Best Practices for Establishing a Biobank
Best Practices for Establishing a Biobank
复制标题
DOI：
10.1007/978-1-59745-423-0_13
复制
发表时间：
2011-01-01
期刊：
影响因子：
--
通讯作者：
Vaught, Jimmie B.
中科院分区：
文献类型：
--
作者：
Hallmans, Goran;Vaught, Jimmie B.
生物库可以定义为用于研究或临床目的的生物样本的长期储存。除了储存设施外，生物库还可能包括一个完整的组织，包括生物样本、数据、人员、政策和处理样本的程序，以及执行其他服务（如数据库管理和科学研究计划）的程序。这种设施、政策和流程的组合也可以称为生物资源中心（BRC） （www.iarc.fr）。使用生物库标本的研究受欧盟（EU）建议（人类生物材料研究建议）的监管。CDBI在2005年10月20日的全体会议上批准了关于人类生物材料研究的建议草案，并通过了美国国家癌症研究所（NCI） （http://biospecimens.cancer.gov）和其他组织的自愿最佳实践。管理研究生物银行的最佳做法因机构和不同的国际法规和标准而异。然而，在许多领域达成了一致意见，形成了应当遵循的最佳做法，以便建立一个生物库来保管高质量的标本和数据。
A biobank may be defined as the long-term storage of biological samples for research or clinical purposes. In addition to storage facilities, a biobank may comprise a complete organization with biological samples, data, personnel, policies, and procedures for handling specimens and performing other services, such as the management of the database and the planning of scientific studies. This combination of facilities, policies, and processes may also be called a biological resource center (BRC) (www.iarc.fr). Research using specimens from biobanks is regulated by European Union (EU) recommendations (Recommendations on Research on Human Biological Materials. The draft recommendation on research on human biological materials was approved by CDBI at its plenary meeting on 20 October 2005) and by voluntary best practices from the U.S. National Cancer Institute (NCI) (http://biospecimens.cancer.gov) and other organizations. Best practices for the management of research biobanks vary according to the institution and differing international regulations and standards. However, there arc many areas of agreement that have resulted in best practices that should be followed in order to establish a biobank for the custodianship of high-quality specimens and data.