Slovenia CTIS Emergency Enrollment Consent Requirements

When emergency enrollment may be used

Conditional and exceptional. Article 35 requires all of the following:

• The participant faces a sudden life-threatening or other sudden serious medical condition.
• The urgency makes it impossible to obtain prior informed consent from the participant and impossible to provide prior information.
• A legally designated representative is not available within the therapeutic window.
• The investigator is not aware of a prior objection to trial participation expressed by the participant.
• The trial relates directly to the emergency condition.
• Participation has the potential to produce a direct clinically relevant benefit for the participant that improves health measurably, alleviates suffering, or improves diagnosis.
• The trial poses minimal risk and minimal burden compared with standard treatment for the condition.

If any condition is absent, obtain prior consent through the ordinary participant or legal-representative pathway. Convenience or recruitment feasibility cannot replace the legal test.

What the application must contain

The protocol and Part II package should define:

• the emergency condition and therapeutic window
• why prior participant and representative consent cannot be obtained
• how prior objections and advance information will be checked
• the intervention permitted before consent
• the risk and burden comparison with standard care
• the expected direct clinically relevant benefit
• who makes and records the enrollment decision
• how and when the participant or representative is approached afterward
• what happens after refusal or withdrawal
• handling of data and samples collected before the decision
• site training, round-the-clock availability, and oversight

KME RS performs the Part II ethical assessment. Do not wait until trial conduct to invent a deferred-consent process that was not reviewed.

Required patient-facing documents

Prepare in Slovenian:

• A concise emergency participant information sheet for use as soon as the participant can receive information.
• A subsequent participant consent form for continued participation.
• A legally designated representative information and consent form for use when the participant remains unable to consent.
• An information sheet explaining what occurred before consent and what choices now exist.
• Any withdrawal or data-use explanation needed if consent is refused.
• An impartial-witness section if a person can consent but cannot write.

Submit blank, versioned forms in CTIS Part II. Do not pre-sign them or use an ordinary adult ICF without emergency-specific explanation.

Initial enrollment and documentation

The authorised investigator should document the emergency, the timing, the failed possibility of prior consent, the absence of a known prior objection, how Article 35 criteria were satisfied, and the intervention performed. The record should allow later review without relying on memory.

Emergency clinical care takes priority. Trial procedures beyond the approved immediate pathway should not continue merely because initial enrollment occurred.

Subsequent information and consent

Provide information and seek consent to continue without undue delay from:

• the participant as soon as the participant can decide, or
• the legally designated representative when the participant remains unable to decide

Explain that enrollment occurred under the emergency pathway, what was done, known risks, possible benefits, alternatives, remaining procedures, data and sample use, and the right to refuse continued participation. Do not present continuation as automatic.

When the participant later regains capacity, provide current information and obtain the participant's own express consent even if a representative previously consented to continuation.

Consent and signatures

At CTIS submission, all participant-facing forms are blank.

During conduct, the participant or legally designated representative and the person conducting the interview sign and date the applicable approved consent record. Give a signed and dated copy. If the person can consent but cannot write, use the Slovenia impartial witness procedure.

Record the date and time carefully because the sequence of emergency intervention, information, and subsequent consent is central to compliance.

Later refusal or withdrawal

If the participant or representative refuses continued participation, stop further trial-specific intervention and follow-up except for safety actions that remain necessary and legally permissible. Explain which data must be retained for safety, regulatory compliance, and scientific integrity and which optional uses can stop.

Article 35 requires information about the right to object to the use of data obtained from the trial. The approved documents should explain that right accurately and avoid promising deletion that law or safety reporting does not allow.

Respect any later dissent from a participant who can form and express a view. A representative's earlier permission does not authorise continued procedures against an explicit refusal.

Slovenia-specific position

No additional Slovenia-specific CTIS emergency-consent form or broader national waiver was identified on the official JAZMP or KME RS pages. Apply Article 35 directly, use Slovenian participant documents, and align the pathway with the Patients' Rights Act and KME RS consent expectations.

KME RS's general instructions mention advance ethical approval only for urgent action in research outside the CTIS workflow. For a medicinal-product trial under the Clinical Trials Regulation, authorisation and the approved CTIS emergency pathway govern. Do not treat the general meeting process as a substitute for CTIS approval.

Return to the Slovenia CTIS hub for all Part II guides.