Hungary CTIS Emergency Enrollment Consent Requirements

When the Hungarian emergency pathway may be used

Hungary's Health Act allows research in an urgent-necessity situation without prior consent only when consent cannot be obtained from the research subject or the person authorised under Section 16, and all of the national conditions are met.

The research must:

• be based on a research plan authorised in advance
• relate to care provided in the emergency situation
• be expected to serve the subject's health directly
• be impossible to conduct with similar effectiveness without enrolling people in the emergency situation

The CTR adds its own Article 35 conditions. Both the EU and national tests must be met.

Do not use emergency enrollment simply because a representative cannot be reached quickly in an otherwise non-emergency trial.

What to submit in Part II

Conditional. If the protocol uses emergency enrollment, describe the emergency-consent procedure in the recruitment and informed-consent procedure documentation.

Prepare participant-facing documents for the later information and consent process. If a legal representative may provide consent after initial enrollment, include the representative version where required.

The documents should explain what research procedures may occur before consent, what happens when the participant or representative becomes available, and what choices exist about continued participation and use of data.

Initial enrollment logic

The investigator should document why the individual met the emergency criteria and why prior consent could not be obtained.

The protocol should define who can make that determination, what must be documented, and which research procedures may occur before consent.

Emergency clinical care and research procedures should be distinguishable. Do not present ordinary emergency treatment as if it depended on research participation.

Deferred and subsequent consent

The CTR requires information and consent to be sought after emergency enrollment as soon as the participant or legally authorised representative is able to take part in the consent process.

The later consent should cover continued participation and the handling of data and samples collected during the emergency period within the approved legal framework.

If the participant later gains capacity, obtain the participant's own consent when required rather than relying indefinitely on a representative decision.

Later refusal or withdrawal

The participant or representative may refuse continued participation when approached. The approved documents should explain the consequences of refusal and what happens to data or samples already collected.

Do not promise destruction or deletion if the applicable law or safety obligations require certain data to be retained. State the actual approved handling.

Hungarian language and signatures

The later consent documents used with Hungarian participants should be in final Hungarian form.

Use the standard Hungarian ICF signature and date fields. If the person giving consent cannot read or write, the two-witness rule may apply. The Hungary impartial witness guide explains that process.

Privacy

The emergency situation does not remove the need to inform the participant about data processing when the person can receive that information.

Explain the data collected before consent, the data collected after consent, access, coding, recipients, transfers, retention, rights and the national data-protection contact.

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