多中心临床试验伦理审查工作的开展及完善  

The development and improvement of ethical review of multi-center clinical trial

作　　者：叶苗苗 陈苑[1] 许小慧 张园海[1] 朱雪琼[1] 

机构地区：[1]温州医科大学附属第二医院,325027

出　　处：《中华医学科研管理杂志》2018年第1期69-72,共4页Chinese Journal of Medical Science Research Management

摘　　要：目的完善多中心临床试验伦理审查工作方式。方法分析目前我国多中心临床试验伦理审查的各种方式及其利弊，阐述我院多中心临床试验伦理审查工作的逐步开展及完善。结果我国多中心临床试验伦理审查方式主要包括以下4种方式：第一，各单位均单独进行伦理审查；第二，组长单位伦理审查，参加单位备案；第三，中心伦理审查；第四，协作伦理审查；该4种方式均各有利弊。医院目前采用的为协作伦理审查方式。结论协作伦理审查方式实现了多中心临床试验各参加单位的一致性和及时性。Objective Improve theethical review models of multi-center clinical trial. Methods Analyze the ethical review models of multi-center clinical trial in China, and summarize advantages and disadvantages of the different methods. Then, clarify the development of ethical review methods of multi-center clinical trial in our hospital Results Four methods were used to review the multi-cen- ter clinical trial in China, including independent ethical review, central institutional ethical review, central review made by committee cooperation, collaborative review. Each method has its advantages and disadvantages. Collaborative review about multi-center clinical trial is adopted now in our hospital. Conclusions Using collaborative review model of multi-center clinical trial, the ethical review could achieve timely and uniformly.

关 键 词：多中心临床试验 伦理委员会 受试者 伦理审查 

分 类 号：R-052[医药卫生]