关于国外伦理委员会管理制度研究

Management Systems of Ethics Committee in Some Foreign Countries

摘要: 随着创新药物临床试验和循证医学研究的不断发展，伦理委员会已成为受试者权益监管的主体部门。从各国的监管经验来看，伦理委员会在临床试验管理中发挥着重要的作用。通过文献检索的方式，分析总结欧盟、英国和美国的伦理委员会的管理制度、伦理委员会的构成、审查原则和审查效率，为改进和完善我国伦理委员会管理制度提供有价值的参考。

Abstract: With the continuous development of clinical trials of innovative drugs and evidence-based medicine research, Ethics Committee has become the main body of subject rights and interests supervision. From the regulatory experience in various countries, Ethics Committee plays an important role in clinical trial management.Through literature search, this article analyzes and summarizes the management system, composition, review principles and review efficiency of Ethics Committee in the European Union, the United Kingdom and the United States, in order to provide valuable reference for improving the management system of Ethics Committee in China.