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生物样本库的现状、挑战、政策及生物伦理

Current status, challenges, policies, and bioethics of biobanks.

作者信息

Kang Byunghak, Park Jaesun, Cho Sangyun, Lee Meehee, Kim Namhee, Min Haesook, Lee Sooyoun, Park Ok, Han Bokghee

机构信息

Division of Biobank for Health Sciences, Korea National Institute of Health, Cheongwon 363-951, Korea.

Division of Vaccine Preventable Diseases, Korea Centers for Disease Control and Prevention, Cheongwon 363-951, Korea.

出版信息

Genomics Inform. 2013 Dec;11(4):211-7. doi: 10.5808/GI.2013.11.4.211. Epub 2013 Dec 31.

DOI:10.5808/GI.2013.11.4.211
PMID:24465232
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3897848/
Abstract

Many biobanks were established as biorepositories for biomedical research, and a number of biobanks were founded in the 1990s. The main aim of the biobank is to store and to maintain biomaterials for studying chronic disease, identifying risk factors of specific diseases, and applying personalized drug therapies. This report provides a review of biobanks, including Korean biobanks and an analysis of sample volumes, regulations, policies, and ethical issues of the biobank. Until now, the top 6 countries according to the number of large-scale biobanks are the United Kingdom, United States, Sweden, France, the Netherlands, and Italy, and there is one major National Biobank of Korea (NBK) and 17 regional biobanks in Korea. Many countries have regulations and guidelines for the biobanks, and the importance of good management of biobanks is increasing. Meanwhile, according to a first survey of 456 biobank managers in the United States, biobankers are concerned with the underuse of the samples in their repositories, which need to be advertised for researchers. Korea Biobank Network (KBN) project phase II (2013-2015) was also planned for the promotion to use biospecimens in the KBN. The KBN is continuously introducing for researchers to use biospecimens in the biobank. An accreditation process can also be introduced for biobanks to harmonize collections and encourage use of biospecimens in the biobanks. KBN is preparing an on-line application system for the distribution of biospecimens and a biobank accreditation program and is trying to harmonize the biobanks.

摘要

许多生物样本库作为生物医学研究的生物储存库而建立,一些生物样本库成立于20世纪90年代。生物样本库的主要目的是存储和保存生物材料,用于研究慢性病、识别特定疾病的风险因素以及应用个性化药物治疗。本报告对生物样本库进行了综述,包括韩国的生物样本库,并分析了生物样本库的样本量、法规、政策和伦理问题。到目前为止,根据大规模生物样本库的数量排名前6的国家是英国、美国、瑞典、法国、荷兰和意大利,韩国有一个主要的国家生物样本库(NBK)和17个地区生物样本库。许多国家对生物样本库都有法规和指导方针,生物样本库良好管理的重要性日益增加。与此同时,根据对美国456名生物样本库管理人员的首次调查,生物样本库管理人员担心其储存库中的样本未得到充分利用,需要向研究人员宣传这些样本。韩国生物样本库网络(KBN)项目第二阶段(2013 - 2015年)也计划用于促进KBN中生物样本的使用。KBN一直在向研究人员介绍在生物样本库中使用生物样本。还可以为生物样本库引入认证程序,以协调样本采集并鼓励在生物样本库中使用生物样本。KBN正在准备一个用于生物样本分发的在线申请系统和一个生物样本库认证计划,并试图使各生物样本库协调一致。

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