Approval Board of Directors UMCG

Medical scientific research executed in more than one institution in the Netherlands simultaneously is called a multicentre research. Based on the Research Declaration (or Site suitability Declaration), the central Ethics Committee grants approval for every participating centre. The CCMO External Review Directive describes the general procedure. After the central approval, the Board of Directors of the other institutions will send a final approval letter.
Please note that for clinical trials with medicinal products a Site Suitability Declaration is mandatory and no final approval by the Board of Directors will be issued. The signature on the clinical trial agreement can be seen as final approval by the Board of Directors. See also: ccmo.nl

What? A Research Declaration or Site Suitability Declaration, signed by the head of the Department, must be sent to the Central Ethics Committee by the (principal) investigator in the UMCG or the applicant. The resume of the (principal) investigator in the UMCG must be attached and, if applicable, a certificate of the subject insurance of the UMCG, unless exemption of a subject insurance is granted. A certificate of the general liability insurance is not necessary.

The application for approval of a participating centre can be submitted simultaneously with the primary application to the central ethics committee or after primary approval has been granted.

Who? The coordinating investigator (applicant) handling the primary application, is responsible for submission of the (additional) documentation and amendment(s) to the central ethics committee.

Where? The application for the approval of (the addition of) the UMCG as participating centre must be submitted to the central ethics committee as a substantial amendment.

In case a Site Suitability Declaration has been issued, no additional approval letter by the Board of Directors of the UMCG is required. The following is in that case not applicable.
A listing in the UMCG research register (PaNaMa) is an important condition. This is the responsibility of the principal investigator. In case the subject insurance of the UMCH is applicable, the principal investigator must contact with the Legal Office to arrange that the correct number of participants are passed on to Centramed.

What? When the central reviewing committee has approved the amendment, the Board of Directors must give their approval for execution of the research. Before this approval is granted,  administrative oversight by the METc Bureau takes place: Is the research listed in the UMCG Research Registry? Are the relevant documents submitted? Have all the for this research relevant and necessary person(s) or departments been informed? For instance, participation of the hospital pharmacy is often required for medical research with (study) drugs.

Who? The coordinating investigator (applicant) submits the relevant documents on a data carrier, such as a USB-drive or CD-ROM, accompanied by a signed application letter which lists the documents being submitted. This should include at least:

  • the (primary) approval letter of the reviewing ethics committee and the documents listed therein;
  • (if applicable) the additional approval letter of the central ethics committee on the participation of the UMCG, the Research Declaration and the resume of the principal investigator in the UMCG;
  • the informed consent letter and informed consent form which will be used in the UMCG;
  • (if applicable) a final and signed clinical trial agreement between the UMCG and the sponsor;

The informed consent letter should at least mention the correct contact details of the (principal) investigator(s) in the UMCG.

Where? The administrative oversight is handled by the METc Bureau on behalf of the Board of Directors. The relevant documents for this application can be submitted to the METc Bureau.

Questions? Do you have any questions? Please don’t hesitate to contact one of the employees of the METc Bureau secretariat.