Objective: Research in acute illness often requires an exception from informed consent. Few studies have assessed the views of patients enrolled in exception from informed consent trials. This study was designed to assess the views of patients and their surrogates of exception from informed consent enrollment within the context of a randomized, placebo-controlled trial of an investigational agent for traumatic brain injury.
Design: Interactive interview study.
Setting: Nested within the Progesterone for the Treatment of Traumatic Brain Injury trial, a Phase III randomized controlled trial in acute traumatic brain injury.
Subjects: Patients and surrogates (for patients incapable of being interviewed) enrolled in Progesterone for the Treatment of Traumatic Brain Injury under exception from informed consent at 12 sites.
Interventions: None.
Measurements and main results: Interviews focused on respondents' acceptance of exception from informed consent enrollment in Progesterone for the Treatment of Traumatic Brain Injury, use of placebo and randomization, understanding of major study elements, and views regarding regulatory protections. Descriptive statistical analysis was performed; textual data were analyzed thematically. Eighty-five individuals were interviewed. Eighty-four percent had positive attitudes toward Progesterone for the Treatment of Traumatic Brain Injury inclusion. Seventy-eight percent found their inclusion under exception from informed consent acceptable, and 72% found use of exception from informed consent in Progesterone for the Treatment of Traumatic Brain Injury acceptable in general. Only two respondents clearly disagreed with both personal and general exception from informed consent enrollment. The most common concerns (26%) related to absence of consent. Eighty percent and 92% were accepting of placebo use and randomization, respectively. Although there were few black respondents (n = 11), they were less accepting of personal exception from informed consent enrollment than white respondents (55% vs 83%; p = 0.0494).
Conclusions: Acceptance of exception from informed consent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants. Exception from informed consent enrollment appears generally consistent with patients' preferences.