Slovakia CTIS Secondary Use Consent Requirements

Start from the main Slovakia consent form

Use the Slovakia patient information and consent guide for the ordinary trial information and the patient-facing QC checklist for consistency checks. The secondary-use text may be a separate form or a clearly separate optional section.

Do not describe required protocol analyses as optional future research. If a sample is needed to establish an endpoint, say so in the main trial information and explain the consequences of refusal.

Data-related secondary use

Conditional. Explain any use of coded trial data for research questions beyond the main protocol, creation of pooled datasets, sharing with academic or commercial researchers, linkage to other records or use in future method development.

State the scope of research, governance, access controls, likely recipients, international transfers and retention. Avoid unlimited wording such as any purpose forever. If future projects cannot be named, define the field, safeguards and review process.

The lawful basis for future processing must be assessed under Regulation (EU) 2016/679. An optional participant choice can express willingness to contribute, but it should not be used to conceal the controller's legal analysis.

Biological-sample secondary use

Conditional. Complete the EudraLex Compliance with applicable rules for biological samples template when the trial collects, stores, transfers or uses human samples. Describe both protocol-required samples and any future-use collection.

The participant information should state:

• sample types and approximate amounts
• required and optional collections
• coding or anonymization method
• storage location and duration
• permitted research scope
• genetic analysis, if planned
• access by third parties and commercial organizations
• transfers outside Slovakia or the European Economic Area
• return or non-return of individual findings
• withdrawal and destruction limits

If tissue, cells or organs are removed or transplanted as part of the trial, Slovak Act No. 362/2011 requires the site to hold the applicable transplant-center authorization. This is a site authorization issue in addition to participant consent.

Separate and optional consent logic

Use a distinct yes or no choice for each materially different optional activity. A practical structure may separate:

• storage for future research related to the disease or treatment
• genetic research
• sharing with external researchers
• transfer outside the European Economic Area
• re-contact about future studies

Do not preselect answers. State that refusal will not affect main-trial participation when that is true. If a proposed use is mandatory for the trial, explain why and do not label it optional.

Withdrawal

Explain how the participant can withdraw permission for future use and where the request should be sent. State what can happen to remaining identifiable or coded samples and what cannot be reversed.

Data already included in analyses, results already generated and genuinely anonymized material may no longer be retrievable. Explain this before consent. Do not promise full deletion in every circumstance.

If a legal representative made the original choice and the participant later gains capacity, review whether the participant should make a new decision. For minors, obtain the participant's own decision at adulthood if storage or future use continues and the material remains identifiable or coded.

Submission documents and signatures

Submit the blank Slovak secondary-use information and choice form under Subject information and informed consent form when it is part of the participant consent set. Upload the biological-sample compliance template in its dedicated Part II placeholder.

The blank documents are not signed at CTIS submission. At the consent visit, the participant or legal representative and the person conducting the discussion sign and date the approved optional form or section. Keep optional decisions visible in source records and trial systems.

Slovakia-specific checks

Confirm that the Slovak text matches the protocol, laboratory manual, data-management plan, transfer arrangements and retention schedule. Keep English and Slovak versions aligned where both are submitted. Do not add a national biobank claim or mandatory template unless it is supported by the current project and authority guidance.

Use the Slovakia Part II document checklist to verify the biological-sample and GDPR locations. Return to the Slovakia CTIS hub for all country guides.