In acute stroke trials, where time is critical, researchers are exploring alternatives to traditional informed consent to balance ethical considerations with the urgency of treatment. A recent editorial in Neurology, co-authored by Yasmin Aziz, MD, and Joseph Broderick, MD, from the University of Cincinnati, examines the current use and potential future of these alternative consent methods.
The Challenge of Informed Consent in Stroke Trials
Stroke trials face a unique challenge: the rapid loss of neurons, approximately 2 million per minute of oxygen deprivation, necessitates swift action. Additionally, patients may be incapacitated and unable to provide consent. This creates a need for emergency consent protocols that respect patient autonomy while enabling timely research.
Exception From Informed Consent (EFIC)
Currently, there is no global standard for emergency consent in stroke trials. The FASTEST trial, led by Broderick, is the first acute stroke trial in the United States to utilize Exception From Informed Consent (EFIC) protocols. EFIC requires community consultation and public disclosure, which the authors note can be "quite expensive and time-consuming, delaying study start-up." Efforts are underway to streamline EFIC and reduce its costs.
Balancing Autonomy and Beneficence
Aziz emphasizes the importance of improving consent procedures to advance stroke research while upholding patient autonomy. "We need to find the best way to honor patient autonomy while moving research forward to ultimately get better treatments to the bedside," she said. The authors stress that the principles of patient autonomy and beneficence must remain central as the field explores effective and efficient alternatives to prospective informed consent.
The Future of Consent in Stroke Research
The editorial highlights the ongoing efforts to refine consent procedures in stroke trials, aiming for a balance between ethical considerations, research efficiency, and the need for timely interventions. The discussion also acknowledges the historical context of unethical research practices and the importance of ensuring patient protection in clinical trials.
