Lithuania CTIS Secondary Use Consent Requirements

When secondary-use consent is relevant

Use a separate optional consent structure when biological samples or coded data collected for the clinical trial may later be used for purposes beyond the objectives of the main trial.

Examples can include:

• future disease research
• biomarker research beyond the protocol endpoints
• development of new diagnostic methods
• research using leftover samples after the main trial ends
• additional coded-data research not necessary to complete the main trial

Do not label a use "future research" if it is actually required to perform the protocol. Main-trial analyses belong in the main consent.

Lithuania's recommended consent structure

The Lithuanian Bioethics Committee recommends one of two approaches.

Separate future-use ICF

Recommended. Prepare a separate information and consent form specifically for use of trial samples and coded data in future research.

This is the clearest option when the future-use program is complex or includes long storage, broad research purposes, transfers or multiple types of material.

Separate opt-in choice in the main ICF

Recommended alternative. Include a clearly separated box or choice allowing the participant to agree or decline future use.

The future-use statement should be preceded by enough information for the participant to understand what they are deciding.

Do not pre-select the choice.

What the future-use information should cover

Lithuanian Bioethics Committee guidance specifically points to:

• the purposes for which samples or coded data will be used
• how long they will be stored
• where they will be stored
• personal data issues
• other information relevant to the proposed future research

Depending on the program, also explain:

• whether samples are coded or anonymised
• who can access the code
• who may receive samples or data
• transfers outside Lithuania or the EEA where relevant
• whether commercial research is possible
• whether genetic analysis is possible
• whether participants will receive individual results
• whether samples may be destroyed after withdrawal
• what happens to data already generated before withdrawal

The scope should be broad enough to cover the intended program but specific enough for the participant to understand the choice.

Relationship with the main trial

Mandatory principle. Refusing future use should not prevent participation in the main clinical trial when future use is not needed for the main trial objectives.

State this directly.

Avoid consent wording such as "I agree to all research use of my samples" inside the mandatory main-trial signature section if future research is genuinely optional.

Biological-sample compliance document

Conditional. Lithuania's Part II document list requires information on compliance with national rules for collection, storage and future use of biological samples when applicable.

The national Part II recommendations provide a sample form for this information.

The administrative biological-sample document and the participant's optional future-use consent should agree on:

• sample types
• storage locations
• retention period
• future-use purpose
• transfer arrangements
• destruction or withdrawal process

A mismatch between the consent and the Part II sample-compliance information is a common avoidable QC problem.

Data-only future research

The same optionality principle applies when the future activity involves coded data rather than physical samples.

The Lithuanian Bioethics Committee FAQ explicitly refers to both biological samples and coded data in its future-use recommendation.

Do not assume that removing the sample makes the future research automatically part of the main trial consent.

Withdrawal from future use

Explain how the participant can withdraw the optional future-use permission and what can still happen to:

• analyses already completed
• data already included in a research dataset
• samples already distributed or consumed
• information that has been irreversibly anonymised

Do not promise destruction or deletion that the sponsor cannot operationally or legally perform.

The withdrawal language should be consistent with the data-protection section of the main ICF.

Language and signatures

The Lithuania future-use form or opt-in section should be in Lithuanian when it forms part of the Part II participant-facing package.

At CTIS submission, submit the blank form.

When the participant decides:

• record a clear yes or no where the form provides both choices
• obtain the participant's signature where a separate future-use consent form is used
• date the consent
• ensure the interviewer signature is included when required by the consent format
• give the participant a copy where the form is part of informed consent documentation

Final secondary-use QC

Before submission, confirm:

• the future use is genuinely separate from main-trial objectives
• refusal does not affect main-trial participation
• the consent is opt-in rather than assumed
• sample and coded-data purposes are described
• storage duration and location are stated
• privacy and transfer information is consistent
• withdrawal is operationally realistic
• the biological-sample compliance document matches the participant consent
• the Lithuanian version matches the intended master content

Use the Lithuania patient-facing QC checklist for the final review and the Lithuania Part II document checklist to confirm the associated sample-compliance document.