Belgium Impartial Witness Consent Requirements

When an impartial witness is appropriate

Article 29 of Regulation (EU) No 536/2014 allows consent to be given and recorded by appropriate alternative means in the presence of at least one impartial witness when a participant is unable to write.

First support the participant's own communication. Accessible formats, assistive technology, reading aloud or an authorised alternative mark may allow the person to complete the process. Use the witness route when writing remains impossible and the approved procedure provides for it.

A language difference alone is not the same as inability to write. Provide information in a language the participant understands and use a competent interpreter when needed. An impartial witness does not repair an inadequate translation or a consent discussion the participant cannot understand.

Witness eligibility

Choose an adult who is independent of the trial and free from conflicts that could affect the attestation. The witness should not be part of the investigator team, controlled by the sponsor, financially dependent on enrolment or acting as the participant's substitute decision-maker.

The application should define how independence is checked and documented. A relative or support person may know the participant well, but personal involvement can undermine impartiality. If such a person is proposed, justify the choice and confirm that the ethics committee accepted the procedure.

Belgium does not publish a separate national witness form for medicinal-product trials. The EU Annex I requires the Part II dossier to explain the reason for the witness, how the witness is selected and the procedure used to obtain consent.

Required documents

Mandatory. Submit the standard participant information and consent form in the participant's official regional language. Adapt the signature page to show the alternative method used and the participant's expression of consent.

Mandatory. Include a witness statement and signature and date fields. The statement should confirm that the information was accurately explained, apparently understood and that consent was freely expressed by the participant.

Mandatory. Describe the complete process in the EU recruitment and informed-consent procedure template, including why the route is needed, witness eligibility, accessibility measures, interpretation, signatures, copies and source documentation.

Submit the forms blank in CTIS. The signatures are collected only when the approved consent process occurs.

Consent and signature sequence

The physician or permitted dental professional conducts the Belgian consent interview and confirms the participant's capacity. The participant receives the same substantive information and time to decide as a participant who can sign conventionally.

Record how the participant expressed consent. The witness signs and dates the attestation after observing the process. The person who conducted the interview also signs and dates the ICF. If the participant can make a mark or use an approved electronic method, retain that record as described in the procedure.

Give the participant a signed and dated copy in an accessible form. Keep the original or validated electronic record at the site with documentation of the witness's identity and independence.

Main differences from standard consent

• Capacity remains with the participant.
• The witness observes and attests but does not authorise participation.
• The procedure states why writing is impossible and which alternative method records consent.
• Accessibility and interpretation are addressed separately.
• The signature page contains a specific witness attestation.
• The site documents witness independence and the full sequence.

Do not use a witness signature to override hesitation, refusal or withdrawal. The participant can refuse or withdraw through the same communication method used to express consent.

Final checks

• Distinguish inability to write from lack of capacity and from a language barrier.
• Define witness eligibility and conflicts in the Part II procedure.
• Include the participant, witness and interviewer signature and date fields.
• Explain the alternative method used to record the participant's own decision.
• Submit the document in the correct regional language and accessible presentation.
• Provide the participant with a signed copy and preserve source documentation.

Use the Belgium patient-facing QC checklist for the final review and return to the Belgium CTIS hub for the full series.