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Basic principles of biobanking: from biological samples to precision medicine for patients
Virchows Archiv ( IF 3.4 ) Pub Date : 2021-07-13 , DOI: 10.1007/s00428-021-03151-0
Laura Annaratone 1, 2 , Giuseppe De Palma 3 , Giuseppina Bonizzi 4 , Anna Sapino 1, 2 , Gerardo Botti 5 , Enrico Berrino 1, 2 , Chiara Mannelli 1 , Pamela Arcella 6 , Simona Di Martino 7 , Agostino Steffan 8 , Maria Grazia Daidone 9 , Vincenzo Canzonieri 10, 11 , Barbara Parodi 12 , Angelo Virgilio Paradiso 3 , Massimo Barberis 4 , Caterina Marchiò 1, 2 ,
Affiliation  

The term “biobanking” is often misapplied to any collection of human biological materials (biospecimens) regardless of requirements related to ethical and legal issues or the standardization of different processes involved in tissue collection. A proper definition of biobanks is large collections of biospecimens linked to relevant personal and health information (health records, family history, lifestyle, genetic information) that are held predominantly for use in health and medical research. In addition, the International Organization for Standardization, in illustrating the requirements for biobanking (ISO 20387:2018), stresses the concept of biobanks being legal entities driving the process of acquisition and storage together with some or all of the activities related to collection, preparation, preservation, testing, analysing and distributing defined biological material as well as related information and data. In this review article, we aim to discuss the basic principles of biobanking, spanning from definitions to classification systems, standardization processes and documents, sustainability and ethical and legal requirements. We also deal with emerging specimens that are currently being generated and shaping the so-called next-generation biobanking, and we provide pragmatic examples of cancer-associated biobanking by discussing the process behind the construction of a biobank and the infrastructures supporting the implementation of biobanking in scientific research.



中文翻译:

生物样本库的基本原理:从生物样本到患者精准医疗

术语“生物样本库”经常被误用在任何人类生物材料(生物样本)的收集上,而不管与伦理和法律问题相关的要求或组织收集所涉及的不同过程的标准化。生物库的正确定义是与相关的个人和健康信息(健康记录、家族史、生活方式、遗传信息)相关的大量生物样本,这些信息主要用于健康和医学研究。此外,国际标准化组织在说明生物样本库的要求 (ISO 20387:2018) 时,强调生物样本库是推动采集和存储过程以及与收集、准备相关的部分或全部活动的法人实体的概念。 , 保存, 测试, 分析和分发定义的生物材料以及相关信息和数据。在这篇评论文章中,我们旨在讨论生物样本库的基本原则,从定义到分类系统、标准化流程和文件、可持续性以及道德和法律要求。我们还处理目前正在生成的新兴样本并塑造所谓的下一代生物样本库,并通过讨论生物样本库建设背后的过程和支持生物样本库实施的基础设施,提供癌症相关生物样本库的实用示例在科学研究中。从定义到分类系统、标准化流程和文件、可持续性以及道德和法律要求。我们还处理目前正在生成的新兴样本并塑造所谓的下一代生物样本库,并通过讨论生物样本库建设背后的过程和支持生物样本库实施的基础设施,提供癌症相关生物样本库的实用示例在科学研究中。从定义到分类系统、标准化流程和文件、可持续性以及道德和法律要求。我们还处理目前正在生成的新兴样本并塑造所谓的下一代生物样本库,并通过讨论生物样本库建设背后的过程和支持生物样本库实施的基础设施,提供癌症相关生物样本库的实用示例在科学研究中。

更新日期:2021-07-13
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