Select the right reviewing committee

Before you can begin a medical research study involving healthy volunteers and/or patients, your research file must be approved by an authorized reviewing committee. In most—but not all—cases, the reviewing committee is an accredited MREC. In the Netherlands, the 20 or so accredited MRECs are located in the seven Dutch University Medical Centers (UMC) and in approximately ten hospitals located throughout the country. A few MRECs are not located at any institute.

For a limited number of research categories, the reviewing committee is the CCMO, rather than an accredited MREC. These research categories includes (amongst others) non-therapeutic intervention research involving minors and/or incapacitated subjects, and clinical studies using unlicensed vaccines, somatic cells or gene therapy products. Thus, depending on the type of research, product or patient population, the file will be reviewed by either an accredited MREC or the CCMO.

For specific research categories—such as research with investigational medicinal products or research with genetically modified organisms (GMOs)—even more organizations are involved in the review and approval process. Finally, since October 1, 2020 for some—but not all—clinical research with medical devices, the manufacturer has to notify the CCMO.

In one specific case (i.e., multinational non-interventional research with a medical product on behalf of the registration authority) the review is not done in the Netherlands, but by the Pharmacovigilance Risk Assessment Committee (PRAC) with the European Medicines Agency (EMA) in London, United Kingdom.

Complicated? Don’t worry, but click on the link to go to the 'Committee Finder' tool that will open in a separate tab on your browser. Use the tool to identify the appropriate reviewing committee for your research application with the legal review timelines. The tool also shows the contact details and location of these committees and (where applicable) the other organizations involved in the approval of your study.