A large part of the irreproducibility of research on human body material originates from the biospecimens used and has been identified as a major undermining factor regarding the translation of research results into clinical applications (Freedman LP et al (2015) PLoS Biol 13(6): e1002165.) According to the new Royal Decree on biobanks in 2018, all human body material used for research has to be registered at a Belgian biobank. Such biobanks can play an important role in reducing research variation by providing high quality, fit-for-purpose samples and associated data.
The European research infrastructure for biobanking BBMRI-ERIC is reflected in the National Node BBMRI.be, established in 2013 at the Belgian Cancer Registry and connects 18 Belgian biobanks. Many of these biobanks arose from existing sample collections, sometimes with limited quality management systems (QMS). These biobanks are now aiming toward further professionalization and implementation of a QMS according to evidence-based guidelines and/or standards. The biobank standard (ISO 20387), which was recently published but not yet included in the portfolio of the Belgian accreditation organization BELAC, will allow biobanks to formalize their competences. In view of their international recognition, the Belgian biobanks will then be able to demonstrate their readiness to support (inter)national translational and clinical research.
In order to harmonize and enhance the quality management activities of the Belgian biobanks, BBMRI.be will develop a stepwise quality improvement program that can be implemented at the individual biobanks. This quality improvement program will facilitate the road towards ISO 20387 for the BBMRI.be biobanks by guiding them step by step. At the same time, an accreditation program will be established by BELAC, ultimately leading to ISO accreditation. The setup of this program and the implementation of the ISO 20387 standard will substantially contribute to (inter)national translational research and foster collaborations between industry and academia in the biomedical sector.
Acknowledgements: The B3-ISO project is financed by BELSPO in the framework of the ESFRI-FED call.