对伦理审查委员会(IRB)监管体制的分析与思考  

Analysis and Reflection on Inspection System of Institutional Review Board (IRB)

作　　者：胡林英[1] 

机构地区：[1]北京大学医学部医学伦理学教研室,北京100083

出　　处：《中国医学伦理学》2006年第2期17-19,共3页Chinese Medical Ethics

摘　　要：伦理审查委员会自身审查能力的提高与其外部监管是相辅相成,互相促进的。随着我国伦理审查委员会的建立和发展,对IRB的监管体制的相对滞后已经难以满足IRB体系完善和规范化发展的需要。这在我国还是一个崭新的课题。本文试图从我国IRB面临的主要问题、国外IRB监管制度的经验,及其对中国构建IRB监管机制的启示等方面,对这一问题做初步的分析和思考。The improvement of IRB＇ s internal reviewing capability and the external inspection on it supplement each other and support mutually. With establishment and development of IRB in our country, the lag of the inspection system on IRB is becoming more and more difficult to met the needs of the development of IRB system and its standardization process. The inspection system on IRB is still a new conception in China so far. This paper is trying to make a primary analysis and reflection on this issue through focusing on the major challenges Chinese IRBs are facing, the relative experiences from foreign countries and their inspiring value to the construction of the inspection system on IRBs in China.

关 键 词：伦理审查委员会 监管体制 美国 

分 类 号：R-052[医药卫生]