The principal investigator decides whether or not the research proposal needs a full review according to the Dutch Medical Research with Human Subjects Law (Wet Medisch-wetenschappelijk Onderzoek met mensen, WMO). However, there may be other regulations applicable, such as the Medical Treatment Agreement Act (in Dutch: Wet geneeskundige behandelovereenkomst, WGBO), the Data Protection Act (in Dutch: Wet bescherming persoonsgegevens, WBP, per 28 May 2018 the EU General Data Protection Regulation) and the Code of Conduct for Responsible Use (FEDERA).
In some cases it is prudent to have an exemption letter from an official Medical Ethics Review Board for publication purposes. At your request, the METc UMCG will review whether or not the scientific research falls within the scope of the WMO.
Examples of non WMO research
- retrospective research with data, gathered from a group of patients’ medical files,
- survey research where participants fill out a single questionnaire, which does not pose additional mental risk or
- scientific research where left-over tissue samples are used, which were taken during and for treatment purposes,
- also, scientific research that is not medical in nature, does not fall within the scope of the WMO.
How do I apply for exemption?
You request exemption for review according to the WMO by emailing us. In your email you ask the METc to review whether or not the research fall within the scope of the WMO. Please mention the official title of the research and the complete contact details of the (principal) investigator (title, name, (postal) address).
A research protocol needs to be attached to the email. This may be a single A4, the template for non WMO research as found in the UMCG Clinical Research Toolbox, or a full research protocol, such as the template protocol used for WMO review.
Please describe the objective of the research, the methods for gathering and analysing the data and, if applicable, how informed consent is obtained.
The email and its attachments can be sent to the general email address of the METc (email@example.com).
NOTE! Non WMO research must also be listed in the UMCG Research Registry before submission to the METc.
What happens after I’ve filed for exemption?
Once a request for exemption is received and we’ve determined we have sufficient information to be able to process the request, the submission is discussed during the weekly meeting of the METc Bureau. The applicant will be notified as soon as possible when exemption has been granted. Should there be any questions, an email containing the questions will be sent to the contact person. After receipt of the response, the submission is discussed anew. The final decision is sent to the applicant.
UMCG non WMO quality review
Non WMO research, executed by employees or in the UMC Groningen, must adhere to certain standards of quality as defined by the Board of Directors of the UMCG in the nWMO Kaderreglement. To see if a non WMO research proposal meets these quality requirements, an application tool has been created (follow this link and press the UMCG logo).
Until further notice, only the following 5 departments will participate in the non WMO review pilot:
- Health Sciences (Community and Occupational Medicine);
- Human Movement Sciences;
- Internal Medicine;
Applications for non WMO quality review of these 5 departments will be processed only when submitted via the application tool.
For information and/or assistance., please contact the research coordinator of your department, the Servicedesk Clinical Research Office UMCG (tel. +31 (0)50-3615522) or the non WMO Office (tel. 06-25650399).