Morrison Michael, Moraia Linda Briceño, Steele Jane C
HeLEX - Centre for Health, Law & Emerging Technologies, Nuffield Department of Population Health, University of Oxford, Ewert House, Ewert Place, Oxford OX2 7DD, UK.
Director, Human Biological Resource Centre (HBRC), University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
Regen Med. 2016 Jan;11(1):73-9. doi: 10.2217/rme.15.66. Epub 2015 Dec 18.
This paper describes a traceability system developed for the Stem cells for Biological Assays of Novel drugs and prediCtive toxiCology consortium. The system combines records and labels that to biological material across geographical locations and scientific processes from sample donation to induced pluripotent stem cell line. The labeling system uses a unique identification number to link every aliquot of sample at every stage of the reprogramming pathway back to the original donor. Only staff at the clinical recruitment site can reconnect the unique identification number to the identifying details of a specific donor. This ensures the system meets ethical and legal requirements for protecting privacy while allowing full traceability of biological material. The system can be adapted to other projects and for use with different primary sample types.
本文介绍了一种为新型药物生物学检测和预测毒理学干细胞联盟开发的可追溯系统。该系统将记录和标签相结合，以追踪跨地理位置以及从样本捐赠到诱导多能干细胞系的科学过程中的生物材料。标签系统使用唯一识别号，将重编程途径每个阶段的每个样本等分试样追溯到原始捐赠者。只有临床招募站点的工作人员才能将唯一识别号与特定捐赠者的识别细节重新关联。这确保了该系统在满足保护隐私的伦理和法律要求的同时，允许对生物材料进行全面追溯。该系统可适用于其他项目，并可与不同的原始样本类型一起使用。
