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Is review required?

Is review required?

Research is subject to the WMO if the following two criteria are met:

  1. It concerns medical scientific research, and
  2. Participants are subject to procedures or are required to follow rules of behaviour.

On the CCMO website you will find more information on when research is subject to the WMO: Your research: Is it subject to the WMO or not?

When in doubt, you can complete the WMO /Non-WMO Form and submit it to the MREC so we can advise you on this. You can download this form via the present page. Please also read the brief explanation on the form.

The MREC will only use the information on the form to determine whether the research falls under the scope of the WMO. You can only add appendices which are relevant in this context, such as questionnaires.

We will not perform a substantive review of the research itself. If the MREC decides that the research does not fall under the scope of the WMO, the investigator will receive a statement of non-applicability of the WMO. Other legislation may still apply, however. You will find an overview of types of research which are not subject to the WMO and of the relevant legislation on the CCMO website.

Whether research that probably does not fall under the scope of the CCMO must be submitted to an MREC depends on the policy of the institution where the research is being conducted. Please check this with the research department of the institution concerned.

Download WMO/Non-WMO Form

Please always use the latest version of the form. As of 1 January 2020 older versions will no longer be processed

Brief explanation on the WMO / Non-WMO Form

Link

Information on institutional policy

Publication of non-WMO research? uitklapper, klik om te openen

By definition, file research does not fall under the scope of the WMO. For publication, medical scientific journals often require a statement that the research has been reviewed by an ethics committee. Usually, the MREC statement of non-applicability of the WMO will be accepted for this purpose. You will find more information on relevant legislation for file research on the CCMO website.

For publication of (other) medical scientific research that is by definition not subject to the WMO because no participants are subject to procedures or are required to follow rules of behaviour, an opinion from a different ethics committee than a recognised MREC may be sufficient. An example of this is research with bodily material obtained previously which has been reviewed by a Biobanks Review Committee. In this case an extra statement of non-applicability of the WMO from an MREC is not required.

Is submission to the MREC Utrecht required if the research has been designated as non-WMO research by a different recognised MREC? uitklapper, klik om te openen

For this you need to check the policy of the institution where the research is being conducted.

Note: A statement of non-applicability of the WMO is not a substitute for the declaration of local feasibility or for permission from the Executive Board.

Should amendments to non-WMO research always be submitted? uitklapper, klik om te openen

Yes

Submission of the changes for re-evaluation is advisable if it concerns changes which may affect the fulfilment of the criteria for applicability of the WMO.

No

If it concerns non-WMO research, the MREC does not have a role to play in the review of the research file. Documents which are being amended, like a subject information sheet, do not need to be submitted to the MREC for review. Matters which need to be reported to an MREC in relation to research that is subject to the WMO, like the start and end dates, progress and the final report / publication, are not applicable here.

The research institution can, however, impose requirements in this regard on investigators. Please check the policy of the institution where the research is being conducted.

Institutional policy uitklapper, klik om te openen

For questions and more information about the policy of UMC Utrecht and the Princess Máxima Center concerning medical research involving human subjects, you can consult the pages listed below:

Non-WMO research with a medical device uitklapper, klik om te openen

If you are using a medical device in a non-WMO study, review by the MREC based on the Medical Devices Decree will be required if the research is subject to a reporting requirement of the CCMO. On the websites of the CCMO you will find explanations on research with a medical device.

On the WMO / Non-WMO Form, you can answer the questions about research with a medical device to verify whether an MREC opinion is required under the Medical Devices Decree. If you are not sure whether the research falls under the scope of the WMO, you must go through this procedure first. If it is already clear that the study is not subject to the WMO, and the MREC opinion is required under the Decree, the file can be submitted for review straight away.

The file should consist of at least the following documents:

  • Clinical research protocol
  • Product information: Investigational Medicinal Device Dossier / Investigator’s Brochure or similar document, depending on the situation, and the user manual for the medical device
  • Subject information / informed consent form or other information for participants and other information / promotional materials and recruitment procedure
  • CV of the principal investigator
  • Insurance (proof of liability cover)
  • Opinion from the medical devices department of the institution where the medical device is being investigated (at UMC Utrecht: Medical Technology & Clinical Physics)

The file will be reviewed during a meeting of one of the MREC chambers. In your cover letter accompanying the file, please state: ‘request for review based on the Medical Devices Decree’.

More information

You can consult the websites of the CCMO and IGJ for more information about research with medical devices.

Participating institutions: UMC Utrecht and Prinses Máxima Center for pediatric oncology

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