Research subjects and the law
The Netherlands has strict rules for research with research subjects. The Medical Research Involving Human Subjects Act (WMO) is intended to protect research subjects.
If you are asked to participate in research, you should ask whether it is subject to the WMO. The researcher will know whether this is the case. Research with a medicinal product is, for example, almost always subject to this Act.
All the information you can find on this website is for research subjects who are participating in this kind of research. Even if your research does not fall under the WMO, your permission will still be required.
Medical Research Ethics Committee (MREC)
Research covered by the WMO has to comply with legal requirements. That is why an independent medical research ethics committee (MREC) will review the research. Sometimes this will be the Central Committee on Research Involving Human Subjects (CCMO, The Hague). Although the people on the review committee have a great deal of knowledge about research, they will have no personal interest in it. The information provided by the researcher states which committee has reviewed your research.
This will involve an assessment of whether the research fulfils all the rules. Will the research have too much of an impact on the research subjects? Is the research properly designed? Is the research really necessary? Have the research subjects been provided with satisfactory information? A strict assessment will take place and the research can only start once it has been approved. Only then can the physician or researcher ask you to participate.
If you are going to participate in research, you will have to provide some personal data. Only a couple of people other than the researcher can access that data. These people check whether the research is of a good quality and reliable. The General Data Protection Regulation (GDPR) includes rules which you have to comply with in order to protect your personal data.
The CCMO registers all the research that is covered by the WMO in the CCMO register. Anyone can search the register for information free of charge.
The CCMO also provides an overview in each of its annual reports of the research that has been assessed in the Netherlands every year.