WMO or non-WMO
If the following two conditions apply to your study, it is subject to the WMO:
- It concerns medical scientific research and
- Participants are subject to procedures or are required to follow rules of behaviour.
The WMO stipulates that all medicinal research must comply with the guidelines of Good Clinical Practice (GCP). A medicinal trial is definied: if the purpose of the study is to investigate the mechanism of action, safety or efficacy of a drug.
Research involving a medical device that also makes use of medicines may also fall within the scope of medicines research within the meaning of the WMO. See also the CCMO on this subject.
Research that does not fall within the scope of WMO legislation does not need to be reviewed and authorised by the Medical Ethics Review Committee (MERC). If you have any doubts about whether your study falls within WMO regulations, you can submit your research proposal to the MERC management board, for more detailed information see the intranetpages of MERC AMC and MERC VUmc. A statement from the MERC that your study is not subject to the WMO may, for example, be necessary for publishing the research results.