生物样本库知情同意研究  

Research on informed consent of biological sample biobank

作　　者：郑君 李义庭[2] 李鑫 ZHENG Jun;LI Yiting;LI Xin(Department of Science and Technology,Beijing Ditan Hospital,Capital Medical University,Beijing 100015,China;Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学附属北京地坛医院科技处,北京100015 [2]首都医科大学,北京100069

出　　处：《中国医学伦理学》2025年第1期72-77,共6页Chinese Medical Ethics

基　　金：北京市卫健委高层次公共卫生技术人才建设项目“培育计划学科带头人——针对常见病、特殊人群及重点人群的健康促进”(学科带头人-03-21);首都卫生发展科研专项重点攻关项目“基于辨证论治艾滋病ART后免疫重建不良的临床疗效评价研究”(首发2024-1-1203);北京市医院管理中心“登峰”人才计划-中西医结合传染病(DFL20221601)。

摘　　要：随着生物样本库逐步在生物医学研究领域显现出的重大价值,其也对现有社会规范和伦理规则提出了挑战,使得研究参与者知情同意的规范性问题备受关注。当前研究对样本收集、保藏、利用等环节知情同意探讨不足,针对各环节复杂性与多样性,倡导细化知情同意策略,确保研究参与者权益得到全面保护。鉴于知情同意的持续性与动态性,建议构建灵活的复审机制,以应对研究内容变更、风险增加或研究参与者能力变化,确保研究的伦理合法性与研究参与者自主决定权。同时,强调在样本入库前充分确认知情同意,出库利用及废物处理时采取适宜同意形式,并特别关注人类遗传资源的相关伦理与法律问题。As biological sample biobanks progressively demonstrate their significant value in the field of biomedical research,they also pose challenges to existing social norms and ethical rules,making the normative issue of informed consent of participants highly concerned.The current research has insufficient exploration of informed consent in the collection,preservation,utilization,and other links of the sample.In response to the complexity and diversity of each link,it is advocated to refine informed consent strategies to ensure comprehensive protection of participants’rights and interests.Given the continuity and dynamism of informed consent,it is recommended to establish a flexible review mechanism to address changes in research content,increased risks,and changes in participant capabilities,ensuring the ethical legitimacy of the research and the autonomy in making decisions of participants.Meanwhile,it is emphasized to fully confirm informed consent before sample entry into the bank,adopt suitable consent forms for outbound utilization and waste disposal,and pay special attention to ethical and legal issues related to human genetic resources.

关 键 词：生物样本库 知情同意 研究参与者 人类遗传资源 

分 类 号：R-052[医药卫生]