Biobanks containing clinical specimens: Defining characteristics, policies, and practices
Biobanks containing clinical specimens: Defining characteristics, policies, and practices
复制标题
DOI：
10.1016/j.clinbiochem.2013.11.023
复制
发表时间：
2014-03-01
影响因子：
2.8
通讯作者：
Henderson, Gail E.
中科院分区：
文献类型：
--
作者：
Edwards, Teresa;Cadigan, R. Jean;Henderson, Gail E.
目的：生物库-人类生物标本的集合存储用于未来的研究-是生物医学进步的关键。生物库获取标本的最常见方式之一是从医院、临床实验室和病理部门获取最初为临床护理收集的残留或“剩余”样本。关于存储临床来源标本的生物库的特征或其政策和实践知之甚少。设计和方法：在本文中，我们介绍了2012年全国调查中存储临床来源标本的261个生物库的数据，重点关注文献中提出的一些伦理问题。结果：大多数生物库是大型组织的一部分，主要是学术医疗中心，大多数报告用于管理采集，存储和发布给研究人员的标准化系统。然而，在知情同意、研究成果返还、标本所有权和开发的技术、利用以及研究人员获得剩余标本后对其的处置等方面的政策和做法存在相当大的差异。我们记录了巨大的异质性，在这些集合的组成，存储的标本的数量和类型，以及每年的标本请求的数量。结论：应对这种变化提出了重大挑战，对于那些谁管理的集合，需要仔细考虑和规划，以保持高质量的做法，在收购，存储和释放的标本，同时努力保护受试者的权利。(C)2013年加拿大临床化学家协会。爱思唯尔公司出版All rights reserved.
Objectives: Biobanks - collections of human biological specimens stored for future research use - are crucial for biomedical advancement. One of the most common ways that biobanks acquire specimens is to obtain residual or "leftover" samples originally collected for clinical care from hospitals, clinical laboratories and pathology departments. Little is known about the characteristics of biobanks that store specimens from clinical sources, or their policies and practices.Design and methods: In this paper, we present data from the subset of 261 biobanks in our 2012 national survey that stores specimens from clinical sources, focusing on a number of ethical issues that have been raised in the literature.Results: Most biobanks are part of larger organizations, mainly academic medical centers, and most report standardized systems for managing acquisition, storage, and release to researchers. Yet, there is considerable diversity in policies and practices regarding informed consent, return of research results, ownership of specimens and technology developed, utilization, and disposition of remaining specimens after researchers have acquired, them. We document tremendous heterogeneity in the composition of these collections, the number and type of specimens stored, and number of requests for specimens per year.Conclusion: Responding to this variation presents significant challenges for those who manage the collections, demanding careful consideration and planning to maintain high quality practices in acquisition, storage, and release of specimens all the while striving to protect the rights of subjects. (C) 2013 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.