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;42(2):272-80. doi: 10.1097/CCM.0b013e3182a27759.
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.
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.
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.
Adult participants in community consultation events.
Community consultation efforts at participating sites.
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%).
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.
评估在大型网络内进行社区咨询工作所得到的各种反馈,以及不同咨询方法对接受研究中知情同意豁免的影响,及其对研究提案的理解。
在参与一项多中心急性创伤性脑损伤治疗的临床试验的 12 个美国中心中,对 12 个中心的 2612 名社区咨询参与者进行了一项经认知前测试的调查工具。
在一个多中心试验网络中,对治疗急性创伤性脑损伤的 III 期随机对照试验进行社区咨询,使用了知情同意豁免。
参与社区咨询活动的成年人。
参与地点的社区咨询工作。
评估了对知情同意豁免的总体接受度、对个人知情同意豁免登记的态度以及对研究内容的理解。54%的参与者认为在拟议研究中,知情同意豁免登记总体上是可以接受的;71%的人接受个人知情同意豁免登记。与非互动式社区咨询活动相比,参与互动式社区咨询活动的参与者对知情同意豁免的总体接受度(63%比 49%)和个人知情同意豁免纳入(77%比 67%)更高。互动式社区咨询参与者对研究内容的记忆水平显著更高(77%比 67%)。与非互动式咨询参与者相比,互动式咨询参与者更有可能回忆起可能的研究益处(61%比 45%),但不太可能回忆起潜在风险(56%比 69%)。
互动式社区咨询方法与增加对知情同意豁免的接受度和对研究信息的总体回忆有关,但降低了对风险的回忆。不同的互动式咨询活动之间也存在知情同意豁免接受度的显著差异。这些发现对进行知情同意豁免研究的机构审查委员会和研究人员以及更广泛的社区参与研究工作具有重要意义。