| 摘要: |
| 传统生物医学研究的知情同意保护制度无法应对人类基因资料库研究集体性、开放性、长期性带来的挑战，面临同意表达、同意获取和同意变更困境。基于利益保护与技术发展平衡理念，知情同意制度的完善措施应当包括： 第一，坚持以个人为知情同意主体，根据不同的研究对象差异化认定群体意见效果，以应对基因资料采集集体性带来的群体同意表达问题。第二，依托信息技术构建以广泛同意为基础、与动态同意相结合的知情同意模式，应对基因资料应用开放性带来的再次同意获取问题。第三，充分考虑基因提供者知情同意能力变化时的同意选择及撤回同意效力，应对基因资料留存的长期性带来的同意变更问题。 |
| 关键词: 人类基因资料库 知情同意 基因研究 生物医学研究 |
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| 基金项目:2022年国家社会科学基金社科学术社团主题学术活动（课题研究类）项目“国家公共卫生应急管理体系法治化研究”（项目编号： 22STA026）、2022年国家自然科学基金重大项目课题“医联网环境下的隐私数据保护与医源性风险决策”（项目编号： 72293583）、四川医事卫生法治研究中心2022年度科研青年项目“人类基因资料库研究中的知情同意问题”（项目编号： YF22Q11） |
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| Improvement of Informed Consent Institution in Biobank Research |
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Man Hongjie & Chen Zhexuan
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| Abstract: |
| Informed consent is an important principle for biobank research, but the institution is also challenged by the collectiveness, openness and chronicity of biobank research. The institution of informed consent for biobank research can be improved from the following three aspects: First, insist the individual as the subject of informed consent and treat community consent differently according to the different subjects of the research, so as to deal with the problem of multiple subjects brought about by the collectiveness of genetic data collection. Second, rely on information technology to construct a model of informed consent what based on broad consent and combined with dynamic consent, in order to cope with the problem of regrant brought about by the openness of genetic data application. Third, consider changes in research participants' consent when the capacity of informed consent changes and the effect of withdrawing consent, to solve the problem of consent change which caused by the long-term storage of genetic data. |
| Key words: Biobank, Informed Consent, Genetic Research, Biomedical Research |
