摘要
2024版《赫尔辛基宣言》强调使用生物样本要获得研究参与者自由和充分知情的同意,伦理委员会要监管生物样本库的建立和持续使用,我国生物样本研究伦理治理面临诸多挑战。适应我国生物样本库快速发展亟须规范治理的现状,使用生物样本研究的伦理审查要点包括:研究剩余生物样本明确目的的二次使用应当获得自由和充分知情的同意;通过严格的治理体系保障泛知情同意有效实施;规范有效使用免知情同意;加强对生物样本库使用的监管;探索委托第三方生物样本库存储,以更加全面地保护研究参与者的权益,促进生物样本库的规范化运行和有效利用。
The 2024 revision of Declaration of Helsinki emphasizes on obtaining free and fully informed consent from research participants for the use of biospecimens.Ethical committees are tasked with overseeing the establishment and ongoing use of biobanks.China's ethical governance of biospecimen research faces numerous challenges amid the rapid development of biobanks.To address the urgent need for regulatory governance,key points for ethical review of biospecimen research include:obtaining free and fully informed consent for the secondary use of remaining biospecimens with clearly defined purposes;ensuring effective implementation of broad informed consent through strict governance systems;standardizing the appropriate use of consent exemptions;strengthening supervision over biobank usage;and exploring entrusted third-party biobank storage to more comprehensively protect participant rights.These measures aim to promote the standardized operation and effective utilization of biobanks.
作者
周吉银
徐玉梅
ZHOU Jiyin;XU Yumei(Clinical Research Center,Second Affiliated Hospital,Army Medical University,Chongqing 400037,China;College of Marxism,Shandong Second Medical University,Weifang 261053,China)
出处
《医学与哲学》
北大核心
2025年第14期28-32,共5页
Medicine and Philosophy
基金
2024年山东省研究生教育教学改革研究项目(SDYJSJGC2024055)
2023年山东省研究生优质课程项目(SDYKC2023144)
2023年山东省本科教学改革研究项目(M2023230)。
