WMO: protection human subjects central

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.

Research with subjects under the age of 16 years or research with incapacitated subjects is in principal prohibited; the WMO applies the principle ‘no, unless’.

Suspension of a positive decision

A reviewing committee (accredited MREC or CCMO) is authorised to suspend or rebuke an issued positive decision if there is valid reason for suspecting that continuation of the research could lead to non-acceptable risks to the participating subject. In certain cases, suspension can be imposed by the CCMO (or in other cases the Ministry of Health, Welfare and Sport) on a study reviewed by another MREC. This applies to studies approved by an accredited MREC (section 3 WMO). Continuation of a study which has been approved, but for which the decision has been suspended or rebuked, is an illegal offence.

Committees are bound to the rules of the WMO when reviewing a research.