The sponsor is, even without fault, liable for all inflicted damages to the participant (or in case of death, his/her beneficiaries) and therefore must disclose a no-fault insurance (strict liability). The legislation provides that the sponsor must take out an appropriate insurance for each trial. In investigator-initiated trials, the hospital or university acts as sponsor and is responsible for taking out the appropriate insurance. When submitting the dossier to HIRUZ CTU, HIRUZ CTU provides the appropriate insurance policy (both for Ghent University Hospital and Ghent University). At present, this insurance is paid centrally both by the Ghent University Hospital and Ghent University and will not be charged to the researcher.

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