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个人公开披露:满足监管要求的新范式,在知情同意的例外之下
Catherine E Ross1,2, Monica E Kleinman3, Michael W Donnino2,4
1Division of Medical Critical Care, Department of Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, MA.
在信息化同意的例外 (EFIC) 试验中个人公开披露尊重自主权,但面临挑战. 许多家庭选择退出,快速临床事件限制了招生效率.
科学领域:
- 临床试验 临床试验
- 生物伦理学生物伦理学
- 公共卫生 公共卫生
背景情况:
- 从知情同意 (EFIC) 规则的例外要求紧急研究的公开披露.
- 在临床研究中,知情同意对于患者自主性至关重要.
- 在重症监护机构中,平衡研究需求与伦理考虑至关重要.
研究的目的:
- 描述和评估一个新的"个人公开披露"方法,以满足儿科重症监护室 (PICU) 的EFIC要求.
- 评估面对面或电话通知对患者/家庭自主性和试验招生的可行性和影响.
主要方法:
- 在一个学术儿童医院的儿科重症监护室 (PICU) 进行了一项单臂干预研究.
- "个人公开披露"涉及研究小组成员在PICU入院时通知可能有资格的家庭关于试验.
- 家庭可以选择未来的参与,并跟踪入学率.
主要成果:
- 在16个月的时间里,与1577个家庭进行了联系;30%的家庭选择退出.
- 只有14%的经历关键事件的患者被录取,69%的因事件发生在披露之前而错过的注册.
- 所有9名被录取的患者都同意继续收集数据.
结论:
- 个人公开披露可以支持EFIC试验中的患者/家庭自主权.
- 该方法在成本效益,可行性和适当性方面表现出局限性,原因是快速的临床事件和选择退出率.
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