中国医学伦理学2025，Vol.38Issue(1)：72-77,6.DOI:10.12026/j.issn.1001-8565.2025.01.11
生物样本库知情同意研究
Research on informed consent of biological sample biobank
摘要
Abstract
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Key words
biological sample biobank/informed consent/research participant/human genetic resource分类
医药卫生引用本文复制引用
郑君,李义庭,李鑫..生物样本库知情同意研究[J].中国医学伦理学,2025,38(1):72-77,6.基金项目
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) （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) （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) （DFL20221601）
