The objectives and activities of each human tissue bank, human tissue intermediary structure and production institution must be the subject of a favourable opinion of an ethics committee, in accordance with the Human Tissue Act of 19 December 2008 (HBM), and the related Royal Decree of 9 January 2018.
In consultation with the various stakeholders, a notification form has been developed that aims to harmonise the way an opinion should be sought from the ethics committee in the context of a biobank's recognition process.
Therefore, BAREC proposes to use this submission form as a first step in harmonising the work of ethics committees with regard to the evaluation of biobank activities. Please submit this form to ec@uzleuven.be
Following approval by the ethics committee, the biobank needs to be notified to the Federal Agency for Medicines and Health Products.
The operator of the biobank must also draw up a two-yearly report on the objectives and activities of the biobank. This report should also be submitted to the ethics committee. Please use the submission form below for this purpose.