WMO
The first FSW policy and SOPs for research subject to the WMO (Wet medisch-wetenschappelijk onderzoek met mensen) are currently in development.
Research is subject to the WMO if the following criteria are met:
- It concerns medical scientific research and
- Participants are subject to procedures or are required to follow rules of behaviour.
The WMO does not offer a definition of the term medical-scientific research. As a result, it is not always clear if the research protocol must be submitted for review by law. The CCMO (Centrale Commissie Mensgebonden Onderzoek) assists in this by offering the following definition:
‘Medical/scientific research is research which is carried out with the aim of finding answers to a question in the field of illness and health (etiology, pathogenesis, signs/symptoms, diagnosis, prevention, outcome or treatment of illness), by systematically collecting and analysing data. The research is carried out with the intention of contributing to medical knowledge which can also be applied to populations outside of the direct research population.’
Please consult the CCMO webpage and this decision tree (in Dutch) on the website of the local Medical Research Ethics Committee (MREC Leiden, Den Haag, Delft: METC-LDD) to check if your research is subject to WMO.
If you are uncertain about whether or not your research is subject to the WMO and/or you need to submit your research project for ethical review to the METC-LDD, you can ask the FSW nWMO advisory committee for advice. For advice, please submit either the completed nWMO advice form or a completed ethics form from your institute to nWMOadvisory@fsw.leidenuniv.nl.
Committee members
The committee is composed of the two FSW representatives in the METC-LDD and a policy advisor.
Documents and regulations
If you plan on submitting your research to a MREC, please inform the faculty monitor: wmomonitoring@FSW.leidenuniv.nl. They can help you with:
- Your monitoring plan
- Deciding if your research can be internally monitored
- Registering your research project as a FSW WMO project (info shared with the relevant Ethics committee: ECPW, CEP (or CEM – so far we have had no WMO research project carried by the social sciences institutes))