Germany CTIS Minor Consent and Assent Requirements

Germany does not use a fixed statutory assent age

Everyone under 18 is a minor, but the German Medicinal Products Act does not create a numeric age at which clinical-trial consent capacity automatically begins. The decisive question is whether the individual minor can understand the nature, significance, and consequences of the trial and decide accordingly.

Practical document bands such as younger child and adolescent can improve comprehension. They are drafting bands, not legal thresholds. The investigator must assess the individual minor.

Required document set

Parent or legal-representative information and consent

Mandatory. Provide the full German trial information to the person or persons who hold legal authority to consent for the minor. The form should record that authority and should match the site's process for verifying parental responsibility, guardianship, or other representation.

The representative information should cover the same core areas as the adult document, plus pediatric rationale, age-specific risks and burden, the minor's involvement in the decision, dissent, and re-consent.

Age and maturity-appropriate information

Mandatory. Give the minor information adapted to age and mental maturity. Use a short child-facing document for younger children who can engage with the decision and a fuller adolescent version where appropriate.

The information should explain what will happen, discomforts, choices, who to ask, and the right to say no in language the minor can understand. Images or visual explanations may help but should not minimize risk.

Minor's written informed consent

Mandatory when the minor has the required understanding. Germany requires the capable minor's own written informed consent in addition to the legal representative's written consent. Do not label this only as optional assent.

For a minor who does not have the required understanding, document the information provided and the child's response in a form appropriate to the protocol and site process. The child's expressed refusal remains decisive.

Other population documents

Conditional. Add separate documents for optional secondary use, genetic research, pregnancy where relevant to adolescents, emergency enrollment, or incapacity when those pathways are included in the protocol.

Consent and signature logic

The blank forms are submitted unsigned in CTIS Part II. Before trial-specific procedures:

• the legally designated representative or representatives with authority sign and date the consent
• a minor with sufficient understanding also signs and dates written informed consent
• the investigator responsible for the vulnerable-population consent process signs and dates as required by the approved form
• each signer receives or has access to the current information, and the family receives a signed copy

The K1 consent-procedure document should explain who assesses the minor's understanding, who verifies representative authority, how disagreement is handled, and which documents are used by age and maturity.

Refusal and dissent

The investigator must respect an explicit wish by a minor who can form an opinion and assess the information to refuse participation or withdraw at any time.

German law goes further for a minor who lacks full understanding. If that minor says or otherwise shows that they do not want to participate, the response counts as an explicit wish under the Clinical Trials Regulation. Do not override persistent verbal or behavioral dissent merely because a representative signed.

Pediatric content differences

The minor and representative documents should explain:

• why the research must involve minors
• expected direct benefit or the permitted population benefit
• pediatric risks, burden, and discomfort
• age-specific procedures and blood volumes
• impact on school, family, growth, puberty, fertility, and daily life where relevant
• assent and refusal
• pregnancy testing and contraception for adolescents where relevant
• how results or new information will be explained to the minor
• what happens if the minor reaches adulthood during the trial

No incentives or financial inducements may be used beyond compensation for expenses and loss directly related to participation.

Re-consent as age or capacity changes

Mandatory. If the participant reaches age 18 during the trial, obtain the participant's own informed consent before continued participation. Use the current adult information and consent form and explain what happens to data and samples already collected.

Reassess understanding during a long trial. A child who becomes capable of the German written-consent decision before age 18 should be informed again and asked for the additional written consent appropriate to the new capacity.

German templates

AKEK's current CTR list contains adult patient and healthy-volunteer model texts. The AKEK child and adolescent model texts shown on the same site are placed under the old-law section and date from 2011. They can help identify age-appropriate topics but should not be treated as current CTR templates without a full update against Regulation (EU) No 536/2014, section 40b of the Medicinal Products Act, the current protocol, and the current data rules.

The Germany patient-facing document QC checklist can be used to check the full family of documents.

Return to the Germany CTIS hub

The Germany CTIS submission guide hub links to the full English guide series.

Other language versions

Read this guide in German.