WMO in a nutshell

Research subject to the Medical Research Involving Human Subjects Act (WMO) must meet several requirements.

If research is subject to the WMO, a review needs to be carried out beforehand by an accredited medical research ethics committee (MREC) or CCMO. The WMO was set up to protect human subjects on the following aspects:

  • Research that falls under the WMO must be reviewed on its medical/scientific and ethical aspects.
  • The research subject must be provided written information on the research.
  • An independent expert must be available to inform the research subject.
  • Written consent must be obtained by the research subject prior to participating in the research.
  • Insurance must be taken out to cover damage endured by the research subject.
  • The law imposes requirements on research involving subjects under the age of 16 years and incompetents.
  • Those carrying out the study must ensure that the privacy of the research subject is protected to the greatest degree.