Upon request we can issue a non-WMO statement for your research. We will assess your research file against the WMO before proceeding to do so.
What is the procedure?
You should submit the research file digitally. Our MREC will check whether the research is subject to the WMO or not. In principle, the review will be completed within 10 working days. We may decide to discuss the file in a meeting. In that case, the review process may take more time.
Once we have established that the research is not subject to the WMO, you will receive a statement to that effect (note that other legislation may still apply). You will receive this statement from us within 10 working days. After receiving the statement, there is no need to submit anything to us with regard to the study, because the study is no longer within the scope of the MREC.
In principle, our MREC will not review the content of your research file upon a non-WMO request. In case your request raises questions, or if we establish that the study is subject to the WMO, we will contact you.
What should I submit?
You should submit the request with a cover letter, protocol and ICF, including all other patient information (e.g. questionnaires). If applicable, please enclose a reference protocol describing the standard of care. It is particularly important that we can assess the burden on the subject (in addition to the standard of care). If other documents are required to do so, we would like to receive them.
You can submit:
- digitally via your own portal or medium of your choice
- by email in attachment(s): email@example.com
- on USB by mail
What should I pay attention to?
Research falls within the scope of the WMO if it meets the following two conditions:
- There is medical scientific research and
- People are subjected to acts, or codes of conduct are imposed on them.
More information about when research is subject to the WMO can be found on the website of the CCMO via the link: Your research: subject to the WMO or not?
An overview of types of research that are not subject to the WMO and relevant legislation can be found on the website of the CCMO via the link: Non-WMO research.