France CTIS Part II Impartial Witness Consent Requirements

When the pathway applies

Use the pathway when the participant has decision-making capacity and can communicate consent through an alternative means but cannot write. Examples may include a physical disability, injury, illiteracy or another barrier to making a written entry. Assess the actual barrier and the person's ability to understand rather than assigning the route from a diagnosis alone.

If the person lacks capacity, use the applicable French legal-representative route instead. The France limited-capacity consent guide explains those pathways. If enrollment must occur during a qualifying sudden emergency, assess Article 35 separately.

Witness eligibility in France

Article 29 of the Clinical Trials Regulation requires at least one impartial witness when informed consent is recorded by alternative means because the participant cannot write. The witness must be independent enough to attest what occurred rather than protect a trial interest.

French law describes the attesting person as the participant's trusted person, a family member or a close person, provided that the person is independent of the investigator and sponsor. Verify the person's relationship and independence before the consent discussion.

Do not use a member of the investigator's trial team, sponsor staff or another person whose role creates a trial interest. A site employee outside the study team should not be treated as automatically impartial. Document the independence assessment.

Where interpretation is also needed, use a qualified interpreter under the site's approved process. Avoid combining interpreter and witness roles unless the sponsor and CPP-approved procedure specifically permits it and independence, language competence and the accuracy of both roles can be demonstrated.

Required document set

Mandatory. The complete French participant information sheet and informed consent form, with a witnessed-consent section or attached attestation.

Mandatory. A French witness attestation that identifies the participant, document version, alternative means used, consent date, witness relationship and independence, and confirms that the information was accurately explained and the participant freely consented.

Mandatory. The French recruitment and informed consent procedure must state when the route applies, how capacity and inability to write are distinguished, how the witness is selected, how the alternative decision is expressed and who signs.

Conditional. Provide accessible or adapted participant materials, such as a read-aloud version, large print, supported communication or an approved translated interaction, where needed. These supports do not reduce the required information.

Consent procedure

Give the participant the full approved French information in an accessible way. Allow adequate decision time and answer questions. The witness should be present for the information and the participant's expression of consent so the witness can attest the process from direct observation.

Ask the participant to confirm the decision through a reliable alternative means suited to the person's abilities. This might be a mark, a verbal response, assisted communication or another documented method. The method must show the participant's own decision and must not be supplied by the witness.

Record why the participant could not write, how information was provided, how understanding was assessed, how consent was expressed and who was present. Avoid vague statements such as unable to sign without recording the alternative method.

Give the participant a copy of the signed and dated consent record in an accessible form. A copy for the witness may be provided under the approved process without disclosing unnecessary participant information.

Signature and dating logic

The investigator or other person conducting the consent interview signs and dates the consent form. The impartial witness signs and dates the form or attached attestation as required by Article 29. The participant makes a signature or mark only if physically possible and meaningful. The absence of a participant signature is explained by the recorded alternative means.

Label the witness signature as attestation of the participant's consent process. It is not consent on the participant's behalf. Record the witness's relationship and independence from the investigator and sponsor.

Use the same date for actions that occurred in the same session and preserve the actual sequence if information, decision and signatures occur at different times. Never ask the witness to sign later based only on what the study team reports.

Changes after initial consent

Use the witnessed route again for re-consent if the participant still cannot write. A witness from the first session does not attest a later decision unless present for it. If the participant can later write, use the standard signature process for the next consent update.

If decision-making capacity changes, stop relying on the witnessed pathway and reassess the legal route. A witness cannot become a legal representative through continued involvement.

National template position

France has no mandatory national impartial-witness form. Create the French signature and attestation structure from Article 29 of the Clinical Trials Regulation, Article L1122-1-1 of the Public Health Code and the submitted recruitment and informed consent procedure.

Check the final record against the France patient-facing document QC checklist. Return to the France CTIS hub for the complete guide series.