人类生物样本库面临的伦理挑战及应对

Ethical challenges and countermeasures of human biobank

人类生物样本是事关公众健康和生物安全的战略性、公益性、基础性资源,对开展生命医学研究以及新药研发、科技创新都具有极其重要的价值,但管理不善也可能带来一系列伦理问题.本文针对目前国内外生物样本库发展相关的伦理讨论和研究进展进行综述,总结国内外伦理治理中的探索与进步.基于多年来对生物样本库的调研,文章聚焦于知情同意、隐私保护、共享利用、商业化应用、弱势群体保护这五大问题并作出分析,强调培养公众信任和加强伦理治理对于生物样本库的伦理管理的重要性.指出应该大力推动生物样本库服务于医疗、科研和社会的健康发展,提升中国在国际生物样本库伦理治理方面的影响力.

Human biospecimens are fundamental resources for the strategy and welfare related to public health and biosecurity.The specimens,while significantly advancing life science research,drug development,and technological innovation,also give rise to a series of ethical problems.This article summarizes current discussions and research progress on ethics in domestic and international biobanks,including the exploration and progress in ethical governance.Based on years of research on biobanks,the article concentrates on the analysis of five critical areas:informed consent,privacy protection,sharing and utilization,commercial application,and protection of vulnerable groups.The article emphasizes the importance of developing public credibility and enhancing ethical governance to better promote biobanks for medicine,science,and society,contributing to China’s influence in the ethical governance of international biobanks.