Czechia CTIS Part II Secondary and Future Use Consent Requirements

When secondary or future-use consent is needed

Use an additional consent choice when participants are asked to permit optional future research that is not required for participation in the main clinical trial.

Common sample-related examples include retention of residual blood or tissue, future disease research, future treatment research, genetic testing or broader research that extends beyond the immediate protocol analysis.

For a protocol-defined mandatory analysis, describe the sample use in the main PIS/ICF rather than presenting it as optional future research.

Biological-sample consent structure

Mandatory when future sample use is requested. SÚKL allows two structures:

1. include future storage and use in the main PIS/ICF with a separate signature dedicated to that future-use consent
2. use a separate future-use information and consent document signed by the participant

A general “I agree to the study” signature is not enough for the optional future-use choice under the current Czech requirement.

Information SÚKL expects

The future-use statement should explain:

• how long samples will be stored
• whether samples remain pseudonymised or become fully anonymised
• the main future research purpose
• whether the research concerns the disease, its treatment, genetic testing or broader unspecified research, as applicable

The wording should match the actual sponsor plan. Do not describe material as fully anonymised if the sponsor retains a code that can reconnect it to the participant.

SÚKL Template No. 7

Mandatory for the applicable biological-sample pathway. Complete SÚKL Template No. 7, Compliance with effective rules of the Member State for sampling, storage and future use of human biological samples, and submit it under Compliance with Use of Biological Samples.

SÚKL states that the form must be completed in full and should provide information not only about future-research samples but also about samples collected during the clinical trial.

The participant-facing document and Template No. 7 should describe the same storage, coding and future-use model.

Optionality and the main trial

A participant should be able to refuse optional future research without being told that refusal automatically prevents participation in the main trial, unless the future use is actually an essential protocol requirement and is therefore not optional.

SÚKL's KLH-22 also recommends a separate information and consent document for an optional substudy independent of the main trial. Refusal of that optional substudy should not affect main-trial participation.

Keep the signature structure visually clear so the participant and site can tell which choices are optional.

Withdrawal

Explain how a participant can withdraw future-use permission while samples remain identifiable or pseudonymised and still under sponsor control.

Do not promise retrieval of material that has already been fully anonymised in a way that makes re-identification impossible. Likewise, do not promise reversal of research already completed before withdrawal.

The participant-facing statement should reflect the actual sample lifecycle and the sponsor's approved process.

Sharing and transfer

If samples or derived data will be transferred to central laboratories, research partners or facilities outside Czechia, explain the relevant handling and sharing at a level the participant can understand.

Where the future research purpose is broad, avoid language that implies unrestricted use without boundaries. State the intended research field and sample status as required by SÚKL.

Data-protection descriptions should be consistent with the sponsor's separate SÚKL Template No. 5 declaration and with the PIS/ICF.

Data-only future research

Regulation (EU) No 536/2014 permits the sponsor to ask a participant for consent to use data outside the protocol for future scientific research, subject to the Regulation and applicable data-protection law.

Do not treat this research consent as a substitute for the legal basis and transparency obligations that apply to personal-data processing. The participant-facing document should distinguish voluntary future-research permission from the sponsor's regulatory data-processing responsibilities.

Czech language and signatures

Use Czech participant-facing wording for the standard Czech submission. A foreign-language version follows SÚKL's certified-translation pathway where applicable.

The future-use signature is obtained during trial conduct, not at CTIS submission. If electronic signatures are used, SÚKL's accepted e-signature methods apply.

Use the Czechia patient-facing QC checklist to verify optionality, signature placement, sample status, storage duration and withdrawal wording.