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.
Observational versus intervention research
In the case of intervention research, the investigator deliberately alters conditions to be able to pass judgment on the consequences of the intervention.
In the case of observational research, the investigator does not alter the existing situation, but only wants to describe and document it. Examples of this are research into patient check-ups, transverse (cross-sectional) studies and cohort research. The CCMO views burden and exertion tests which are part of an observational study as non-therapeutic interventions. It is for this reason that these studies have to be submitted for review to the CCMO.
Review: accredited MREC or CCMO?
Therapeutic research and observational (non-therapeutic) research with subjects under the age of 16 years must be submitted for review to an accredited MREC. Non-therapeutic intervention research with these subjects must be submitted for review to the CCMO. See also the CCMO-note therapeutic versus non-therapeutic research.
An accredited MREC can transfer the review of a proposal for non-therapeutic observational research with subjects under the age of 16 years to the CCMO as long as it has reason to do so. If this occurs, the MREC will inform the submitting party.
In case of research with children under the age of 12 years, both parents/legal guardian must give consent for participation in the research. Adolescents aged 12 to 16 years give consent together with their parents/legal guardian, and adolescents aged 16 years and older give consent by themselves.
In accordance with the Code of conduct involving minors, the declaration of consent for the parents must contain information on resistance; if the child resists during the research, consent for further participation in the research is lapsed.