生物样本库知情同意研究
Research on informed consent of biological sample biobank
郑君 1李义庭 2李鑫1
作者信息
- 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
- 折叠
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.
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引用本文复制引用
出版年
2025
国家科技期刊平台
NSTL
万方数据