France CTIS Part II Emergency Enrollment Consent Requirements

When emergency enrollment may be used

The pathway applies only when the participant faces a sudden life-threatening or other sudden serious medical condition and is unable to give prior informed consent or receive prior information. The investigator must need to make the enrollment decision and deliver the first trial intervention within the protocol's therapeutic window.

The investigator must have no knowledge of a prior objection to trial participation. A legally designated representative must not be available within the therapeutic window. If the representative can be contacted in time and can validly authorize participation, the emergency exception is not used.

There must be scientific grounds to expect that participation can produce a direct clinically relevant benefit for the participant, leading to a measurable health-related improvement that alleviates suffering or improves health, or to diagnosis of the condition.

The trial must relate directly to the condition causing the inability to consent and must be of such a nature that it can be conducted exclusively in emergency situations. Compared with standard treatment, it must pose only minimal risk and minimal burden to the participant.

Required submission documents

Mandatory. The protocol must define the emergency population, therapeutic window, Article 35 eligibility checks, decision maker, first intervention, benefit rationale, risk and burden comparison, documentation and later-consent process.

Mandatory. The French recruitment and informed consent procedure must reproduce the operational pathway. It should show how the investigator checks prior objection, representative availability and all other conditions before enrollment.

Mandatory. A French full participant information and consent document for use as soon as the participant can receive information and decide.

Mandatory. A French legal-representative information and authorization version for use when the participant remains unable to consent and a representative becomes available.

Recommended. A short French emergency information aid for any explanation that can be provided safely before or immediately after the first intervention. It does not replace the full later document or create an alternative legal test.

Recommended. A site checklist or source-note template recording the date and time of each Article 35 condition, the therapeutic window, representative contact attempts, the investigator's decision and the first intervention. This internal record is not a substitute for the participant-facing documents.

Conditional. Prepare a French genetic-testing information and consent form if later genetic examination is planned. Emergency enrollment does not automatically authorize optional genetic or future research.

Initial decision and documentation

The investigator should complete the eligibility and Article 35 assessment before the first trial intervention. Record objective facts, not only a statement that emergency consent applied. Include the participant's condition, reason prior information and consent were impossible, therapeutic-window timing, representative search, prior-objection check, direct-benefit basis and risk and burden assessment.

Do not use a witness as a replacement for an unavailable representative when the participant lacks capacity. The France impartial-witness pathway applies to a participant who can consent but cannot write, not to an unconscious or otherwise incapable participant.

Information and consent after enrollment

Provide the information required by Article 29 as soon as possible. Seek consent to continue from the participant without undue delay once capacity is available. If the participant remains unable, seek authorization from the legally designated representative without undue delay after that person becomes available.

The later document should explain that the participant was enrolled under the emergency pathway, what has already happened, what continued participation involves, foreseeable risks and alternatives, data and samples already collected, and the available choices now. Give a signed copy to the participant or representative.

If a representative initially authorizes continued participation and the participant later regains capacity, inform the participant and seek the participant's own consent. Do not wait for a routine annual update.

Later refusal or withdrawal

If the participant or representative refuses continued participation, stop further trial interventions and collections except for necessary safety care that is not dependent on trial consent. Explain the effect on follow-up, samples and data already collected.

Article 35 requires the participant or representative to be informed of the right to object to use of data obtained from the clinical trial when later consent is not given. Build that information and the site's escalation route into the French document. The effect of an objection must be assessed with the sponsor's regulatory and privacy teams under the Regulation and applicable law, not promised as automatic deletion of every record.

Respect any explicit refusal or withdrawal communicated by the participant. A later representative signature cannot override the participant's capable decision.

Signatures and dates

The CTIS documents are filed unsigned with planned fields. The later consent record is signed and dated by the participant or the valid legal representative and by the investigator or other person conducting the consent interview. Record when full information was provided, when capacity was assessed and when the decision was made.

The emergency source record should identify the investigator who made the Article 35 decision and the timing of the first intervention. It does not replace the later consent signatures.

France-specific position and templates

France has no mandatory national emergency-consent template. Article 35 of the Clinical Trials Regulation supplies the controlling conditions for a medicinal-product trial, while the French Public Health Code and the national Part II guidance inform the documentation and CPP review.

Describe the France route explicitly in the submitted recruitment and informed consent procedure. A general protocol sentence stating that deferred consent may be used is not enough. Run the set through the France patient-facing document QC checklist and return to the France CTIS hub for the full guide collection.