ECMultiCenterStudiesEthicalReview object
Ethical approval (favourable opinion) required from
Central EC (authorised to issue a single opinion)
Submission of application required to
Central EC (authorised to issue a single opinion)
Additional Information
• KFEB is the only competent Ethics Committee authorised to approve single- and multi-site clinical trial protocols with IMPs.
• HRB evaluates single- and multi-site clinical trials dealing with interventions for human reproduction, with human genetics and advanced medicinal products (cell and gene therapy).
• Non-interventional single-centre trials are evaluated by TUKEB.
• Institutional Research Ethics Committees (IKEB): The role of the local (hospital) ethics committees is to safeguard patients’ interest during the trials and give only advice on the feasibility of a medicinal products trial.
