WMO informed consent
One of the implications of WMO legislation is that human subjects must be informed about the trial both orally and in writing, and that they have to give their written consent to participate in the trial. Their informed consent must be given completely voluntarily.
A Subject Information Form (in Dutch: Proefpersonen Informatie Formulier PIF) and the Informed Consent Form (ICF) or consent form have fixed fields, a number of which are mandatory under law and therefore cannot be omitted. The CCMO website offers various models for the Subject Information Form and Informed Consent Form for adults and children.
A standard procedure has been drawn up for researchers at Amsterdam UMC pertaining to this important aspect: GCT SOP 01 Informed Consent Procedure
General information brochure
In the Netherlands, the Government has made a general information brochure for medical scientific research available. You are advised to give this brochure to the participants for information purposes, in addition to the subject information form and any additional information approved by the review committee. This brochure does not need to be submitted to the review committee. The link can be added to the subject information form. General information about medical scientific research remains available at www.rijksoverheid.nl/mensenonderzoek.
non-WMO informed consent
If research does not fall within the scope of the WMO, there may be other rules to take into account. For example the Medical Treatment Agreement Act (in Dutch de Wet op de geneeskundige behandelovereenkomst, WGBO), the General Data Protection Regulation (in Dutch AVG) and the Code of Conduct for Health Research.
Usually permission is required, but there are exceptions. The main concern is whether the data is identifiable/can be traced back to persons or not.
A mandatory SOP 'Reuse of care data for the purpose of research' has been drawn up at Amsterdam UMC for the reuse of anonymous and/or coded data and to request data extraction from the EPD.
Information about the use of residual material from existing biobanks can be found on the intranet page of the Amsterdam UMC biobank.
E-consent non-WMO en WMO
For some time now for non-WMO, but for research subject to the WMO, an electronic Informed Consent (eIC) has been permitted under certain conditions since 1st of July 2022. Potential participants may give permission electronically for participation in research subject to the WMO, provided that “this method is sufficiently reliable and confidential, is appropriate for the research and is laid down in the research protocol” and a number of other conditions are met. In that case, only requesting permission electronically is also permitted: “It may be stipulated in the research protocol that, with the exception of the possibility of verbal consent referred to below, permission can only be granted electronically. If the participant is unable to write or give consent electronically, consent may be given verbal in the presence of at least one witness.” You can find this amendment to the WMO here. Information about the process and parliamentary documents can be found here. The WMO legislation can be found here.