When does the WMO apply to research

The Medical Research Involving Humans Act (a.k.a. Wet medisch-wettenschappelijk onderzoek met mensen WMO) applies to research if both of the following conditions apply:

  1. The research is medical-scientific research
  2. Research subjects must undergo procedures or must follow specific rules of behaviour

The Central Committee on Research Involving Human Subjects (CCMO) goes into further detail on this topic on this page in English and on this page in Dutch.

It can be confusing as to whether the WMO applies to your research or not, in part because there is no legal definition of “medical-scientific research”. Additionally, the intensity or invasiveness of the procedures/rules of behaviour can impact whether your research is judged as subject to the WMO. You might argue that your research is not medical-scientific research, but if you need to take blood samples from your research subjects, your research will be considered invasive enough to fall under the WMO.

Because there is nuance in what does and does not fall under the WMO, it’s recommended to take the short FGB-based quiz (if you haven’t already) to help determine if the WMO is applies to your research or not.

Other medical research regulations

There are other regulations that can also apply to medical-scientific research. More information is found on this page about these other regulations. In short:

  • Of all the additional regulations, FGB researchers are most likely to have to deal with the Medical Devices Regulation (MDR). The MDR can apply to both WMO and non-WMO research. The FGB page on other regulations, therefore, focuses primarily on the MDR and what it means for FGB researchers.
  • The Clinical Trial Regulation (CTR) can apply to FGB WMO research but very rarely. The CTR usually applies when there is a collaboration with a medical institution. More information can be found here on the CTR.
  • The In Vitro Diagnostics Regulation (IVDR) also rarely applies to FGB research. More information can be found here on the IVDR.

The WMO review process for FGB researchers

The submission procedures described here will primarily refer to NedMec+, an METC representing the Antoni van Leeuwenhoek, Prinses Maxima Centrum and UMC Utrect hospitals, and which the Amsterdam UMC joined on July 1 2026. The guidance should be transferable to other METCs because all METCs are guided by the national CCMO, but keep in mind that procedures could differ slightly outside of the NedMec+ context.

➣Review the submission requirements

Make sure to follow all of the NedMec+ (or other METC) submission requirements. You do not need to follow any of the institution specific requirements (such as those for the AUMC) unless your research is in collaboration with a relevant institution. The templates used in all standard submissions are written with multiple use-cases in mind, so if you find yourself unsure how to fill in certain sections of a template, check the FGB specifics section.

As part of the standard submission, make sure to review the following:

➣FGB specifics

  • A1 Template cover letter (Dutch guidance / English guidance) & A1.Addendum NedMec
    • WMO research at FGB often requires an onderzoekscontract (a.k.a. Clinical Trial Agreement) so adjust the text in the second paragraph to wel een onderzoekscontract afgesloten. Clinical Trial Agreement’s are explained further below under K3 Clinical trial agreements
      • If you have a Clinical Trial Agreement, also make sure question 9 of the NedMec addendum is answered “yes”
    • The text relating to geneesmiddelonderzoek met ongeregistreerde middelen should be removed (except, of course, in the rare case of pharmaceutical research with unregistered products within FGB)
    • Under the section “Invoice sheet” of the NedMec addendum, if you are unsure how to fill in the billing information, you can contact your department manager for assistance
  • B1 ABR form (Dutch guidance / English guidance)
    • Under section 1.5, if you are unsure how to fill in the billing information, you can contact your department manager for assistance
    • Section 8.10 of the ABR form is about insurance. See “Insurance for WMO research within FGB” for more information on how insurance is organized for WMO research within the VU.
    • Section 11.3 is about publishing research data. If your aim is to publish de-identified participant data, make sure to follow FGB and VU requirements to ensure this is done safely, legally and ethically. You can assess the level of risk posed by the data you plan to share with this risk app. Based on the risk level, you can review the recommended procedures for reuse of data after the current research project. You can also contact the FGB Privacy Officer for guidance on how to approach this topic. NB: it is possible to determine your data sharing plan after your research is reviewed by the METC, but make sure you have a plan in place before you begin data collection because consent is very often one of the most important aspects that will allow future data reuse.
  • C1 Research protocol
  • E1 Subject Information Sheet and informed consent form (Dutch guidance / English guidance)
    • Section 6 of the information letter template is about insurance. See “Insurance for WMO research within FGB” for more information on how insurance is organized for WMO research within the VU.
    • Appendix A contact information:
    • In addition to Section 5 and Appendix C of the template, it is a VU requirement to have a privacy statement that participants can refer to at their leisure. See this page for more information on privacy statements. You can submit the privacy statement in section E4 Other informational materials of the standard research file.
      • It is recommended to include a reference to the privacy statement in the information letter. Include the following text: “In de bijgevoegde privacyverklaring vindt u meer informatie over hoe wij uw persoonsgegevens gebruiken in dit onderzoek” at the end of section 5 of the model information letter. It is also advised to include a motivation in your standard research file to inform the METC of this minor addition and the reason for its inclusion. You can use the following standard text for this: “Conform het beleid van de Vrije Universiteit Amsterdam dient elk onderzoek te worden voorzien van een privacyverklaring als aanvulling op de informatiebrief. Deze is ingediend onder categorie E4 (‘Overig voorlichtingsmateriaal’). Tevens is daartoe een verwijzende zin in de informatiebrief opgenomen.”
  • G Insurances (Dutch guidance / English guidance)
  • I2 Site Suitability Declaration (VGO) / Research declaration (Dutch guidance / English guidance)
    • Most FGB research uses the research declaration (onderzoeksverklaring) for this part of the standard research file; a full VGO is only necessary when research with medical products is being carried out
  • K3 Clinical Trial Agreements(Dutch guidance / English guidance)
    • Since FGB research usually requires a research declaration (onderzoeksverklaring) to declare the suitability of the research site, if you require a clinical trial agreement you must use the template (only in English) that is suited to studies with a research declaration.

Things you should be aware of

  • Ensure that the number of participants you plan to include is consistent across all submitted documents. For WMO research this will generally be stated in:
    • Your research protocol
    • The ABR form that you fill in in the Research Portal
  • It is best practice that all researchers conducting WMO research complete either the BROK (basiscursus regelgeving en organisatie van klinisch onderzoek) course or another Good Clinical Practice (GCP) certification. The BROK course is preferable to other GCP certifications because it is not limited to research on medicinal products, but to all WMO research as well as relevant non-WMO clinical research.
    • Bear in mind that the BROK course was created for UMC researchers, meaning some aspects may still not apply to you as an FGB researcher. When in doubt, contact FGB REPS for support.

➣Insurance for WMO research within FGB

The METC will determine if your WMO research requires participants’ insurance. If you believe that your research does not pose risks to your participants, you must include a written request to the METC for exemption from the insurance requirement. This written request must be included in the initial submission of your standard research file. If you are certain that your research will require participants’ insurance, you will need to include proof of participants’ insurance in your submission. You can find the latest participants’ insurance documentation on this VUweb page. Regardless of whether your research requires participants’ insurance, you are also required to include proof of liability insurance in your submission. For proof of liability insurance, contact for a copy of the relevant documentation.

NB: VU liability insurance covers all research and education activities carried out by VU staff, even when they are doing those activities on location.

If you do not request an exemption from participants’ insurance or the METC rejects your request for an exemption, you will need to register for participants’ insurance via this form. You can only fill in this form after you have received approval for your research from an METC because you need to submit the letter of approval from the METC that states that participants’ insurance is required. The FGB REPS team collects most registrations from this form once a year in the fall for processing by VU Corporate Finance. You may fill in this form at any time of the year, but if you do so outside of the usual mass registration period (every year in September), please contact to confirm that your registration has been received.

NB: There are no additional costs with liability insurance, but the participants’ insurance will be billed to your research project from whichever funding source is applicable to you. This means that if you are obtaining funding from a grant provider, the costs of participants’ insurance need to be included in the budgeting. See the next section “Costs of WMO research and budgeting” for more information.

➣Costs of WMO research and budgeting

WMO research involves many extra costs that need to be estimated and accounted for in your budgeting, especially if you are obtaining funding from a grant provider. You are expected to cover these costs with your project budget, therefore it’s important to estimate what these costs will be during your grant application. The primary costs that you need to take into account are:

  • The costs of a WMO review by an METC
  • The costs of participants’ insurance
    • If your research requires participants’ insurance, there will be additional costs per participant included in the study. For 2026, this cost is €45 per participant.

Support

If you have questions or need additional support, contact the FGB REPS team. REPS has also created a peer-to-peer Teams channel for researchers conducting WMO research; the channel provides a place where researchers can help each other out in finding answers and solutions to questions or issues that arise around their WMO review process (and the REPS team is in the channel too to help of course!). If you would like to join this Teams channel, contact .