Hungary CTIS Secondary and Future Use Consent Requirements

When renewed consent is required

ETT-KFEB states that when data are not anonymous and the participant was not informed at the time of primary use about the purpose of the later use, renewed participant consent is required for secondary use.

This rule also applies in the committee's guidance to blood and tissue samples collected in a trial or substudy and to genetic-data transfers.

Do not assume a broad global phrase such as "research purposes" will automatically cover every new identifiable use. The original information should describe the future purpose with enough specificity to support the intended use.

Separate and optional consent logic

Recommended where future use is not part of the main trial. Present future research as a separate optional choice so refusal does not block participation in the main trial.

For genetic samples, the Hungarian Genetics Act reinforces this separation. Healthcare cannot be made conditional on agreeing to research use or archiving of genetic samples or data.

The participant should be able to understand what is required for the main trial and what is optional future research.

Data-related secondary use

Explain:

• what categories of data may be reused
• the purpose or range of future purposes
• whether data remain coded, pseudonymised or become anonymous
• who may receive the data
• where data may be stored
• the retention period or governing retention rule
• whether data may be transferred outside the EEA and what safeguards apply
• whether commercial research partners may receive data
• how withdrawal applies

If future use is changed materially from what was explained, assess whether renewed consent is required before using non-anonymous data.

Biological-sample future use

For stored blood, tissue or other samples, explain the sample types, storage location, duration, permitted analyses, possible transfer and what happens at withdrawal.

Distinguish samples that remain linkable from samples that have been irreversibly anonymised. The practical effect of withdrawal may differ.

If the sample will be used for genetic research, apply the separate genetic consent rules.

Genetic samples and data

Mandatory when genetic research is planned. ETT-KFEB requires genetic information and genetic consent as separate documents.

The Hungarian Genetics Act requires detailed written consent before genetic sampling and allows the participant to indicate whether the sample or data may be used only for the primary purpose, for other purposes allowed by the Act or specifically for research. It also addresses storage in identifiable, coded, pseudonymised or anonymous forms.

For a new research use of archived non-anonymous genetic samples or data, the Act generally requires the participant's consent. The Act contains specific provisions for situations where consent cannot be obtained, so do not treat those exceptions as a broad sponsor discretion.

Withdrawal

Explain how the participant can withdraw consent for future use.

For genetic material, the Genetics Act gives the participant rights to withdraw consent for handling identifiable, coded or pseudonymised genetic data and to request destruction of samples and resulting genetic data, subject to the statutory rules and timing.

For non-genetic clinical-trial data, ensure the wording is consistent with applicable trial-record, safety and regulatory obligations. Do not promise deletion of data that must lawfully remain in the trial record.

Sharing and international transfer

ETT-KFEB expects the privacy information to identify transfers, recipients and safeguards, particularly for transfers to third countries.

For genetic data and samples, review the additional Hungarian Genetics Act rules before planning cross-border transfer or biobank use.

State the actual destination or recipient categories supported by the protocol and data-management plan.

Minors and limited-capacity participants

If future-use consent is sought from a minor or a participant with restricted capacity, use the correct participant and representative logic. Genetic consent has its own Hungary-specific rules for these populations.

Revisit consent when the participant reaches adulthood or gains capacity if the future use remains ongoing and the law requires the person's own decision.

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The full English guide cluster is at https://trialagents.com/ctis/hungary/en.