The WMO applies the ‘no, unless’ principle for research with participants under the age of 16 years. Scientific research with participants in this age category is in principle prohibited.

This prohibition does not apply to:

  1. Research which is of direct benefit to the research participant (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 participant. If there is no standard treatment, the nature and severity of the condition of the research participant 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.