The high hurdle clinical researchers face in obtaining informed consent for trial participation

Abstract

Stroke therapy in the hyperacute stage must be initiated within a limited time window after symptom onset, and clinical practice is often conducted under severe time constraints. When enrolling patients into clinical trials, investigators must also obtain informed consent within this restricted time frame. The authors have conducted clinical trials in this manner for many years. However, stroke patients frequently have consciousness disturbance or aphasia, making communication difficult, and in many cases no legally authorized representative is present, such as when patients live alone. Excluding such patients from clinical trials not only delays trial progress but may also introduce selection bias, resulting in study populations that do not adequately reflect the full spectrum of the disease. Therefore, simplification of informed consent procedures or the use of consent waivers in clinical trials involving acute stroke patients should be actively considered to ensure appropriate trial conduct.