医疗卫生机构泛知情同意实施指南  

Guidelines for the Implementation of Broad Informed Consent in Medical and Health Institutions

作　　者：陈晓云[1] 沈一峰[2] 熊宁宁[3] 汪秀琴[4] 陆麒[5] 陈勇川 江一峰[7] 王美霞 许重远[9] 樊民胜[10] 伍蓉[11] 刘胜[12] CHEN Xiaoyun;SHEN Yifeng;XIONG Ningning;WANG Xiuqin;LU Qi;CHEN Yongchun;WANG Yifeng;WANG Meixia;XU Chongyuan;FAN Minsheng;WU Rong;LIU Sheng(Department of Medical Ethics Office,Longhua Hospital,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Shanghai Mental Health Center Office,Shanghai 200030,China;Department of Medical Ethics Committee,Jiangsu Province Hospital of Chinese Medicine,Nanjing 210029,China;Department of Scientific Research,Jiangsu People’s Hospital,Nanjing 210029,China;Department of Medical Ethics Office,Renji Hospital,Shanghai Jiaotong University,School of Medicine,Shanghai 200240,China;Department of Pharmacy,the First Hospital Affiliated to Army Medical University of Chinese PLA,Chongqing 400038,China;Shanghai General Hospital,Shanghai Jiaotong University,School of Medicine,Shanghai 200080,China;Department of Agency Office,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China;Central of Clinical Trail,Nanfang Hospital,Southern Medical University,Guangzhou 510515,China;10 Department of Ethics,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;11 Department of Medical Ethics Committee,Huashan Hospital Affiliated to Fudan University,Shanghai 310106,China;12 Department of Medical Ethics Committee,Longhua Hospital,Shanghai Universityof Traditional Chinese Medicine,Shanghai 201203,China)

机构地区：[1]上海中医药大学附属龙华医院医学伦理办公室,上海201203 [2]上海市精神卫生中心机构办公室,上海200030 [3]江苏省中医院医学伦理委员会,江苏南京210029 [4]江苏省人民医院科技处,江苏南京210029 [5]上海交通大学附属仁济医院医学伦理办公室,上海200240 [6]陆军军医大学第一附属医院药剂科,重庆400038 [7]上海交通大学附属第一人民医院伦理办公室,上海200080 [8]首都医科大学附属佑安医院机构办,北京100069 [9]南方医科大学南方医院药物临床试验中心,广东广州510515 [10]上海中医药大学伦理教研室,上海201203 [11]复旦大学附属华山医院伦理委员会,上海310106 [12]上海中医药大学附属龙华医院伦理委员会,上海201203

出　　处：《中国医学伦理学》2020年第10期1203-1209,共7页Chinese Medical Ethics

基　　金：上海市卫生和计划生育委员会科研课题“医疗大数据研究中信息伦理问题的调查与分析”(201840030)。

摘　　要：泛知情同意是知情同意的特殊形式,在医疗机构实施泛知情同意必须明确其实施范围,应首先建立医院管理层面严格的“治理体系”,来保证受试者的随时退出权、研究信息知晓权和隐私保护权等,在这样的体系架构下才可以实施泛知情同意的具体操作。对生物样本入库前的泛知情同意、临床诊疗数据授权使用的泛知情同意和临床研究剩余样本和数据的授权使用三种情形的泛知情同意书的设计进行了分类要点举例,并对医疗卫生机构的伦理审查侧重点,样本或数据的转移管理要求,研究结果的分享进行了全过程的实施指导。Broad informed consent is a special form of informed consent.To implement broad informed consent in medical institutions,its implementation scope must be clarified,and a strict“governance system”at the hospital management level should be established first to ensure that the subjects’exit right at any time,the research information about rights and privacy protection,etc.Under this architecture,the specific operation of informed consent can be implemented.This study gave examples of the key points of classification for the design of broad informed consent in three situations,including:the broad informed consent before the biological samples would put into the database,the broad informed consent for the authorized use of clinical diagnosis and treatment data,and the authorization of the remaining samples and data of clinical research.The focus of the ethical review of medical and health institutions,the transfer management requirements of samples or data,and the sharing of research results have been guided throughout the implementation process.

关 键 词：泛知情同意 治理系统 样本库 数据授权 

分 类 号：R-052[医药卫生]