Before research with human subjects can commence in the Netherlands the research file must first be approved by an accredited MREC or the CCMO. This requires you submit a complete research file. Do not forget to check the meeting dates and the submission deadlines for the committee carrying out the review (MREC or CCMO). To prevent any misunderstandings, and when in doubt over the review timelines, contact the accredited MREC or the CCMO.
Are you not sure whether your research falls under the scope of the Medical Research Involving Human Subjects Act (WMO) and which reviewing committee is authorised to review your research? Go to the Help-me-on-my-way tool. You can also use the new online tool 'Select the right reviewing committee in the Netherlands'.
The decentral review lies in the hands of the accredited medical research ethics committee (MREC). The majority of MRECs are linked to an institution, for example, a university medical centre or a hospital. A number are not linked to an institution.
The accredited MRECs review the vast majority of the studies. This includes all research with capable adult subjects. Also, therapeutic research and non-therapeutic observational research with minors and incapacitated subjects fall under their reviewing jurisdiction.
You can choose which accredited MREC you would like to review your study. Despite each MREC having an assigned geographical region, the majority of them actually review research submitted throughout the whole country. The accredited MRECs charge their own rates. An MREC is entitled to charge an amount for costs related to the review (art. 20 WMO). There is no national agreement on how much this amount can be. For information on this is, per MREC together with addresses, available in the list of accredited MRECs.
The CCMO is the authority to which administrative appeals can be submitted against a negative decision by an MREC.
Do you have any complaints regarding the functioning of an MREC? All accredited MRECs have a complaints procedure. These can be found in the form of an attachment in the list of accredited MRECs on this website.
In the case of certain types of research the legislator chose to combine expertise in one single committee. This concerns the review of research with specific ethical, legal or social aspects and research in fields with limited expertise. The review of these types of research has been appointed to the Central Committee on Research Involving Human Subjects (CCMO) in the Central Review of Medical Research Involving Human Subjects Decree. The reviewing task of the CCMO is limited to a number of specific fields of research:
- non-therapeutic interventional research with subjects under the age of 16 years and incapacitated adults;
- research with vaccines (only unauthorised vaccines since the 1st of November 2009);
- research in the field of cell therapy;
- research in the field of gene therapy/medicinal products with GMO (genetically modified organisms);
- research with antisense oligonucleotides;
- research in the field of RNA interference;
- research in the field of xenotransplantation with live animal parts. A moratorium (in Dutch) applies to this type of research;
- research with products that fall under the Opium Act (in Dutch) (as part of the treatment for addiction to these products);
- research with human gametes whereby cells taken from human subjects for use in the research are obtained through procedures (for example extracting sperm through a surgical procedure);
- research with human gametes whereby embryos are produced as part of ivf treatment (Embryos Act, in Dutch);
- research with embryos left over of an ivf treatment (leftover embryos) (Embryos Act, in Dutch).
- invasive observational research on fetuses (Embryos Act, in Dutch):
The CCMO does not charge a fee for reviewing a protocol.
You can submit an objection against a negative decision by the CCMO.
Do you have any complaints with regards to the functioning of the CCMO? The CCMO has a complaints procedure.
The CCMO as reviewing committee prefers digital submission of your files. For this purpose all documents need to be submitted in pdf format on cd-rom, accompanied by a signed cover letter (paper).
It is also allowed to submit your file on paper (unbound, singular). Go to: How to submit & addresses.
Research with a medicinal product: review by the competent authority
In case of research with a medicinal product your research file must undergo an extra, marginal review by the competent authority: the CCMO or the Ministry of Health, Welfare and Sport (VWS).
Your research may only commence after both the reviewing committee and the competent authority have issued approval.
More information on submitting to the competent authority can be found at Research with a medicinal product & extra review competent authority.