| 摘要: |
| 精准医学计划和"健康中国2030"规划战略的提出，使生物样本库迎来了难得的发展机遇。目前我国生物样本库建设依然面临诸多挑战，包括样本库标准难以统一、电子信息系统标准不统一、临床治疗标准不同、相关的法律法规不完善和可持续发展障碍等。需要通过样本库行业人员的不懈努力，才能使中国的生物样本库发展走上标准化、信息化和规范化的正轨。 |
| 关键词: 生物样本库 标准化 信息化 法规 伦理学 |
| DOI：10.16781/j.0258-879x.2017.03.0265 |
| 投稿时间：2017-03-10修订日期：2017-03-16 |
| 基金项目:上海交通大学医学院科技创新项目（Z2016-02），上海交通大学"985工程"三期样本库专项建设. |
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| Opportunity and challenge of clinical biobank in China |
| LIU Shi-jian*,FU Qi-hua,WANG Wei,JIANG Fan,JIANG Zhong-yi |
(Department of Biobank, Pediatric Translational Medicine Institute, Shanghai Children's Medical Centers Shanghai Jiaotong University School of Medicine, Shanghai 200127, China
*Corresponding author) |
| Abstract: |
| Precision Medicine Initiation and "Healthy China 2030" Plan have created a good opportunity for development of biobank. However, it also faces many challenges in the process of building up Chinese biobank, including different standards for biobank, electronic information system and clinical treatment, incomplete laws and regulations, and the obstacles of sustainable development. Unremitting efforts are needed to guide, Chinese biobank development on the right track of standardization, informatization and normalization. |
| Key words: biobank standardization informatization regulation ethics |
