Minors under 18 years are defined as a vulnerable population in the regulations and the requirements set out for the inclusion of minors must be fulfilled (CTR article 32 and corresponding articles in MDR and IVDR).
The following applies to the enrolment of minors in research that involves bodily intervention or testing of medicinal products:
- The guardians (or guardian, if applicable) must consent to participation in the research.
- Minors up to 15 years of age: An age-appropriate information form/leaflet must be prepared. If younger children are to be recruited (for example under the age of 12), it may be necessary to prepare several information forms/leaflets for the different age groups. The minor may sign the form as an expression of their wish to participate.
- 16- and 17-years old participants must consent to trial participation, in addition to the guardians. The information provided should be the same as that provided to guardians/participants who have reached the age of 18. If they were included before the age of 16, consent must be obtained when they turn 16.
- For consent to future research (broad consent), the minor is entitled to provide consent from the age of 16 (no consent from guardians), given that participation does not involve bodily intervention. However, as a general rule, minors should not be included in future research. The ethics committee will make a case-by-case assessment in this regard.
