Public opinion of a stroke clinical trial using exception from informed consent

Background: Acute stroke is a leading cause of morbidity and mortality. Clinical trials in stroke are challenging because victims often do not have the capacity to provide informed consent, excluding those patients most likely to benefit from the research. Aim: We evaluated patient willingness to participate in a hypothetical acute stroke trial using an exception from informed consent. Methods: Consecutive patients presenting to four emergency departments (EDs) underwent structured interviews regarding a hypothetical stroke trial using an exception from informed consent. Results: Of 461 (72% of eligible) participants, 55% (95% CI, 50%-59%) were willing to be enrolled in the hypothetical study without giving informed consent. After multivariable analysis, independent predictors of willingness to enroll included Catholic religion (OR 1.57, 95% CI 1.17-2.10) and belief that current therapy offers a >50% chance of full recovery (OR 1.29, 95% CI 1.05-1.57). There was no difference between the proportion willing to enroll in a cardiac arrest study vs. a stroke study (55% vs. 55%, p=0.83) Conclusions: Fifty-five percent of ED patients would be willing to be enrolled in a stroke trial using exception from informed consent. © The Author(s) 2010.