Czechia CTIS Part II Emergency Enrollment Consent Requirements

When Article 35 may be used

Conditional. Emergency enrollment is available only when all Article 35 conditions are met.

The participant must be in a sudden life-threatening or other sudden serious medical condition that makes it impossible within the therapeutic window to obtain prior informed consent and provide prior information to the participant or legally designated representative.

The trial must relate directly to the medical condition causing the emergency and be of a nature that can be conducted only in emergency situations. Article 35 also requires an expectation of a direct clinically relevant benefit and limits the trial to minimal additional risk and burden compared with standard treatment, together with the other conditions in the Regulation.

Do not label a protocol “deferred consent” simply because prospective consent is operationally difficult.

What Part II must describe

Annex I to the Clinical Trials Regulation requires the application to describe:

• the procedure for obtaining consent from the participant or legally designated representative to continue the trial
• how the urgency of the emergency situation is identified
• how that urgency is documented
• the information that will later be given to the participant or representative

The recruitment and consent procedure should also be reflected in SÚKL Template No. 1.

Required patient-facing documents

Conditional. Prepare the Czech information and consent document that will be used when the participant or representative can be approached after emergency inclusion.

Where the protocol includes minors or incapacitated adults, prepare the corresponding representative and participant information pathways. Use the minor consent guide or limited-capacity guide alongside the emergency procedure.

SÚKL's general Czech PIS/ICF requirements still apply to the relevant document versions.

Initial enrollment logic

The first intervention may occur before informed consent only if the Article 35 conditions are met and the decision follows the protocol-approved emergency procedure.

Record why prospective consent could not be obtained within the therapeutic window and why the participant met the emergency inclusion conditions. The application should make the documentation process clear enough for the Ethics Committee and SÚKL to assess it.

SÚKL's KLH-22 contains practical recommendations for emergency or severely deteriorated participants. Where an abbreviated information stage is used, plan a fuller information and continued-consent stage after stabilisation.

Consent to continue

Mandatory after emergency inclusion. Article 35 requires informed consent for continued participation to be sought without undue delay.

For an incapacitated participant or minor, the investigator seeks consent from the legally designated representative without undue delay and gives the required information to the participant and representative as soon as possible.

For other adults, seek consent without undue delay from the participant or legally designated representative, whichever is available first under the Article 35 rule. If the representative initially consents and the participant later becomes capable of consent, obtain the participant's own consent as soon as possible.

Later refusal or withdrawal

If the participant or representative does not consent to continued participation, do not treat emergency inclusion as permanent consent.

Article 35 requires the person to be informed of the right to object to the use of data already obtained. The protocol and participant documents should describe this accurately and consistently.

Signatures

The emergency procedure is described and approved in advance, but future participants and representatives do not sign the blank forms at CTIS submission.

When consent to continue is obtained, the applicable participant or representative and the person conducting the consent interview sign and date the consent record under Article 29. If an impartial witness is needed because the person cannot write or read, apply the Czechia impartial witness consent guide.

Czech national drafting points

The continued-participation PIS/ICF should include the national SÚKL content that applies to all Czech versions, including trial identification, ethics contact, results statement, source-record access and copy-of-consent wording.

Do not rely on older national emergency wording where it conflicts with the directly applicable Clinical Trials Regulation. Article 35 is the controlling legal framework for current CTIS trials. KLH-22 is useful as SÚKL's recommended drafting guidance.

Use the Czechia patient-facing QC checklist to check consistency between the protocol, emergency procedure, representative documents and later-consent forms.