我国生物样本库建设管理中存在的问题及规范化管理策略

The Problems in the Management of Biobank Construction in China and Standardized Management Strategies

从法律法规、监管机制、伦理争议、资源和隐私保护等方面,分析我国生物样本库建设管理中存在的问题,参照国外发展生物样本库的管理措施和经验,提出发展我国生物样本库的一些具体建议,包括完善法律、法规体系,制定国家统一的人类研究伦理准则和伦理审查细则等方面。

The paper analyzes the existing problems in Biobank construction management from the aspects of laws and regulations, supervision mechanism, ethical disputes, resources and privacy protection. It also puts forward some specific suggestions on developing Biobank in China with reference of Biobank management countermeasures and experience in foreign countries, including perfecting laws and regulations, establishing a national unified human research ethics guidelines and ethical review rules, etc.