Modernizing Canada’s Regulations for Clinical Trials in Medical Emergencies

Keywords: clinical trials; emergency; stroke• Health Canada recently announced the publication of proposed Clinical Trial Regulations, with specific sections addressing consent practices for clinical trials in medical emergencies.• These regulations aim to simplify existing guidelines on how clinical trials are conducted in Canada and modernize the regulatory framework to support innovation and reduce inefficiencies.• With this goal in mind, the proposed regulations can be modified to reframe the criteria that permit emergency consent procedures, clarify the extent of effort required to identify substitute decision-makers and consider the process of written consent in the context of participation in a clinical trial in a medical emergency.In December 2025, Health Canada announced updates to its Clinical Trial Regulations and invited public comment.Several of these updates pertain to the conduct of clinical trials in medical emergencies.As stroke researchers engaged in major clinical trials, we propose the following changes to consent practices for clinical trials conducted in medical emergencies: the justification of emergency consent procedures should be based on a model of minimizing harm; seeking consent from a substitute decision-maker should not go beyond the patient's bedside; and the written content of informed consent should be abbreviated in medical emergencies. What is the Current Emergency Consent Procedure in the Context of Acute Stroke Trials?