Croatia emergency enrollment consent requirements

Conditions for enrollment without prior consent

Conditional. Enrollment before consent may be used only when all of the following are satisfied:

• The participant cannot give prior informed consent or receive prior information because of a sudden life-threatening or other sudden serious medical condition.
• There are scientific grounds to expect direct clinically relevant benefit for the participant, producing measurable health improvement, alleviating suffering, or improving diagnosis.
• It is impossible within the therapeutic window to provide the information and obtain prior consent from the participant's legally designated representative.
• The investigator is not aware of a prior objection by the participant to joining the trial.
• The trial relates directly to the medical condition causing the emergency and can be conducted only in emergency situations.
• The trial poses minimal risk and minimal burden compared with standard treatment of the participant's condition.

If one condition is missing, do not use emergency enrollment. A protocol cannot broaden the legal exception by calling a planned procedure urgent.

Croatia-specific initial decision logic

Central Ethics Committee guidance describes a local sequence for a person who cannot consent at that moment. Consent should first be sought from a parent, guardian, or legally appointed representative if the person has one and that person can be contacted. If that is not possible, a family member who is present may act in the described pathway. If none of those options is possible, the investigator may make the decision when the investigator is also the treating physician.

This national guidance must be read together with Article 35. The presence of a family member does not remove the need to show that the Article 35 conditions and approved protocol are satisfied. Describe the decision-maker's role, authority, and order precisely in the Part II recruitment and consent procedure.

Do not confuse a treating physician's emergency decision with informed consent. It is a temporary enrollment decision under an approved emergency pathway, followed by the required information and consent process as soon as possible.

Documents to submit

Mandatory for an emergency-consent protocol. Submit a detailed emergency enrollment procedure. It should define the qualifying condition, therapeutic window, direct-benefit basis, minimal-risk and minimal-burden assessment, prior-objection check, representative and family-contact attempts, treating-physician role, documentation, timing, and escalation.

Mandatory. Submit the Croatian participant informed consent to be used when the participant can receive information and decide. Submit a separate Croatian representative document for cases in which the participant remains unable to consent. These are blank, versioned, and dated at CTIS submission.

Recommended. Include an approved short initial information script or sheet for any information that can be given during the emergency without delaying necessary treatment. It must not imply that full consent was obtained.

Conditional. Add child assent and parent or guardian documents if minors may be enrolled. Add pregnancy follow-up, optional sample, genetics, caregiver, or third-party documents if those activities are part of the protocol.

Information and subsequent consent

Provide full information and seek consent as soon as possible after the immediate emergency. If the participant regains capacity, seek the participant's own consent for continued participation. If the participant remains unable to decide, seek consent from the legally designated representative according to the approved process.

The physician or dentist conducting the consent interview and the participant or representative sign and date the paper document. Record the exact sequence, including initial emergency enrollment, contact attempts, recovery of capacity, provision of information, and signature.

Routine electronic consent is not permitted under current Croatian guidance. An emergency does not convert an electronic acknowledgement into permanent consent. Obtain the in-person paper consent at the first possible opportunity.

Later refusal or withdrawal

The participant or representative may refuse continued participation after receiving the information. Stop future trial interventions and follow the approved withdrawal and safety process. Do not frame continued treatment, data use, or sample use as automatic.

Explain what happens to data and samples collected before refusal. The consent and protocol should distinguish information needed for safety and legal record integrity from optional future research. Give the participant or representative the choices and rights that remain available.

A known prior objection prevents emergency enrollment. Build a practical check into the site procedure, including available records, advance directives where relevant, and information from people present, without delaying necessary clinical care.

Consent signatures and impartial witnesses

If the participant regains decision-making ability but cannot write, use an impartial witness in the later consent process. The witness pathway does not authorise the original emergency enrollment. It only records valid later consent from a capable person who cannot provide a written signature. The Croatia impartial witness guide explains the distinction.

If the participant does not regain capacity, use the correct legal representative. A family member present during the emergency is not automatically the legally appointed representative for ongoing consent.

Croatia-specific final checks

• Every Article 35 condition is addressed in the protocol and Part II procedure.
• The therapeutic window and reason prior consent is impossible are trial specific.
• The local representative, family member, and treating-investigator sequence is described.
• Prior objections are checked and respected.
• The initial enrollment decision and later informed consent are not conflated.
• Croatian participant and representative documents are ready before recruitment begins.
• Exact dates, times, contact attempts, decision-maker, capacity changes, and signatures can be documented.
• Later refusal stops future participation and triggers the approved data and sample process.
• Minor, pregnancy, sample, and witness variations are added when applicable.

Return to the Croatia CTIS hub for the complete guide collection.