To have your biobank recognized under the Belgian leglisation (RD2018, updatedRD2022) , you need to follow the next steps:
- Approval of the activities and objectives of your biobank by a fully recognised Ethics Committee
- BAREC has developed in collaboration with BBMRI.be a template that can faciltate the initial EC submission of your biobank: EC submission form for biobanks
- Registration of your biobank with FAMPH
- By using this form (NL/FR):
- Each two years, a biennual report needs to be submitted to the Ethics Committee
- BAREC has developed in collaboration with BBMRI.be a template that can faciltate this biennual evaluation: EC submission form for biobanks _ biennial evaluation
BBMRI.be also organized, in the framework of the B3-ISO project, a webinar that covers all ethical/legal aspects you need to take into account when setting up your biobank.
The slides of this meeting can be found here: ELSI Webinar. A recording of this meeting is availalble upon request (contact us below)
More information on the Belgian biobank legislation as wel as a comprehensive FAQ (Compendium) about this legislation can be found on the website of the FAMHP:
– Instellingen voor menselijk lichaamsmateriaal | FAGG (NL) / Etablissements de matériel corporel humain | AFMPS (FR)
– Compendium_20072018.pdf (fagg.be) (NL/FR/ENG)
The compendium document is currently being updated in accordance with the update of the Royal Decree in 2022.
Would you rather add your collections to an existing BBMRI.be biobank than setting up your own biobank?
Or do you have any other questions for our biobanks.
Then please contact us with the button below and we will get you into contact with the most suited biobank expert in our network.