The participation of minors in clinical trials is subject to special ethical and legal protection. Since minors are not fully legally competent to consent, written consent from both legal guardians is required. In addition – depending on age and maturity – the active assent of the minor must be obtained, in order to respect their autonomy.
The information provided must be prepared in a child-appropriate manner (e.g. through illustrations or simple language). Trials involving minors are only permissible if the research results are relevant for this age group and cannot be obtained through trials in adults (subsidiarity). This is often agreed with the EMA within the framework of a Paediatric Investigation Plan (PIP).
For CROs, this requires specialised expertise in the recruitment process and in dealing with ethics committees. Monitoring must ensure that both parental consent and the child’s assent are correctly documented, and that renewed consent is obtained if the participant reaches the age of majority during the trial. This safeguards the legal and ethical integrity of the trial.
Mediconomics – für individuelle CRO-Lösungen.
