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