2026 Volume 43 Issue 3 Pages 165-169
Clinical trials targeting hyperacute conditions such as stroke require the initiation of treatment and research interventions within extremely limited time windows, often summarized by the phrase “Time is Brain.” Under these circumstances, obtaining appropriate informed consent (IC) poses significant practical and ethical challenges, particularly when patients are unable to provide consent themselves. Clinical trials in emergency situations, therefore, involve complex interactions among clinical urgency, research ethics, and regulatory requirements.
Alternative approaches to informed consent, including exception from informed consent (EFIC) and deferred consent, have been developed in the United States and Europe to address these challenges in acute stroke trials. In Japan, however, several issues persist, including legal and regulatory constraints, ethics review processes, operational challenges in clinical practice, and a limited public understanding of emergency clinical research.
In response to these challenges, the REFINED–IC research group (“Research on ELSI of Deferred INformed consent in clinical trials for stroke and Emergency Medicine : International Comparison”) engages diverse stakeholders―researchers, clinical trial professionals, ethics and legal experts, and members of the public―to investigate regulatory frameworks and implementation practices in Japan and beyond, assess public attitudes, and delineate practical challenges related to informed consent in emergency clinical trials.
