Slovenia CTIS Minor Consent and Assent Requirements

Slovenia age and capacity framework

Under 15 years

The Patients' Rights Act presumes that a child under 15 cannot consent to healthcare, unless the doctor assesses the child as sufficiently mature. For a clinical trial, the legally designated representative still provides the legally effective trial consent while the child receives information and gives assent when capable of forming an opinion.

Use age-appropriate information rather than relying on one adult document. The amount and format should reflect the child's maturity, reading ability, trial burden, and setting.

Age 15 to 17 years

The Patients' Rights Act presumes a child aged 15 or older can consent to healthcare unless the doctor assesses otherwise. KME RS guidance says invited minors aged 15 or older must provide their own agreement in addition to the consent of their parents or representative.

For a medicinal-product trial under the Clinical Trials Regulation, the legally designated representative remains the person who gives legally effective consent while the individual remains under 18. Prepare an adolescent information and assent or agreement form that supports a meaningful personal decision and records it clearly.

At age 18

When a participant reaches the age of legal competence during the trial, obtain the participant's express informed consent before continued participation as required by the Clinical Trials Regulation. Do not rely indefinitely on the earlier representative consent.

Required document set

Mandatory when minors are included. Prepare:

• A Slovenian parent or legally designated representative Patient Information Sheet and Informed Consent Form.
• A Slovenian child information and assent document suited to younger children who can understand and express a view.
• A Slovenian adolescent information and assent or agreement form for participants aged 15 to 17.
• A re-consent version for participants who reach 18 during follow-up or treatment.
• Slovenian recruitment material addressed to parents, children, or adolescents.
• Separate optional-consent material for future data or sample use where applicable.

No fixed national leaflet bands below age 15 were identified in current JAZMP or KME RS CTIS guidance. Choose defensible age and maturity groupings and explain them in the recruitment and informed consent procedure. Do not omit assent because the child is below a sponsor-created age band when the child can understand and express a view.

Parent or representative information

The representative document should cover all content required for the standard PIS and additionally explain:

• why research with minors is necessary
• potential direct benefit or group benefit and the related uncertainty
• age-specific risks and burdens
• child-friendly procedures and distress controls
• who provides legally effective consent
• how the child's wishes are sought and respected
• when re-consent will occur
• school, travel, family, and caregiver burden
• privacy between the adolescent, parents, site, and sponsor
• pregnancy testing and reproductive information for adolescents where relevant

Confirm who has legal authority for the particular child under Slovenian law and the family circumstances. Do not assume that a person accompanying the child is automatically authorised to consent.

Child and adolescent information

Give information through a person trained or experienced in working with children. Explain the trial's purpose, procedures, discomfort, risks, possible benefits, alternatives, voluntary nature, right to say no, and right to change their mind in language suitable to the minor.

The child or adolescent should understand that the adults are asking for their view, not testing compliance. Avoid phrases suggesting that a parent has already decided and the child only needs to sign.

For participants aged 15 to 17, the document should be sufficiently complete to support the national expectation of their own agreement. It may mirror the adult PIS in simpler language if that is more useful than a short assent sheet.

Consent, assent, and signatures

At CTIS submission, upload blank, versioned forms. No parent, representative, child, adolescent, or interviewer signs the application copy.

When enrollment occurs, the legally designated representative and the person conducting the consent interview sign and date the representative consent record. Record the child or adolescent's assent or agreement in the approved way. Give the family signed and dated copies of the relevant records.

If a child who can form an opinion explicitly refuses or wants to withdraw, respect that wish. The Clinical Trials Regulation requires the investigator to respect an explicit wish of a minor capable of forming an opinion. A representative's signature does not erase dissent.

Re-consent and changing maturity

Review understanding during long trials. Move to a more mature information document when a child's ability to understand changes materially, even before legal adulthood if the approved package provides for staged assent.

Obtain direct adult consent at 18. Also update consent when new safety information, procedures, privacy uses, or optional research could affect willingness to continue.

If the representative changes, document the new legal authority and determine whether fresh consent is needed under the approved process. Preserve the participant's own earlier and current views.

Data, samples, and adolescent privacy

Explain what information parents or representatives will receive and what may remain confidential within the limits of law, safety, and the protocol. Do not promise absolute confidentiality from parents when it cannot be maintained.

Optional future use of data or samples should have a separate choice. Decide whose permission and assent are needed at collection, what happens when the child reaches adulthood, and how future contact or withdrawal will work. Use the Slovenia secondary-use guide.

No dedicated national paediatric template

No current Slovenia-specific CTIS paediatric PIS, parent-consent, or assent template was identified on the JAZMP or KME RS pages. Use the CTR rules, the Patients' Rights Act, and the current KME RS guidance. Document the age and maturity logic in the recruitment and informed consent procedure.

Return to the Slovenia CTIS hub for the full Part II guide set.