Protocol for Deferral of Consent in Acute Stroke Trials

Abstract

The challenges of conducting hyperacute stroke research and obtaining informed consent have been increasingly recognized within the stroke research community in recent years. Deferral of consent, in which a patient is enrolled in a trial and then provides consent at some point thereafter, is increasingly used to enroll patients into hyperacute stroke trials in Canada and Europe, though it is not permitted in the United States. Deferral of consent offers several potential advantages – quicker door-to-randomization, increased enrolment, decreased selection bias – but these must be balanced against the risk of enrolling patients against their wishes. We seek to minimize the attendant risks of deferral of consent by offering practical guidance regarding how to conduct acute stroke trials using deferral of consent. Building upon existing guidelines and recent experiences with deferral of consent in acute stroke trials, we have developed a protocol for the use of deferral of consent that aims to maximize patient involvement while minimizing ethical and scientific risks.

Advance Consent in Acute Stroke Trials: Survey of Canadian Research Ethics Board Chairs

“…1 Deferral of consent, an exception to consent allowed under Article 3.8 of the TCPS-2, is currently a common practice in the conduct of acute stroke trials in Canada but is not widely adopted in Quebec nor allowed in the United States. 9 We would have expected REB respondents to prefer advance consent over deferral of consent, in that participants have an opportunity to provide or decline informed consent before enrollment in a trial, though this was not the case. The results of our survey show no clear preference for the use of advance consent over deferred consent, with comments emphasizing the importance of the study's context when choosing between both approaches.…”

Deferral of Consent in Randomized Clinical Trials of Acute Stroke

“…This is also true in a situation that calls for immediate action, aimed at improving outcome of a patient with acute stroke. In this issue of Neurology® , Faris et al 1 clearly described 5 important and concise checkpoints for implantation of deferral of consent (DOC). DOC means that a treatment of yet unproven benefit is allocated to patients in the context of a randomized trial, without their knowledge.…”