社区接受儿科预先医院例外的知情同意试验
Matt Hansen1, Shannon W Stephens2, Miriam R Elman3
1Department of Emergency Medicine, Oregon Health & Science University, Portland, Oregon, USA.
概括
社区成员在很大程度上支持了儿科医院前呼吸道复苏试验 (Pedi-PART). 父母和受过高等教育的人群对这种紧急护理研究表现出更大的支持.
科学领域:
- 紧急医疗研究的研究.
- 儿科重症监护 儿科重症监护 儿科重症监护
- 临床试验伦理学临床试验伦理学
背景情况:
- 联邦知情同意豁免 (EFIC) 条例允许在特定条件下进行紧急研究.
- 社区咨询和公开披露 (CC/PD) 是EFIC合规的组成部分.
- 评估社区接受对于儿科紧急护理试验至关重要.
研究的目的:
- 评估社区对儿科医院前呼吸道复苏试验 (Pedi-PART) 的接受度.
- 确定与支持试验相关的人口特征.
- 在调查受访者中确定试验批准的预测因素.
主要方法:
- 使用商业调查平台 (Qualtrics Inc.) 获取社区反.
- 作为Pedi-PART的CC/PD活动的一部分,进行了18个问题调查.
- 分析了人口统计数据和支持水平,以确定批准预测因素.
主要成果:
- 超过6700人完成了调查,对Pedi-PART的总体支持很高.
- 根据性别,种族/种族和父母身份,支持略有不同.
- 高等教育水平和作为父母/监护人与试验支持有显著的关联.
结论:
- 该Pedi-PART试验得到了社区的大量支持.
- 父母地位和高等教育程度成为影响接受的关键因素.
- 社区参与战略有效地衡量了公众对紧急研究的看法.
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