Ethical review for nWMO studies

• this process is meant for proposals outside the scope of the WMO (Wet medisch wetenschappelijk onderzoek met mensen)
• please check if the proposal fits within the scope of the  nWMO Kaderreglement UMCG;
• if you wish to submit an amendment to your approved research proposal, please contact the nWMO Loket. Please do not submit amendments for studies not previously approved by the CTc. Please indicate clearly by e-mail if it concerns an amendment with adaptations resulting from the Corona measures;
• ascertain that for studies your submission documents are PDF files (as opposed to bio-databank submissions, to which this rule doesn't apply). This is obligatory for the safety of your information;
• the applicant needs an UMCG account (eg have an UMCG email address) to start the submission procedure;
• note that only the applicant has access to the study files and receives (email) messages from the CTc/METc offices. This is: the person who logs in and completes the application form. However, the final decision of the CTc will also be send to the Principal Investigator (cc) as recorded in the application form;
• names, emailadresses of other persons mentioned in the form will not be used for correspondence unless the applicant no longer works at the UMCG;
• after submission, you should receive an acknowledgement of receipt. If you do not receive this within 1 hour, please contact the nWMOloket.
• tip: if you are not sure whether you need to ask informed consent or might be able to request a waiver please use the flow-chart: SOP Obtaining Informed Consent nWMO (in Dutch)

Read more about Ethical review for nWMO studies templates

Meetings CTc

In the odd weeks, the CTc meets on Thursday morning. The agenda is closed on the Tuesday of the week before that. Studies are placed on the agenda in order of having been submitted. When submitting, take into account a preparation time that is required to place the study on the agenda. Therefore there is no guarantee that your study will be discussed at the next meeting.

Members of committee
A professor/medical doctor, an ethicist, a legal expert, participant perspective respresentative, a researcher, and a statistician/methodologist.

Contact
[email protected]
M.T. Dreves (secretary)
Dr. H. Groenewegen (secretary)
M. Jager (supporting)
Dr. C. de Jong (secretary)
H.A.M. Tebbe (secretary)

Applicable only if the study has been ethically reviewed bij another certified reviewing committee. Please note that we refer here to an ethical, in depth, review and not the 'geen WMO verklaring'. The latter is merely a legal statement that the study does not fall under the WMO law and not an ethical in depth review.

The focus of a local feasibility assessment is not the content of the study, but its local feasibility. For example:

• are the facilities of the hospital suitable for a proper execution of the study;
• have (supporting) departments agreed to provide the necessary cooperation in the framework of the study;
• does the study fit within the UMCG's policy on research and patient care;
• will the local data be correctly processed in all study documents;
• have the privacy guidelines of the UMCG been met.

Practical

Requesting local feasibility is done by submitting the nWMO study (in the usual way). Remember to include with your submission the approval letter from the recognized Medical-Ethical Review Committee and to indicate in your submission that it is a local feasibility assessment.

Tips

• use the UMCG nWMO protocol template to fill in all relevant items for implementation in the UMCG. The basic questions about the study (background, research question, etc) can be answered with a reference to the original protocol;
• or use this template to check whether the protocol contains all the information needed for a local feasibility assessment by the CTc. The template is not required, it is only a supporting document;
• make sure that participant information letters written from other institutions are adapted for UMCG patients.