This instrument assists you in the reviewing procedure for medical/scientific research. This page is a static alternative to the interactive version.
Does my research have to undergo a medical ethical review?
First you must determine if your research falls under the scope of the WMO.
Research with human subjects must undergo a medical ethical review if it falls under the Medical Research Involving Human Subjects Act (WMO).
Research falls under the WMO if the following two criteria are met:
Does your research fall under one of the areas given below?
Depending on the field of research your research proposal must be reviewed by either the CCMO or an accredited MREC.
Does it concern research with/in the field of:
- a non-authorised vaccine
- antisense oligonucleotides
- (somatic) cell therapy
- gene therapy
- genetically modified organisms (GMOs)
- gametes or (leftover) embryos (with the exception of non-invasive observational research on the foetus)
- xenotransplantation of live cells from animals
- Research with products that fall under the Opium Act in the case of treatment for addiction to these products.
The types of research given above must undergo a central review by the CCMO. For more information see the Central Review Decree (Besluit Centrale Beoordeling, BCB, in Dutch) and the Amendment Decree of the Central Review Decree (Besluit tot wijziging van Besluit Centrale Beoordeling, in Dutch).
Are all research subjects adult and capable?
When is a person deemed capable?
Subjects are capable if:
- they are 16 years or older, and
- are able to make a reasonable judgement of their own interests with regards to the study.
Subjects aged 16 years and older who are not capable of making a reasonable judgement of their own interests are deemed incapacitated. The same applies to subjects under the age of 16 years.
Note: The WMO applies extra conditions to research with minors and/or incapacitated research subjects. See also the reviewing framework Reviewing research with minors (in Dutch) and the CCMO memorandum: Therapeutic vs non-therapeutic research (in Dutch).
Is the research therapeutic?
Therapeutic research is research that is of direct benefit to the research subject.
In the case of research with a medicinal product the following often applies:
- phase I is non-therapeutic
- phase II, III and IV are therapeutic
See also the CCMO memorandum Therapeutic vs non-therapeutic research. (in Dutch).
Does it concern intervention research or is the research observational?
Intervention or observational research
In the case of intervention research the investigator deliberately alters conditions to be able to pass judgement on the consequences of the intervention. The CCMO determines burden and exertion tests to fall under this type of research.
In the case of observational research the investigator does not alter the existing conditions, but only wants to describe and document them. For example:
- research into patient check-up
- transverse (cross-sectional) studies
- cohort research