药物临床试验伦理委员会监管及改进对策

Discussion of Supervision of the Ethics Committee in Drug Clinical Trials and Improvement Suggestions

药物临床试验中,伦理委员会的作用多体现在初始审查,在跟踪审查中,一般根据主要研究者申请来安排审查,较为被动。本文根据相关法律法规与笔者所在医院实际,试就伦理委员会主动监管作用进行探讨。分别从跟踪审查的常规审查、实地访查、宣教沟通与自身建设等方面进行论述。

In most cases, the ethics committee plays an important role in the initial review in drug clinical trials. While in the follow-up review, the committee is more passive because of the ethical review only conducted after application in general. We discussed the advantages of active supervision of the ethics committee based on relevant laws and regulations, and practice in our hospital, from four aspects including routine follow-up review, field visit, educational communication and self construction.