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 intended for scientific research.
The section relating to biobanking has recently entered into force by publication of the Royal Decree (9th of January 2018). All biobanks have to be EC approved and registered with the FAGG. Information about the Belgian law can be found here. A compendium with frequently asked questions can be found on the website of the FAGG. In general, the biobanks have been given a central role in the management of HBM for research purposes, and have an appointed Medical manager with clearly defined responsibilities.
Information sessions regarding the Belgian Law and its implications have been given by the Bioresource Center Ghent. The presentation of this information session and related documents can be requested at
firstname.lastname@example.org. The registration of biobanks liaised with Ghent University Hospital and Ghent University, is centrally coördinated by the Bioresource center Ghent, where the local policy can also be obtained. After EC approval, new biobanks can fill in their contact details and information on https://surveysredcap.uzgent.be/surveys/?s=DXJ7NENPPT to be registered as local biobank.
The expert related to the Belgian law and the local implemented framework is Elke Berneel (Biobank manager, Elke.email@example.com).