[法国IRB研究:伦理委员会对研究的评价]
Charles-Hervé Vacheron1, Arnaud Friggeri1, Maxime Lambert2
1Département d'anesthésie-réanimation, centre hospitalier Lyon sud, hopices civils de Lyon, 69000 Lyon, France; Centre international de recherche en infectiologie (CIRI) (Team PHE3ID), Inserm U1111, CNRS, UMRS5308, ENS Lyon, université de Lyon, université Claude-Bernard Lyon 1, 69007 Lyon, France.
概括
法国研究伦理委员会 (CER) 和保护人员委员会 (CPP) 在合格的健康研究项目中显示出显著的异质性. 需要进行标准化的培训,以确保对涉及人类受试者 (RIPH) 和非RIPH研究的研究调查的一致资格.
科学领域:
- 卫生研究伦理 卫生研究伦理
- 临床试验监督 临床试验监督
- 监管科学 监管科学
背景情况:
- 在法国,涉及人类受试者的研究 (RIPH) 受到个人保护委员会 (CPPs) 的强制性法律审查.
- 其他健康研究由研究伦理委员会 (CER) 进行评估,没有明确的法律框架,导致各种评估途径.
- 研究作为RIPH或非RIPH (RNIPH) 的资格决定了应用的监管审查.
研究的目的:
- 评估CER和CPP在符合RIPH或RNIPH条件的健康研究项目的表现.
- 以2021年Inserm指南作为标准来识别资格过程中的不一致性.
- 为了比较CER和CPP之间的资格一致性.
主要方法:
- 与大学,医院和医学协会联系,以确定参与的CER和CPP.
- 管理一个在线问卷,包含四个案例研究,以资格委员会成员.
- 对Inserm"健康研究资格指南"进行评估,以进行个人和委员会级别的分析.
主要成果:
- 35个中心参与,产生了175个个人回复.
- 个人成员与INSERM指南的一致性在61%至79%之间.
- 各委员会在资格方面观察到显著的异质性,CER和CPP之间没有明显的差异.
结论:
- 在CER和CPP如何资格健康研究项目方面存在很大差异.
- 委员会类型 (CER或CPP) 没有影响观察到的异质性.
- 对所有委员会实施标准化的信息和培训对于协调研究资格程序至关重要.
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