Objective To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent (EFIC) research and understanding of the proposed study. Design A cognitively pre-tested survey instrument was administered to 2,612 community consultation participants at 12 US centers participating in a multi-center trial of treatment for acute traumatic brain injury (TBI). Setting Survey nested within community consultation for a Phase III, randomized controlled trial of treatment for acute TBI conducted within a multi-center trial network and using EFIC. Subjects Adult participants in community consultation events. Interventions Community consultation efforts at participating sites. Measurements and Main Results Acceptance of EFIC in general, attitude toward personal EFIC enrollment, and understanding of the study content were assessed. 54% of participants agreed EFIC was acceptable in the proposed study; 71% were accepting of personal EFIC enrollment. Participants in interactive versus non-interactive community consultation events were more accepting of EFIC in general (63% vs. 49%) and personal EFIC inclusion (77% vs. 67%). Interactive community consultation participants had high-level recall of study content significantly more often than non-interactive consultation participants (77% vs. 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs. 45%) but less likely to recall potential risks (56% vs. 69%). Conclusions Interactive community consultation methods were associated with increased acceptance of EFIC and greater overall recall of study information but lower recall of risks. There was also significant variability in EFIC acceptance among different interactive consultation events. These findings have important implications for IRBs and investigators conducting EFIC research and for community engagement efforts in research more generally.
Study Objective: Clinical trials conducted under the Exception from Informed Consent (EFIC) Guidelines (21 CFR 50.24) require investigators to attempt prospective consent if possible before enrolling patient under EFIC. Investigators subsequently obtain consent for continued participation for patients enrolled under EFIC when a legally authorized representative (LAR) becomes available. The objective of this study is to describe the timing of patient enrollment into a traumatic brain injury study conducted under EFIC. Methods: This study is a post hoc analysis of prospectively collected data from a randomized, controlled traumatic brain injury clinical trial evaluating the effectiveness of progesterone vs. placebo on patients 18 years and older who have sustained a moderate to severe brain injury (GCS 4-12). The study protocol required study drug to be started within 4 hours from time of injury. Research teams had 60 minutes from patient arrival to the facility to make meaningful contact with an LAR before enrolling the patient under EFIC. If an LAR was identified and at the facility within 60 minutes of arrival, the study team attempted to obtain prospective consent. If no LAR was identified within that timeframe, patients were enrolled under EFIC and subsequently consented for continued participation at a later time. Descriptive statistics for the patient population were tabulated, and time from injury to randomization and study drug start were calculated for the EFIC and consent groups. Time to consent intervals and Kaplan-Meier curves for the EFIC and LAR consent groups were also calculated. Results: A total of 882 patients were randomized between April 2010 and October 2013 (442 progesterone, 440 control). Patient demographics were balanced between groups, with a median age of 35 years, 73.7% male, 15.2% black, and a median GCS of 7. The most frequent mechanism of injury was a motor vehicle crash. Six hundred fifteen patients were enrolled under EFIC (69.7%). Median time from injury to consent was 2 hours, 55 minutes (IQR 2:25-3:30) hours for patients enrolled with prospective consent. Patients enrolled under EFIC had a median time from injury to consent for continued participation of 19 hours (IQR 5:14-23:26). The median time from injury to randomization for the EFIC group was lower compared to the consent group [2:45 (IQR 2:19-3:13) versus 3:15 (IQR 2:42-4:08)], as was time from injury to study drug initiation [3:37 (IQR 3:10-3:57) versus 3:54 (IQR 3:31-4:01)]. For the prospective consent group, the cumulative prospective consent rate at 1, 2, 3, and 4 hours from time of injury was 1%, 8%, 56%, and 100%, respectively. Conclusions: As expected, a larger number of patients were enrolled under EFIC, and patients enrolled under EFIC had faster time to randomization and study drug start compared to patients enrolled under consent. For patients enrolled using traditional prospective consent, the vast majority were enrolled between 2 and 4 hours from time of injury. The range of time to subsequent consent for pati...
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