Belgium Minor Consent and Assent Requirements

Who represents a minor in Belgium

Under the Law of 7 May 2017, the legally designated representative for a minor is identified through the Belgian Patients' Rights Act. The relevant person is someone who exercises parental authority or is the child's legal guardian.

The EU Clinical Trials Regulation permits consent from one legally designated representative. Belgian parental authority is usually exercised jointly by both parents, including when parents do not live together. The 2026 national advice says that the ordinary presumption that one parent acts with the other's agreement may be inappropriate for a high-stakes decision such as an experimental medicinal-product trial.

The ICF should therefore contain two parent signature lines. Simultaneous signing is not required. One parent may take the form for the other parent to review and sign, provided enough time is allowed before enrolment.

When one parent may sign

Obtaining both signatures may be impossible or inappropriate when one parent is genuinely unavailable, for example because the parent is deceased, incarcerated or unreachable, or is truly estranged and there is no indication of disagreement. This exception does not arise merely because one parent is absent from the visit or because the parents are separated or divorced.

In exceptional circumstances, one parent's written consent may be ethically acceptable after reasonable efforts to inform and involve both parents and when participation is considered in the child's best interest. Ask the signing parent whether the other parent agrees. Document whether the parent signs personally or on behalf of both parents and record the justification.

If the investigator knows that the other parent refuses, the child must not be enrolled on the present parent's signature alone. The current national advice requires the disagreement to be respected while the child's interests and evolving autonomy are considered.

Information and assent for the minor

The investigator should assess understanding using age, maturity, the intervention's impact, the child's mental state, personality, family and social environment and education. No fixed age band replaces this assessment.

Prepare information that matches the child's likely comprehension. A young child may need a short illustrated explanation. An older child or adolescent may need a fuller assent document that covers purpose, procedures, discomfort, voluntary participation, privacy and the right to say no. The document set should be defined in the protocol and the consent procedure.

The minor's assent or dissent should be actively sought and documented. A child's explicit wish to refuse participation or withdraw must be respected when the child can form an opinion and assess the information. Lack of a signature line is not a reason to ignore dissent.

Required document set

Mandatory. Submit a parent or guardian information and consent form in each required regional language. Include two parent signature lines as recommended by the 2026 national advice.

Conditional. Submit age-adapted child and adolescent information or assent forms for the enrolled ages and maturity levels. The absence of statutory numeric bands does not remove the need for documents the intended population can understand.

Conditional. Add separate optional-consent sections for future sample use, genetic analysis, pregnancy follow-up or other substudies. A parent choice for optional research should remain distinct from consent to the main paediatric trial.

Describe all versions and signature pathways in the mandatory EU recruitment and informed-consent procedure template. Submit blank forms in CTIS under L.61 and L.63. Signatures are obtained before enrolment, not at submission.

Re-consent when age or capacity changes

Review consent whenever the child's understanding materially develops or the approved documents change. Provide new age-appropriate information and document renewed assent when appropriate.

When the participant reaches 18 during the trial, obtain the participant's own informed consent for continued participation as soon as the person can complete the adult process. Do not rely indefinitely on parental consent after legal adulthood. Explain what happens if the new adult refuses continued participation and distinguish further intervention from lawful retention of data already generated.

Dissent, refusal and withdrawal

The parent or guardian can refuse or withdraw permission. The capable minor's explicit refusal or wish to withdraw must also be respected under the Clinical Trials Regulation. Explain in both parent and minor documents how withdrawal works and what care or safety follow-up continues.

Do not describe assent as equivalent to legal consent. The legal representative authorises participation, while the child's assent confirms willing involvement to the extent the child can understand. Both layers matter.

Final paediatric checks

• Confirm parental authority or guardianship before consent.
• Include two parent signature lines and a documented single-parent exception process.
• Create age-appropriate information based on the actual population rather than invented national age bands.
• Document the investigator's assessment of discernment and the minor's assent or dissent.
• Align blood volumes, procedures, contraception, long-term follow-up and optional research with the protocol.
• Build re-consent at age 18 and renewed assent into the protocol and consent procedure.
• Provide every document in the official participant language of the trial region.

The Belgium patient-facing QC checklist helps verify the full set. Return to the Belgium CTIS hub for all related guides.