生物样本泛知情同意的撤回权及相关问题探讨  

Discussion on the Right to Withdraw Broad Consent of Biological Specimen and Related Issues

作　　者：李旭 王妍 刘玉秀 苏皖 LI Xu;WANG Yan;LIU Yuxiu(Hospital Administration Office,Jinling Clinical Medical College,Nanjing Medical University/General Hospital of Eastern Theater Command,PLA,Nanjing 210002,China)

机构地区：[1]南京医科大学金陵临床医学院/东部战区总医院院部,江苏南京210002 [2]南京医科大学金陵临床医学院/东部战区总医院重症医学科,江苏南京210002

出　　处：《医学与哲学》2023年第10期16-18,共3页Medicine and Philosophy

基　　金：2022年江苏省医学人文社会科学基金项目(JSWSFX-2022-2023-002)。

摘　　要：泛知情同意的撤回权是指通过泛知情同意模式参加生物样本库的捐献者具有随时撤销其泛知情同意的权利,其在国内外都有相应的法律与道德基础。明确这一权利符合捐献者、生物样本库等多方的长远利益,既能更好地保护捐献者,也对生物样本库建设有重要意义。一般情况下,捐献者可随时向生物样本库撤回泛知情同意,然而在涉及国家利益、干细胞治疗、样本去识别等特殊情况时,撤回权将受到一定限制。此外,我们提出信息交互平台的建设是泛知情同意撤回管理的优化策略,为有关机构进一步健全泛知情同意撤回制度和加强实践指导提供理论依据。The right to withdraw broad consent means that donors who participate in biobanks through the broad consent model have the right to withdraw broad consent at any time,and it has corresponding legal and ethical foundations at home and abroad.Clarifying this right benefit donors,biobanks and other parties in the long-term,which can not only better protect donors,but also has great significance for the construction of biobanks.Generally,donors can withdraw their broad consent from biobanks at any time,but the right of withdrawal will be limited when special circumstances such as national interests,stem cell therapy,and sample de-identification are involved.In addition,we propose that the construction of the information interaction platform is an optimal strategy for the management of broad consent withdrawal,which provides a theoretical basis for relevant institutions to further improve the withdrawal system and strengthen practical guidance.

关 键 词：生物样本 泛知情同意 撤回权 医学伦理 

分 类 号：R-05[医药卫生]