METC NedMec discontinues parallel review of biobank dossiers
In consultation with the UMC Utrecht Biobank Review Committee (TCBio), METC NedMec has decided to discontinue the parallel review of biobank dossiers within WMO, MDR, IVDR, or CTR research. This change has been implemented to improve the quality and transparency of the review process and to more clearly distinguish between the study and the biobank.
Researchers who wish to establish a new biobank within such studies must now submit a separate biobank dossier to TCBio. Residual material from such studies that is used for broader research purposes will also fall under TCBio review.
Amendments to previously approved combined studies may still be submitted via METC NedMec, unless a separation between study and biobank is chosen; in that case, TCBio will review the biobank as a new biobank dossier.
For more information about the revised procedure and its implications for researchers, please visit: