Neal W Dickert1, Victoria A Mah, Michelle H Biros, Deneil M Harney, Robert Silbergleit, Jeremy Sugarman, Emir Veledar, Kevin P Weinfurt, David W Wright, Rebecca D Pentz. 1. 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.
Abstract
OBJECTIVES: 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 research and understanding of the proposed study. DESIGN: A 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. SETTING: Survey 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. SUBJECTS:Adult participants in community consultation events. INTERVENTIONS: Community consultation efforts at participating sites. MEASUREMENTS AND MAIN RESULTS: Acceptance 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%). CONCLUSIONS: Interactive 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.
RCT Entities:
OBJECTIVES: 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 research and understanding of the proposed study. DESIGN: A 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. SETTING: Survey 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. SUBJECTS: Adult participants in community consultation events. INTERVENTIONS: Community consultation efforts at participating sites. MEASUREMENTS AND MAIN RESULTS: Acceptance 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%). CONCLUSIONS: Interactive 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.
Authors: Charles Contant; Laurence B McCullough; Lorna Mangus; Claudia Robertson; Alex Valadka; Baruch Brody Journal: Crit Care Med Date: 2006-08 Impact factor: 7.598
Authors: Robert Silbergleit; Valerie Durkalski; Daniel Lowenstein; Robin Conwit; Arthur Pancioli; Yuko Palesch; William Barsan Journal: N Engl J Med Date: 2012-02-16 Impact factor: 91.245
Authors: Deborah Fish Ragin; Edmund Ricci; Rosamond Rhodes; Jennifer Holohan; Margaret Smirnoff; Lynne D Richardson Journal: Soc Sci Med Date: 2008-01-30 Impact factor: 4.634
Authors: Jeremy Sugarman; Colleen Sitlani; Dug Andrusiek; Tom Aufderheide; Eileen M Bulger; Daniel P Davis; David B Hoyt; Ahamed Idris; Jeffrey D Kerby; Judy Powell; Terri Schmidt; Arthur S Slutsky; George Sopko; Shannon Stephens; Carolyn Williams; Graham Nichol Journal: Resuscitation Date: 2009-04-22 Impact factor: 5.262
Authors: David W Wright; Pamela L Clark; Rebecca D Pentz; Vicki Hertzberg; Arthur L Kellermann Journal: Ann Emerg Med Date: 2007-10-15 Impact factor: 5.721
Authors: Theresa L Chin; Ernest E Moore; Marilyn E Coors; James G Chandler; Arsen Ghasabyan; Jeffrey N Harr; John R Stringham; Christopher R Ramos; Sarah Ammons; Anirban Banerjee; Angela Sauaia Journal: Surgery Date: 2014-10-14 Impact factor: 3.982
Authors: Louisa W Whitesides; Jill M Baren; Michelle H Biros; Ross J Fleischman; Prasanthi R Govindarajan; Elizabeth B Jones; Arthur M Pancioli; Rebecca D Pentz; Victoria M Scicluna; David W Wright; Neal W Dickert Journal: Clin Trials Date: 2016-11-15 Impact factor: 2.486
Authors: Neal W Dickert; Victoria M Scicluna; Jill M Baren; Michelle H Biros; Ross J Fleischman; Prasanthi R Govindarajan; Elizabeth B Jones; Arthur M Pancioli; David W Wright; Rebecca D Pentz Journal: Crit Care Med Date: 2015-03 Impact factor: 7.598
Authors: Neal W Dickert; David Wendler; Chandan M Devireddy; Sara F Goldkind; Yi-An Ko; Candace D Speight; Scott Yh Kim Journal: Clin Trials Date: 2018-10-03 Impact factor: 2.486
Authors: Makini Chisolm-Straker; Denise Nassisi; Mohamud R Daya; Jennifer N B Cook; Ilene F Wilets; Cindy Clesca; Lynne D Richardson Journal: AJOB Empir Bioeth Date: 2020-09-29
Authors: Neal W Dickert; Kathleen Metz; Michael D Fetters; Adrianne N Haggins; Deneil K Harney; Candace D Speight; Robert Silbergleit Journal: Acad Emerg Med Date: 2021-05-26 Impact factor: 5.221
Authors: Nina H Gobat; Micaela Gal; Nick A Francis; Kerenza Hood; Angela Watkins; Jill Turner; Ronald Moore; Steve A R Webb; Christopher C Butler; Alistair Nichol Journal: Trials Date: 2015-12-29 Impact factor: 2.279
Authors: Spyros D Mentzelopoulos; Keith Couper; Patrick Van de Voorde; Patrick Druwé; Marieke Blom; Gavin D Perkins; Ileana Lulic; Jana Djakow; Violetta Raffay; Gisela Lilja; Leo Bossaert Journal: Notf Rett Med Date: 2021-06-02 Impact factor: 0.826