Austria Minor Consent and Assent Requirements

Documents required for minors

Mandatory. Submit the parent or legally designated representative Patient Information Sheet and Informed Consent Form for the minor's participation.

Mandatory from age 8 under current AustrianEthics guidance. Submit a separate age-appropriate child or adolescent information and consent document. The national platform recommends adapting the language for 8 to 9 years, 10 to 13 years and 14 to 17 years rather than using one generic paediatric text for all minors.

Recommended for younger children who can understand. The currently linked Forum of Austrian Ethics Committees recommendation advises informing younger children in a way appropriate to their abilities, even below age 8.

All participant-facing documents for Austrian sites are German. If a planned minor or representative does not sufficiently understand German, certified translations into a language they understand must be available.

Consent and assent logic

The EU CTR requires the legally designated representative's informed consent. It also requires the minor to receive information adapted to age and mental maturity and to participate in the consent process accordingly.

Austria goes further for a decision-capable minor. Section 39 of the Austrian Medicines Act states that the trial may be conducted only if that minor has also consented. This makes the child's own decision legally important rather than merely a courtesy assent.

The current AustrianEthics page describes separate consent from both the parents or legal guardians and children or adolescents from age 8. The official sources reviewed do not provide one universal rule on whether one or more representatives must sign in every family and custody situation. Confirm who is legally entitled to represent the particular minor rather than hard-coding a one-parent or two-parent rule into the template.

Age bands and written signatures

For current submission preparation, use the AustrianEthics age bands as the document-planning baseline:

• under 8 years: parent or representative consent is required, and the child should still be informed according to understanding where possible
• 8 to 9 years: separate age-adapted child information and consent plus parent or representative consent
• 10 to 13 years: separate age-adapted child information and consent plus parent or representative consent
• 14 to 17 years: separate adolescent information and consent plus parent or representative consent

The currently linked Forum recommendation, Version 1.1 dated 28 May 2002, states that from age 14 the minor's consent should also be obtained in writing with the minor's personally dated signature. It remains linked by the current AustrianEthics platform as guidance for linguistic design, but its age examples should be read together with the newer current platform requirements and section 39 AMG.

Refusal and dissent

Mandatory. A minor who can form an opinion and assess the information must be able to refuse or withdraw. Article 32 of the CTR requires the investigator to respect that explicit wish. Austrian section 39 also makes the consent of a decision-capable minor a condition of participation.

The currently linked Austrian Forum recommendation states that where several consents are required, the trial cannot proceed if a required consent is missing or withdrawn. The paediatric documents should therefore explain both the representative's decision and the child's own right to refuse in language appropriate to the age group.

Re-consent when the child reaches adulthood

Mandatory. If a participant reaches the age at which they can legally give informed consent during the trial, Article 32 of the CTR requires the participant's express informed consent before continuing participation. For Austria, plan an adult re-consent process when a minor reaches adulthood during the trial.

Do not wait for the next major protocol amendment to address this. The adult ICF should be ready before the participant reaches the relevant age if continued participation is expected.

Content differences from the standard adult ICF

The paediatric information should explain the same essential trial facts as the adult document but at a level that the age group can understand. Include the research purpose, what will happen, discomforts and risks, expected benefit if any, alternatives where relevant, voluntariness, the right to say no and who the child can ask for help.

Do not simply shorten the adult ICF by deleting complex sections. Keep the legally relevant concepts but explain them differently. The national Forum recommendation notes that age, maturity, disease experience and the child's knowledge of their condition can all affect the appropriate level of detail.

The Austrian sample insurance and data-protection wording requirements still apply to the representative documentation. The child-facing version should explain privacy and insurance at a level appropriate to the age group without creating a contradiction with the legal text used in the representative document.

Other population overlaps

If a minor is temporarily unable to consent in an emergency, the Article 35 emergency pathway and the paediatric rules both matter. Use the Austria emergency enrollment guide together with this guide.

If optional future sample or data use is planned, make the optional choice clear in the parent or representative and age-appropriate minor documents. The Austria secondary and future use guide explains the national sample and data rules.