Consulting Communities When Patients Cannot Consent: A Multicenter Study of Community Consultation for Research in Emergency Settings
Consulting Communities When Patients Cannot Consent: A Multicenter Study of Community Consultation for Research in Emergency Settings
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DOI：
10.1097/ccm.0b013e3182a27759
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发表时间：
2014-02-01
影响因子：
8.8
通讯作者：
Pentz, Rebecca D.
中科院分区：
文献类型：
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作者：
Dickert, Neal W.;Mah, Victoria A.;Pentz, Rebecca D.
目标：评估在大型网络中进行的社区咨询工作的反应范围，以及不同咨询方法对接受知情同意研究例外情况和理解拟议研究的影响。设计：对参与急性创伤性脑损伤多中心试验的美国 12 个中心的 2,612 名社区咨询参与者使用了认知预测试的调查工具。设置：在多中心试验网络中进行的一项针对急性创伤性脑损伤治疗的 III 期随机对照试验的社区咨询中嵌套的调查受试者：社区咨询活动中的成年参与者。干预措施：参与地点的社区咨询工作。测量和主要结果：评估一般情况下对知情同意例外的接受程度、对知情同意登记中的个人例外的态度以及对研究内容的理解。 54% 的参与者同意，在拟议的研究中，知情同意登记的例外情况总体上是可以接受的； 71% 的人接受知情同意登记中的个人例外。与非互动社区咨询活动相比，互动社区咨询活动的参与者总体上更能接受知情同意例外情况（63% vs 49%），以及个人知情同意例外情况（77% vs 67%）。互动社区咨询参与者对研究内容的高水平回忆明显高于非互动咨询参与者（77% vs 67%）。互动咨询的参与者更有可能回忆起可能的研究益处（61% vs 45%），但不太可能回忆起潜在的风险（56% vs 69%）。结论：互动社区咨询方法与对知情同意例外情况的接受程度提高以及对研究信息的整体回忆能力更强但对风险的回忆能力较低有关。在不同的互动咨询活动中，接受知情同意的例外情况也存在显着差异。这些发现对于机构审查委员会和研究者进行知情同意研究例外以及更广泛的社区参与研究工作具有重要意义。
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.