受试者保护体系构建的困境及思考  

The Dilemma and Consideration about the Construction of the Subject Protection System

作　　者：张增瑞 刘小燕 陈刘流 郑洋 陈正君 ZHANG Zengrui;LIU Xiaoyan;CHEN Liuliu;ZHENG Yang;CHEN Zhengjun(The Clinical Research Ethics Committee,Aff iliated Hospital of Southwest Medical University,Luzhou 646000,China;School of Public Health,Southwest Medical University,Luzhou 646000,China;Graduate School of Southwest Medical University,Luzhou 646000,China;National Drug Clinical Trial Institution,Aff iliated Hospital of Southwest Medical University,Luzhou 646000,China)

机构地区：[1]西南医科大学附属医院临床试验伦理委员会,四川泸州646000 [2]西南医科大学公共卫生学院,四川泸州646000 [3]西南医科大学研究生院,四川泸州646000 [4]西南医科大学附属医院国家药物临床试验机构,四川泸州646000

出　　处：《中国医学伦理学》2022年第11期1209-1213,共5页Chinese Medical Ethics

基　　金：2020年西南医科大学校级课题“地方医学院校人体研究受试者保护体系构建的困境及对策研究”(2020-ZSQN-023);2018年四川省科技厅条件平台项目“医疗联合体专科联盟一体化网络平台建设”(2018TJPT0051)。

摘　　要：单纯依靠伦理委员会对受试者保护是不足的,受试者保护体系的建立是受试者权益保护的必然趋势。从法规和行政监管的不足、医院重视程度不够、受试者保护体系构建不畅、相关人员责任缺位四个方面对中国受试者保护体系的现状进行阐述,并从完善法规及加强监管、动员相关部门参加、加强相关培训三个方面提出了应对措施,以期规范受试者保护体系的构建,促进受试者保护工作的开展。Relying only on the ethics committee to protect subjects is not enough,and the construction of the subject protection system is an inevitable trend for the protection of subjects rights.This paper elaborated on the current situation of Chinese subject protection system from four aspects:the lack of laws and regulations and administrative supervision,the insufficient attention of hospitals,poor construction of the subject protection system,and the absence of responsibilities of relevant personnel.Then this paper put forward countermeasures from three aspects:improving laws and regulations and strengthening supervision,mobilizing relevant departments to participate,and strengthening relevant training,in order to standardize the construction of the subject protection system and promote the development of the subject protection work.

关 键 词：受试者保护体系 伦理委员会 受试者权益 

分 类 号：R-052[医药卫生]