Slovakia CTIS Impartial Witness Consent Requirements

Start from the ordinary Slovak consent form

The participant must receive the same substantive information described in the Slovakia patient information and consent guide. Use the approved Slovak Participant Information Sheet and Informed Consent Form, with a witness attestation added for the defined situation.

Do not use a witness merely because the participant has limited literacy, a disability or needs language support. First provide accessible information and any reasonable communication support. An interpreter and an impartial witness perform different roles, although one person may perform both only if independence and competence are justified and the procedure permits it.

When the witness pathway applies

Conditional. Use a witness when the participant or representative cannot read the information. When the person understands and can consent but cannot write, Slovak law permits oral consent entered into a record signed by at least one witness.

Do not use this route when the person lacks decision-making capacity. That situation requires the Slovakia limited-capacity and legal representative pathway.

Witness eligibility

The witness should be independent of the trial and free from improper influence by trial staff or anyone with a direct interest in enrollment. The witness must understand the language used and be present for the complete information and consent discussion.

Avoid routine use of a member of the study team. If no external person is available and local procedure permits another person, document why that person is impartial and able to protect the participant's interests.

Consent procedure

The investigator or delegated qualified person reads and explains the approved information in Slovak. The participant or representative has time to ask questions and states the decision voluntarily.

If able, the participant or representative signs and personally dates the form. The witness then signs and dates the witness attestation. If the participant can consent but cannot write, record the oral consent in the approved minutes or form and obtain the witness signature required by Slovak law. The person conducting the discussion also signs and dates the record.

Provide the participant or representative with a copy of the signed record in an accessible format. Document the reason for witness use and the witness's presence in the source notes.

Witness attestation

The form should state that the witness:

• was present throughout the information and consent discussion
• observed that the information was accurately explained
• observed that questions were answered
• believed the participant or representative understood the information
• observed that consent was given voluntarily
• has no interest that could compromise impartiality

Do not ask the witness to certify medical capacity, eligibility or the truth of protocol information.

Submission and QC

Describe the witness route in the version 2.0 recruitment and informed consent procedure template. Submit the blank Slovak witness-ready form under Subject information and informed consent form. It is not signed at CTIS submission.

Check that the witness block, oral-consent record, participant block and interviewer block cannot be confused. Verify whether an interpreter block is also needed. Use the Slovakia patient-facing QC checklist and Part II checklist before upload.

Return to the Slovakia CTIS hub for all guides.