Belgium Emergency Enrolment Consent Requirements

Conditions for enrolment before consent

The protocol may allow the first trial intervention before consent only when all of the following are satisfied:

• a sudden life-threatening or other sudden serious medical condition makes an urgent decision necessary
• the participant cannot provide prior informed consent and cannot receive prior information
• no legally designated representative is available within the therapeutic window
• the investigator is not aware of a prior objection to trial participation
• there are scientific grounds to expect a direct clinically relevant benefit for the participant, producing a measurable health improvement that alleviates suffering or improves health, or permits diagnosis
• the trial poses no more than minimal risk and minimal burden compared with the standard treatment for the condition

Do not use emergency enrolment to solve recruitment difficulty, delayed representative contact or an avoidable planning problem. Define the clinical window and the reason consent cannot wait.

Documents to submit

Mandatory. In the EU recruitment and informed-consent procedure template, describe the emergency trigger, capacity assessment, search for a representative, check for prior objections, eligibility decision, initial intervention, notification, later information and consent process.

Mandatory. Submit a participant information and subsequent-consent form for use when the participant regains capacity. Include permission for continued participation and clear options if the person refuses.

Mandatory. Submit a legally designated representative information and consent form for use when the representative becomes available before the participant can decide. Identify the Belgian representative hierarchy described in the limited-capacity consent guide.

Conditional. Prepare an age-appropriate and parent or guardian pathway if minors may be enrolled. Article 35 does not remove the minor safeguards in Article 32.

Provide every patient-facing form in the official language or languages of the Belgian trial region. Submit the blank documents in Part II and identify their version and purpose clearly.

Initial enrolment and documentation

The investigator should document the acute condition, incapacity, time pressure, representative search, absence of a known objection and why the protocol's benefit and minimal-risk conditions apply. The record should identify who made the decision and the exact intervention performed before consent.

Routine emergency care follows clinical law and standards. Trial enrolment is a separate decision and must remain within the authorised Article 35 pathway. A general emergency-treatment rule is not permission to conduct research.

Subsequent information and consent

Give the participant or legally designated representative the approved information as soon as possible after the intervention. Seek consent without undue delay for continued participation and for any further trial procedures. If the participant later becomes capable, the participant's own decision replaces representative permission for continued participation.

The consent discussion should explain what already occurred, why prior consent could not be obtained, what data and samples were collected, what further activities are proposed and what choices remain. Do not write the form as if consent had preceded enrolment.

Later refusal or withdrawal

If the participant or representative refuses continued participation, stop further trial interventions and follow the protocol's withdrawal and safety provisions. Explain which data collected before refusal may still be used under the Clinical Trials Regulation and applicable data-protection law. Do not imply that later refusal can undo an intervention already performed.

Document the decision and provide appropriate medical care. A refusal must not prejudice the person's right to treatment outside the trial.

Final emergency-pathway checks

• Confirm that every Article 35 condition appears in the protocol and consent procedure.
• Define the therapeutic window and the representative-search process.
• Include participant, representative and minor versions where applicable.
• Distinguish emergency clinical care from the research intervention.
• Use regional participant languages and blank forms at submission.
• Build rapid later information, consent, refusal and withdrawal steps into site training.
• Confirm that optional future use is not bundled into deferred consent.

Use the Belgium patient-facing QC checklist before submission. Return to the Belgium CTIS hub for the connected guides.