Collection of human biological material – Special situation
METC NedMec discontinues parallel review of biobank dossiers uitklapper, klik om te openen
On April 1, 2026, METC NedMec and the UMC Utrecht Biobank Review Committee (TCBio) decided to revise the review procedure for biobank dossiers conducted in parallel with WMO, MDR, IVDR, or CTR research.
Since 2014, the METC of UMC Utrecht has assessed not only the research component but also the biobank component in studies that establish a biobank (the so-called combined review), in accordance with the UMC Utrecht Biobank Framework Regulation. This approach was originally based on two considerations:
- a joint assessment of participant burden;
- the convenience of a single point of submission for researchers.
Why is change necessary? uitklapper, klik om te openen
A joint evaluation by METC NedMec and TCBio showed that this approach no longer aligns optimally with both internal developments within the METC and national and international developments.
The current procedure makes it more difficult to structurally safeguard quality and leads to ambiguity for both researchers and research participants regarding the distinction between study and biobank. To improve quality and transparency, it has therefore been decided that as of April 1, 2026, METC NedMec will discontinue the parallel review of biobank dossiers for this type of research.
What does this mean for researchers?
New studies with a biobank
Researchers who wish to establish a new UMC Utrecht sub-biobank within such research are requested to:
- prepare a separate biobank dossier for the collection of human body material and associated data for as yet unspecified research questions from participants in a WMO, MDR, or CTR study. This dossier must at least include a biobank protocol and a biobank information letter and should be submitted to TCBio;
- indicate in the accompanying email when submitting to TCBio that the material is collected from participants in an ongoing study, and clearly describe in the biobank protocol the burden arising from that study, so that the total participant burden is transparent to TCBio.
Storage of residual material from such research
In medical scientific research where any remaining residual material is stored for purposes broader than the original research question, subsequent research using this material will be reviewed by TCBio.
In future TCBio assessments regarding the release of this residual material, based on the information letter of the original study and, where applicable, the consent form, it will be evaluated whether:
- the follow-up research falls within the scope of the original purpose limitation (broad consent) for which the material was collected;
- it is clear whether biological material is transferred to countries outside the EU, what safeguards apply, and whether explicit consent for this purpose has been obtained;
- any potential commercial use of the residual material is explicitly stated and whether consent has been obtained for this purpose;
- sensitive applications, such as genetic research or the creation of organoids or cell lines, are clearly explained and explicitly consented to.
These aspects must therefore be taken into account when drafting the study information letter and consent form. These documents will be reviewed by an METC during the initial assessment.
Amendments to previously approved combined studies
For amendments to METC-approved biobanks, existing documents can be amended and submitted via the Research portal to METC NedMec. In this case, a new biobank protocol and biobank information letter are not required.
If a clear separation between study and biobank is subsequently chosen, a new biobank protocol with accompanying information letter must be submitted as a separate biobank dossier to TCBio. These will then be reviewed by TCBio as a new sub-biobank.
More information uitklapper, klik om te openen
For questions about this revised procedure, please contact the METC NedMec secretariat (metc@nedmec.nl) or TCBio (tcbio@umcutrecht.nl).