Most, if not all, research conducted within FGB will require some form of ethical review. Not all FGB research projects can be reviewed by the faculty’s Scientific and Ethical Review Board (VCWE) because certain Dutch & EU laws (e.g. WMO, MDR etc.) require that some forms of clinical research be reviewed by a Medical Research Ethics Committee (METC).

Determining which situation applies to you can be confusing and if you determine that your research is subject to the WMO and/or MDR, the process can be quite complicated for FGB researchers because all METCs are external to the VU. The following guide aims to help you determine which ethical review process(es) apply to you and, once that’s known, help you navigate the applicable ethical review process.


Which ethical review process do you need information on?







WMO requirements for FGB research

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 .



MDR and other regulations for medical FGB research

When does the MDR apply to research

The EU Medical Devices Regulation applies to your research if you are studying the safety and/or (clinical) performance of a medical device. If your research involves the use of a medical device, but that device is not the subject of investigation, the MDR does not apply, but other regulations, including the WMO may still apply.

For example, if you’re evaluating the performance of a wearable device to accurately measure heart rate and blood pressure, the MDR applies. If you’re using the wearable to measure blood pressure and heart rate as a proxy for emotional response, but the performance, safety and effectiveness of the wearable itself are not under study, the MDR does not apply.

What constitutes a medical device?

This CCMO page (in Dutch and in English) explains the MDR definition of a medical device. Additionally, some devices without medical purposes are subject to the MDR and sometimes software can be considered a medical device.

Examples of medical devices within FGB include:

  • Interactive Walkway
  • Electrical stimulation device for prevention of pressure ulcers in wheelchair users

Frameworks for clinical investigation

This CCMO page (in Dutch and in English) helps you determine which framework to apply to your clinical research with a medical device. This is necessary because each framework has specific requirements for the review process, including:

The MDR review process for FGB researchers

The submission procedures described here will primarily refer to the CCMO or 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 CCMO, but keep in mind that procedures could differ slightly outside of the NedMec+ context.

All submissions will go through the Research Portal(Onderzoeksportaal) regardless of the committee reviewing your submission. If your MDR research is for the purposes of obtaining or expanding the CE certification of the medical device, your standard research file will be reviewed first by the CCMO (still within the Research Portal) to confirm that your application is complete and valid (more information in Dutch and in English).

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.

➣Review the submission requirements

  • Standard submission requirements
    • The coding described for each document should be automatically added when each document is uploaded in the the Research Portal(Onderzoeksportaal) and the portal should ask you to provide a version date and number for each document.
  • Primary review (Dutch guidance / English guidance)
    • You must submit a standard research file on your primary submission. The documents required for a standard research file are listed here in Dutch and here in English)
    • The content of the MDR standard research file depends on the framework your MDR research falls within. You also need to know which framework applies so that you can adjust any template documentation according to the applicable framework.
    • There are some specific language requirements for the standard research file:

➣FGB specifics

  • 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.
      • If your MDR research is only subject to the MDR but not the WMO, make a request for exemption from insurance.
    • 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 MDR research within FGB” for more information.
    • 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. If your MDR research is not subject to the WMO, you can alternatively use this template (only in English).

Things you should be aware of

➣Insurance for MDR research within FGB

If your MDR research is also subject to the WMO, follow the guidance on the page “Insurance for WMO research within FGB” for more information on how insurance is organized for WMO research within the VU.

If the WMO does not apply to your MDR research and you only need to provide proof of VU liability insurance, contact for a copy of the necessary documentation.

NB: VU liability insurance covers research and education activities carried out by VU staff, even when they are doing those activities on location. There are no additional costs associated with the VU’s liability insurance.

➣Costs of MDR research and budgeting

MDR 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 MDR review by an METC/CCMO
    • For FGB researchers (i.e. external applicants) funded by research grants (i.e. not by industry), the cost of review depends on the framework your MDR research falls within. Costs can range from €2670 to €4000. Review of substantial amendments can range from €221 to €850 and the review of an Investigational Medical Device Dossier (IMDD) costs €885 per device submitted.
    • The costs of review can differ across METCs.
  • The costs of participants’ insurance
    • If your MDR research is subject to the WMO and also requires participants’ insurance, there will be additional costs per participant included in the study. For 2026, this cost is €45 per participant.

Other medical research regulations

There are other regulations that can also apply to medical-scientific research. For example:

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!). Questions about the MDR and other medical research regulations are very likely to come up in this channel, so even if the WMO doesn’t apply to your research, if you have to deal with these other regulations you are welcome to join for support.

If you would like to join this Teams channel, contact .



Standard FGB ethical review process

The Scientific and Ethical Review Board of FGB (VCWE)

You can find all the necessary information about standard ethical review within FGB and the VCWE on the VCWE’s VUweb page. On this page, you will find:

  • References to relevant codes of conduct
  • Steps required prior to submission to the VCWE
  • Templates for information letters and informed consent forms
    • In Dutch and English
    • Versions for participants under 16
  • Information about the ethical review submission portal
  • Contact information for the VCWE

Is ethical review always required?

There are relatively few cases within FGB where ethical review wouldn’t be recommended. Additionally, an increasing number of scientific journals require proof of ethical review before your research article can be published. The VCWE will not provide post-hoc ethical review. To avoid the risk of not being able to publish your work anywhere, it is wisest to err on the side of caution and obtain ethical review.

What happens if I am only reusing existing data?

Even if you are reusing data and aren’t including any active participants, there may still be ethical questions posed by your research, meaning ethical review is still advised. Additionally, there are very often privacy or legal questions that arise when data are reused for new research. If you plan to reuse data for your research, contact the Research and Policy Support Team (REPS) prior to ethical review to ensure that you can (legally) reuse the data.

Insurance for non-medical/non-WMO research within FGB

VU liability insurance covers all research and education activities carried out by VU staff, even when they are doing those activities on location. There are no additional costs associated with the VU’s liability insurance.

You don’t need to provide evidence of the VU’s liability insurance to the VCWE, but if you are working with external partners and the question of liability insurance comes up, you can contact for further support. Where appropriate, a copy of the insurance documentation can be provided to you.

Let’s figure it out!

Depending on your answers, you will either advance to the next question or immediately receive advice on which path applies to you. You can always come back to this quiz by reselecting “I need help to figure out which process(es) apply to me”.

1. Will your research project have human research participants?

FGB examples
  • Includes:
    • Lab experiments with volunteers in brain/movement labs
    • Online surveys (including those with respondents from MTurk or Prolific)
    • Research trials on patient populations
    • Observation of research subjects in day-to-day activities
  • Excludes:
    • Review of existing medical records
    • Reuse of existing data sources
    • Research on animals or existing biobanked materials



2. Will your research project aim to answer questions related to illness, health or other medical/clinical topics?

FGB examples

Research related to etiology, pathogenesis, signs & symptoms, diagnostics, disease prevention, disease outcomes or treatment of illness. For example:

  • Genetic factors in (mental) illness or developmental differences
  • Societal contributors to (mental) illness
  • Non-pharmaceutical psychological treatments
  • Pain management methods
  • (Cost) effectiveness of (new) psycho- and/or physiotherapy methods



3. Will you take blood samples from your research participants in the course of the research project?




4. Will your research participants be required to follow specific rules of behaviour?

FGB examples
  • Following a specific diet and/or exercise regiment
  • Participation in group therapy sessions of varying intensity
  • Continuously wearing accelerometers/ambulatory monitoring devices for several days
  • Regular self-reporting in a journal for an extended period



5. Will your research participants receive experimental treatments as a part of the research project?

FGB examples
  • High-intensity vs low-intensity psychotherapy in depressive subjects
  • Muscle-stimulating pressure cushions
  • Application of non-invasive brain stimulation
  • Augmented/virtual-reality tools and applications
  • Exposure to anti-misinformation “innoculation” methods



6. Will your research participants be subjected to procedures that could likely be experienced as physically and/or psychologically invasive?

FGB examples
  • Stressful psychological experiments where participants are subjects to extreme emotional and/or ethical pressure
  • Studies of human physical performance that require rectal thermometers to record accurate body temperature measurements



7. Will your research participants be subjected to procedures that have a reasonable potential to cause physical and/or psychological harm?

FGB examples
  • Experiments in heat labs investigating the body’s response and management of temperature regulation during exertion
  • In-depth psychological interviews on deeply distressing, upsetting or stigmatized topics



8. Will your research participants be administered anything (medications, hormones, supplements) as a part of their participation in your research project?

FGB examples
  • Experiments where stress hormones are administered to study stress responses during emotional interpersonal interactions
  • Studies involving any tailoring or adjustment of psychotherapeutic medication regimens



WMO review is required

Based on your responses, the WMO applies to your research and you will need to undergo review by an METC. Below you can find more information on the WMO review processes and how they apply to you as an FGB researcher. The information also includes references to other regulations that might apply to your research such as the Medical Devices Regulation (MDR).

View WMO Guidance

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 .

Standard FGB ethical review is required

Based on your responses, the WMO does not apply to your research. Submit your research to the VCWE (FGB’s ethical committee) to ensure that it meets all ethical requirements.

NB: If your research undergoes substantial amendments, it may become subject to the WMO. Substantial amendments will require a new ethical submission to the VCWE.

View VCWE Guidance

The Scientific and Ethical Review Board of FGB (VCWE)

You can find all the necessary information about standard ethical review within FGB and the VCWE on the VCWE’s VUweb page. On this page, you will find:

  • References to relevant codes of conduct
  • Steps required prior to submission to the VCWE
  • Templates for information letters and informed consent forms
    • In Dutch and English
    • Versions for participants under 16
  • Information about the ethical review submission portal
  • Contact information for the VCWE

Is ethical review always required?

There are relatively few cases within FGB where ethical review wouldn’t be recommended. Additionally, an increasing number of scientific journals require proof of ethical review before your research article can be published. The VCWE will not provide post-hoc ethical review. To avoid the risk of not being able to publish your work anywhere, it is wisest to err on the side of caution and obtain ethical review.

What happens if I am only reusing existing data?

Even if you are reusing data and aren’t including any active participants, there may still be ethical questions posed by your research, meaning ethical review is still advised. Additionally, there are very often privacy or legal questions that arise when data are reused for new research. If you plan to reuse data for your research, contact the Research and Policy Support Team (REPS) prior to ethical review to ensure that you can (legally) reuse the data.

Insurance for non-medical/non-WMO research within FGB

VU liability insurance covers all research and education activities carried out by VU staff, even when they are doing those activities on location. There are no additional costs associated with the VU’s liability insurance.

You don’t need to provide evidence of the VU’s liability insurance to the VCWE, but if you are working with external partners and the question of liability insurance comes up, you can contact for further support. Where appropriate, a copy of the insurance documentation can be provided to you.

Standard FGB ethical review is required

Based on your responses, the WMO does not apply to your research. Submit your research to the VCWE (FGB’s ethical committee) to ensure that it meets all ethical requirements.

NB: If your research undergoes substantial amendments, it may become subject to the WMO. Substantial amendments will require a new ethical submission to the VCWE.

Potential additional concerns

Other regulations may apply to your research (even if the WMO does not apply) because of the medical nature of your research. More information on how to apply these regulations within FGB can be found under the “MDR and Other Regulations Guidance”.

View VCWE Guidance

The Scientific and Ethical Review Board of FGB (VCWE)

You can find all the necessary information about standard ethical review within FGB and the VCWE on the VCWE’s VUweb page. On this page, you will find:

  • References to relevant codes of conduct
  • Steps required prior to submission to the VCWE
  • Templates for information letters and informed consent forms
    • In Dutch and English
    • Versions for participants under 16
  • Information about the ethical review submission portal
  • Contact information for the VCWE

Is ethical review always required?

There are relatively few cases within FGB where ethical review wouldn’t be recommended. Additionally, an increasing number of scientific journals require proof of ethical review before your research article can be published. The VCWE will not provide post-hoc ethical review. To avoid the risk of not being able to publish your work anywhere, it is wisest to err on the side of caution and obtain ethical review.

What happens if I am only reusing existing data?

Even if you are reusing data and aren’t including any active participants, there may still be ethical questions posed by your research, meaning ethical review is still advised. Additionally, there are very often privacy or legal questions that arise when data are reused for new research. If you plan to reuse data for your research, contact the Research and Policy Support Team (REPS) prior to ethical review to ensure that you can (legally) reuse the data.

Insurance for non-medical/non-WMO research within FGB

VU liability insurance covers all research and education activities carried out by VU staff, even when they are doing those activities on location. There are no additional costs associated with the VU’s liability insurance.

You don’t need to provide evidence of the VU’s liability insurance to the VCWE, but if you are working with external partners and the question of liability insurance comes up, you can contact for further support. Where appropriate, a copy of the insurance documentation can be provided to you.

View MDR and Other Regulations Guidance

The Scientific and Ethical Review Board of FGB (VCWE)

You can find all the necessary information about standard ethical review within FGB and the VCWE on the VCWE’s VUweb page. On this page, you will find:

  • References to relevant codes of conduct
  • Steps required prior to submission to the VCWE
  • Templates for information letters and informed consent forms
    • In Dutch and English
    • Versions for participants under 16
  • Information about the ethical review submission portal
  • Contact information for the VCWE

Is ethical review always required?

There are relatively few cases within FGB where ethical review wouldn’t be recommended. Additionally, an increasing number of scientific journals require proof of ethical review before your research article can be published. The VCWE will not provide post-hoc ethical review. To avoid the risk of not being able to publish your work anywhere, it is wisest to err on the side of caution and obtain ethical review.

What happens if I am only reusing existing data?

Even if you are reusing data and aren’t including any active participants, there may still be ethical questions posed by your research, meaning ethical review is still advised. Additionally, there are very often privacy or legal questions that arise when data are reused for new research. If you plan to reuse data for your research, contact the Research and Policy Support Team (REPS) prior to ethical review to ensure that you can (legally) reuse the data.

Insurance for non-medical/non-WMO research within FGB

VU liability insurance covers all research and education activities carried out by VU staff, even when they are doing those activities on location. There are no additional costs associated with the VU’s liability insurance.

You don’t need to provide evidence of the VU’s liability insurance to the VCWE, but if you are working with external partners and the question of liability insurance comes up, you can contact for further support. Where appropriate, a copy of the insurance documentation can be provided to you.

Standard FGB ethical review is most likely required

Based on your responses, the WMO probably doesn’t apply to your research, but with limited information it’s not feasible to fully exclude the possibility. Submit your research to the VCWE (FGB’s ethical committee). Upon review, the VCWE might determine that the WMO applies to your research, especially depending on intensity of the interventions/experiments involved and/or the nature of the research population you plan to study, in which case, further ethical assessment will be carried out by an METC. The VCWE can only determine if the WMO applies to your research by reviewing a full submission.

NB: If your research undergoes substantial amendments, it may become subject to the WMO. Substantial amendments will require a new ethical submission to the VCWE.

Potential additional concerns

Other regulations may apply to your research (even if the WMO does not apply) because of the interventions/experiments used in your research. More information on how to apply these regulations within FGB can be found under the “MDR and Other Regulations Guidance”.

View VCWE Guidance

The Scientific and Ethical Review Board of FGB (VCWE)

You can find all the necessary information about standard ethical review within FGB and the VCWE on the VCWE’s VUweb page. On this page, you will find:

  • References to relevant codes of conduct
  • Steps required prior to submission to the VCWE
  • Templates for information letters and informed consent forms
    • In Dutch and English
    • Versions for participants under 16
  • Information about the ethical review submission portal
  • Contact information for the VCWE

Is ethical review always required?

There are relatively few cases within FGB where ethical review wouldn’t be recommended. Additionally, an increasing number of scientific journals require proof of ethical review before your research article can be published. The VCWE will not provide post-hoc ethical review. To avoid the risk of not being able to publish your work anywhere, it is wisest to err on the side of caution and obtain ethical review.

What happens if I am only reusing existing data?

Even if you are reusing data and aren’t including any active participants, there may still be ethical questions posed by your research, meaning ethical review is still advised. Additionally, there are very often privacy or legal questions that arise when data are reused for new research. If you plan to reuse data for your research, contact the Research and Policy Support Team (REPS) prior to ethical review to ensure that you can (legally) reuse the data.

Insurance for non-medical/non-WMO research within FGB

VU liability insurance covers all research and education activities carried out by VU staff, even when they are doing those activities on location. There are no additional costs associated with the VU’s liability insurance.

You don’t need to provide evidence of the VU’s liability insurance to the VCWE, but if you are working with external partners and the question of liability insurance comes up, you can contact for further support. Where appropriate, a copy of the insurance documentation can be provided to you.

View WMO Guidance

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 .

View MDR and Other Regulations Guidance

The Scientific and Ethical Review Board of FGB (VCWE)

You can find all the necessary information about standard ethical review within FGB and the VCWE on the VCWE’s VUweb page. On this page, you will find:

  • References to relevant codes of conduct
  • Steps required prior to submission to the VCWE
  • Templates for information letters and informed consent forms
    • In Dutch and English
    • Versions for participants under 16
  • Information about the ethical review submission portal
  • Contact information for the VCWE

Is ethical review always required?

There are relatively few cases within FGB where ethical review wouldn’t be recommended. Additionally, an increasing number of scientific journals require proof of ethical review before your research article can be published. The VCWE will not provide post-hoc ethical review. To avoid the risk of not being able to publish your work anywhere, it is wisest to err on the side of caution and obtain ethical review.

What happens if I am only reusing existing data?

Even if you are reusing data and aren’t including any active participants, there may still be ethical questions posed by your research, meaning ethical review is still advised. Additionally, there are very often privacy or legal questions that arise when data are reused for new research. If you plan to reuse data for your research, contact the Research and Policy Support Team (REPS) prior to ethical review to ensure that you can (legally) reuse the data.

Insurance for non-medical/non-WMO research within FGB

VU liability insurance covers all research and education activities carried out by VU staff, even when they are doing those activities on location. There are no additional costs associated with the VU’s liability insurance.

You don’t need to provide evidence of the VU’s liability insurance to the VCWE, but if you are working with external partners and the question of liability insurance comes up, you can contact for further support. Where appropriate, a copy of the insurance documentation can be provided to you.

Research requires more planning

You should determine more of what your research will entail before assessing the ethical review process that applies to you. You can find more information on what you need to consider at this stage of the research process on this VUweb page. If you feel that your research is fairly well planned, and you’re not sure why you landed here, you can contact the Research and Policy Support Team (REPS).

Support

Your situation is not so clear, meaning its difficult to make an assessment of which ethical review process applies to you. We recommend first contacting the Research and Policy Support Team (REPS) for support on your research planning.