Latvia Emergency Enrollment Consent Requirements

Conditions that must all be met

Conditional. The investigator may enroll before prior consent only when all Article 35 conditions are met:

• the person faces a sudden, life-threatening or other sudden serious medical condition
• because of urgency, prior informed consent from the participant and prior information cannot be obtained
• no legally designated representative is available to provide prior consent within the therapeutic window
• the participant has not previously expressed an objection to taking part
• the research relates directly to the medical condition causing the inability to consent
• the protocol defines a therapeutic window in which the investigational intervention must begin
• the trial poses minimal risk and minimal burden compared with standard treatment for the condition

The intervention under this route must be limited to the approved therapeutic window. The ethics assessment must accept the conditions and process before the pathway is used.

Latvia's current national Part II overview does not publish a separate national emergency-consent form. This does not reduce the EU conditions or the national patient-rights protections.

Documents to submit

Mandatory when emergency enrollment is planned. Explain the initial decision process in the protocol and version 2.0 Recruitment and Informed Consent Procedure template. Define who confirms eligibility, how prior objections and available representatives are checked, what is documented, and how quickly the subsequent-consent team is contacted.

Prepare Latvian documents for:

• concise initial information for a representative who becomes available within the window
• full subsequent information and consent for the participant after capacity returns
• full subsequent information and consent for the legally designated representative while the participant remains unable to consent
• optional continued follow-up or data and sample choices that are not covered by the emergency intervention

The blank documents are submitted unsigned in CTIS Part II. Operational logs or investigator checklists may be included when they help show that every condition will be documented.

Subsequent informed consent

After the emergency intervention, seek informed consent to continue participation without undue delay. If the participant can consent, obtain their own written consent. If they remain unable, seek consent from the legally designated representative. Provide all information required under Article 29 and explain what already occurred under the emergency pathway.

If the participant later regains capacity, ask them directly to consent to continued participation. Revisit optional secondary-use or sample choices rather than relying on the representative's decision.

The signed record should show who gave consent, the authority of any representative, the date and time, the person conducting the interview, and the version used. Give a copy to the participant or representative.

Refusal and withdrawal

If subsequent consent is refused, stop trial interventions that depend on consent and follow the protocol's withdrawal and safety arrangements. Explain which data collected before refusal may be retained or used under applicable law and the approved protocol. Do not promise automatic deletion of legally required safety or trial records.

An objection expressed before incapacity excludes the emergency route. An objection or withdrawal expressed after enrollment must also be respected. The investigator should document the decision and provide appropriate clinical care outside the research.

Check the complete document set with the Latvia patient-facing document QC checklist and return to the Latvia CTIS guide hub for standard, representative, minor, and witness-assisted consent routes.