd, Victoria ORCID: https://orcid.org/0000-0002-7687-0817 2022. Trials using deferred consent in the emergency setting: a systematic review and narrative synthesis of stakeholders' attitudes. Trials 23 , 411. 10.1186/s13063-022-06304-x

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Abstract

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.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Medicine
Additional Information:	This article is licensed under a Creative Commons Attribution 4.0 International License
Publisher:	BioMed Central
ISSN:	1745-6215
Date of First Compliant Deposit:	21 April 2022
Date of Acceptance:	13 April 2022
Last Modified:	03 May 2023 10:42
URI:	https://orca.cardiff.ac.uk/id/eprint/149255

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