In the Netherlands, medical research involving human subjects is regulated by law: the Medical Research Involving Human Subjects Act (WMO). Research is subject to the WMO if:
- It concerns medical-scientific research, and
- Participants are subject to procedures or are required to follow rules of behavior.
Read more information to decide if your research falls under the WMO. (also in Dutch)
If your research satisfies these two criteria, you have to undergo a review by an accredited MREC or the CCMO, instead of a review by our Natural Sciences and Engineering Sciences Ethics Committee. In practice, there will always be cases in which it is not clear immediately if a study is or is not subject to the WMO: the so-called grey area. When in doubt it is best you contact the MREC or CCMO.
The University of Twente and Rehabilitation Centre Het Roessingh cooperate with the accredited MREC 'Research Ethics Committee in the region Arnhem-Nijmegen (CMO A/N)' and stimulate research to submit there. You can submit your research dossier to the CMO A/N through their online portal. There is an instruction manual available for submission to CMO A/N. This procedure can also be used for advice on WMO applicability (non-WMO statement).
TechMed supports UT researchers with this type of research. Get in contact.
If your research does not fall under the scope of the WMO then it does not have to be reviewed by an accredited MREC or the CCMO. However, please note you may need a non-WMO declaration in case you carry out your research in a hospital or another medical institution. Both METCs can provide this statement: CMO A/N or MEC-U.
Also, identify whether the organization with which you will be working has its own requirements and policy for the ethical review of research. If it does, submit your proposal to this organization, and provide us with a copy of your application and the resulting decision.