Informed Consent

  • WMO
  • Non-WMO

A key requirement of WMO legislation is that potential participants must be informed about the study both orally and in writing. It must be clearly stated that participation is voluntary and that refusal or withdrawal from participation will have no consequences. Additionally, participants must provide written consent (e.g. informed consent) before taking part in the study.

The CCMO provides national templates for the Subject Information Sheet (in Dutch: Proefpersonen Informatie Formulier, PIF) and the Informed Consent Form (ICF) on their website, for both adults and children. The templates are structured with specific elements, some of which are legally required and cannot be omitted.

Furthermore, the Ministry of Health, Welfare and Sport provides general information on participating in medical scientific research on their website: https://www.rijksoverheid.nl/onderwerpen/medisch-wetenschappelijk-onderzoek. This link is included in the PIF templates, and researchers are expected to bring it to the attention of potential participants during the recruitment process. 

At Amsterdam UMC, the standard procedure for obtaining informed consent is described in GCT SOP 01 Informed Consent Procedure.

If research is not subject to the WMO, other regulations may still apply, such as the Medical Treatment Agreement Act (in Dutch: Wet op de geneeskundige behandelovereenkomst, WGBO), the General Data Protection Regulation (GDPR), and the Code of Conduct for Health Research.

Usually informed consent is required, but there are exceptions. The main consideration is whether the study data is identifiable/can be traced back to individuals.

At Amsterdam UMC, a mandatory SOP: Reuse of care data for the purpose of research has been established. This SOP outlines the procedures for reusing anonymous and/or coded data and requesting data extraction from the Electronic Patient Record (EPD).

Templates for the non-WMO PIF and non-WMO ICF are available on the MREC Amsterdam UMC website, for both adults and children.

For medical scientific research, biological materials are also often required. When biological materials are collected and stored specifically for future research, or when residual material from an existing biobank is used to answer a research question, informed consent must usually be obtained in advance. The Commissie Toetsing Biobanken (CTB) provides templates for both scenarios.

Electronic informed consent (e-consent) has been permitted for non-WMO research for some time. For research subject to the WMO, e-consent is allowed under certain conditions since July 1, 2022.

Potential participants may provide e-consent for participation in WMO-research, provided that:

  • It is appropriate for the study;
  • The method is sufficiently reliable and confidential;
  • The method is described in the study protocol.

For the evaluation of a research file that includes the use of e-consent, the CCMO and NVMETC have developed a guideline for Medical Research Ethics Committees (METCs) that provides further clarification of these conditions. The guideline includes a step-by-step plan (with explanations) outlining the steps the METC follows to arrive at an assessment of electronic consent.

One of the most important aspects of digitally signing an e-consent is demonstrating that the signatory is indeed the person who has given consent. Strict requirements apply to the digital signature used for e-consent. Within AmsterdamUMC, a positive recommendation has at least been given for the use of MyChart to obtain e-consent. Where possible and applicable to your study, you may include this method in your protocol for approval by the reviewing committee. An alternative method for obtaining e-consent will require a more extensive assessment.

When the use of e-cosent via MyChart is approved for your research by the MERC, you can make an EPIC notification to the Eva Service Center Research.   

You can find the amendment to the WMO regarding e-consent here. Information on the process and parliamentary documents is available here. The full WMO legislation can be found here.