摘要
针对伦理审查质量的含义进行了深入的剖析,对伦理审查质量体系的各个要素,包括法规框架,人员资质、独立性、管理和资源、审查工作的一致性和可预见性、明晰的职责流程等进行了逐一解释,同时提出质量管理环节中建立伦理委员会的内部评估机制,并定期进行独立于伦理委员会的第三方评估的重要意义。
The author explains the meaning of "Quality in Ethics Committee Review", introducing the quality elements which include the regulatory framework, the members' qualification, the independence, resource and administration, the consistency and predictability in review, standard operating procedure. He highlights that the internal and external review system play an important role in quality management.
出处
《医学与哲学(A)》
北大核心
2011年第5期6-7,11,共3页
Medicine & Philosophy:Humanistic & Social Medicine Edition
关键词
审查质量
独立性
一致性
可预见性
内部评估
外部评估
review quality, independence, consistency, predictability,internal review, external review