ECGeneralEthicalReview object

Clinical trials must be assessed by a reviewing EC based on the WMO (en).
Reviewing EC: The law determines whether a research must be reviewed by the CCMO or an accredited MREC/METC. This is laid down in the Central Review Decree (Besluit Centrale Beoordeling, BCB). Both the accredited METCs and the CCMO are independent governmental bodies with a legal status that reach a legally binding decision on research protocols, and thus are not advisory boards.

In practice, accredited MRECs/METCs review the vast majority of the research protocols. Most of them are linked to an institution such as an academic medical centre or a hospital. An accredited MREC/METC determines the region it covers with regards to reviewing research. However, in practice, the majority of MRECs review for the whole of the Netherlands.

CCMO is the competent reviewing EC for:
• Appeal aginst a negative desicion of a MREC/METC
• Non-therapeutic interventional research with minors and incapacitated adults
• Research with vaccines (only unauthorised vaccines since the 1st of November 2009)
• Research in the field of cell therapy and gene therapy/medicinal products with GMO (genetically modified organisms), embryos and human gatemetocytes
• Etc.
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Further information on competence of MREC and CCMO is provided on CCMO website in section: Home>Investigators>Review procedure> Reviewing committee: MREC or CCMO