Germany CTIS Emergency Enrollment Consent Requirements

When emergency enrollment may be used

All Article 35 conditions must be satisfied at the moment of enrollment:

• the person is unable to give prior informed consent and unable to receive prior information because of a sudden life-threatening or other sudden serious medical condition
• a legally designated representative is not available within the therapeutic window
• the investigator is not aware of any prior objection by the person
• the research relates directly to the medical condition causing the impossibility of consent
• the trial cannot be conducted within the therapeutic window by first obtaining consent from the person or representative
• there are scientific grounds to expect a direct clinically relevant benefit for the person
• participation creates no more than minimal risk and minimal burden compared with standard treatment for the condition

The protocol and Part I justification must support these conclusions. Part II must show how the site will apply them to individual enrollment decisions.

Required Part II documents

Emergency recruitment and initial enrollment procedure

Mandatory. In K1, explain the emergency condition, therapeutic window, capacity check, representative search, prior-objection check, investigator certification, enrollment decision, documentation, and escalation process.

State who may make the enrollment decision at each site and how round-the-clock investigator availability is assured.

Later participant information and consent

Mandatory. Submit a German information and consent document for the participant if capacity returns. Explain the intervention already performed, continued participation, follow-up, data and samples already collected, future procedures, withdrawal, and the right to object to use of trial data.

Later legal-representative information and consent

Mandatory when the participant remains unable to consent. Submit a German representative document that supports the consent required without undue delay after enrollment.

Short immediate information

Conditional. A short staged-information document may help when the person or representative can receive limited information before the full process. It does not replace the Article 35 conditions or the later full information and consent.

Withdrawal or refusal record

Recommended. Provide a clear way to record refusal of continued participation and objection to use of data obtained under the emergency pathway. This may be part of the later consent form.

Initial enrollment logic

No one signs a conventional prospective participant consent at the emergency enrollment moment. The investigator must certify that no prior objection is known and record why every Article 35 condition is met.

Do not use an impartial witness as a substitute for unavailable participant or representative consent in this situation. The witness pathway is for a capable person who cannot write, not for an unconscious or otherwise incapable emergency patient.

Later information and consent

Seek informed consent without undue delay. For a minor or adult who remains unable to consent, the investigator seeks consent from the legally designated representative. For another participant, consent is sought from the participant as soon as capacity returns or from the representative when applicable.

The information should distinguish clearly between:

• what already happened under Article 35
• procedures necessary for immediate clinical care
• future trial-specific procedures
• continued trial treatment or follow-up
• use of data and samples already collected

The participant or representative must be able to object to use of data obtained from the emergency participation. The document should explain how the site records and implements that objection within legal and scientific limits.

Handling later refusal or withdrawal

If consent for continued participation is refused, stop future trial-specific activities that are not required for immediate safety or clinical care. Explain any safety follow-up that remains medically necessary and which data must be retained or reported under law.

Do not word the form as retrospective approval of a decision the person was unable to make. It should provide honest information, seek consent for continuation, and present the Article 35 data objection separately.

Investigator and site responsibilities

AKEK states that emergency consent tasks under Article 35 involve the investigator. The investigator certifies the absence of known prior objection and seeks the later consent. Do not allocate those legal decisions solely to a coordinator or other non-investigator team member.

Train each site on the therapeutic window, representative search, documentation, capacity reassessment, refusal, and rapid delivery of the current German documents.

German templates

AKEK does not list a dedicated current CTR emergency-enrollment model text on its medicinal-product trial page. Draft the documents specifically around Article 35, section 40b(5), the protocol, and the site's clinical workflow.

Use the Germany patient-facing document QC checklist to test the emergency and later-consent pathway.

Return to the Germany CTIS hub

The Germany CTIS submission guide hub contains the full English guide series.

Other language versions

Read this guide in German.