Greece Impartial Witness Consent Requirements

Who may act as a witness

Each witness must have legal capacity and must not be connected in any way with the clinical trial. The witness should be independent of the sponsor, investigator, study team and recruitment decision. Confirm and document independence before consent.

A translator or interpreter does not automatically satisfy the witness role. If one person will perform both functions, confirm that the person meets the independence and competence requirements and that the approved process allows the combined role.

Deaf participant or participant unable to speak

Conditional. For a deaf participant, provide the information in writing so the participant can read it. Questions and answers are also handled in writing. For a participant who cannot speak, provide the written information and a way to ask written questions.

The participant and the authorized study-team member certify on the information and consent documents that this process was followed. At least one independent witness remains present throughout the process and co-signs the documents.

Adapt the communication method to the person. The national rule describes the minimum written route. It does not justify excluding accessible sign language, assistive technology or another approved accommodation when these improve understanding.

Participant unable to read or write

Conditional. When the participant cannot read or write, the information and consent forms are signed by the authorized study-team member and by two independent witnesses with legal capacity who are not connected to the trial. The participant's voluntary agreement must still be obtained and documented in the approved manner.

The two-witness rule is a national addition and should be visible in the submitted blank form. Include witness name, independence statement, signature and full-date fields for both witnesses.

Audio or video alternative

Conditional. Greek law permits consent in the above situations to be recorded through an appropriate alternative method, such as audio or video, with at least one independent witness present. The witness signs the consent documentation.

Describe the method, storage, access, privacy, retention and contingency process in the protocol and Part II consent procedure. The recording route should not be introduced at a site unless it is covered by the approved application and complies with data-protection requirements.

Documents and statements

Prepare the main Greek information and consent form plus the witness statement or witness fields needed for the protocol population. The form should state:

• why the ordinary signature pathway could not be used
• how information was presented
• how questions were asked and answered
• that the participant appeared to understand the information
• that agreement was voluntary
• that the witness was present for the full process
• that the witness is legally capable and independent of the trial
• which documents or recording the witness observed

At CTIS submission, the forms are blank and unsigned. During conduct, the participant, investigator or authorized team member, and required witness or witnesses sign and date according to the approved route. Give the participant a signed copy or an accessible equivalent.

Witnesses are not legal representatives

A witness confirms the consent process. A witness does not make the participation decision for an adult who lacks legal capacity. If a court-appointed representative is required, use the Greece limited-capacity guide.

For a minor, parental or guardian consent and the child's assent remain necessary even if a witness is also needed. Use the Greece minor guide.

Greek National Ethics Committee guidance also asks a pregnant-partner follow-up form to contain fields for two impartial witnesses and a legal representative because the sponsor cannot predict the pregnant partner's ability to consent. The Greece pregnancy follow-up guide explains that document.

Return to the Greece CTIS guide hub and use the Greece patient-facing QC checklist before submission.