伦理审查委员会跟踪审查制度探析

Exploration and Analysis of Tracking Review by Ethics Review Committee

伦理审查委员会对研究项目的跟踪审查是保障受试者权益的核心手段。通过对国内外跟踪审查相关法规的梳理,界定了跟踪审查的概念,探讨了跟踪审查的意义。在介绍了美国、中国台湾以及我国跟踪审查现况的基础上,提出了完善我国跟踪审查制度的一些建议。

Tracking review of research projects is a principal method to protect subjects. By studying relevant laws and reg- ulations of other countries and regions, the paper defines the concept of tracking review and discusses its significance. The paper also makes an introduction of the status of tracking review system in United States, Taiwan and China Mainland. After making some comparisons, the paper gives a series of suggestions for improving the system in China.