Slovenia CTIS Secondary Use Consent Requirements

When a separate secondary-use choice is needed

Conditional. Prepare separate information and consent when data or samples may be used beyond the protocol-defined clinical trial purpose and that use is not required by law or necessary for the main trial. Common examples include:

• storage for unspecified future disease research
• optional genetic, genomic, biomarker, or exploratory analysis
• sharing with future academic or commercial collaborators
• creation of a biobank or reusable research database
• future contact about other studies
• linkage to external records beyond the main protocol
• use of leftover samples after required analyses end

If an analysis is required to answer the approved trial objectives, describe it in the main PIS and ICF rather than falsely presenting it as optional. If a future use is optional, refusal must not block main-trial participation.

Data-protection consent is not the same as trial consent

Slovenia's Information Commissioner states that informed consent to participate in a clinical trial must be distinguished from consent as a GDPR legal basis. The correct basis depends on the actual processing and national and EU law. Scientific research alone does not create a general, unconditional basis for processing health data in Slovenia.

The controller should document the legal basis for main-trial processing and each secondary purpose. If explicit GDPR consent is used for an optional purpose, it must be freely given, specific, informed, unambiguous, and capable of withdrawal. Power imbalance or dependence can make consent invalid.

Avoid asking one signature to perform three different functions without explanation. Separate trial participation, optional data processing, and optional sample use in the document and records.

Anonymised and pseudonymised data

Use the terms accurately.

• Pseudonymised or coded data remain personal data when re-identification is possible through a key or other reasonably available information.
• Irreversibly anonymised data fall outside the GDPR only when identification is no longer reasonably possible.
• Removing names alone does not make clinical-trial data anonymous.

Explain when anonymisation occurs and what it means for withdrawal. Once data are genuinely anonymised and cannot be linked back, they normally cannot be located and removed on request.

The short KME RS model consent form includes a statement allowing demographic and health data to be used in anonymised form for scientific purposes. Treat that as a narrow model statement, not permission for identifiable, pseudonymised, genetic, commercial, or unlimited future use.

Biological samples

When samples are collected, stored, exported, or reused, complete the applicable CTIS biological-sample compliance document. The assessment form may be in Slovenian or English, while participant information and choices must be in Slovenian.

Explain:

• sample type and amount
• required and optional collections
• present and future purposes
• coding and who holds the key
• genetic or genomic analyses
• storage location and duration
• countries and organisations receiving samples
• commercial collaboration where applicable
• destruction, exhaustion, or anonymisation
• return of individual or incidental findings
• withdrawal process and practical limits

Do not promise that every sample can be returned or destroyed after it has been consumed, distributed lawfully, or irreversibly anonymised.

Required secondary-use document structure

Use a separate Slovenian form or a clearly separated optional section with its own choice and signature. Include:

• a short explanation of how the optional research differs from the main trial
• reasonably specific research areas and exclusions
• types of data and samples involved
• possible future researchers and commercial partners
• storage and transfer arrangements
• whether re-contact may occur
• privacy and confidentiality safeguards
• participant rights and contact details
• withdrawal route and limits
• a clear yes or no choice that does not affect main-trial participation

Avoid pre-ticked boxes and combined wording such as agreement to all future research anywhere in the world forever. Where future details cannot yet be known, define a meaningful governance boundary and explain ethics review and access controls.

Sharing and international transfers

Identify expected recipients and countries or categories of country. Explain the safeguards used for transfers outside the European Economic Area and whether direct identifiers are removed. Align the consent text with contracts, controller arrangements, the protocol, laboratory manual, and CTIS data-protection statement.

If a future recipient will decide independent purposes, assess whether it becomes a separate controller. A contractual label does not determine the GDPR role if actual activities show otherwise.

Withdrawal

Provide a practical contact and explain what withdrawal can achieve. Distinguish:

• stopping future collection
• stopping new optional analyses
• destroying remaining identifiable or coded samples where feasible
• preventing new sharing where feasible
• retaining data already used in completed analyses
• retaining safety or regulatory records required by law
• inability to retrieve irreversibly anonymised material

Withdrawal from optional future use should not automatically withdraw the person from the main trial. Likewise, withdrawal from the trial does not need to erase a separately chosen future-use permission if the participant wants it to continue and the legal basis remains valid.

Children and adults lacking capacity

For samples or data collected from a minor, explain who authorises optional future use, how the minor assents, what happens at adulthood, and whether re-contact is planned. Use the Slovenia minor guide.

For an adult lacking capacity, avoid broad optional future use unless the legal and ethical basis is clear and the use reflects the person's interests and presumed wishes. Seek the person's own decision if capacity is gained or regained. Use the Slovenia limited-capacity guide.

No dedicated national secondary-use form

No current Slovenia-specific CTIS secondary-use or biobank consent template was identified on the JAZMP or KME RS pages. Use the EudraLex biological-sample template for the assessment document where applicable and create a trial-specific Slovenian optional-consent form supported by the actual governance and data-protection analysis.

Return to the Slovenia CTIS hub for the document checklist and all participant variations.