Portugal Emergency Enrollment Consent Requirements

Conditions for enrollment without prior consent

Conditional. Emergency enrollment may be used only when all of the following are satisfied:

• the participant faces a grave or immediate risk to life or physical integrity
• it is not possible to obtain the participant's informed consent in time
• it is not possible to obtain timely consent from the legally authorized representative
• the research is directly related to the emergency condition
• the research cannot be carried out outside the emergency setting
• the protocol and emergency pathway were approved in advance by the competent ethics committee
• additional risks and burdens are minimal
• there is a well-founded expectation of direct benefit for the participant
• informed consent is obtained as soon as possible

The Portuguese conditions operate with Article 35 of the EU Clinical Trials Regulation. Do not use deferred consent merely because the recruitment window is short, the representative is inconvenient to contact or the ordinary form is long.

Documents to prepare

Mandatory. Describe the emergency pathway in the protocol. Define the medical emergency, objective eligibility criteria, why prior consent cannot be obtained, the expected direct benefit, the minimal additional risk and burden, and the process for seeking a representative.

Mandatory. Describe the pathway in the EudraLex recruitment and informed-consent procedure template. State who confirms that the conditions are met, what is recorded, how quickly the participant or representative is approached and who conducts subsequent consent.

Mandatory. Prepare a full Portuguese PIS and ICF for prompt subsequent consent. It should explain that enrollment already occurred, why prior consent was not possible, what was done, current choices, ongoing procedures, data, samples, withdrawal and safety follow-up.

Conditional. Prepare a Portuguese representative version if the participant may remain unable to consent. Prepare a direct adult form for participants who recover capacity. Add age-specific forms if minors are eligible.

Recommended. Prepare a short approved emergency information sheet that can be given when full discussion is temporarily impossible. It does not replace the later full consent process.

Portugal has no separate mandatory national emergency-consent template. The trial-specific documents and procedure must be submitted for CEIC assessment.

Initial enrollment record

At enrollment, record the emergency facts and the legal basis for proceeding. Include the participant's condition, time, efforts to identify or contact a representative, the investigator's assessment of each criterion, intervention timing and the persons involved.

The investigator should not ask clinical staff to make an undocumented assumption that consent was impossible. The record must support later oversight and the subsequent discussion.

Subsequent consent

Mandatory. Seek informed consent as soon as possible from the participant if capacity is available. If not, seek consent from the legally authorized representative. When the participant later regains capacity, provide the approved information and obtain the participant's own written informed consent to continue.

Explain what occurred before consent, what further participation involves and what choices remain. The participant or representative and the person conducting the interview sign and date the appropriate ICF. Give them a signed copy.

Do not present continued participation as automatic. Allow questions and enough time for the decision once the emergency permits it.

Later refusal or withdrawal

If consent is refused or later withdrawn, stop prospective research interventions subject to immediate clinical safety needs. Explain what data must remain in the trial record, what further safety information may be collected and what happens to stored samples.

Do not promise automatic deletion of data already required for safety, scientific integrity or regulatory duties. Optional future use can be refused or withdrawn separately under its own consent and Portuguese sample rules.

Relationship with other pathways

If the participant is a minor, apply the Portugal minor consent and assent guide as soon as the emergency permits. If an adult remains unable to consent, apply the Portugal limited-capacity guide.

An impartial witness cannot authorize emergency enrollment. The witness pathway applies when the participant or representative can consent but cannot write. See the Portugal impartial witness guide.

Final review

Confirm that:

• every Portuguese and EU emergency condition is stated in the protocol
• the direct-benefit and minimal-additional-risk tests are justified
• CEIC approves the exception before enrollment
• efforts to obtain prior consent are recorded
• the investigator records each emergency enrollment decision
• Portuguese subsequent-consent forms exist for all likely pathways
• consent is sought as soon as possible
• later refusal stops prospective research
• data and sample wording distinguishes withdrawal from mandatory retention
• the emergency pathway matches the protocol, CTIS and site procedure

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