Hungary CTIS Limited-Capacity Participant and Legal Representative Consent Requirements

When this variation applies

Conditional. Use it when an adult participant lacks capacity, or has a court-limited capacity that covers healthcare decision rights, so another person must exercise the relevant consent right under Hungarian law.

Do not label a participant incapable merely because of diagnosis, age, hospitalisation or communication difficulty. Capacity and legal representation are separate questions.

The CTR rules for incapacitated subjects also apply. The trial must meet the additional protective conditions in the Regulation, including the requirements on representative consent, information, wishes of the participant, absence of improper incentives and the permitted benefit or risk framework.

Identify the authorised person

Hungary's Health Act sets an order and mechanism for people who may exercise consent rights when the patient cannot do so, including a designated person, legal representative and specified relatives in the statutory order.

The trial site should verify the basis of the representative's authority before relying on the signature.

ETT-KFEB requires the identity details of the person authorised under Section 16 of the Health Act to be included in the ICF when the participant is incapable or relevantly limited in capacity.

Participant information and involvement

Mandatory. Give the participant information suited to the participant's ability to understand. The representative receives the information required to make the legal consent decision, but the participant should not disappear from the process.

Hungarian law requires the opinion of an incapable or limited-capacity person to be taken into account to the extent professionally possible.

The CTR also protects the participant's explicit wish to refuse participation or withdraw when the person can form and assess an opinion.

Consent and signature logic

The approved document set should make clear:

• who receives full information
• who gives the legally effective consent
• how the participant's own wishes are recorded
• who signs and dates each document
• what happens if the participant objects
• what happens if capacity changes

Use one signature set per consent document, following ETT-KFEB's general ICF format.

If the person giving consent cannot read or write, apply the Hungary-specific two-witness oral-consent rule in the impartial witness guide.

Objection and dissent

Do not draft the form as if representative consent allows participation regardless of the participant's wishes.

The participant's capable refusal or withdrawal must be respected under the CTR. Hungarian law also requires the participant's opinion to be considered to the professionally possible extent.

Train sites to distinguish inability to sign from refusal. A physical inability to write may call for the witness procedure. Refusal is not a signature problem.

Re-consent if capacity improves

Mandatory when the legal trigger occurs. If the participant regains the ability to provide valid consent, provide the study information without delay and obtain the participant's own consent for continued participation.

The Medical Research Council Bioethics Code likewise states that if a vulnerable participant later regains capacity, the person should be informed and continued participation should depend on that person's consent.

The protocol should describe how capacity will be reassessed when recovery is reasonably foreseeable.

Hungarian privacy requirements

Provide the participant and representative with the privacy information relevant to the participant's data. Do not assume the representative becomes the data subject.

The privacy section should still cover data categories, coding, access, recipients, transfers, retention, rights and NAIH contact details.

If representative contact data are collected, describe that processing appropriately.

Genetic sampling

The Hungarian Genetics Act has specific rules for people with limited capacity. A partly limited adult whose legal restriction covers healthcare and personality rights may make a genetic consent declaration with the legal representative's consent or later approval. Sampling cannot occur before the required approval.

For an incapable person, the legal representative acts subject to the statutory protections.

ETT-KFEB requires genetic information and genetic consent as separate documents. Do not use the main-trial representative signature as a substitute for the genetic consent process.

Compensation

The Medical Research Council Bioethics Code states that financial compensation for participation should not be offered to incapacitated persons. Necessary and documented expenses are a separate issue and should match the approved financial arrangements.

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The country directory is at https://trialagents.com/ctis/hungary/en.