Greece Emergency Enrollment Consent Requirements

Conditions for use

Conditional. Emergency enrollment may be used only when all applicable Article 35 conditions are satisfied:

• the participant cannot provide prior informed consent because of a sudden life-threatening or other sudden serious medical condition
• the participant has not previously expressed an objection known to the investigator
• the investigator cannot obtain prior consent from a legally designated representative within the therapeutic window
• the trial relates directly to the medical condition causing the emergency
• the intervention has a scientifically supported potential to provide a direct clinically relevant benefit to the participant
• the trial presents no more than minimal risk and minimal burden compared with standard treatment of the condition, as Article 35 requires
• the protocol and Part II documents describe the emergency process and later consent

Do not use operational inconvenience, nighttime staffing, recruitment pressure or inability to contact a preferred family member as a substitute for the Article 35 test.

Greece's emergency representative rule

For Article 35 only, Greek law expands the person who may act as the participant's legally designated representative beyond the ordinary minor or court-support rules. Consent may be sought from the spouse, a partner under a civil partnership, adult descendants, ascendants or siblings. The person from these groups whose informed consent can be obtained most quickly may act for the emergency pathway.

This special definition is limited to emergency enrollment. It should not be reused for ordinary consent by an adult under court-appointed support.

Documents to prepare

Mandatory. Describe the emergency identification, eligibility confirmation, prior-objection check, representative search, enrollment authorization and documentation steps in the EU Recruitment and Informed Consent Procedure template.

Mandatory. Prepare a Greek participant information and subsequent-consent form for a participant who regains the ability to decide.

Mandatory. Prepare a Greek emergency representative information and consent form for use when an eligible representative becomes available before the participant can consent.

Recommended. Prepare a short source-document worksheet for the site to record the emergency condition, therapeutic window, why consent was impossible, attempts to identify a representative, the absence of known prior objection, the person authorizing enrollment under the protocol, and the time of intervention. This worksheet supports conduct records and is not automatically a separate CTIS submission document.

At submission, patient-facing forms are blank and unsigned. Include future fields for the participant or emergency representative, the investigator or authorized team member, full dates and times where timing affects compliance.

Initial enrollment and later consent

The protocol should identify who confirms Article 35 eligibility and how the decision is recorded. Treatment must not be delayed by steps that are not required for participant protection, but the emergency exception must be documented contemporaneously.

As soon as possible after the intervention, provide the required information and seek informed consent for continued participation from the participant or the legally designated representative. If the participant regains capacity, the participant's own decision controls. Provide a signed copy under the Greek paper-consent process.

Explain what has already occurred, what further procedures are proposed, what data and samples have been collected, available alternatives, and the right to refuse further participation. Do not present the completed emergency intervention as creating an obligation to continue.

Later refusal or withdrawal

If later consent is refused, stop further trial-specific interventions and follow-up that lack another lawful and ethically approved basis. Provide clinically appropriate care. Explain how data and samples already obtained will be handled under the CTR, the protocol and applicable privacy rules.

Record the refusal and any safety information that must still be retained. Avoid promising deletion of safety data that the sponsor is required to preserve.

Special populations

If the emergency participant is a minor, apply the pediatric protections and move to the child and parental pathway as soon as possible. See the Greece minor guide.

If the participant is under court-appointed support, use the ordinary judicial supporter when available and respect the participant's own capable objection. See the Greece limited-capacity guide.

Return to the Greece CTIS guide hub and use the Greece patient-facing QC checklist before submission.