Exploring the current use and future of alternatives to traditional informed consent in acute stroke trials

University of CincinnatiNov 8 2024

The University of Cincinnati's Yasmin Aziz, MD, and Joseph Broderick, MD, coauthored an editorial published Nov. 7 in the journal Neurology analyzing the current use and potential future of alternatives to traditional informed consent in acute stroke trials. 

Patient informed consent is a crucial part of ethical clinical trial design and implementation, but time is of the essence for stroke trials. Approximately 2 million neurons die each minute they are deprived of oxygen, and patients are also sometimes incapacitated and therefore unable to consent to a trial, highlighting the need for emergency consent in certain cases. 

There is currently no worldwide standard for emergency consent for stroke trials, with various approaches taken by different countries. 

This editorial is intended to educate the greater neurology community about these consent procedures and their current relevance to stroke research in particular."

Yasmin Aziz, MD, assistant professor in the Department of Neurology and Rehabilitation Medicine in UC's College of Medicine and a UC Health physician

Broderick is principal investigator of the FASTEST trial, the first acute stroke trial in the United States to use exception from informed consent (EFIC) protocols. 

"...Community consultation and public disclosure are unique to EFIC," the authors wrote. "Both requirements can be quite expensive and time-consuming, delaying study start-up. Efforts to make EFIC more efficient and less costly in the US are ongoing." 

The coauthors noted as the field continues to explore the most effective and efficient alternatives to prospective informed consent, the "principles of patient autonomy and beneficence remain imperative." Aziz said improving consent procedures is an opportunity to "keep moving the chains forward" for stroke research. 

"The United States in particular has a very dark, very recent, unethical history with certain populations and the performance of clinical research," she said. "We need to find the best way to honor patient autonomy while moving research forward to ultimately get better treatments to the bedside."