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.
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.