Advanced consent for participation in acute care randomised control trials: protocol for a scoping review

Abstract

IntroductionInformed consent is essential to clinical research, though obtaining informed consent for participation in research for emergency conditions is challenging. Adapted consent methods include consent from a substitute-decision maker, deferral of consent and waiver of consent. A novel approach is to use advanced consent, where a potential participant provides consent in the present in the event that they become eligible for enrolment into a future study. This scoping review will map and synthesise the literature on the use of advanced consent for participation and enrolment in randomised control trials for emergency conditions.Methods and analysisGuided by Arksey and O'Malley’s scoping review methodology framework, we will search electronic databases (Medline, Embase, Web of Science and the Cochrane Register of Clinical Trials), the grey literature sources and reference lists of relevant studies. Eligible studies will include English language articles that discuss, examine or employ the use of advanced consent for enrolment in randomised control trials, specifically related to emergency conditions or emergency treatment. Diverse types of articles will be eligible for inclusion, including peer-reviewed qualitative and quantitative studies such as randomised control trials, observational studies, surveys, systematic reviews, as well as narrative reviews and ethics papers. Studies will be screened by two independent reviewers to determine eligibility for inclusion. Data on bibliographic information, study characteristics and methodology, and reported results, specifically author disposition, will be extracted and described using qualitative analysis.Ethics and disseminationFormal ethics review is not required as primary data will not be collected. The findings of this study will be disseminated through a peer-reviewed publication. The findings of this study will help identify knowledge gaps that may guide areas for future research and may aid in the design of future clinical trials using advanced consent.

Motivation to participate and experiences of the informed consent process for randomized clinical trials in emergency obstetric care in Uganda

“…They could have been recruited into the study and study procedures initiated before full enrollment. While the latter was perceived by some participants as against autonomous decision-making (in line with self-determination theory of motivation), advanced consent provides an opportunity to obtain informed consent from populations with risk factors for certain emergency conditions such as severe pre-eclampsia [24,25].…”

Advance consent for participation in randomised controlled trials for emergency conditions: a scoping review

“…We conducted a scoping review to search the literature for experiences with advance consent for participation in RCTs for emergency conditions. 19 A detailed protocol of the study design and methods was developed and published a priori. 19 This scoping review was designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses–Extension for Scoping Reviews guidelines.…”

“… 19 A detailed protocol of the study design and methods was developed and published a priori. 19 This scoping review was designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses–Extension for Scoping Reviews guidelines. 20 It was conducted using the framework of Arksey and O’Malley and further defined by Levac et al .…”

“…19 A detailed protocol of the study design and methods was developed and published a priori. 19 This scoping review was designed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Extension for Scoping Reviews guidelines. 20 It was conducted using the framework of Arksey and O'Malley and further defined by Levac et al 21 22 Information sources and search strategy We performed a search of MEDLINE, Embase (Embase Classic+Embase), Cochrane Central Register of Controlled Trials and Web of Science from inception to 10 February 2020.…”

Advance Consent in Acute Stroke Trials: Survey of Canadian Stroke Physicians

“…3 Each of these approaches has drawbacks, most important being the risk that patients may be enrolled into trials against their wishes. 4 Advance consent, 5 a practice accepted and used in dementia research, 6 could address some of the challenges experienced in acute stroke research by identifying at-risk patients in stroke prevention clinics, informing them about ongoing trials, and then inviting them to consent while they are capable of doing so. Their consent could then be documented in the health record, facilitating quicker trial participation for those who are willing and preventing enrollment for those who are not.…”