Slovakia CTIS Minor Consent and Assent Requirements

Start from the main Slovakia consent requirements

The Slovakia patient information and consent guide covers the common content on procedures, risks, benefits, alternatives, privacy, insurance, samples, contacts and withdrawal. Adapt that information to the parent or legal representative and to the child's level of understanding.

Do not rely on the adult form alone. The Clinical Trials Regulation requires information to be given to the minor in an age-appropriate way by investigators or team members trained or experienced in working with children.

Practical age and understanding bands

Slovak national Part II guidance identifies a separate participant information and consent set for ages 12 to 18 as a typical submission document. It does not create a rule that children below 12 receive no information. Capacity to understand must be assessed individually.

Use a practical document plan such as:

• Young children. Parent or legal-representative information and permission, plus a short verbal or visual explanation suited to the child.
• School-age children who can understand. Parent or legal-representative information and permission, plus a child information and assent form written for that age group.
• Adolescents, commonly 12 to 17. Parent or legal-representative information and permission, plus a fuller adolescent information and assent form that closely reflects the adult content.

The Ethics Committee may expect more than one child version when the age range is wide or the procedures are complex. Explain and justify the age bands in the recruitment and informed consent procedure template.

Parent or legal-representative permission

Mandatory. Obtain informed consent from the parent or legal representative recognized under Slovak law. The permission must reflect the minor's presumed will and may be withdrawn without adverse consequences for the child.

The submission package should state whose permission will be obtained in each family situation and how legal authority will be verified. Do not assume that any accompanying adult can consent. The Clinical Trials Regulation leaves the national definition of legally designated representative to Member State law.

If national law or the individual custody arrangement requires two representatives, plan the signature blocks and verification process accordingly. Where one signature is proposed, document the legal basis and site procedure rather than guessing from family circumstances.

Child information, assent and dissent

Mandatory when the child can form an opinion. Explain the trial, procedures, risks, burdens and possible benefits in language the child can understand. The investigator must check whether the child can form a view and understands the right to refuse or stop.

Assent supports the child's involvement but does not replace the representative's legal consent. A signed assent form is useful when the child can read and write, but the process matters more than the signature alone. Record verbal assent when a written form is not suitable.

Respect explicit refusal and later dissent by a minor capable of forming an opinion. The protocol should explain any immediate safety steps needed after refusal without turning safety follow-up into forced continued participation.

Required pediatric documents

The usual Slovakia package includes:

• parent or legal-representative Participant Information Sheet and permission form
• adolescent Participant Information Sheet and assent form for the planned older age band
• child information and assent material for younger children who can understand
• a consent procedure describing assessment of understanding, parent authority, assent and dissent
• re-consent materials for participants who turn 18 during the trial

All participant-use documents must be in Slovak. Keep English and Slovak versions aligned where both are submitted. Blank forms are not signed in CTIS. At enrollment, the representative and person conducting the consent discussion sign and date the permission form, and the child signs the assent form when appropriate.

Re-consent as age or capacity changes

When a participant turns 18, obtain the participant's own informed consent promptly using the approved adult form if trial participation or follow-up continues. Do not treat earlier parental permission as adult consent.

If a younger child gains enough understanding during a long study, provide the appropriate age-level information and document assent. If the child loses capacity, reassess the consent pathway and legal authority rather than continuing on an outdated form.

Payments, risk and direct benefit

No financial inducement may be offered to the parent or legal representative beyond compensation for expenses and loss connected with participation. Explain reimbursement clearly and separate it from any payment permitted for the child's time or burden.

The pediatric risk and benefit explanation must match Articles 28 and 32 of the Clinical Trials Regulation. Minimize pain, fear and other foreseeable burden. State which procedures offer possible direct benefit and which are performed for research only.

Submission checks

Confirm that every enrolled age and decision-maker has an approved document pathway. Cross-check Slovak wording, signature blocks, parental authority, assent, dissent, re-consent at 18, privacy rights, sample choices and reimbursement.

Use the Slovakia patient-facing QC checklist before upload and the Slovakia Part II checklist for the complete dossier. Return to the Slovakia CTIS hub for the full guide series.