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 Central Committee on Research Involving Human Subjects (CCMO) provides national templates for the Information Sheet for Research Participants (IRP, in Dutch: Informatiebrief voor Onderzoeksdeelnemers, IVO) 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 IRP 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. Further information on these exceptions, as well as guidance on how to justify applying them to your study is available in the Handreiking beroep op "geen bezwaar" voor gebruik medische gegevens (only in Dutch).

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 IRP and non-WMO ICF are available on the websiteof the Non-WMO Review Committee of Amsterdam UMC, 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 Biobank Review Committee (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 permitted under specific conditions since July 1, 2022. The amendment to the WMO regarding e-consent is available here. Information on the process and parliamentary documents are available here.

The key conditions for the use of e-consent are:

  • The use of e-consent is appropriate for the study;
  • The method used is sufficiently reliable and confidential;
  • The method is adequately described in the study protocol
  • The protocol is approved by MREC and BoD. 

To support the assessment of WMO-research that include the use of e-consent, the CCMO and the Netherlands Association of Medical Research Ethics Committees (NVMETC) have developed a guideline for Medical Research Ethics Committees (MRECs). This guideline provides further clarification of the above-mentioned conditions and includes a step-by-step framework explaining how MRECs assess the use of e-consent.  

In addition to the CCMO guidance, the Privacy, Information Security & Compliance (PB&IB) department has developed a decision guide to help researchers determine whether e-consent is appropriate from a privacy perspective for their specific study. Researchers are strongly advised to consult this guide before drafting the study protocol and submitting it to the reviewing METC for approval.

Within Amsterdam UMC, e-consent can currently be implemented through Mijn Dossier. If this method might be suitable for your study, practical instructions, including example protocol text, can be found in GCT T46 Submitting e-consent Mijn Dossier WMO.

The use of alternative e-consent solutions requires a more comprehensive assessment by Amsterdam UMC before they can be approved for use in research.

Once the MREC and BoD has approved the use of e-consent via Mijn Dossier for your study, you can submit an EPIC notification to the Eva Service Center Research.