Help-me-on-my-way!

This instrument assists you in the reviewing procedure for medical/scientific research. If the equipment you use for visiting this site does not allow you to use this tool please visit the static version of this tool.

Does my research have to undergo a medical ethical review?

• My research falls under the WMO

• • Does your research fall under one of the areas given on the side window?

    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
    • interference-RNA
    • (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).

  • My research falls under one of these areas

    Your research must be reviewed by the CCMO

    Practical information can be found at Primary submission to the reviewing committee.

    In the case of research with a medicinal product the Ministry of Health, Welfare and Sport acts as competent authority for carrying out an extra, marginal review. See for more information Research with a medicinal product & extra review competent authority.

    Background information on the obligations as stated in the WMO with regards to medical/scientific research can be found here.

  • My research does not fall under one of these areas

  • • 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).

    • All research subjects are adult and capable

      Your research must be reviewed by an accredited MREC.

      Practical information can be found at Primary submission to the reviewing committee.

      In the case of research with a medicinal product the CCMO acts as competent authority for carrying out an extra, marginal review. See for more information Research with a medicinal product & extra review competent authority.

      Background information on the obligations as stated in the WMO with regards to medical/scientific research can be found here.

    • Not all research subjects are adult and capable

    • • Is the research therapeutic?

        Therapeutic research

        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).

      • My research is therapeutic

        Your research must be reviewed by an accredited MREC.

        Practical information can be found at Primary submission to the reviewing committee.

        In the case of research with a medicinal product the CCMO acts as competent authority for carrying out an extra, marginal review. See for more information Research with a medicinal product & extra review competent authority.

        Background information on the obligations as stated in the WMO with regards to medical/scientific research can be found here.

      • My research is non-therapeutic

      • • 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:

          • case-control studies
          • transverse (cross-sectional) studies
          • cohort research

           

        • It concerns intervention research

          Your research must be reviewed by the CCMO

          Practical information can be found at Primary submission to the reviewing committee.

          In the case of research with a medicinal product the Ministry of Health, Welfare and Sport acts as competent authority for carrying out an extra, marginal review. See for more information Research with a medicinal product & extra review competent authority.

          Background information on the obligations as stated in the WMO with regards to medical/scientific research can be found here.

        • It concerns observational research

          Your research must be reviewed by an accredited MREC.

          Practical information can be found at Primary submission to the reviewing committee.

          In the case of research with a medicinal product the CCMO acts as competent authority for carrying out an extra, marginal review. See for more information Research with a medicinal product & extra review competent authority.

          Background information on the obligations as stated in the WMO with regards to medical/scientific research can be found here.

• My research does not fall under the WMO

  More information can be found under Non-WMO research

• I'm not sure

  In practice there will always be unclear cases; the so-called grey area. When in doubt it is best you contact an accredited MREC.