Croatia impartial witness consent requirements

When an impartial witness applies

Conditional. Use a witness when the participant or legally designated representative can provide informed consent but is unable to write. Regulation (EU) No 536/2014 permits consent to be given and recorded by an appropriate alternative means when at least one impartial witness is present.

Examples may include a physical impairment preventing a signature. Confirm the person's decision-making ability and the reason the ordinary signature cannot be used. Document the approved alternative means used to express the decision.

Do not use this pathway solely because the participant cannot read Croatian, has low literacy, lacks decision-making capacity, is unconscious, or is in an emergency. Each of those situations requires a different solution or may prevent enrollment.

Witness eligibility

The witness must be impartial. Select someone independent of the sponsor, investigator, and trial team and free from interests that could influence the participant's decision. The person should be able to understand the information and observe the full consent process.

Avoid using a person who is subordinate to the investigator, involved in recruitment, paid for trial performance, or otherwise dependent on a favourable enrollment decision. The protocol or site procedure should define how independence is checked and documented.

Family members may have a personal interest and should not be treated as automatically impartial. If a site proposes a particular witness category, justify independence in the procedure and confirm acceptability during ethics review.

Documents and procedure to prepare

Mandatory when the pathway is planned. The recruitment and informed-consent procedure should state when a witness is used, how capacity is confirmed, how information is delivered, which alternative means records consent, how witness independence is checked, and who signs and dates each field.

Mandatory. The Croatian informed consent should contain a witness section. The attestation should confirm that the information was accurately explained, the participant or representative appeared to understand it, the decision was voluntary, the chosen alternative means recorded consent, and the witness observed the process.

Submit the blank Croatian document in CTIS Part II. It is versioned and dated but not signed at submission. A separate witness information or confidentiality form may be added if the witness will receive personal or health information beyond what is necessary to observe consent.

Conducting witnessed consent

Provide all approved information to the participant or representative in an understandable way. Allow time for questions and confirm comprehension. The witness must be present for the consent process, not called in only to sign a completed page.

Croatian law requires the person conducting the interview to be a physician or dentist who is the principal investigator or a delegated investigator. The interviewer signs and dates the consent. The witness signs and dates the witness attestation. The participant's decision is recorded through the approved alternative means.

Give the participant or representative a copy of the completed signed and dated document. Record why a conventional signature could not be used, who attended, and how the decision was expressed.

Current Central Ethics Committee guidance requires routine consent to be obtained in person on paper. Do not use a remote witness or electronic signature unless the specific exceptional process has prior approval and the required later paper consent is planned.

Participant, witness, and investigator signature logic

• Participant or representative: provides consent through the approved alternative means and signs or marks only if physically possible.
• Impartial witness: signs and dates the attestation after observing the complete process.
• Physician or dentist interviewer: signs and dates to confirm the information and consent discussion.
• Additional translator or communication support: signs only if the approved document and procedure require it. A translator is not automatically the impartial witness.

Do not label the witness as the decision-maker. The participant or legal representative makes the decision. The witness confirms how the decision was informed, voluntary, observed, and recorded.

Language, capacity, and emergency distinctions

Participant-related documents submitted for Croatia must be in Croatian. If a potential participant cannot understand the approved Croatian information, obtain an approved language version and suitable communication support before enrollment. A witness cannot make untranslated information understandable.

If the person lacks capacity, use the legally appointed representative pathway and still involve the participant as far as possible. The Croatia legal representative consent guide explains that process.

If consent cannot be obtained within a genuine therapeutic window, witnessed consent is not a shortcut. The trial must satisfy the Article 35 pathway in the Croatia emergency enrollment guide.

Croatia-specific final checks

• The person can understand and decide but cannot write.
• The reason for alternative recording is documented.
• The witness is independent and present for the whole consent process.
• The Croatian consent contains a clear witness attestation.
• The participant or representative, witness, and physician or dentist roles are not confused.
• The interviewer and witness sign and date when consent is obtained, not at CTIS submission.
• The participant or representative receives a completed copy.
• Translation, communication support, incapacity, and emergency pathways are handled separately.

Return to the Croatia CTIS hub for the full participant-document guide set.