Portugal Impartial Witness Consent Requirements

When the witness pathway applies

Conditional. Use an impartial witness when the person can consent but is unable to write. This may include a physical inability to sign or another barrier that prevents written consent despite decision-making capacity.

Do not use a witness to replace a capacity assessment. If the adult cannot provide informed consent, use the Portugal limited-capacity and legal-representative pathway.

Do not use a witness to replace the emergency exception. If prior consent cannot be obtained because of a serious immediate emergency, use the Portugal emergency enrollment pathway.

An interpreter and an impartial witness have different functions. A person who translates the discussion is not automatically suitable to attest the unable-to-write process. If one person is proposed for both roles, justify that the person remains impartial and can perform both functions accurately.

Witness eligibility

The EU Regulation requires the witness to be impartial. Select someone who is independent of the consent decision and has no interest that could influence the participant or the record. The witness must be able to understand the information and observe the full consent procedure.

Portugal has not published a separate national profession, nationality or relationship requirement for this witness. Do not invent one. The site should document why the selected person was impartial and comply with any protocol or CEIC condition.

Members of the study team who recruit, treat or assess the participant are poor choices because their role may undermine impartiality. A convenient signature from a person who did not observe the process is not acceptable.

Required documents

Mandatory. Submit the standard Portuguese PIS and ICF with an approved alternative-consent and witness section. The form should identify the reason the person could not write, the alternative means used to record consent, and separate fields for the participant or representative where possible, witness and interviewer.

Conditional. Provide accessible formats such as large print, audio, easy-read material or communication support when needed. The format must provide the same approved information and preserve a reliable consent record.

Recommended. Include a short witness attestation confirming that the information was accurately explained, questions were answered, the person appeared to understand and freely agreed, and the witness observed the entire process.

Portugal has no dedicated mandatory national witness form. Adapt the main document and describe the process in the EudraLex recruitment and informed-consent procedure template.

Consent procedure

1. Give the participant or representative the approved Portuguese information in an accessible form.
2. Explain the trial, answer questions and assess understanding and voluntariness.
3. Keep the impartial witness present throughout the relevant information and consent process.
4. Record consent through an appropriate alternative means when the person cannot write.
5. Have the witness sign and date the ICF.
6. Have the person conducting the consent interview sign and date the ICF.
7. Record the participant's mark or other confirmation when possible without turning it into an unsupported legal requirement.
8. Give the participant or representative a copy of the completed signed form.

Signatures must be made at the time of consent. The blank model submitted in CTIS is not signed by a participant, representative or witness.

What the witness attests

The witness attests to the integrity of the process, not to the medical suitability of the trial. The witness should not sign a statement claiming that the participant understood facts the witness could not observe or assess.

The attestation should match what occurred. If an interpreter was used, identify the interpreter separately and record the language. If a remote process is proposed, explain how the witness observed the complete process and how identities and signatures were verified.

Final review

Confirm that:

• the person has capacity to consent
• inability to write is documented without stigmatizing language
• the witness is impartial and present for the full process
• Portuguese information is provided in an accessible form
• witness, interviewer and participant or representative roles are separate
• the form records the alternative consent method
• signatures and dates are contemporaneous
• a signed copy is provided
• interpreter details are separate when applicable
• the procedure matches the protocol and CTIS description

Use the Portugal patient-facing document QC checklist before submission. Return to the Portugal CTIS hub for all guides.