Ethics approval
Every study that is carried out at CAPHRI and that falls under the WMO law should be approved by an accredited ethics committee. If your study is not subject to WMO you should seek ethics approval from the FHML ethics committee.
The researcher is responsible for obtaining ethical approval before data collection. Most journals also ask for ethical/research approvals once you submit your manuscript (please note that you cannot ask for ethical approval retrospectively). Dutch law requires ethical approval from a medical ethics committee if your research falls under the WMO law.
The first step is to decide whether your research falls under the WMO or not.
The study falls under WMO if:
The study falls under WMO if it concerns medical/scientific research. Research with a medicinal product is also categorised as medical-scientific research. And behavioural-scientific research can in certain cases also be deemed medical-scientific. Furthermore, nursing, physiotherapy and psychology research can in some cases fall under the WMO.
Participants are subject to procedures or are required to follow rules of behaviour. In general, research with human subjects only falls under the WMO if there is an infringement of the physical and/or psychological integrity of the subject. The subject himself/herself must be physically involved in the research for the research to fall under the WMO. In a randomized clinical trial subjects are being assigned at random to one of the treatment or control groups. By doing so the subjects are required to follow certain rules of behaviour. It depends on the nature of this rule whether the research will or will not fall under the WMO – assuming the study meets the first criterion of medical-scientific research.
What to do if your study falls under WMO
If you think your research falls under the WMO, then submit it to an accredited ethical review committee. Be aware that regulations may depend on local requirements. For example, if the study is performed in MUMC+, it needs to be approved by the ethical committee of the MUMC+.
In case of doubt this website helps you to decide.
Also do not hesitate to contact the ethical review committee of MUMC+ or the CCMO.
Clinical Trial Center Maastricht has a useful webpage if you have questions about WMO research.
What to do if your study does not fall under WMO
If your study is not subject to WMO you should seek ethics approval from the FHML Research Ethics Committee.
If you are not sure if your study falls under the WMO, you could also consider to go to the ethical review committee of FHML (contact person: David Shaw). The committee will give advice whether indeed the proposed study falls under the WMO or not. If so, they will redirect you to an accredited ethical review committee. If not, they will review it themselves.
Please note that the exact forms that you have to complete differ per committee. The ethical review committee of FHML requires less information. However, if they redirect you to another ethical review committee, then you still have to provide that other committee with all information according to their procedures. So, the ethical review committee of FHML should not be seen as a simple procedure (because they are not allowed to judge research that falls under the WMO law, and they require different information anyway).
Applications to the FHML-REC should be made using specific forms (which contain details of how to submit the forms). You can find these forms here.