Lithuania CTIS Impartial Witness Consent Requirements

When an impartial witness is relevant

Conditional. Use the witnessed pathway when the participant or legally designated representative can make the consent decision but is unable to write the consent in the usual way.

Do not use an impartial witness as a substitute for a legally designated representative when the participant lacks decision-making capacity. Those are different consent problems.

If the participant lacks capacity, first use the Lithuania limited-capacity and legal representative guide.

What must be described in Part II

The recruitment and informed consent procedure should state:

• why a witnessed pathway may be needed
• which participants may use it
• how the impartial witness will be selected
• how the information will be communicated
• what alternative method records the participant's consent
• how the witness confirms the process
• who signs and dates the consent record
• how the participant receives a copy

Lithuania's national sample consent-procedure form contains a dedicated section for witnessed consent. No separate mandatory national witness form was identified in the Part II materials reviewed for this guide.

Witness selection

The Clinical Trials Regulation requires an impartial witness but does not create a Lithuania-specific job title or fixed witness category.

The sponsor should define a selection process that preserves impartiality and avoids a person whose interests could compromise the reliability of the consent record.

Because the Lithuanian national recommendation asks specifically how the witness is selected, do not leave witness selection to ad hoc site practice.

Signature and dating logic

Article 29 states that when the participant cannot write and the witnessed pathway is used, the witness signs and dates the informed consent document.

The person conducting the consent interview also signs and dates the consent record under the standard Article 29 rule.

The participant's own consent still needs to be validly given and recorded through the appropriate alternative method. The witness signature does not itself create consent.

The participant or legally designated representative should receive a copy of the document or record by which consent was given.

Participant information

The participant should receive the same substantive trial information as any other participant, adapted only as necessary to make the information accessible.

Check whether the inability to write also creates another accessibility need, such as visual, motor or communication support. The consent procedure should explain the practical method without changing the participant's right to ask questions, take adequate decision time or refuse.

Lithuanian language

Mandatory. The submitted Lithuania Part II consent documents and the national consent-procedure document should follow the Lithuanian language requirement.

If an alternative language is needed because the participant does not understand Lithuanian, define the translation and consent process in advance. Do not assume a witness can compensate for a participant not understanding the language.

Final witness-consent QC

Before submission, confirm:

• the witness is used for inability to write, not lack of capacity
• the reason and selection method are described in the Part II consent procedure
• the witness signature and date fields are present
• the interviewer signature and date fields remain present
• the participant's alternative consent method is documented
• the participant receives a copy
• the documents are in Lithuanian
• the process is consistent with the main ICF

Use the Lithuania patient-facing QC checklist for the final review.