Primary submission to the review committee (WMO)
The review of research that falls under the scope of the Medical Research Involving Human Subjects Act (WMO) is carried out in accordance with a fixed procedure by an accredited MREC or the CCMO.
Please note! From 31 January 2023, all primary submissions for research with a medicinal product are subject to CTR and must be submitted in CTIS. Separate information is available for clinical trials with medicinal products in accordance with CTR, clinical investigations with medical devices and performance studies using in-vitro diagnostics.
Before research with human subjects can commence in the Netherlands the research file must first be approved by an independent committee of experts. This is laid down in the Medical Research Involving Human Subjects Act (WMO).
The review system is a decentral one, whereby accredited reviewing committees spread throughout the country are responsible for the review. The legislator made the conscious decision not to appoint this task solely to the central government. This was to prevent the central government having too much influence on the medical/ethical review of medical research resulting in a form of state ethics.