Baber Ronny, Hummel Michael, Jahns Roland, von Jagwitz-Biegnitz Magdaléna, Kirsten Romy, Klingler Corinna, Nussbeck Sara Y, Specht Cornelia
1Institute of Laboratory Medicine, Clinical Chemistry and Molecular Diagnostics, University of Leipzig Medical Center, Leipzig, Germany.
2Leipzig Medical Biobank, University Leipzig, Leipzig, Germany.
Biopreserv Biobank. 2019 Aug;17(4):372-374. doi: 10.1089/bio.2019.0042. Epub 2019 Jul 17.
Under the umbrella of the German Biobank Node (GBN), 11 biobanks and two IT development centers are funded by the Federal Ministry of Education and Research (BMBF) to work together in the German Biobank Alliance (GBA). Their common aim is to make existing biomaterials hosted by different biobanks nationally and internationally available for biomedical research. This position article reflects and summarizes contributions and comments made during a GBA workshop, on the cooperation between academic biobanks and pharmaceutical and diagnostics companies that took place in Leipzig on the 21st of June 2018. It documents key points agreed on by all participating biobanks during the workshop thereby addressing several of the challenges identified. Although there are various possibilities for cooperation between academic biobanks and industry, this position article focuses exclusively on projects where academic biobanks give access to their biosamples and related data to industry partners. In doing so it considers the general conditions/framework and procedures in the German biobanking environment and raises ethical, legal, and procedural issues to be addressed when initiating such collaborations. It intends to furnish a basis for further activities to foster cooperation with industry and to push an overarching national coordination process. The final aim is to develop GBN-recommendations. Of course, many hospitals already have clear regulations on collaboration(s) with industry partners. These naturally take precedence for the GBA biobanks. However, where interest exists, GBN/GBA recommendations could help to induce changes to existing local policies nonetheless.
在德国生物样本库节点(GBN)的框架下,11个生物样本库和两个信息技术开发中心由联邦教育与研究部(BMBF)资助,在德国生物样本库联盟(GBA)中开展合作。它们的共同目标是使不同生物样本库在国内和国际上保存的现有生物材料可用于生物医学研究。这篇立场文章反映并总结了在2018年6月21日于莱比锡举行的GBA研讨会上,关于学术生物样本库与制药和诊断公司之间合作所发表的意见和评论。它记录了所有参与的生物样本库在研讨会上达成的要点,从而应对了所确定的若干挑战。尽管学术生物样本库与行业之间存在多种合作可能性,但这篇立场文章仅专注于学术生物样本库向行业合作伙伴提供其生物样本及相关数据的项目。在此过程中,它考虑了德国生物样本库环境中的一般条件/框架和程序,并提出了启动此类合作时需要解决的伦理、法律和程序问题。它旨在为促进与行业的合作以及推动全面的国家协调进程的进一步活动提供基础。最终目标是制定GBN建议。当然,许多医院已经对与行业合作伙伴的合作有明确规定。这些规定自然优先于GBA生物样本库。然而,在有兴趣的地方,GBN/GBA建议仍可能有助于促使对现有地方政策进行变革。