伦理委员会审查临床试验方案的常见问题及对策  

Common problems in the ethical review of clinical trial protocols and the countermeasures

作　　者：向宇[1] 谢囡[1] 刘云[1] 魏玉萍[1] 钱芳桥[1] 李娌[1] 王莹[1] 

机构地区：[1]北京大学第一医院科研处,北京100034

出　　处：《中国临床药理学杂志》2013年第2期158-160,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：随着临床研究的逐渐增多,涉及人的伦理问题也逐渐显现。伦理委员会的任务是审查临床试验方案是否合乎伦理要求,其肩负着确保受试者的安全、健康和权益受到保护等重要职责。本文结合实际工作,分析本院医学伦理申请及审查中容易遇到的问题并对此进行探讨。With the gradual increase of clinical researches, the ethical problems involving human are emerging. The ethics committee is responsible for the rationality of ethics in the clinical trial protocols and for the protection of the safety, health and legal rights of the subjects. The analysis and discussion were made on the common problems in the ethical application and review according to the work of the clinical research ethics committee of Peking University First Hospital.

关 键 词：临床试验方案 伦理委员会 知情同意 

分 类 号：R954[医药卫生—药学]