Romania CTIS Part II Emergency Enrollment Consent Requirements

Start with the main Romania consent requirements

Emergency enrollment is a variation of the Romania patient information and consent requirements.

Participant-facing documents used after the emergency should be in Romanian.

When deferred consent may be used

Conditional. Article 35 applies when the participant is in a medical emergency, the first trial-specific intervention must occur within a short timeframe, the participant cannot provide prior consent and a legally designated representative cannot be identified in time.

The trial must directly relate to the medical condition causing the emergency and there must be scientific grounds to expect a direct clinically relevant benefit for the participant.

The European Commission's current Q&A makes clear that deferred consent cannot be used merely because there is not enough time when the trial is not actually studying a medical emergency.

What Romania's national form asks for

The emergency section of the Romanian recruitment and consent procedure asks the sponsor to explain:

• why prior consent from the participant or legal representative cannot be obtained
• what procedure will be used to obtain informed consent from the participant or representative as soon as possible
• how the study will ensure that the participant has not previously objected to taking part

Complete these answers for the actual Romanian site workflow.

Initial enrollment logic

The protocol should make clear who decides that the emergency conditions are met and how that decision is documented.

If prior consent can be obtained from some patients but not others, the protocol may include a mixed pathway. It should explain why Article 35 is needed for the subgroup enrolled without prior consent.

Do not use the emergency pathway if prior consent can be obtained from all participants or their representatives.

Subsequent consent

Mandatory. After emergency enrollment. Informed consent should be sought without undue delay from the participant or legally designated representative, whichever can validly provide it first.

Document the efforts to obtain consent in the participant's medical record and source documents.

Once the participant can consent, provide the approved Romanian participant information and consent form and complete the normal consent interview.

Prior objection

A known prior objection to participation must be respected.

The European Commission Q&A gives examples such as a clearly documented objection in the medical record or other information known to the investigator. The Romanian national form asks the sponsor to explain how prior objections will be checked.

Later refusal or withdrawal

If the participant or representative later refuses continued trial participation, no further research data should be collected beyond what is lawfully permitted.

The current EU Q&A states that data already collected in compliance with Article 35 may remain in the trial. The participant documents should not promise automatic deletion of data already collected.

Signature logic

When subsequent consent is obtained, use the standard signature pathway. The consent is signed and dated by the person conducting the interview and by the participant or legally designated representative.

If the participant cannot write, add the Romania impartial-witness pathway.

If the participant lacks capacity beyond the emergency, also apply the Romania limited-capacity pathway.

Submission package

Prepare the protocol emergency-consent rationale, Romanian post-enrollment participant information and consent documents, the completed national recruitment and consent procedure and any representative or capacity-related documents that may be needed.

Use the Romania Part II checklist for the rest of the dossier and return to the Romania CTIS hub for related guides.