Norway CTIS Emergency Enrollment Consent Requirements

Conditions for enrollment before consent

Conditional. Enrollment before prior consent may occur only when all Article 35 conditions are met:

• a sudden life-threatening or other sudden serious condition prevents the participant from receiving information and consenting
• the legally designated representative cannot receive all information and consent within the therapeutic window
• participation is expected to provide a direct, clinically relevant benefit to the participant
• the investigator is not aware of a prior objection to research participation
• the trial relates directly to the emergency condition and can be conducted only in emergency situations
• the trial adds only minimal risk and burden compared with standard treatment for that condition

Document how the investigator confirms these points at the first intervention. Do not substitute a witness for a missing participant or representative when the Article 35 conditions are not met.

Documents to submit in Part II

Prepare the Norwegian documents needed for the full sequence:

• information and consent for a participant who later becomes able to consent
• information and consent for the legally designated representative of a minor or incapacitated participant
• age- or capacity-adapted participant information where relevant
• the REK KULMU Norwegian information form on the right to object to use of data if later consent is not given
• a recruitment and informed consent procedure describing timing, responsibilities, documentation and escalation

Submit blank, version-controlled documents in CTIS. The protocol and procedure should identify who makes the emergency-enrollment decision, what is recorded, how the representative is located and how the team seeks consent without delay.

Consent after the emergency intervention

Mandatory after enrollment. For a minor or incapacitated participant, the investigator must seek consent from the legally designated representative without undue delay and give information to both representative and participant as soon as possible.

For other participants, seek consent without undue delay from the participant or representative, whichever becomes available first. If a representative first consents, obtain the participant's own consent to continue as soon as the participant becomes capable.

The participant or representative and the person conducting the consent interview sign and date the applicable approved form when consent is obtained. Give them a copy.

Later refusal, withdrawal and data objection

If the participant or representative refuses consent after the emergency intervention, stop further trial participation that depends on consent. Explain the right to object to use of data already obtained. Use the REK KULMU reservation-right template for this specific Article 35(3) situation.

Do not promise automatic destruction of all previously collected information. Explain the applicable data-handling rules accurately and distinguish withdrawal from continued intervention, safety reporting, legally required retention and optional follow-up.

Norway operational checks

All participant-facing forms used for the Norwegian pathway must be in Norwegian. The standard national requirements for comprehensible language, privacy, realistic research dates, biological samples, insurance and contacts still apply.

Use the Norway limited-capacity consent guide or minor consent and assent guide where those populations are included. Review the full document set against the Norway patient-facing QC checklist. Return to the Norway CTIS hub for all guides.