生物样本所有权及相关法律争议的处理与启示——以美国司法实践为例  

The Ownership of Biospecimens and Its Relevant Legal Controversies:Taking the Judicial Practice in the United States as Examples

作　　者：黄清华[1] HUANG Qing-hua(Tongji IP Institute/Tongji Law School, Tongji University, Shanghai 518036, China)

机构地区：[1]同济大学法学院/知识产权学院,上海518036

出　　处：《医学与哲学（A）》2017年第2期15-19,共5页Medicine & Philosophy:Humanistic & Social Medicine Edition

基　　金：2016年同济大学人文社会科学跨学科研究基金资助项目(pip003)

摘　　要：在生物样本库管理过程中,由于生物样本包含个人独特的生物信息,可能具有巨大的经济价值,生物样本的所有权可能成为捐赠者的关切,可派生出相关的知情同意、专利收益和不当得利问题。对此,美国案例法提示我们,生物样本捐赠者的同意捐赠,应当是被充分告知和知情的,强调明示的知情同意;生物样本库产权单位,应当建立相关专利的权属归其所有的知识产权政策;在与研究者和捐赠者的关系中,要求生物样本库产权单位明确实现利益分享的条件。这些规则,对于包括国家基因库在内的我国生物样本库的伦理和法制建设,具有启示意义和借鉴价值。In the governance of biobank,the ownership of biospecimens which contain unique personal biological information and have great economic value could be a big concern for donors,and raising legal problems,such as informed consent,benefits of patent and unjust enrichment.By introducing and learning from the case laws of the United States,the author argued that the valid consent should be a clear expression of consent by biospecimen donors who have been fully informed;the property owner of a biobank should establish its own intellectual property policies;and the mechanism of benefit sharing between researchers and donors should also be set up.These rules have significance and reference value for the construction of ethics and legal system of biobanks,including the China National Genebank.

关 键 词：生物样本 所有权 知情同意 专利收益 不当得利 

分 类 号：R052[医药卫生] D992.16[政治法律—国际法学]