Finland Emergency Enrollment Consent Requirements

This is a variation of the main consent set

Use the Finland Patient Information and Consent Requirements guide for the ordinary information, privacy, insurance and signature content. The emergency variation changes timing and creates a later-consent sequence. It does not reduce the information that must ultimately be provided.

Conditional. Use Article 35 only when every regulatory condition is built into the protocol and approved. Poor planning, investigator availability or a short recruitment opportunity is not an emergency situation under the Regulation.

Conditions for enrollment before consent

All of the following must apply:

• a sudden life-threatening or other sudden serious condition makes the participant unable to receive information and consent beforehand
• a direct, clinically relevant benefit is scientifically expected for that participant
• the legal representative cannot receive all information and consent within the therapeutic window
• the investigator is not aware of a previously expressed objection to trial participation
• the trial relates directly to the condition causing the emergency and can only be conducted in emergency situations
• the trial presents minimal risk and minimal burden compared with standard treatment for the condition

The decision to include the participant is made at the time of the first intervention and in accordance with the approved protocol.

Required Part II documents

Prepare:

• a Finnish and/or Swedish description of the emergency recruitment and consent procedure
• a method for identifying, confirming and documenting the urgency and therapeutic window
• the participant information sheet and consent form used as soon as the participant can decide
• the legal-representative information sheet and consent form used when the representative is available first
• age-appropriate documents for minors when relevant
• adapted documents for adults with reduced capacity when relevant
• staff instructions that distinguish trial documentation from urgent clinical care

Complete the current EU Recruitment and Informed Consent Procedure template and explain the Finland-specific roles, timing and records. Submit blank documents. They are not signed at CTIS submission.

Initial enrollment and documentation

The source record should show the sudden serious condition, why the participant could not be informed, why the representative could not be reached in time, the therapeutic window, the direct-benefit basis, the investigator's check for prior objections and the time of the first intervention.

Do not create a consent form that retrospectively states the participant consented before enrollment. Record the lawful emergency inclusion separately, then use the approved later-consent form for continuation.

Information and consent after the intervention

For a minor or adult with reduced capacity, the investigator seeks representative consent without undue delay and provides information to both representative and participant as soon as possible.

For another adult, the investigator seeks consent without undue delay from the participant or representative, whichever can decide sooner. If the representative consents first, obtain the participant's own consent as soon as the participant becomes capable.

The later discussion must cover the intervention already performed, ongoing participation, risks, alternatives, follow-up, data and sample handling, compensation and the right to refuse continued participation. The participant or representative and the person receiving consent sign and date the approved form.

Later refusal or withdrawal

If the participant or representative does not consent to continued participation, stop further trial-specific activities except measures needed for safety or lawful data handling. Inform the person of the right to object to use of data already obtained in the emergency phase.

The approved documents and protocol should explain how the site records an objection and what data can still be retained under applicable law. Do not promise deletion that conflicts with safety, legal or scientific-integrity duties.

Finland's Article 30 simplified cluster-consent route is not available. Do not confuse non-objection in a cluster trial with emergency inclusion under Article 35.

Use the Finland limited-capacity consent guide or minor consent guide when those populations are included. Run the final package through the Finland patient-facing document QC checklist and return to the Finland CTIS hub.