• Neal W Dickert, Victoria A Mah, Michelle H Biros, Deneil M Harney, Robert Silbergleit, Jeremy Sugarman, Emir Veledar, Kevin P Weinfurt, David W Wright, and Rebecca D Pentz.
• 1Division of Cardiology, Emory University School of Medicine, Department of Epidemiology, Rollins School of Public Health, and Atlanta VA Medical Center, Atlanta, GA. 2Division of Cardiology, Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, Atlanta, GA. 3Department of Emergency Medicine, University of Minnesota School of Medicine, Minneapolis, MN. 4Department of Emergency Medicine, University of Michigan School of Medicine, Ann Arbor, MI. 5Berman Institute of Bioethics, School of Medicine, and Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD. 6Division of Cardiology, Emory Clinical Cardiovascular Institute, Emory University School of Medicine, Atlanta, GA and Baptist Health South Florida, Center for Research Grants, Miami, FL. 7Department of Psychiatry and Behavioral Sciences, Department of Psychology and Neuroscience, Duke University School of Medicine, Duke Clinical Research Institute, Durham, NC. 8Department of Emergency Medicine, Emory University School of Medicine, Atlanta, GA. 9Winship Cancer Institute, Emory University School of Medicine, Atlanta, GA.
• Crit. Care Med.. 2014 Feb 1;42(2):272-80.

ObjectivesTo 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 research and understanding of the proposed study.DesignA cognitively pretested survey instrument was administered to 2,612 community consultation participants at 12 U.S. centers participating in a multicenter trial of treatment for acute traumatic brain injury.SettingSurvey nested within community consultation for a phase III randomized controlled trial of treatment for acute traumatic brain injury conducted within a multicenter trial network and using exception from informed consent.SubjectsAdult participants in community consultation events.InterventionsCommunity consultation efforts at participating sites.Measurements And Main ResultsAcceptance of exception from informed consent in general, attitude toward personal exception from informed consent enrollment, and understanding of the study content were assessed. Fifty-four percent of participants agreed exception from informed consent enrollment was acceptable in general in the proposed study; 71% were accepting of personal exception from informed consent enrollment. Participants in interactive versus noninteractive community consultation events were more accepting of exception from informed consent in general (63% vs 49%) and personal exception from informed consent inclusion (77% vs 67%). Interactive community consultation participants had high-level recall of study content significantly more often than noninteractive 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%).ConclusionsInteractive community consultation methods were associated with increased acceptance of exception from informed consent and greater overall recall of study information but lower recall of risks. There was also significant variability in exception from informed consent acceptance among different interactive consultation events. These findings have important implications for institutional review board and investigators conducting exception from informed consent research and for community engagement efforts in research more generally.

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