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Ethical review for nWMO studies
nWMO studies are scientific studies that are outside the scope of the WMO and fit within the scope of the nWMO Kaderreglement UMCG​.
Relevance

How our research benefits society

This process is meant for proposals outside the scope of the WMO (Medical Research Involving Human Subjects Act).

The UMCG reviews all nWMO research that falls within these three criteria as described in the nWMO kaderreglement UMCG and Research Code UMCG:

  • The UMCG is ultimately responsible
  • Research participants are included in or from the UMCG (consent or 'no objection' arrangement)
  • It concerns the start of biobanks or databases for future scientific research or an issue from them

This ethical review is conducted by the CTc (Central Ethical Review Committee of the UMCG).
The CTc assesses nWMO studies, bank issuances and bank initiations following the criteria described in the nWMO kaderreglement UMCG.  
Before submitting please read the following carefully in order to improve the quality of your application and contribute to a efficient assessment process:

  • Read the Additional Important Information section below
  • Check if your documents are complete using templates (read section below: Templates)
  • Ensure that the study number and titles on the documents match the information as registered in the Research Register (Panama), and that the correct signatures have been included in the protocol
  • Submit your proposal to the CTc (read section below: meeting schedule Central ethics Review Board)
  • Please note that studies that have already started implementation cannot be reviewed!
  • START SUBMISSION

    • If you wish to submit an amendment to your approved research proposal or bank protocol, please contact the official secretary via e-mail. Please do not submit amendments for studies not previously approved by the CTc
    • The applicant needs an UMCG account (e.g. 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 official secretary. 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, e-mail adresses 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 official secretary. You will not receive confirmation when submitting a rebuttal
    • 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 Standard Research File and 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 official secretary

    [email protected]
    M.T. Dreves (secretary)
    Dr. H. Groenewegen (secretary)
    M. Jager (supporting)
    Dr. C. de Jong (secretary)
    Dr. S. Postma (team lead)
    Drs. 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.

  • Biyearly the CTc committee and the official secretary releases their report including the assessment times. Please find the most recent report below:

    • Report CTc 2023-2024
       

Contact

Expected response time from the CTc is 30 days.

[email protected]
+31 6 55 25 76 00

UMCG, De Brug; 7 th floor (room 7.014)