Estonia CTIS Emergency Enrollment Consent Requirements

Start from the standard Estonia consent framework

Use the Estonia Patient Information and Consent Requirements guide for the ordinary consent process that applies as soon as consent can be sought.

Participant-facing materials used after the emergency intervention must follow Estonia's language rule and include the EU CT number.

When Article 35 can be used

Conditional. The emergency pathway may be used only when all Article 35 conditions are met.

The core conditions include:

• a sudden life-threatening or other sudden serious medical condition prevents prior consent and prior information
• the trial has the potential to produce a direct clinically relevant benefit for the participant
• prior information and consent from the legally designated representative cannot be obtained within the therapeutic window
• the investigator is not aware of a previously expressed objection by the participant
• the trial directly concerns the emergency medical condition and can only be carried out in emergency situations
• the trial adds only minimal risk and minimal burden compared with standard treatment of the condition

These conditions should be visible in the protocol and consent-procedure description. Do not rely on generic statements such as "consent is impossible in emergencies".

Part II documents to prepare

The EU Part II informed-consent and recruitment procedure template requires the sponsor to describe the emergency consent pathway.

Prepare:

• the procedure for identifying and documenting the emergency situation
• the reason prior participant consent is impossible
• the process for checking whether a legal representative is available within the therapeutic window
• the process for checking known prior objections
• the protective measures used before consent
• the participant information and consent document used after the intervention
• the legal-representative version where relevant
• the procedure for obtaining consent to continue
• the handling of refusal or withdrawal after initial enrollment

Estonia does not publish a separate national emergency-enrollment form in the official clinical-trial materials reviewed. Adapt the standard Estonia PIS/ICF and the EU Part II procedure to the protocol.

Consent after the first intervention

Mandatory. After an Article 35 emergency intervention, informed consent to continue must be sought without undue delay.

For an incapacitated participant or a minor, seek consent from the legally designated representative without undue delay and give the participant and representative the required information as soon as possible.

For other participants, seek consent without undue delay from the participant or legal representative, whichever is available first, and provide the information as soon as possible.

Once the participant can make the decision, the ordinary Estonia consent requirements apply.

Later refusal or withdrawal

A later refusal must be respected according to the Clinical Trials Regulation. The participant should not be presented with the post-emergency consent as a formality.

Explain what happens to treatment, follow-up and data already collected if consent to continue is refused. Keep this consistent with the protocol, applicable safety obligations and data-protection framework.

For minors or limited-capacity participants, also apply the relevant population rules:

• Estonia minor consent requirements
• Estonia limited-capacity and legal representative requirements

Signatures and documentation

When consent becomes possible, use the standard signed and dated informed-consent process.

Estonia allows legally valid digital signatures. If the post-emergency consent is obtained remotely, the national remote-consent requirements and prior ethics approval still apply.

Document the timing of the emergency intervention, why prior consent could not be obtained, when the participant or representative was informed, and when the ongoing-consent decision was recorded.

QC before submission

Confirm that:

• the protocol satisfies every Article 35 condition
• emergency identification is operational, not vague
• the representative search fits the therapeutic window
• later consent is sought without undue delay
• refusal and withdrawal are meaningful choices
• participant materials are in Estonian and include the EU CT number
• child or incapacity rules are layered on when relevant
• data and samples collected before later consent are handled consistently with the protocol and applicable law

Use the Estonia patient-facing QC checklist for the final document review.

Return to the Estonia CTIS hub for all Estonia guides.