涉及人的生物医学研究的伦理审查：加快审查  

Ethical review of biomedical research involving human subjects:expedited review

作　　者：汪秀琴[1,2] 熊宁宁[2] 刘沈林[2] 李七一[2] 蒋萌[2] 刘芳[2] 邹建东[2] 高维敏[2] 薛学坤[2] 

机构地区：[1]南京中医药大学 [2]南京中医药大学附属医院临床药理科,江苏南京210029

出　　处：《中国临床药理学与治疗学》2007年第12期1398-1400,共3页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：国家科学技术部"药物临床研究关键技术研究与应用"课题资助(2006BAI14807)

摘　　要：伦理委员会对涉及人的生物医学研究的审查可以分为会议审查和加快审查。加快审查的前提条件为研究风险不大于最小风险。本文参照国际指南并结合我国审查涉及人的生物医学研究的机构伦理委员会的审查范围,提出了适用加快审查的研究类别和操作程序,同时指出了实施加快审查的几点注意事项。There are two modes of Institutional Review Board （IRB） review： ＂expedited＂ and ＂full board＂ or ＂full committee＂ review. The preliminary requirement of expedited review is minimal risk. Taking some international guidelines as reference, and considering the scope of review of IRB which review biomedical research involving human subjects in China as well, this paper put forward the categories of research subject to expedited review and the operating procedure of expedited review, point out several items which should be paid attention to when conducting expedited review in the meantime.

关 键 词：生物医学研究 伦理委员会 加快审查 

分 类 号：R969[医药卫生—药理学]