Czechia CTIS Part II Minor Consent and Assent Requirements

Czech age bands and documents

Children under 12

Conditional. Prepare age-appropriate information when the child's maturity and protocol population make it meaningful. SÚKL's 2026 guideline says younger minors may sign the same informed consent form together with their parents to express willingness to participate, but a signature for minors under age 11 is not mandatory.

The absence of a mandatory signature below that age does not remove the child's involvement. Article 32 of the Clinical Trials Regulation requires information adapted to age and mental maturity and respect for the explicit wish of a minor who can form an opinion and assess the information.

Ages 12 to 14

Mandatory. SÚKL requires written patient information for minors aged 12 to 14.

KLH-22 recommends simple language, a short document of no more than about four pages and age-appropriate Czech wording. It advises against contraception instructions in this age-band document. If a teratogenic fetal risk is clinically relevant, it may still be explained as an adverse-effect risk in age-appropriate terms.

The minor signs the age-specific document to confirm free willingness to participate. The child document does not replace the consent of the parent or legally designated representative.

Ages 15 to 17

Mandatory. SÚKL requires written patient information for ages 15 to 17.

KLH-22 permits this version to be closer to the adult document in length and detail. Contraception information should be included when relevant for sexually active adolescents and must remain consistent with the protocol. The minor signs the age-specific document to confirm willingness.

The parent or legally designated representative still provides the legally required consent while the participant remains a minor.

Parent or guardian information and consent

Mandatory. Provide the parent or legally designated representative with information sufficient to make the legally relevant decision for the minor. The parent information should cover the same essential trial issues as the adult participant information, adapted to the fact that the decision concerns a child.

SÚKL's KLH-22 contains an important CTIS-specific point. For trials submitted through CTIS, one parent's signature is acceptable according to the current national guidance. This differs from older Czech wording that referred to both parents.

The child's own information and willingness remain separate from the parent's legal consent. A minor's document should therefore not be drafted as if the child were the sole consent-giver.

Refusal and dissent

Article 32 requires the investigator to respect the explicit wish of a minor who is capable of forming an opinion and assessing the information to refuse participation or withdraw.

The Czech document set should make this practical. Do not tell a child that signing is merely symbolic. The information should explain that questions, disagreement and withdrawal can be raised with the study team.

Re-consent as age changes

Mandatory when the participant moves into a new consent category. KLH-22 says that when a child reaches the next age band, the investigator should discuss the study again and obtain the higher-age document.

A participant moving from the 12 to 14 group into the 15 to 17 group should receive the adolescent version and complete the corresponding process. When a participant turns 18, obtain the adult PIS/ICF. The parent's or guardian's consent no longer substitutes for the adult participant's own consent.

Plan these transitions before the first participant enters the study. The site should know which document version is triggered by birthday and how version control will be recorded.

Main differences from the adult PIS/ICF

• Information must be adapted to age and maturity.
• Ages 12 to 14 and 15 to 17 require separate written Czech information under SÚKL's current rule.
• The child's signature documents willingness, while the parent or representative provides the legally relevant consent during minority.
• Contraception wording differs by age under KLH-22.
• Re-consent is required as the participant moves into an older age band and at adulthood.
• Dissent and withdrawal wishes of a sufficiently mature minor must be respected.

The underlying Czech national content still applies. Include the EU CT Number, full trial title, ethics committee email, source-record access wording, results-availability statement and copy-of-consent statement in the applicable versions.

Signatures at submission and during conduct

Do not pre-sign participant or parent consent forms for CTIS submission. Submit blank Czech forms.

During trial conduct, obtain the applicable parent or representative consent and the minor's age-specific signature where required. The person conducting the consent interview also signs and dates according to the CTR consent process.

If electronic consent is used, apply SÚKL's accepted electronic-signature methods. Do not assume a sponsor platform signature is automatically accepted.

QC before submission

Check all age bands planned in the protocol and recruitment strategy. The Czechia patient-facing document QC checklist is useful for confirming age coverage, pregnancy wording, versioning, signatures and protocol consistency.