From 2013-2019, BBMRI.be has matured into a solid partner network on biobanks in Belgium and has proven to reach out to a broader community beyond the founding partners. From 2019 onwards, BBMRI.be invites all Belgian biobanks with translational research potential to join the BBMRI.be network. Currently, our network connects 20 biobanks that are linked to public institutions such as hospitals, universities and research centers.
The BBMRI.be network connects 20 biobanks that are linked to public institutions such as hospitals, universities and research centers and welcomes all Belgian biobanks with translational research potential to join the BBMRI.be network.
If you are interested to join our network, then complete the registration form and we will get in touch with you soon!
Are you interested to join BBMRI.be?
BBMRI.be welcomes all Belgian biobanks with translational research potential to join the BBMRI.be network.
If you are interested to join our network, then complete the registration form and we will get in touch with you soon!
Have a look at our available collections!
Frequently asked questions
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.
- Go to https://negotiator.bbmri-eric.eu/login.xhtml
- Try to login through your home institution
- find your institution and log in
- if your institution is not available, try adding it and log in
- if both methods above do not work, register an account with “our Hostel” and log in
- Register with the list of collection IDs you are representing (see Directory)
- BBMRI-ERIC will review your registration and if OK, they approve it – and you are ready to go!
- Receive sample requests!
More detailed information about the Negotiator and a more detailed guide for the registration can be found with the following links:
BBMRI.be is currently developing a quality improvement program to support the biobanks in reaching the different levels of quality management.
Within this program, webinars are organized and templates developed to guide the biobanks.
More information on this project and the material developed can be found here: B3-ISO project
BBMRI-ERIC is also offering several training & support opportunities that are available for all biobanks of BBMRI.be.
You can find back more information on these opportunities here:
- Quality Management – BBMRI-ERIC: Making New Treatments Possible
- E-learning of BBMRI.QM Academy
- BBMRI.QM Training series on ISO 20387
- BBMRI.QM Training Series on technical specifications for molecular IVD diagnostic pre-examination processes
The Royal Decree of 9 January 2018 on biobanks, published in the Belgian Official Gazette on 05.02.2018 in implementation of Article 22 of the Law of 19 December 2008 regarding the procurement and use of human substances destined for human medical applications or for scientific research purposes, enters into force on 01.11.2018. The full text can be found here in Dutch & French: Belgian Biobank Law 2018
The Royal Decree on biobanks provides for:
- the procedure whereby the biobank should declare itself to the Federal Agency for Medicines and Health Products, as well as the content of the declaration file;
- rules relating to the harvesting of human substances intended for a biobank;
- the provisions relating to changes to and cessation of the biobank’s activities;
- the manner and frequency with which the biobank reports to the ethics committee and under what conditions the ethics committee can amend or withdraw its opinion;
- the data that the register held by the biobank should contain;
- the content of the agreement between the biobank and the recipient of the human substances;
- the procedures relating to donor encoding, traceability and identification.
In 2022, an update has been published, which can be found here: Belgian Biobank Law update- February 2022
In order to shed clarity as to how to interpret and implement the complex system of legal requirements, the Federal Agency for Medicines and Health Products (FAMHP) developed the Compendium. During the preparation of the Compendium, the input of relevant stakeholders was sought, namely representatives of academic and industrial biobanks, ethical committees and juridical experts. By providing answers to 47 consolidated questions, the document covers a broad range of topics such as, inter alia, the scope of the biobank legislation, consent, notification procedure, transformation of HBM, traceability and anonymization, ethics committees. The full document is available (in NL/FR/ENG) here: Compendium 2018 The Federal Agency for Medicines and Health Products (FAMHP) is currently working on an update of the Compendium in response to the updated Royal Decree published in 2022.
An Overview of Belgian Legislation Applicable to Biobank Research and Its Interplay with Data Protection Rules can also be found in this book chapter: Lalova et al, GDPR and biobanking, Law, Governance and Technology Series (ISBN 978-3-030-49388-2 (eBook)).
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 via secretariat.BBMRIbe@kankerregister.org).
In 2022, BBMRI.be received funding through an ESFRI-FED call from BELSPO for the setup of a quality improvement program towards ISO 20387 accreditation for the biobanks (B3-ISO project). Within this project we develop & offer templates, webinars & guidance to biobanks that want to prepare for this accreditation.
More information about this project and the developed material can be found here
The available collections from all biobanks of BBMRI.be can be found in the BBMRI-BE Directory
The BBMRI.be Directory is a collection level catalog which gives you a glance of the material that is available at our biobanks and is freely available for all researchers.
In the Directory, you can filter the biobanks with your criteria. After the search, you can contact all biobanks of interest at once through the communication platform of BBMRI-ERIC (the Negotiator). The Negotiator substantially simplifies the communication steps that are necessary to obtain information on the availability of relevant samples/data, particularly if the researchers need to communicate with multiple candidate biobanks.
If you do not find the samples you are looking for in the BBMRI.be Directory, then go have look at the BBMRI-ERIC Directory, the biggest biobanking catalogue on the globe,w hich harbours all collections of BBMRI-ERIC.
The data in the Directory can be consulted on the homepage of the Directory by all users (no login is required).
More detailed information on the different options can be found in this document: Consult data in Directory – BBMRI.be
To update the data of your biobank in the Directory, you need to login (one login available per biobank). Contact us (secretariat.BBMRIbe@kankerregister.org) if you would need a login for your biobank.
Updates can be done either manually via “Advanced search” in the web application or by uploading an excel file via “Import Data”.
When using the “import data” option, make sure to start from the most recent data from your biobank.
A step-by-step guide for both update options can be found in this document: Update data in BBMRI.be Directory – BBMRI.be
If you need an excell export of your current data in the Directory as a starting point for your updates, please contact secretariat.BBMRIbe@kankerregister.org
In this document, you can find a manual about the data model and the accepted values for each variable.
This functionality is only possible with an admin account.
Please contact secretariat.BBMRIbe@kankerregister.org to get an excel export of your data.
