Minor research subjects (till 18 years) cannot give legal consent for participation in medical/scientific research. The WMO applies the ‘no, unless’ principle for minors (younger than 18 years).
Scientific research with these people is in principle forbidden. The only exception to this is research which is of direct benefit to the research subject (therapeutic) or (in the case of non-therapeutic research) research which is conducted with a selected population (group restricted) and for whom the risks are negligible and the objections minimal.
Therapeutic research with minors must be submitted for review to an accredited MREC. See also the CCMO-note therapeutic versus non-therapeutic. In the case of research with a medicinal product the following generally applies:
- phase I research is non-therapeutic;
- phase II, III en phase IV research are therapeutic.
Observational versus intervention research
Non-therapeutic observational research with minors must also be submitted for review to an accredited MREC. An accredited MREC can transfer the review of a proposal for non-therapeutic observational research with minors to the CCMO as long as it has reason to do so. If this occurs, the MREC will inform the submitting party.
In the case of intervention research the investigator deliberately alters conditions to be able to pass judgement on the consequences of the intervention. Non-therapeutic intervention research with minors must be submitted for review to the CCMO. 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.
Both parents/legal guardians of children and adolescents under the age of 18 years must give consent. The WMO states the requirement for written consent of ‘the parents who have legal custody’, or the guardian (section 6, paragraph 1, under d). The research can only commence after both have (counter) signed. In the case of minors between the age of 12 and 18 years, both the teenager and the parents/legal representatives must give written consent.
In the case of research with 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 rebuked. This is in accordance with the Code of conduct involving minors