When you are preparing a study, you need to be sure whether your study is in the scope of WMO. Your study falls under the scope of WMO (Wet medisch-wetenschappelijk onderzoek met mensen / Medical Research Involving Human Participants Act).
Your study is in the scope of WMO when:
- The study is a medical scientific study and
- Participants in the study are subjected to practices or to behavioural rules.
More details can be found on the website of CCMO (Centrale Commissie Mensgebonden Onderzoek).
If the study is in the scope of the WMO, then the study application must be approved by an accredited MREC (Medical Research Ethical Committee). The cETO is not an accredited MREC (METC in Dutch) and is thus not authorized to give approval for this type of studies. The researcher is responsible for submitting the study application to the MREC and for the (possible) costs without the involvement of the cETO.
In exceptional cases, funding bodies and institutions could demand an ethical approval by a MREC, even if the study is not in the scope of the WMO. In such a case, the approval of the cETO would be insufficient. It is the responsibility of the researcher to find out which procedure is most appropriate.
Are you unsure?
If you are unsure whether your study is in the scope of WMO, you can ask the cETO for a WMO check before the start of the study. You can submit an online full track application, which includes a WMO check. In case the study is in the scope of WMO, the researcher has to contact an accredited MREC to apply for ethical assessment. It is also possible that the researcher adapts the research application in such a manner that WMO rules no longer apply. Studies that are not in the scope of the WMO, will automatically be assessed by the cETO for ethical acceptability. Here you can find more information about the full track procedure.