The principal investigator decides whether or not the research proposal needs a full review according to the Dutch Medical Research with Human Subjects Law (Wet Medisch-wetenschappelijk Onderzoek met mensen, WMO). However, there may be other regulations applicable, such as the Medical Treatment Agreement Act (in Dutch: Wet geneeskundige behandelovereenkomst, WGBO), the Data Protection Act (in Dutch: Wet bescherming persoonsgegevens, WBP, per 28 May 2018 the EU General Data Protection Regulation) and the Code of Conduct for Responsible Use (FEDERA).
In some cases it is prudent to have an exemption letter from an official Medical Ethics Review Board for publication purposes. At your request, the METc UMCG will review whether or not the scientific research falls within the scope of the WMO.