The aim of this Working Group is to support biobanks and their stakeholders with all ELSI related issues and give advice where possible.
This covers both ELSI topics on the national level (Belgian Biobank Law, interaction with ethical committees, …) as well as the interplay with the EU legislations (GDPR, EHDS, …).
Chairs
The aim of this Working Group is to support biobanks and their stakeholders with all ELSI related issues and give advice where possible.
This covers both ELSI topics on the national level (Belgian Biobank Law, interaction with ethical committees, …) as well as the interplay with the EU legislations (GDPR, EHDS, …).
Chairs
Recent news of this working group
Find out more about the ELSI activities at the BBMRI-ERIC level!
FAQs related to this Working Group
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.
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).