Belgian Act on experiments on human being
If the study falls under the Belgian Act on experiments on human beings (7 May 2004), a (no-fault) insurance certificate must be submitted to EC Research. Article 29 of this act states that even if there is no fault - the sponsor is liable for the damage incurred by the participant or, in case of death, their beneficiaries, which is directly or indirectly related to their participation in the study. Consequently, before starting an experiment, the sponsor should take out such insurance to cover this liability.
Please note that the sponsor or the sponsor's legal representative, must be established in the European Union.
A reference to the act of 7 May 2004 should be specified on the insurance certificate.
If UZ / KU Leuven is the sponsor of the study, you can find the insurance certificate on the internal website of the CTC.
MDR
If the study falls under the MDR, a ("no-fault") insurance certificate must be submitted to EC Research. Article 32 of the Royal Decree of 22 December 2020 (Medical Devices Act) states that even if there is no fault - the sponsor is liable for the damage incurred by the participant, or in case of death, his/her beneficiaries, which is directly or indirectly related to his/her participation in the study. If a clinical trial has more than one sponsor, all sponsors are jointly and severally liable. One principal shall be designated to take out the insurance. Consequently, before the start of the clinical trial, the sponsor shall take out such insurance covering this liability.
A reference to the act of 22 December 2020 should be specified on the insurance certificate.