Medical-scientific research in which UMCG is involved, or for which UMCG acts as sponsor, that is not subject to review under the Medical Research Involving Human Subjects Act (WMO), the Clinical Trials Regulation (CTR), the Medical Devices Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR), must undergo a quality assessment. The minimum quality criteria for this assessment are laid down in the nWMO Framework Regulations and the UMCG Research Code (see also: Ethical review for nWMO studies (umcgresearch.org).
Change to the submission procedure from 1 October 2026
From 1 October 2026, the submission procedure for this nWMO quality assessment will change.
As of that date, all studies that are not subject to the WMO and in which UMCG is involved in any capacity must be submitted through Research Manager. This new system will replace the current Zenya portal for the submission and review of non-WMO research by the Central Review Committee (CTc) (non-WMO committee). UMCG staff will receive further information about this change from the CTc.
In addition, from 1 October 2026, the CTc will, on behalf of the UMCG Medical Ethics Review Committee (METc), state in its decision letter that a research proposal falls outside the scope of the WMO or related legislation. As a result, researchers will no longer receive two separate letters—one from the METc regarding WMO status and one from the CTc containing the quality assessment—but instead a single combined decision letter.
September 2026: Temporary suspension of submissions
Due to this transition, no applications for non-WMO research can be submitted to the METc or CTc during September 2026. This also applies to applications relating to biobanks and data repositories.
Researchers who have previously received advice from the UMCG METc regarding a biobank and/or data repository will be informed separately about future procedures.
Nothing will change for studies for which the UMCG METc has previously determined that they are not subject to the WMO.
The current procedure will also remain unchanged for external parties that request the UMCG METc to determine whether their research falls outside the scope of the WMO.