Portugal Limited-Capacity and Legal Representative Consent Requirements

When this pathway applies

Conditional. Use the pathway only when the adult is unable to give informed consent and did not give or refuse consent before the incapacity began. A diagnosis alone does not establish incapacity. The investigator must assess the person's ability to understand, retain, weigh and communicate the trial decision in the relevant context.

If the person can provide valid consent with reasonable communication support, use direct participant consent. Do not replace the participant's decision with representative consent for convenience.

The trial must satisfy Article 31 of the EU Regulation. This includes a sound scientific reason for involving the population, minimized risk and burden, and the required prospect of benefit or permitted group benefit.

Required documents

Mandatory. Prepare a Portuguese participant information document adapted to the person's cognitive and communication abilities. Explain the immediate procedures, discomfort, choices and right to object in a form the person can understand.

Mandatory. Prepare a Portuguese representative PIS and ICF. Explain the representative's role, the basis for including adults unable to consent, expected benefit, risks, alternatives, withdrawal, data, samples and what happens if capacity changes.

Conditional. Provide communication aids, easy-read material, supported-decision tools or an impartial-witness section when needed. A witness records an unable-to-write consent process. A witness does not replace the representative.

CEIC has no dedicated mandatory national limited-capacity template. Adapt the approved main document and record the legal pathway in the recruitment and informed-consent procedure.

Legal representative and consent process

Portuguese law defines a legally authorized representative as the person, entity or body empowered under applicable law to consent for an incapacitated person or minor. Verify and document the authority before consent. Do not assume that a relative automatically has authority.

The representative and the person conducting the interview sign and date the ICF. Give the representative a signed copy. The participant's information, behavior and expressed preferences remain part of the process.

The representative must decide for the participant within the legal and ethical framework, not according to the representative's own interest. Explain conflicts of interest and contact CEIC if the authority or decision is uncertain.

Participant information, assent and objection

Provide information that matches the participant's capacity. Invite questions and allow enough time. Record the participant's affirmative willingness when it can be expressed, even though the formal authorization comes from the representative.

Respect an explicit wish to refuse participation or withdraw. Do not use representative consent to override the participant's objection. Distinguish transient distress during a necessary clinical procedure from a sustained objection to research and document the investigator's assessment.

Adults in institutional placement

Portuguese law generally excludes an adult unable to consent who is in institutional placement. Enrollment is possible only when nonparticipation would cause a potential prejudice or disadvantage to that person.

In that narrow situation, representative consent must be given in coordination with the treating physician and the responsible investigator must participate in the process. Explain the justification in the protocol and the consent procedure. Obtain CEIC approval before using the pathway.

Recovery or loss of capacity

Mandatory. If the participant regains capacity, provide the approved adult PIS and obtain direct written informed consent for continued participation. Do this promptly and before further non-urgent trial procedures where possible.

If a directly consenting participant later loses capacity, follow the protocol, the participant's prior decision, the EU Regulation and Portuguese law. Do not automatically seek replacement consent that contradicts an earlier refusal or unsupported prior wishes.

Withdrawal and later refusal

The participant's objection or the representative's withdrawal stops prospective participation subject to necessary immediate safety care. Explain how already collected data are retained for trial integrity and legal duties. Handle optional samples and future use according to the separate consent and Portuguese sample law.

Use the Portugal secondary-use consent guide when future research is proposed.

Final review

Confirm that:

• incapacity is assessed for the actual decision
• representative authority is verified and recorded
• the participant receives understandable Portuguese information
• participant objection is respected
• the EU conditions for research with incapacitated adults are documented
• institutional placement is handled only under the Portuguese exception
• the treating physician and investigator roles are clear where required
• direct written re-consent is planned if capacity returns
• optional future use is separate from main participation
• the submitted models are blank and correctly versioned

Use the Portugal patient-facing document QC checklist before submission. Return to the Portugal CTIS hub for the complete guide series.