If a minor is eight years or older and able to give consent, he/she must be informed and asked to give consent in addition to the parents or legal guardians. In addition, written consent (date, signature) must be obtained from individuals 14 years and above. At least two information leaflets are required:
- one for the parents or legal guardians and
- one for children or adolescents (under 14 years: information only, 14 years and above: an informed consent form as well)
If the consent of several people is required, the clinical trial may not be conducted if informed consent is withdrawn by any of the people.