Hungary CTIS Minor Consent and Assent Requirements

Legal framework

The Clinical Trials Regulation sets the EU conditions for clinical trials on minors. The minor must receive information adapted to age and mental maturity from appropriately trained or experienced personnel, and the minor's explicit wish to refuse participation or withdraw must be respected when the minor is capable of forming and assessing an opinion.

Hungary's Health Act adds national rules on who may exercise healthcare consent rights and requires the opinion of a minor with limited or no legal capacity to be taken into account to the extent professionally possible.

ETT-KFEB also requires the identity details of the person authorised to make the relevant declaration to appear in the consent document for a minor who cannot exercise the right independently.

Age bands

The official Hungary Part II sources reviewed for this guide do not publish a fixed national CTIS assent-document age-band table. Do not invent one.

Create child and adolescent versions based on the protocol population, developmental ability and the CTR requirement for age and maturity appropriate information. The document set should be defensible to ETT-KFEB for the actual children to be enrolled.

Hungarian general healthcare law gives minors aged 16 or older certain rights to designate who may exercise consent or refusal rights in healthcare. This does not remove the separate research protections in the CTR or the Health Act. Do not treat age 16 as automatic independent clinical-trial consent.

Parent or legal-representative consent

Mandatory. Obtain the consent required from the legally authorised person before enrollment, unless the narrow emergency-research pathway lawfully applies.

The representative should receive the full information needed to make the decision. The consent form should identify the representative as required by Hungarian guidance.

Where family or guardianship circumstances create doubt about who is authorised, resolve that before consent. Do not solve an uncertain legal-representative status by adding extra signature lines without legal basis.

Information and assent for the minor

Mandatory when the minor can understand. Give information in a form appropriate to age and maturity. A short child information sheet may be appropriate for younger children, while adolescents may need a more complete document closer to the adult information.

Explain that the child can ask questions and can say they do not want to take part. The investigator should document the child's assent or other meaningful involvement in a way appropriate to the approved documents.

Do not present the parent's consent as cancelling the child's right to be heard.

Refusal and dissent

The CTR requires the explicit wish of a minor who is capable of forming and assessing an opinion to refuse participation or withdraw to be respected.

Hungarian healthcare law likewise requires the views of minors with limited or no legal capacity to be considered to the professionally possible extent.

The protocol and participant documents should therefore explain how active dissent is handled. Avoid language suggesting the parent can force continued research participation despite a capable child's refusal.

Re-consent as age or legal capacity changes

Conditional. If a participant reaches legal adulthood during a long-running trial, obtain the participant's own informed consent for continued participation as soon as required by the applicable law and approved process.

If a participant's legal status or capacity changes earlier, reassess who can consent and whether a revised information process is required.

Keep the re-consent plan aligned with protocol duration and visit schedule rather than treating it as a generic administrative event.

Hungarian language

Parent, child and adolescent participant documents used in Hungary should be in final Hungarian form and use language appropriate to the intended reader.

ETT-KFEB specifically checks Hungarian linguistic quality. A literal translation of an adult global ICF is not an acceptable substitute for a child-facing document.

Privacy for minors and parents

ETT-KFEB's GDPR recommendation specifically refers to separate information for a minor participant and parent or legal representative. Each document should address the privacy information relevant to that person.

Be clear about whose data are collected. Parent contact details are not the same data set as the child's health and trial data.

Genetic sampling

The Hungarian Genetics Act has specific consent rules for minors and people with limited capacity. A minor with limited capacity makes the genetic consent declaration with the legal representative's consent or later approval, and sampling cannot occur before the required approval. For an incapable person, the legal representative acts subject to the statutory protections.

Because ETT-KFEB requires separate genetic information and genetic consent documents, reflect the correct minor and representative signature logic in those forms as well.

Compensation

The Medical Research Council Bioethics Code states that financial compensation for participation should not be offered to minors or incapacitated persons. Legitimate reimbursement of expenses should be distinguished from payment for participation and should match the approved financial arrangements.

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All Hungary English guides are at https://trialagents.com/ctis/hungary/en.