医疗卫生机构生物样本库样本及信息采集泛知情同意书示范  

Model of broad informed consent form for sample and information collection in biobanks operated by healthcare institutions

作　　者：石宇辉 姚海嵩 张小燕 满秋红 王亚文[5] 丁帆 梁玮 朱伟 张易 杨亚军[1] SHI Yuhui;YAO Haisong;ZHANG Xiaoyan;MAN Qiuhong;WANG Yawen;DING Fan;LIANG Wei;ZHU Wei;ZHANG Yi;YANG Yajun

机构地区：[1]复旦大学生命科学学院,上海200438 [2]复旦大学生物医学研究院,上海200438 [3]上海芯超生物科技有限公司,201203 [4]同济大学附属上海市第四人民医院检验科,上海200434 [5]西安交通大学第一附属医院生物样本信息资源中心,710061 [6]复旦大学科学技术研究院,上海200438 [7]上海临床研究中心,201210 [8]复旦大学马克思主义学院,上海200438 [9]复旦大学附属中山医院临床医学研究院,200032

出　　处：《中国医药生物技术》2025年第S1期45-49,共5页Chinese Medicinal Biotechnology

基　　金：上海市卫生健康委员会科研项目(202240063)。

摘　　要：《医疗卫生机构生物样本库通用样本采集知情同意书示范范本》自2019年发布以来,备受认可。鉴于近年来国家法律法规的不断完善和伦理准则的适时更新,为准确反映新规要求,我们对旧版进行了修订,更加强调信息的利用和保护,讨论“去标识化”和“匿名化”的区别,阐述样本和信息可能的利用途径和范围,以及知识产权的分配、捐献者的获益等,重新修订形成了《医疗卫生机构生物样本库样本及信息采集泛知情同意书示范》文本,以供相关从业人员讨论和参考。The"Model General Informed Consent Form for Sample Collection in Biobanks Operated by Healthcare Institutions",which was originally released in 2019,has garnered widespread recognition.In light of the ongoing refinement of national laws,regulations,and ethical guidelines in recent years,we have revised the previous version to better align with the updated requirements.The new version places a stronger emphasis on the utilization and protection of information,clarifies the distinction between"de-identification"and"anonymization"in technical implementation,and provides detailed insights into the potential uses and scope of biospecimens and associated data.Additionally,it covers aspects such as intellectual property allocation and potential benefits for donors.In view of these revisions,we have introduced the"Model of Broad Informed Consent Form for Sample and Information Collection in Biobanks Operated by Healthcare Institutions"to serve as a reference and foundation for discussion among relevant practitioners.

关 键 词：医疗机构 人类生物样本库 知情同意书 知情同意 

分 类 号：R-052[医药卫生]