Guide to the review procedure
The information on this page is intended to guide you through the review procedure for medical scientific research.
Does my research have to undergo a medical-ethical review?
First of all you have to determine whether your research falls under the scope of the Medical Research Involving Human Subjects Act [Wet medisch-wetenschappelijk onderzoek met mensen] (WMO). You can read how to do that on the Your research: Is it subject to the WMO or not? page. If your research is subject to the WMO, a review needs to be carried out beforehand by an accredited medical research ethics committee (MREC) or the Central Committee on Research Involving Human Subjects (CCMO). Would you like to know more about the review of medical research with human subjects in the Netherlands? Follow the free e-learning.
Clinical investigations on the safety, (clinical) performance and/or effectivity of a medical device fall within the scope of the EU Medical Device Regulation (MDR). In the section Clinical investigations with medical devices you may determine if your study falls within the scope of the MDR.
My research is not covered by the WMO
You can find more information under Non-WMO research.
I am not sure
In practice there will always be dubious cases, otherwise known as grey areas. If in any doubt, the best thing is to submit your question to an accredited MREC. In your request please clearly state the research question, the study population, the goal and the design of the research. If available please also submit a (summary of a) research proposal.
Review by an accredited MREC or the CCMO?
In most cases research which is subject to the WMO must be reviewed by an accredited MREC. The CCMO can only carry out a medical-ethical review for certain types of research. You can read more about this under Review committee: accredited MREC or CCMO?. In order to determine which committee should review your research, you can use the Committee Finder. In the case of research with a medicinal product you can also find here which competent authority should carry out the marginal review.
Research with a medicinal product: extra review by the competent authority
In the case of research with a medicinal product your research proposal should also be marginally reviewed by the competent authority: the CCMO or the Minister of Health, Welfare and Sport (VWS). Your research is only allowed to start if you have received the go-ahead from both the review committee and from the competent authority. You can read more about this under Research with a medicinal product: extra review by competent authority.
Research with a medicinal product: Voluntary Harmonisation Procedure (VHP plus)
The Netherlands participates within the European Voluntary Harmonisation Procedure (VHP-plus). The review committee (MREC), which will assess the submitted research file within the Netherlands in the national phase, will be involved in the VHP procedure. The Netherlands may participate only if the MREC participates within the VHP. You can find more information about this under Research with a medicinal product: Voluntary Harmonisation Procedure (VHP).
Research that is subject to the WMO is reviewed via a fixed procedure by an accredited MREC or the CCMO. You can read more about this under Primary submission to the review committee. In the case of research with a medicinal product an extra, marginal review by the competent authority is obligatory. You can read more about this under Primary submission to the competent authority.
Standard research file
At the time of the primary submission to an accredited MREC or the CCMO, your research file must consist of a number of basic documents. The set of documents to be submitted – the file – for the competent authority (only applicable in the case of research with a medicinal product) is identical to that for submission to the review committee. The documents you have to submit can be found in the Standard research file.
Additional requirements for certain types of research
The legislation and regulations relating to medical scientific research involving human subjects are not the same for all types of research. Additional requirements apply in a number of cases. You can find more information on this under Types of research.
Appeals and objections
If you do not agree with a decision by an MREC you can, if you are a concerned party, instigate an administrative appeal to the CCMO, subject to certain conditions. Do you not agree with a decision by the CCMO? If so, and if you are a concerned party, you can submit an objection to the CCMO subject to certain conditions. You can read more about this under Appeals and objections.
During and after the research
The party performing/submitting the research must also submit details to the review committee during the research, upon completion and thereafter and, in the event of research with a medicinal product, to the competent authority as well. You can read more about this under During and after the research: notifications to the review committee and under During and after the research: notifications to the competent authority (only applicable in the case of research with a medicinal product).