WMO - Medical Scientific Research with Persons

The ‘Wet Medisch-Wetenschappelijk Onderzoek met Mensen’ (WMO) settles the requirements for executing scientific research with human beings in the medical domain. It contains as well the requirements for clinical trials. Consent in the WMO is exclusively oriented towards providing consent for participating to the research that is envisioned and relates to providing information concerning the risks, and rights and obligations concerning opting-in and opting-out to this research. The law does not contain specific requirements concerning consent in relation to processing of personal data.

The WMO is relevant for companies that conduct clinical trails (in the Netherlands) in order to develop their product. More information about the WMO and if your research obligated is to the WMO can be found here