Is review required?
Is review required?
Research is subject to the WMO if the following criteria are met:
1. It concerns medical scientific research ánd
2. Participants are subject to procedures or are required to follow rules of behaviour.
More explanation about when research is subject to WMO can be found on the website of the CCMO via the link Your research: Is it subject to the WMO or not?
In case of doubt as to whether or not a study is subject to WMO uitklapper, klik om te openen
MREC NedMec has developed a (non-)WMO form for researchers who have doubts about whether or not a study falls within the scope of the WMO. MREC NedMec will only assess whether the research falls within the scope of the WMO on the basis of the information on the form. Only attachments which may be relevant, such as questionnaires, can be included.
There is no substantive review of the research itself. If MREC NedMec decides that the research does not fall within the scope of the WMO, the researcher receives a statement that the research is non-WMO. Other legislation may apply. An overview of types of non-WMO research and relevant legislation can be found on the CCMO website.
Please note that MREC NedMec will charge costs for such an assessment. See our 'Fees for review' page for the current tariffs.
If in doubt, you can submit the (non-)WMO mandatory form to the MREC. The form can be downloaded from this page. The form and a brief explanation of the form can be downloaded via the 'Documents & forms' page. Please also read the brief explanation accompanying the form.
Please note that METC NedMec will charge costs for such an assessment. See our 'Fees for review' page for the current tariffs.
Whether research that is presumably not subject to the WMO must be submitted to an MREC depends on the policy of the institution where the research is being conducted. Check with the research bureau of the institution concerned. Contact details and information on institutional policy can be found on the pages below:
Antoni van Leeuwenhoek
Princess Máxima Center
UMC Utrecht
Publication of non-WMO research?
By definition, file research is not subject to the WMO. For publication, medical scientific journals often require a statement that the research has been submitted to an ethics committee. The MREC statement of non-WMO research is usually accepted for this purpose. More information on relevant legislation on file research can be found on the CCMO website.
For publication of (other) medical scientific research which, by definition, does not fall under the scope of the WMO because human subjects are not subjected to procedures and/or no conduct is imposed, advice from an ethics committee other than a recognized MREC may also suffice. An example is research with previously collected body material that has been reviewed by a Biobank Review Committee. In that case no additional non-WMO statement from an MREC is required.
Is submission to MREC Nedmec required if the research has been designated as non-WMO by another accredited MREC? uitklapper, klik om te openen
For this, check the policy of the institution where the research is being conducted.
Note: a non-WMO statement is not a substitute for local feasibility or board approval.
Always submit changes of research not subject to WMO?
Yes
It is recommended that changes that may affect the criteria by which a study may become subject to WMO be submitted for review.
No
For research not subject to the WMO, the MREC has no role in reviewing the research file. Documents that contain changes, such as an information letter, do not have to be submitted to the MREC for review. Matters which must be reported to an MREC in the case of research subject to the WMO, such as start and finish dates, progress and final report/publication, do not apply.
However, the research institution can impose obligations on researchers in this regard. Check the policy of the institution where the research will be conducted.
Research involving a medical device which is not subject to the WMO uitklapper, klik om te openen
If you are using a medical device in research that is not subject to the WMO, assessment by the MREC in accordance with the Medical Device Regulation (MDR) is still required in some cases.
Please consult the CCMO website for more information.
Link uitklapper, klik om te openen
CCMO: Your research: Is it subject to the WMO or not?
CCMO: Non-WMO research
CCMO: File research
Participating institutions: UMC Utrecht, Prinses Máxima Center for pediatric oncology and Antoni van Leeuwenhoek