Ireland CTIS Emergency Enrolment Consent Requirements

When prior consent may be deferred

At the time of the first trial intervention, all Article 35 conditions must be met. In summary:

• the participant faces a sudden life-threatening or other sudden serious medical condition
• the urgency makes it impossible to obtain prior informed consent from the participant and impossible to give prior information
• no legally designated representative is available within the therapeutic window
• the participant has not previously expressed an objection known to the investigator
• the trial relates directly to the medical condition causing the emergency
• participation has the potential to produce a direct clinically relevant benefit for the participant
• the trial poses minimal risk and minimal burden compared with standard treatment for the condition

The protocol must define the emergency, therapeutic window, eligibility decision, attempt to locate a representative, first trial intervention and consent follow-up. NREC approval of that specific pathway is required.

Actions at enrolment

Record why prior consent was impossible, which Article 35 conditions were met, the time of the first intervention and the efforts made to identify a representative. Do not delay necessary clinical care to complete research procedures.

Give any information the participant can understand at that point. Respect a known prior objection and any current resistance that can be meaningfully expressed.

Obtain consent as soon as possible

After the intervention, seek informed consent without undue delay from the participant or from the legally designated representative, whichever can validly decide first. Explain:

• why enrolment occurred before consent
• what trial procedures and data collection have already occurred
• current risks, alternatives and possible benefits
• continued procedures and follow-up
• the right to refuse continued participation
• what happens to data and samples already collected

If a representative initially consents and the participant later regains capacity, obtain the participant's own consent promptly. A witness cannot act as the representative. See the impartial witness guide.

Irish data-protection route

Deferred consent to trial participation does not automatically authorise processing of health data. The Health Research Regulations contain a limited route linked to vital interests and deferred consent, subject to strict conditions. Where that route does not cover the proposed processing, a Health Research Consent Declaration Committee decision may be needed.

Resolve this before opening the site. Align the protocol, DPIA, NREC data statement, participant documents and HRCDC application or decision. State when processing begins, what is necessary before consent and what happens if consent is later refused.

Document set

Prepare:

• a protocol section and recruitment procedure defining the emergency pathway
• a short immediate information sheet where useful and feasible
• a full post-enrolment participant SIS and ICF
• representative information and consent documents
• participant re-consent documents for regained capacity
• a record of the emergency decision and attempts to obtain consent
• data-protection wording that matches the approved Irish route

Ireland has no dedicated mandatory national emergency-consent template. Use the EU recruitment and informed-consent procedure template and trial-specific patient and representative documents that NREC-CT can assess as one pathway.

Submission checks

• All Article 35 conditions are addressed, not selected individually.
• The first trial intervention and therapeutic window are unambiguous.
• The emergency population cannot practicably be studied with prior consent.
• The direct-benefit and minimal-risk and burden tests are supported.
• Representative searches and consent attempts are documented.
• Post-enrolment consent and participant re-consent are prompt.
• Refusal and withdrawal consequences are clear.
• The Irish data-processing safeguard is lawful and operational.
• Staff training and round-the-clock contacts are in place.

Return to the Ireland CTIS Part II guide hub for all national guides.