伦理委员会持续审查制度建设探讨

A Brief Discussion on the Continuing Review Policy Construction of Institutional Review Board

持续审查作为伦理审查的重要环节,是保护受试者的重要机制。但在我国的伦理审查实践中,持续审查却一直没有得到应有的重视和规范。究其原因,不仅是因为相关法律法规的缺失,还因为在执行层面也缺少相对明确和具体的制度和标准操作规程。在借鉴美国持续审查制度建设相关经验的基础上,结合北京大学生物医学伦理委员会制度建设实践,对持续审查的范围、频率、形式、内容和标准等问题展开论述和探讨。

Continuing review,as one of the key procedures of ethical review,is one of the most important mechanisms that protecting human subject.However,it is always underestimated in the practice of ethical review in China.This is not only because of the absence of related laws and regulations in the field of human subject protection,but also the lack of practical policies and standard operation procedures in the practice.In this article,the author will have a brief discussion of the scope,frequency,formation,content and criteria of continuing review based on the consideration of U.S.experiences and the system construction practices of Peking University Institutional Review Board.