Italy impartial-witness consent requirements

When the witness route applies

Use this route when the participant understands the study and can communicate a choice but cannot complete a written signature because of illiteracy, a physical limitation or another inability to write. Provide accessible information and any communication aid needed to support the participant's own decision.

Do not use a witness merely because the person needs more explanation, speaks another language or has limited decision-making capacity. A participant who lacks capacity needs a legally authorised representative. A participant who does not understand Italian needs accurate translated information and qualified language support. These safeguards may coexist, but each has a different purpose.

Who can be the impartial witness

Select an adult who is independent of the trial team and free from interests that could influence the participant's decision. The person must be able to understand the information, observe the full discussion and attest to what occurred.

Avoid the investigator, sponsor staff and anyone responsible for recruitment or trial payment. A family member may have a personal interest and may not be impartial. Use a neutral witness whenever practicable and document the basis for impartiality.

An interpreter or cultural mediator should not automatically serve as the witness. Combining roles may compromise independence or make the record unclear. If local law and the ethics-approved process allow the same person to hold both roles, document both functions explicitly and explain why independence was preserved.

Conduct the consent discussion

Give the participant the approved Italian information in a form they can access. Read it aloud or use another approved method. Explain the purpose, procedures, risks, potential benefits, alternatives, privacy, samples, costs, injury arrangements and right to withdraw. Allow questions and check understanding.

The witness should be present for the entire material discussion, not only for the signature. The participant must communicate a clear voluntary decision by an accepted alternative method. This may include a mark, an electronic method or an audio or video record when approved and lawful.

The CCNCE guidance requires at least one impartial witness when an alternative recording method is used because the participant cannot write. Do not improvise an unapproved remote or recorded process at the site.

Signature and attestation

The investigator or doctor who provided the information signs and dates the form. The impartial witness signs and dates an attestation that the information was accurately read or explained, the participant had an opportunity to ask questions, appeared to understand and freely indicated consent.

Record the participant's alternative mark or method in the place provided. Include date, time and place where the approved form requires them. Identify the witness sufficiently for audit while avoiding unnecessary personal data in the submitted blank template.

Give the participant a copy of the completed consent record in an accessible form. Keep any approved audio, video or electronic record under the protocol's security, access and retention controls.

A witness is not a legal representative

The witness cannot consent for another person. If the participant cannot understand, appreciate or decide about the trial, stop the witness pathway and assess whether a legally authorised representative may act. See the limited-capacity and legal-representative guide.

Similarly, a representative's decision does not remove the need to involve the participant and respect an objection. Label signature lines by role so a site cannot accidentally use the witness block as a representative block.

CTIS package and QC

Describe the witness-assisted process in the recruitment and informed-consent procedure. Include the witness attestation in the applicable participant form or as a controlled appendix. Explain eligibility for the route, independence, how information is provided, the participant's alternative indication, signatures, copy delivery and record retention.

Make the submitted document blank and version controlled. Train sites before use and document the reason for the alternative method in the source record. Do not use witness signatures to correct a missing participant signature after the event.

Use the main patient information and consent guide and patient-facing QC checklist. Return to the Italy CTIS guide hub.