Spain CTIS Part II Emergency Enrollment Consent Requirements

Start with the main Spanish PIS/ICF

Participants still need the full information required for the trial. The difference is the timing and the person able to decide at the emergency moment. The Spain main patient information and consent guide covers the content that should be adapted for the subsequent consent discussion.

All participant and representative documents submitted for Spain should be in Spanish. Upload blank approved forms in CTIS. Signatures are obtained only when the emergency or later consent procedure reaches the applicable stage.

When enrollment without prior consent may be used

Conditional. The participant must be in a sudden life-threatening or other sudden serious medical condition that makes prior information and consent impossible. A legally designated representative must also be unavailable within the therapeutic window.

The investigator must not know of any prior objection to trial participation. There must be scientific grounds to expect a direct clinically relevant benefit for the participant, such as measurable improvement, alleviation of suffering or better diagnosis. The trial intervention must pose no more than minimal risk and minimal burden in comparison with the standard treatment for the condition.

The need to administer the investigational medicinal product within the emergency window must justify the pathway. Operational convenience, recruitment pressure or a slow representative search is not enough.

Spain's family-consultation rule

Mandatory when circumstances permit. Before enrollment, consult people connected to the participant by family or factual relationship whenever the emergency allows it. This consultation does not replace legally valid informed consent, but it helps identify the participant's prior wishes and relevant objections.

The protocol should define who will be contacted, how much time may be used without compromising care and how the attempt and outcome are documented.

Documents to prepare

Mandatory. Emergency enrollment procedure. Describe the medical trigger, therapeutic window, decision-maker, absence of prior objection, representative search, family consultation, investigator confirmation, enrollment record and subsequent consent process. The same logic must appear consistently in the protocol and Part II consent procedure.

Conditional. Short initial information. When the participant or family can receive some information without delaying necessary care, provide an approved concise explanation. Do not present it as full consent when the person cannot make the decision.

Mandatory. Subsequent participant PIS/ICF. Prepare a Spanish document that explains the trial, why enrollment occurred before consent, what intervention and data collection already occurred, what continued participation involves and the available choices.

Conditional. Representative PIS/ICF. Prepare a version for a legally designated representative when the participant remains unable to consent after enrollment.

Mandatory. Refusal and data-objection information. Explain what happens if the participant or representative does not consent or ratify participation. They must be told of the right to object to use of data obtained in the trial.

Spain publishes no separate national emergency-consent template. Adapt AEMPS Annex VIIIA and make the emergency sequence explicit.

Enrollment decision and documentation

The investigator should document how each legal condition was met before the trial intervention. Record the emergency, inability to consent, lack of an available representative, prior-wish check, family consultation where possible, expected direct benefit and risk and burden assessment.

Keep the clinical decision and trial enrollment decision distinct. The emergency pathway cannot reduce the participant's standard of care or delay urgent treatment.

Information and consent as soon as possible

Mandatory. Inform the participant or legally designated representative as soon as possible after enrollment. Obtain consent to continue where continued participation is proposed, and obtain ratification of the participation already initiated in every case where the Spanish rule requires it.

Give enough time for questions and provide the full Spanish PIS/ICF. Explain which study activities have already happened, which remain optional, whether study treatment continues and what safety follow-up is recommended even if further participation is refused.

When the participant regains capacity, their own decision governs continued participation. Do not rely on representative consent after the participant can decide.

Later refusal or withdrawal

If the participant or representative does not consent, stop non-essential trial procedures and follow the approved safety and data plan. Explain the right to object to use of data obtained under the emergency enrollment.

If consent is initially given and later withdrawn, apply the ordinary withdrawal rules. A signed revocation document is not mandatory. Distinguish required safety follow-up from optional research activities.

Consent and signature logic

At CTIS submission, all forms are blank. When later consent is obtained, the participant or legally authorised representative and investigator sign and date the appropriate Spanish ICF. Give the signer a signed and dated copy.

The emergency enrollment record is completed by the investigator according to the approved procedure. It does not substitute for the later consent form.

Spain-specific final review

Confirm that the protocol, Part II procedure, PIS/ICF, representative form and investigator record use the same eligibility conditions and timeline. Confirm that the emergency plan covers minors or adults unable to consent if either population is eligible.

Use the Spain limited-capacity and legal representative guide for the non-emergency representative pathway and the Spain patient-facing document QC checklist for final review. Return to the Spain CTIS guide hub for the complete country dossier.