Poland CTIS Part II Minor Consent and Assent Requirements

Poland age bands for consent

The practical consent split is:

Current NKB good practice also clarifies how age ranges should be written in participant documents. A range written as 13-18 years means that the participant has reached 13 but has not yet reached 18.

Use titles and document labels that make the boundaries unambiguous. Avoid a label such as "children 12-18" if the signature logic changes at 13.

Documents to prepare

The exact set depends on age and maturity, but a Poland pediatric package commonly needs:

• Polish parent or legal-representative PIS and ICF
• Polish adolescent information and consent document for participants from age 13 to under 18
• age-appropriate child information or assent material for younger children where they can understand and participate in the decision
• recruitment and informed consent procedure explaining the minor pathway
• any pregnancy information relevant to adolescents
• optional secondary-use choices adapted to the person who can legally make each decision

Do not force all ages into one form if it makes the consent-giver or signature requirements unclear.

Under 13 years

Mandatory. Current NKB good practice states that for a minor who has not reached 13, consent is given by the legal representative. This does not remove the EU requirement to involve the child in the informed-consent procedure in a way adapted to age and mental maturity.

Prepare child-facing information when the child's age and understanding make it meaningful. The document may be shorter than the parent PIS, but it should explain what will happen to the child, the main burdens and that the child can tell the study team if they do not want to continue.

Do not create a legally binding child signature merely to make the form look complete if Polish law does not require that child's formal consent at that age. If an assent signature is used as an ethical record, label it as assent and keep it distinct from the legal representative's informed consent.

From age 13 to under 18

Mandatory. NKB states that once the minor has reached 13, consent is required from both the minor and the legal representative. The adolescent information should therefore support a real informed decision by the minor rather than function only as a simplified child leaflet.

The signature block should record the minor's consent and the representative's consent. The investigator or other person performing the consent interview also signs and dates in line with Article 29 of the Clinical Trials Regulation.

If the minor and representative disagree, do not treat the representative's signature as overriding the minor. Current Polish law cited by NKB provides for guardianship-court involvement in the legal consent framework, while the Clinical Trials Regulation separately requires the investigator to respect an explicit wish of a minor capable of forming an opinion to refuse participation or withdraw.

When both parents have parental authority

Current NKB good practice makes a Poland-specific distinction between representation and the underlying decision. Each parent may generally represent the child, but NKB considers participation in a clinical trial an important matter that should be the result of a joint parental decision when both parents hold parental authority.

NKB gives two ways to document that joint decision:

1. both parents sign the informed consent form 2. one parent signs the informed consent form and the form contains an attestation that the signing parent's consent is the result of a joint decision with the other parent

Build one of these routes into the parent ICF. Do not leave the site to improvise an attestation after approval.

Where parental authority is held by only one person or another legal arrangement applies, the site should verify the actual legal authority before consent. The Part II procedure should allow for those cases without assuming that every family has the same structure.

Information for the child or adolescent

The Clinical Trials Regulation requires the minor to receive information from investigators or team members who are trained or experienced in working with children. Information must be adapted to age and mental maturity.

Explain the procedures the minor will personally experience. Include pain, blood draws, imaging, hospital stays, restrictions and reproductive requirements when relevant. Keep parent-only legal and administrative detail out of a young child's document unless it helps the child's decision.

For adolescents, include enough detail for a genuine consent decision. A highly simplified leaflet is not a substitute for informed consent when the 13-year Polish threshold has been reached.

Refusal and dissent

Mandatory. Article 32 of the Clinical Trials Regulation 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 at any time.

The site process should therefore explain how verbal or behavioural dissent is handled, especially for younger children who are not formal consent-givers. Avoid language in the parent PIS suggesting that parental permission guarantees continued participation regardless of the child's expressed opposition.

Re-consent at 18

Mandatory when the participant reaches legal competence during the trial. Article 32(3) requires the participant's express informed consent before continued participation once the participant reaches the age of legal competence under national law.

For Poland, plan this as an adult re-consent at 18. Track approaching birthdays so the adult PIS and ICF can be used without interrupting trial conduct. The recruitment and informed consent procedure template v2.0 specifically asks sponsors to describe this process.

Pregnancy and reproductive information for adolescents

Conditional. If post-menarchal participants can be enrolled, explain pregnancy testing, contraception and pregnancy reporting in age-appropriate Polish. Decide what information is provided directly to the adolescent and how confidentiality is handled within the legal representative framework.

If pregnancy follow-up may occur, align the pediatric documents with the Poland pregnancy follow-up guide.

Secondary use and optional research

Do not assume that permission for the main pediatric trial automatically covers optional future use of data or samples. If the sponsor asks for optional secondary use, design the choice around the person or persons legally entitled to make it at that age and involve the minor according to capacity.

When a participant reaches adulthood, consider whether a new adult choice is needed for ongoing optional use that continues beyond the original pediatric consent framework. The Poland secondary-use consent guide explains the separation from main-study consent.

CTIS submission and signatures

Submit blank Polish controlled versions of the parent, adolescent and child documents that apply. The consent-givers do not sign the CTIS dossier copy. Signatures are obtained when consent is taken at the site on the authorised version.

The Part II recruitment and informed consent procedure should state the age groups, which document each group receives, who signs, how joint parental decision is documented and how adult re-consent will occur.

Use the Poland patient-facing document QC checklist to check age bands, signature blocks and consistency. Return to the Poland CTIS Part II guide hub for the full Poland content set.