WMO or non-WMO

  • WMO
  • Non-WMO

WMO

Research subject to the Medical Research Involving Human Subjects Act (WMO) must be reviewed and approved beforehand by an independent accredited Medical Research Ethics Committee (MREC) or the Central Committee on Research Involving Human Subjects (CCMO). The purpose of the review is, among others, to safeguard the rights, safety and welfare of participants. It also weighs scientific importance against any potential burden and risks to participants.

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

  1. It concerncs medical-scientific research; and
  2. Participants are subjected to procedures or are required to follow rules of behaviour.

In addition to the WMO, several other laws and regulations exist for medical-scientific research involving human subjects, such as the Embryo Act, the European Clinical Trial Regulation (CTR), the European Medical Devices Regulation (MDR) and the European In Vitro Diagnostics Regulation (IVDR). A number of supplementary laws, decrees and ministerial regulations, CCMO directives and codes of conduct may also be relevant.

Non-WMO

If your research does not meet the WMO criteria, it does not require approval from an accredited MREC or the CCMO. However, a statement from a review committee confirming that your research is not subject to the WMO may be necessary- for example, when publishing the results in a scientific journal.
At Amsterdam UMC, the Non-WMO Review Committee provides such statements. Additionally, they offer advice on other applicable laws and regulations, including: Dutch Medical Treatment Contracts Act (WGBO), General Data Protection Regulation (GDPR), Code of Conduct for Health Research, Population Screening Act (WBO), Regulations of the Biobank Review Committee (CTB) of Amsterdam UMC and the Amsterdam UMC Research Code.

If you are uncertain whether your research is subject to the WMO, more details and guidance is available on the CCMO website. You can also direct your questions to the METC Office via metc@amsterdamumc.nl. For more information, visit the MREC Amsterdam UMC website.