Tukacs Edit, Korotij Agnes, Maros-Szabo Zsuzsanna, Molnar Agnes Marta, Hajdu Andras, Torok Zsolt
Bioinformation. 2012;8(6):290-2. doi: 10.6026/97320630008290. Epub 2012 Mar 31.
Biobanks are essential tools in diagnostics and therapeutics research and development related to personalized medicine. Several international recommendations, standards and guidelines exist that discuss the legal, ethical, technological, and management requirements of biobanks. Today's biobanks are much more than just collections of biospecimens. They also store a huge amount of data related to biological samples which can be either clinical data or data coming from biochemical experiments. A well-designed biobank software system also provides the possibility of finding associations between stored elements. Modern research biobanks are able to manage multicenter sample collections while fulfilling all requirements of data protection and security. While developing several biobanks and analyzing the data stored in them, our research group recognized the need for a well-organized, easy-to-check requirements guideline that can be used to develop biobank software systems. International best practices along with relevant ICT standards were integrated into a comprehensive guideline: The Model Requirements for the Management of Biological Repositories (BioReq), which covers the full range of activities related to biobank development. The guideline is freely available on the Internet for the research community.
The database is available for free at http://bioreq.astridbio.com/bioreq_v2.0.pdf.
生物样本库是个性化医疗相关诊断和治疗研发的重要工具。现有多项国际建议、标准和指南讨论了生物样本库的法律、伦理、技术和管理要求。如今的生物样本库远不止是生物样本的集合。它们还存储了大量与生物样本相关的数据，这些数据可以是临床数据或来自生化实验的数据。一个设计良好的生物样本库软件系统还提供了找到存储元素之间关联的可能性。现代研究性生物样本库能够管理多中心样本采集，同时满足数据保护和安全的所有要求。在开发多个生物样本库并分析其中存储的数据时，我们的研究小组认识到需要一个组织良好、易于检查的需求指南，可用于开发生物样本库软件系统。国际最佳实践以及相关信息通信技术标准被整合到一个全面的指南中：《生物样本库管理的模型要求》（BioReq），它涵盖了与生物样本库开发相关的全部活动范围。该指南可在互联网上免费提供给研究界。
