Slovenia CTIS Impartial Witness Consent Requirements

When an impartial witness is appropriate

Conditional. Article 29 of the Clinical Trials Regulation permits consent to be given by appropriate alternative means in the presence of at least one impartial witness when the participant or legally designated representative is unable to write.

Examples can include a physical impairment, injury, or illiteracy that prevents completion of the written signature process while understanding and decision-making remain intact. The site should document why the ordinary written signature could not be used.

Do not use a witness merely because:

• the person needs a Slovenian interpreter
• the person has limited vision but can use an accessible electronic or physical signature method
• the person lacks decision-making capacity
• the legally designated representative is unavailable
• staff want to shorten the consent interview

If capacity is absent, use the Slovenia legal-representative pathway. If a participant cannot understand Slovenian, provide competent interpretation and translated or orally interpreted information as approved.

Witness eligibility

The witness must be impartial and able to understand the consent process being witnessed. Use a person independent of the trial team and free from interests or relationships that could influence the participant or the witness's account.

The witness should not be the person who conducts the consent interview, recruits the participant, or has a direct financial interest in enrollment. Avoid a close family member when dependence or conflict could undermine impartiality. Record the witness's name and role so independence can be reviewed.

An interpreter may also serve as the impartial witness only if the approved procedure permits both roles, the person meets the independence standard, and each role is documented clearly. The safer structure is to use different people when feasible.

Required documents and CTIS submission

Prepare a Slovenian PIS and ICF that can support oral or otherwise accessible consent and includes:

• the reason the participant or representative cannot write
• confirmation that the full approved information was provided
• confirmation that questions were answered and understanding was checked
• the participant's or representative's alternative expression of consent
• the name, role, signature, and date of the person conducting the interview
• the witness's printed name, independence statement, signature, and date
• the date and time where the sequence matters
• confirmation that a signed and dated copy was provided

Upload the clean, blank form in CTIS Part II. Do not add a witness only after approval if the protocol foreseeably recruits people who may need this pathway. Describe the process in the recruitment and informed consent procedure.

Consent procedure

The qualified trial-team member provides the same information required for ordinary informed consent and checks understanding. The witness remains present for the information and consent process, not only for the final signature.

The participant or representative indicates consent using the approved method. This may be an oral statement, mark, or accessible electronic action. The person conducting the interview and the impartial witness then sign and date the record.

The witness statement should confirm personal observation that:

• the information was accurately explained
• the person appeared to understand it
• questions were answered
• the decision was made freely
• the consent expressed matched the record

Give the participant or representative a signed and dated copy in an accessible form. Retain the other copy in the trial archive in line with KME RS guidance.

Interpreter and accessibility issues

A witness does not cure an untranslated document. Slovenia requires participant-facing documents in Slovenian. When the person communicates in another language or sign language, use an approved interpretation pathway and record the language and interpreter.

Provide large print, audio, screen-reader compatible text, supported communication, or other reasonable formats when these allow the person to review information directly. Use the witness only when inability to write remains relevant after accessibility support.

No dedicated national witness form

No current Slovenia-specific CTIS impartial-witness form or witness wording was identified on the JAZMP or KME RS pages. The published KME RS generic consent form contains participant and investigator signature fields but no witness block. Add a compliant witness section when the pathway applies and ensure it is assessed with the application.

Return to the Slovenia CTIS hub for all country guides.