Research with subjects under the age of 16 years

Research subjects under the age of 16 years cannot give legal consent for participation in medical/scientific research. The WMO applies the ‘no, unless’ principle for these subjects. Scientific research with subjects in this age category is in principle prohibited.

This prohibition does not apply to:

  1. Research which is of direct benefit to the research subject (therapeutic);
  2. Non-therapeutic research which can only be conducted with that group of people (group restricted). In non-therapeutic research, it is required that the risks and the burden are minimal compared to the standard treatment of the research subject. If there is no standard treatment, the nature and severity of the condition of the research subject should be considered.

The NVMETC and the CCMO have made a reviewing framework Reviewing research with minors (in Dutch) for the review of research with minors. This also outlines the criteria for the review of non-therapeutic research.