Hungary CTIS Impartial Witness Consent Requirements

When the two-witness pathway applies

Conditional. Use this pathway when the participant is unable to give written consent because of inability to write or illiteracy.

Do not use witness consent to replace a legal representative when the issue is lack of decision-making capacity. Do not use it because the participant is temporarily unavailable. Those are different consent problems.

A person can be capable of deciding but physically unable to write. The witness pathway exists to document that capable person's oral consent.

Witness eligibility

The Health Act requires two witnesses who are not interested in the research and do not participate in it.

Choose witnesses who can observe the information and oral-consent process without a conflict that undermines independence.

The ETT-KFEB Q&A additionally requires the witnesses to provide their address or contact details.

Consent procedure

The participant should receive the information orally in a form the person can understand, together with any accessible information methods appropriate to the situation.

The participant gives oral consent in the simultaneous presence of the two witnesses.

The oral declaration is recorded in writing and both witnesses sign to confirm that the oral consent occurred.

The investigator or person providing the information should complete the investigator signature and date fields required by the approved Hungarian ICF.

Required document fields

For a trial in which this pathway can reasonably occur, the approved ICF should allow documentation of:

• participant identity
• date of the consent process
• participant's oral consent
• investigator or information-provider signature
• first witness name, signature and address or contact
• second witness name, signature and address or contact

Do not rely on handwritten additions to a global one-witness form if the population makes this pathway foreseeable. Prepare the correct approved version before enrollment.

Re-confirmation if writing ability returns

Hungary's Health Act states that if the participant regains the ability to write, the consent declaration must be confirmed in writing before the research continues. Without written confirmation, the consent is treated as withdrawn and research on that person may not continue.

This makes re-confirmation a substantive consent step, not merely a documentation preference.

Language and accessibility

The Hungarian participant information still needs to be understandable and in the appropriate Hungarian form. Inability to read does not justify giving less information.

Consider accessible formats or communication support where appropriate, but do not confuse support with substituted decision-making.

Genetic consent

If separate genetic information and consent are required, the same inability-to-write issue must be handled within the genetic-consent rules. The Hungarian Genetics Act itself also contains two-witness mechanisms for certain oral declarations.

Keep the genetic consent separate from the main ICF as required by ETT-KFEB.

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