German researchers kick-off National Biobank Initiative
Berlin – Germany has begun to cross-link and to standardise its existing registries for medical human samples and data (so-called biobanks) at five locations, to make the promise of personalised medicine a reality. Each of the centres in Berlin, Kiel, Würzburg, Heidelberg, and Aachen have biobank collections of several hundreds of thousands of existing blood, urine or tissue samples and appropriate medical information. The aim of the National Biobank Initiative (NBI), which will be funded with EU17m from the German Research Ministry, is to link the resources and to concentrate them in a standardised manner for generating a critical mass of information for biomarker research. In a first step, the centres will establish standardised SOPs, quality management structures, sample storage protocols and documentation, patient consent forms, encryption methods to prevent unauthorised access to the sensible information and preventing non-authorised re-identification of patients. In a second step, information from the biobanks, along with data about running projects with the samples, will be made accessible in a national biobank registry provided by Berlin-based TMF e.V., which will be the communication platform for the biobank researchers, according to plans of the research ministry. Until now, biobanks have been scattered and fragmented. Cross-linking of existing biobanks offers the potential to provide access for researchers to a critical mass of bio-specimens for analysing disease pathways, biomarker-based patient stratification and identification of novel drug targets and molecular diagnostics. However, there are many challenges that will be now solved within the 5 biobank clusters. Additionally, Germany has started an initiative for a National Cohort that aims at organising a prospective study on 200,000 people, aged from 20-69, to identify disease markers. The initiatives aims to provide links to the European BBMRI initiative which aims to link up all major existing European biobanks. One day before the kick-off meeting of the 5 biobank centres, TMF and the German Ethics Council had re-opened a political debate on the best way to protect the personal data linked to biobanks while ensuring medical progress. While the Ethics Council favours the establishment of a biobank law, Germany's largest research funding organisation DFG favoured a self-regulation mechanism. Up to now it is unclear which approach will provide the best results.