Primary submission to the review committee
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. Research with a medicinal product must undergo an extra, marginal review. This review is carried out by the competent authority.
Information on the assessment of clinical investigations with medical devices can be found at Primary submission investigations with clinical devices.
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.