The use of human body material (HBM) for research purposes, is regulated in Belgium by law (“Act on the acquisition and use of human body material (HBM) for medical application to humans or for scientific research.”, 19th of December 2008). This Act applies to the donation, removal, procurement, testing, processing, preservation, storage, distribution, import and use of human body material and of prepared products derived from human body material, including the linked data, intended for scientific research. The Act has entered into force by the publication of the Royal Decree (9th of January 2018), detailing the context of the official registration of biobanks in Belgium.
All biobanks need EC approval for their goals, a clear defined Medical management and official notification at FAGG before performing any activities. Biobanks are given a central role into the HBM flow for research purposes, inducing more transparency and clear sample tracking.
Additional explanatory information relating to the law can be found in the Compendium for biobanks by the FAGG.
The registration of biobanks liaised with Ghent University Hospital and Ghent University, is centrally coordinated by HIRUZ biobank. More information regarding the FAGG notification, can be found in the ‘decision tree for registering a biobank at FAGG’
For questions regarding the ethical-legal framework of biobanking, contact Elke Berneel firstname.lastname@example.org