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Protocol for Deferral of Consent in Acute Stroke Trials
Hannah Faris1, Brian Dewar1, Mark Fedyk1
1From the Ottawa Hospital Research Institute (H.F., B.D., D.D., M.S.), Ottawa, Ontario, Canada; School of Medicine (M.F.), University of California, Davis; Department of Medicine (D.D., M.S.), University of Ottawa & the Ottawa Hospital, Ontario; Department of Clinical Neurosciences (B.M., M.D.H.), University of Calgary and Calgary Stroke Program, Alberta; and Department of Medicine (R.H.S.), University of Toronto & Sunnybrook Health Sciences Centre, Ontario, Canada.
Insights
Deferral of consent allows faster enrollment in hyperacute stroke trials, balancing speed with patient wishes. This guidance minimizes ethical risks for acute stroke research using this method.
Area of Science:
- Neurology
- Clinical Trials
- Medical Ethics
Background:
- Hyperacute stroke research faces challenges in obtaining timely informed consent.
- Deferral of consent is used in Canada and Europe but not the US for stroke trials.
- This method involves enrolling patients first, then obtaining consent later.
Purpose of the Study:
- To provide practical guidance for conducting acute stroke trials using deferral of consent.
- To minimize ethical and scientific risks associated with deferral of consent.
- To maximize patient involvement in stroke research.
Main Methods:
- Developing a protocol based on existing guidelines and recent experiences.
- Focusing on practical strategies to implement deferral of consent.
- Balancing potential benefits (quicker enrollment, reduced bias) against risks.
Main Results:
- A protocol has been developed for using deferral of consent in acute stroke trials.
- The protocol aims to enhance patient involvement while mitigating risks.
- Guidance is offered to navigate the ethical and scientific complexities.
Conclusions:
- Deferral of consent presents a viable strategy for hyperacute stroke research when ethically managed.
- Implementing a structured protocol is crucial for minimizing risks.
- This approach can improve patient enrollment and reduce selection bias in critical stroke interventions.
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, although 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 on 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.
