Changes in CCMO's assessment task for specific types of research
CCMO’s assessment task has been adapted for specific types of research. These adaptations have been laid down in the Dutch Central Review Decree [Besluit Centrale Beoordeling, BCB].
As of May 26, 2021, CCMO is the designated review committee for four types of research. These concern:
- research with a product containing living (micro-)organisms or viruses directly aimed at combating disease-causing factors;
- research with a medicinal product involving pregnant and/or breastfeeding women;
- clinical investigations with medical devices involving pregnant and/or breastfeeding women
- clinical investigations with medical devices for in-vitro diagnostics involving pregnant and/or breastfeeding women.
A complete overview of all types of research for which the CCMO is the review committee can be found at Review by CCMO.
Research with a product containing living (micro-)organisms or viruses directly aimed at combating disease-causing factors
As of May 26, 2021, CCMO is the designated review committee for research with a product containing living (micro-)organisms or viruses directly aimed at combating disease-causing factors. This category includes, for example, research into the efficacy and safety of bacteriophages to combat infections.
More information can be found on this page.
Research involving pregnant and/or breastfeeding women
As of May 26, 2021, CCMO is the designated review committee for research with a medicinal product, clinical investigations with medical devices and/or medical devices for in-vitro diagnostics involving pregnant and/or breastfeeding women. This is due to the EU regulations on clinical trials (CTR), medical devices (MDR) and in-vitro diagnostics (IVDR), that contain specific rules for research involving pregnant and breastfeeding women partly overlapping with the rules in the Dutch Embryo Act [Embryowet].
The adaptation of the BCB ensures the correct application of the legal framework. The new rules concern a.o. the risks and burden for the woman involved, the embryo, the fetus and the newborn child.
More information can be found on this page.
Transitional regulation
If you submitted a study in one of the four added categories for assessment to an accredited MREC or CCMO prior to May 26, 2021, you do not need to resubmit your research to CCMO from May 26, 2021, onwards. In that case, the rules that applied prior to the adapted BCB still apply.
Research with products that fall under the Dutch Opium Act
In addition to the four new types of research mentioned above for which CCMO is the designated review committee, one category of research has lapsed as of May 26, 2021. This concerns research with products falling under the Dutch Opium Act [Opiumwet], used as part of the treatment for addiction to these products. This type of research is no longer carried out.