• Joshua N Goldstein, Janice A Espinola, Jonathan Fisher, Daniel J Pallin, and Carlos A Camargo.
• Int J Emerg Med. 2010 Nov 10; 3 (4): 385-9.

BackgroundAcute 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.AimWe evaluated patient willingness to participate in a hypothetical acute stroke trial using an exception from informed consent.MethodsConsecutive patients presenting to four emergency departments (EDs) underwent structured interviews regarding a hypothetical stroke trial using an exception from informed consent.ResultsOf 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)ConclusionsFifty-five percent of ED patients would be willing to be enrolled in a stroke trial using exception from informed consent.

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