Italy minor consent and assent requirements

Required document set

Prepare the parent or legal-guardian participant information and consent form for the trial. In addition, use the CCNCE mature-minor information and assent form for participants aged 12 to 17 and the child information sheet for participants aged 6 to 11, adapted to the person's maturity and the study.

The formal CCNCE appendix heading and current model identify the younger group as 6 to 11. Check the current source form when a child is close to an age boundary. A younger child should still receive an explanation suited to their ability even if a separate written assent form is not meaningful.

Provide all participant-facing documents in Italian. Add translated information and qualified mediation when the family does not understand Italian. Do not rely on the child to translate complex research information for a parent.

Parent or legal-guardian consent

Explain the trial, risks, potential benefit, alternatives, procedures, burdens, privacy, samples, reimbursement and injury arrangements to the parent or guardian. The legally operative consent must come from the person or persons entitled to make the decision under Italian law.

The current CCNCE parent model provides signature routes for the mother and father or a legal guardian. Build the form and site process to obtain the required parental signatures or document the legally valid guardian route. Do not assume that one accompanying adult automatically has sole authority. Verify identity, relationship and any court order or custody limitation before enrolment.

The doctor or investigator who provided the information and obtained consent also signs and dates the form. Give the family copies of the completed documents.

Information and assent for ages 12 to 17

The mature-minor document should explain, in age-appropriate language, why the study is being done, what will happen, what may hurt or be inconvenient, possible benefit, alternatives, privacy and the right to ask questions. It should make clear that the parent or guardian gives the legal consent but that the young person's view matters.

Invite the adolescent to express assent in writing when capable. A signature should record the discussion, not serve as the only evidence of understanding. The investigator should assess comprehension and document questions or hesitation.

Respect an explicit refusal or withdrawal by a minor who can form and express an opinion, subject to the narrow legal framework for necessary care. The Clinical Trials Regulation requires the investigator to respect a minor's wish to refuse participation or withdraw at any time.

Information for ages 6 to 11

Use a short, concrete child information sheet. Explain who the research team is, why the child is being invited, what visits and procedures feel like, whether anything may hurt and whom to tell if the child wants a break or wants to stop.

Pictures or simple visual aids may help, but they must not make the research look like entertainment or promise a favourable result. Avoid frightening detail that belongs in the parent form while still explaining immediate experiences honestly. Record how the explanation was given and how the child responded.

Risk, burden and potential benefit

A paediatric trial must meet the protections in Article 32 of the Clinical Trials Regulation. The research must address a condition affecting minors or be essential to validate data from other groups, and the expected benefit or scientific value must justify the research. Risk and burden must be minimised and continually monitored.

The information should distinguish direct potential benefit to the child from benefit to the affected paediatric population. Do not use family hope to soften uncertainty. Explain placebo, rescue treatment, painful procedures, sedation, extra visits, missed school and caregiver burden in practical terms.

Reimbursement and family costs

Describe reimbursement for actual study-related travel, meals, accommodation, childcare or documented loss of income where approved. The CCNCE reimbursement arrangement must match the consent form. Financial terms must not exert undue influence on the parent or child.

State who receives reimbursement, what evidence is needed and what happens if the child withdraws. Avoid presenting gifts or tokens as a reason to participate.

Privacy, samples and future use

Provide the separate Italian privacy information and consent for the minor's data. Explain data access and withdrawal in terms the parent and adolescent can understand. Where the child can understand, tell them that authorised people will use coded information about their health.

Separate protocol-required samples from optional future storage, genetics or secondary use. Obtain the parent or guardian's legally valid choice and seek the child's age-appropriate agreement. Refusal of an optional sample activity must not automatically exclude the child from the main trial. See the secondary-use consent guide.

Turning 18 during the trial

Plan for legal adulthood in the protocol and consent workflow. When a participant turns 18 while trial activities or follow-up continue, provide the approved adult information and obtain the participant's own informed consent without undue delay. Do not rely indefinitely on the earlier parental consent.

Explain what happens if the new adult declines continued participation or optional future use. Preserve data already lawfully collected as permitted, stop new non-essential collection and follow approved safety arrangements.

Changes in maturity or family authority

Revisit information as the child matures, especially in a long trial. A child who moves into the 12-to-17 group should receive the age-appropriate adolescent information and assent process. Re-consent after material new information also involves both the legally authorised adult and the minor to the extent of the minor's capacity.

If parental responsibility or guardianship changes, verify the new authority and update the records before the next consent-dependent activity. Do not place custody details in CTIS templates beyond what is necessary to show the valid pathway.

Use the main patient information and consent guide and patient-facing QC checklist. Return to the Italy CTIS guide hub for the full package.