The METc UMCG charges a fee for the review performed according to the Medical Research Involving Human Subjects Act. This is applicable for research financed by a profit-seeking company. Research financed by a subsidising party, a grant or not-for-profit foundation is reviewed without charging a fee.
Sponsor
The review fee is charged directly to the sponsor with reference to the protocol code, unless in the cover letter another party is designated with the handling of the fees/payments, i.e. a Clinical Research Organization (CRO). In such case, please mention the correct address details and relevant payment references in the cover letter so that the bill can be sent to the appropriate person and a quick payment is ensured.
Amounts
The METc has the following tariffs for review.
For an initial review according to the WMO a fee of € 3000,- is applicable for research that (in the Netherlands) will only be conducted in the UMCG. For research that (in the Netherlands) is conducted in other sites besides the UMCG, the following tariffs apply:
€ 3.500,– multicentre research (in the Netherlands) in up and including to 5 sites
€ 4.000,– multicentre research (in the Netherlands) in up and including to 10 sites
€ 4.500, – multicentre research (in the Netherlands) in 11 or more sites
There is an annual recurring fee of € 800,- for every year (or part thereof) that the METc acts as central reviewing committee (and therefore may be requested to review amendments, SAE reports and such). The recurring fee falls due 1 year after the date of the initial approval letter. The recurring fee is applicable until the moment the End of Trial date for the Netherlands has been reported and acknowledged.
For international multicentre research this means that the sponsor may request the METc UMCG to review line-listings, amendment to the Investigator’s Brochure or IMPD, even though the End of Trial notification for the Netherlands has been reported. In such case, the METc UMCG will charge the sponsor an annual fee.
The METc UMCG doesn’t charge a fee per amendment. The review of amendments is included in the annual fee.