Is review required?
Research is subject to the WMO if the following two criteria are met:
1. It concerns medical scientific research ánd
2. Participants are subject to procedures or are required to follow rules of behaviour.
Further information and examples of research not subject to the WMO can be found on the CCMO website.
Please see the following link: Your research: subject to the WMO or not?
In case of doubt as to whether or not a study is subject to WMO
If in doubt, you can submit the (non-)WMO form to the METC NedMec+. The METC will use this form to assess whether the WMO applies. There is no substantive assessment of the research.
The (non-)WMO form can be downloaded from the ‘Documents & Forms’ page. Always use the most recent version of the form, and only attach relevant appendices (e.g. questionnaires).
Please note: the METC NedMec+ charges a fee for assessing whether or not a study falls within the scope of the WMO. You can find our current rates on the ‘Rates’ page.
Whether submission to the METC NedMec+ is mandatory depends on the policy of the client and/or the institution where the research is being carried out. If necessary, please contact the institution’s research office or research support department.
If the research does not fall within the scope of the WMO, the researcher receives a statement that the research is non-WMO. Please note, however, that internal review of non-WMO research by an IRB or the institution’s own Non-WMO Review Committee may be required. You should therefore always consult the policy of the institution concerned:
Further information on the specific institutional policies of the institutions with which METC NedMec+ is affiliated:
Changes to non-WMO research
Please resubmit any changes that may affect eligibility under the WMO for review. Please also check the requirements of the client and the institution(s) where the research is being carried out.
Important
A non-WMO declaration does not replace an assessment of local feasibility, approval by the IRB/Non-WMO Review Committee of the institution concerned, or authorisation from the Executive Board.
Other legislation may also apply if the research falls outside the scope of the WMO.
Useful links
CCMO: Your research: Is it subject to the WMO or not?
CCMO: Non-WMO research
CCMO: File research
Thank you for your review!