Spain CTIS Part II Impartial Witness Consent Requirements

When an impartial witness is appropriate

Conditional. Use the witness pathway when the participant can make an informed decision but is unable to read or write. The witness safeguards the information and consent process and records what occurred.

Do not use an impartial witness to substitute for a legally designated representative when the participant lacks capacity. Do not use it to avoid providing a translation or interpreter to someone who does not understand Spanish. Do not use it as the emergency-enrollment pathway.

The Spain main patient information and consent guide covers the standard document that remains the basis of the discussion.

Witness eligibility

Mandatory. The witness must be impartial and unrelated to the study. The person should have no role or interest that could influence the participant's decision or weaken the independence of the attestation.

Confirm that the witness can understand the information being given and can observe the full consent discussion. Record the witness's full name and role in the approved form.

A family member may be familiar to the participant but may not meet the required independence in every case. The site should select and document a person who meets the CEIm-approved eligibility criteria rather than assuming any companion is acceptable.

Documents to prepare

Mandatory. Spanish PIS. Use the same approved participant information as for a reader, with accessible explanations and enough time for questions. The participant should receive a copy.

Mandatory. Witnessed ICF. AEMPS Annex VIIIA provides a national “Informed Consent before witnesses” model. It records that the PIS was read to the participant, questions were allowed, enough information was received, participation was understood as voluntary and withdrawal remains possible.

Conditional. Interpreter documentation. If a separate interpreter is needed, define that role and documentation in the approved process. An interpreter is not automatically the impartial witness.

Submit blank Spanish versions in CTIS under “Subject information and informed consent form.” The forms are not signed at submission.

Conducting the consent discussion

A study staff member should read the PIS to the participant and review it in a way the participant can understand. Give the participant an opportunity to ask questions, speak with other people and take the time reasonably available for the decision.

The witness should be present for the information, discussion, questions and expression of consent. The witness is confirming the integrity of the process, not making the decision for the participant.

Confirm the participant's capacity and voluntariness. Record any accessible support used. If the participant can use another valid means to record consent, follow the approved procedure and AEMPS form.

Signatures and attestation

When consent is obtained, the witness and investigator sign and date the witnessed ICF. The AEMPS model asks the witness to attest that the participant was informed, the information was read, questions were possible, enough information was received and the participant freely agreed.

The model also uses the witness and investigator signatures for choices about receiving health-relevant research information or genetic findings when those choices apply. Do not let the witness choose on the participant's behalf. The witness records the participant's expressed decision.

Give the participant the PIS and a signed and dated copy of the witnessed ICF. Keep the original according to trial and site procedures.

Withdrawal and later document changes

The participant may withdraw at any time without a signed withdrawal form. If new information requires re-consent, repeat the witnessed process unless the participant can use the standard process at that time.

If the participant's ability to read or write changes, use the consent method that best supports their own decision. The witness pathway should not become a permanent label.

Spain-specific final check

Confirm that the protocol or consent procedure explains why a witness may be used, how the witness is selected and how consent is recorded. The Clinical Trials Regulation requires these details in the application when an impartial-witness procedure is planned.

Check the witness form against AEMPS Annex VIIIA and the exact optional choices in the main PIS. Use the Spain patient-facing document QC checklist before submission and return to the Spain CTIS guide hub for the full dossier.