Estonia CTIS Secondary and Future Use Consent Requirements

Start from the main Estonia consent package

Use the Estonia Patient Information and Consent Requirements guide for the core trial PIS/ICF.

Participant-facing materials must be in Estonian and include the EU CT number. If the future-use information is a separate document, it remains participant-facing and should follow the same national language rule.

When separate future-use consent is needed

Conditional. A separate or additional choice is relevant when the sponsor wants to retain or use data or biological samples for scientific purposes outside the main clinical-trial protocol.

Examples include:

• future biomarker research not defined in the protocol
• optional genetic research
• storage of residual samples for later research questions
• future research collaborations
• new analyses using pseudonymised trial data outside the original protocol

Do not label an activity as "future research" if it is already a required protocol procedure. Keep required protocol use and optional secondary use distinct.

Estonia's separate-consent recommendation

Recommended. Ravimiamet states that the participant should be able to give separate consents in the information form for participation in the trial and for use of health data or biological samples in pseudonymised form.

This is a practical reason to avoid one bundled "I agree to everything" signature.

The optional choice should make clear that refusing future use does not by itself prevent participation in the main trial when the future use is not required by the protocol.

Data-related future use

For optional future use of personal or pseudonymised data, explain:

• the intended scientific scope
• whether future questions are defined or broad
• who may receive or access the data
• whether data may be shared with other research organisations
• geographic transfers
• coding or pseudonymisation
• retention
• what the participant can withdraw
• what may already have been used before withdrawal

The European Commission's CTR and GDPR Q&A states that secondary use of personal data outside the protocol requires a valid legal ground under the GDPR. The ethical consent under Article 28(2) of the Clinical Trials Regulation is not automatically the GDPR legal basis.

Anonymised data fall outside the GDPR only when they are truly no longer personal data.

Biological-sample future use

When biological samples are retained, Estonia asks sponsors to describe:

• what is collected
• whether it is pseudonymised or anonymised
• how it is transported
• where it is stored
• how long it is stored in years
• when it will be destroyed

Use the European Commission Compliance with Applicable Rules for Biological Samples form where applicable.

For optional future use, also explain the research scope, access, sharing, possible genetic analysis, whether samples may leave Estonia or the EEA, and what happens if consent is withdrawn.

Withdrawal

Do not promise that withdrawal can always retrieve data already incorporated into analyses or fully anonymised material.

Explain the practical consequences accurately and distinguish:

• stopping new optional future use where possible
• retention required for trial safety, reliability or legal obligations
• data already used before withdrawal
• material that has been irreversibly anonymised

The wording should match the sponsor's actual data and sample governance process.

Minors and participants lacking capacity

If optional future use involves a minor or an incapacitated participant, layer the relevant representation and participant-involvement rules onto the secondary-use choice.

Use:

• Estonia minor consent and assent requirements
• Estonia limited-capacity and legal representative consent requirements

Where the participant later gains legal capacity, consider whether direct re-consent is needed for ongoing optional future use.

QC before submission

Confirm that:

• future use is clearly separate from required protocol use
• optional choices are not bundled with the main participation decision
• data and sample language is consistent across ICF, protocol and sample forms
• retention and destruction periods match operational plans
• sharing and transfers are described
• withdrawal wording is realistic
• GDPR legal-basis language is not confused with CTR participation consent
• Estonian language and EU CT number requirements are met

Use the Estonia patient-facing QC checklist before submission.

Return to the Estonia CTIS hub for the complete guide set.