Italy emergency-enrolment consent requirements

Conditions that must all be met

The urgent need for the intervention must arise from a sudden life-threatening or other serious medical condition. Because of that condition, the participant must be unable to give prior informed consent and unable to receive prior information.

There must be scientific grounds to expect that participation can produce a direct clinically relevant benefit for the participant. The investigator must not know of a prior objection to trial participation.

The trial must relate directly to the condition causing the emergency and be of a kind that can only be conducted in emergency situations. It must pose minimal risk and minimal burden compared with the standard treatment of the condition.

If the participant can decide, or a legally authorised representative can be reached without compromising the required treatment window, obtain prior consent. Do not use deferred consent merely because the normal process is inconvenient or the site is busy.

Protocol and CTIS description

Define the emergency condition and the intervention window. Explain why prior consent and information will ordinarily be impossible in that window. Identify the clinical evidence supporting expected direct benefit and the basis for minimal additional risk and burden.

Describe how the investigator checks for a known prior objection, attempts to identify and contact a legal representative and records why prior consent was not possible. Set a maximum time and escalation process for seeking later consent.

The recruitment and informed-consent procedure should match the protocol exactly. Include scripts or short emergency information for a representative who can be reached in time, plus the full deferred-consent documents for use after enrolment. The ethics committee must approve the pathway before it is used.

Immediate documentation at enrolment

Record the participant's emergency condition, incapacity, time-critical window, absence of a known prior objection, representative-search steps and the investigator's determination that Article 35 conditions were met. Record the intervention time and the first practical opportunity for later information.

Do not fabricate a participant or representative signature for the emergency moment. The legal basis is the approved Article 35 pathway and contemporaneous evidence that all conditions were satisfied.

Seek consent without undue delay

After the emergency intervention, provide the full approved information and seek informed consent without undue delay. Approach the legal representative while the participant remains unable to decide. When the participant becomes capable, inform the participant and obtain their own consent for continued participation.

Explain the emergency enrolment, procedures already performed, data and samples already collected, remaining activities, risks, alternatives and right to refuse further participation. Give time for questions and provide a signed copy.

If a representative initially consents and the participant later recovers capacity, do not rely indefinitely on representative consent. Obtain the participant's own decision. Use the limited-capacity and legal-representative guide for authority and re-consent checks.

Refusal, withdrawal and data already collected

Respect a later refusal or objection. Stop future trial-specific intervention and new data collection except for immediate safety measures or another lawful, approved basis. Explain any safety follow-up needed after the intervention.

Current EU guidance recognises that data already collected under a valid Article 35 emergency pathway may be retained when required for trial integrity and regulatory obligations, even if later consent is not obtained. The site must have made the later-consent effort without delay. Do not use this rule to justify avoidable delay or continued optional collection.

The participant or representative must be told about the right to object to use of data and about the practical limits that apply after lawful emergency collection. Align the wording with the separate privacy notice.

Death before consent can be sought

The protocol and ethics submission should explain how data are handled if the participant dies before consent can be sought. Follow the approved Article 35 pathway, GDPR roles, Italian law and the ethics opinion. Do not add a next-of-kin signature as a substitute unless that person is legally authorised and the approved process requires it.

Keep the explanation sensitive and separate bereavement communication from any research request. Limit collection to what the approved protocol and lawful basis permit.

Samples and optional research

Emergency authority should cover only the protocol procedures justified by Article 35. It does not create broad permission for optional biobanking, future genetics or unrelated secondary research. Seek separate consent before optional future use when the participant or representative can decide.

If a sample is required for the time-critical intervention, describe its immediate purpose and later-consent process. Use the secondary-use consent guide for any storage or future research choice.

Site readiness

Train emergency, intensive-care, pharmacy, laboratory and research staff before activation. Provide a short eligibility checklist, time-stamped documentation, representative-search instructions and twenty-four-hour escalation contacts. Simulate the process so treatment is not delayed by research paperwork.

Audit the first emergency enrolments promptly. A missed Article 35 condition is a consent and trial-compliance issue, not a clerical deviation.

Use the main patient information and consent guide and patient-facing QC checklist. Return to the Italy CTIS guide hub.