关于伦理委员会是否应作为同情用药审查主体的探讨  

Discussion on whether ethics committee should serve as the review subject of compassionate drug use

作　　者：耿希 顾翠峰[1] 马俊坚[1] GENG Xi;GU Cuifeng;MA Junjian(Office of Ethics Committee,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属曙光医院伦理委员会办公室,上海201203

出　　处：《中国医学伦理学》2024年第2期214-218,共5页Chinese Medical Ethics

基　　金：2023年度上海中医药大学科技发展项目“同情用药伦理审查框架研究”(23KFW23)。

摘　　要：在中国相关法规未对同情用药审查主体予以明确的前提下,谁来承担审查和批准的责任存在争议。就同情用药的特点进行总结和阐述,从伦理委员会的职责、专业性和审查的必要性等方面展开讨论,认为伦理委员会应当作为同情用药审查主体,需对医生资质、风险受益比、知情同意书和利益冲突等方面进行重点审查。Under the premise that the relevant laws and regulations in China do not specify the review subject of compassionate drug use,it is controversial who should bear the responsibility for the review and approval.This paper summarized and elaborated on the characteristics of compassionate drug use,and discussed the responsibilities,professionalism,and necessity of review of the ethics committee.It is believed that the ethics committee should serve as the review subject of compassionate drug use,and focus on doctor qualifications,risk-benefit ratio,informed consent forms,and conflicts of interest.

关 键 词：同情用药 伦理委员会 伦理审查 风险受益比 

分 类 号：R-052[医药卫生]