泛知情同意概念在我国的引入与实践思考  

Introduction and practice of broad consent in China

作　　者：彭华[1] 袁达[1] 黄鹂[1] 潘慧[1] 岳靓 姜海琳 韩丁[1] Peng Hua;Yuan Da;Huang Li;Pan Hui;Yue Liang;Jiang Hailin;Han Ding(Chinese Academy of Medical Sciences Peking Union Medical College Hospital,Beijing 100730,China;Beijing Huawei Law Firm,Beijing 100034,China;Department of Law,School of Humanities,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]中国医学科学院北京协和医院,北京100730 [2]北京市华卫律师事务所,北京100034 [3]北京中医药大学人文学院法律系,北京100029

出　　处：《中华医院管理杂志》2022年第3期222-224,共3页Chinese Journal of Hospital Administration

摘　　要：近年来国外正在逐步推行泛知情同意来提升医疗数据和生物样本的利用率,但泛知情同意可能面临着告知不完善而影响受试者权利等伦理问题。国外对于泛知情同意已有相关规定和实践。我国法律并未明确泛知情同意的概念,目前在实践中生物样本的处理大致可分为4类,存在泛知情同意的潜在适用空间。应明确泛知情同意的具体范围,与捐献行为作出区分,在保障受试者权利的基础上探索实施泛知情同意。In recent years,foreign countries are gradually implementing broad consent to improve the utilization of medical data and biological samples,but broad consent may face ethical issues such as imperfect notification and affecting the rights of subjects.There are already relevant regulations and practices on broad consent in foreign countries.The concept of broad consent is not clearly defined in China′s laws.At present,the treatment of biological samples can be roughly divided into four categories in practice,and there is potential application space for broad consent.The specific scope of broad consent should be clarified,distinguished from donation behavior,and the implementation of broad consent should be explored on the basis of protecting the rights of subjects.

关 键 词：知情同意 泛知情同意 临床试验 生物标本库 患者权利 隐私权 

分 类 号：D923[政治法律—民商法学] R-05[政治法律—法学]