Lithuania CTIS Emergency Enrollment Consent Requirements

When emergency enrollment can be used

Under Article 35, all of the following must be satisfied.

Mandatory. The situation is urgent because of a sudden life-threatening or other sudden serious medical condition.

Mandatory. The participant is unable to provide prior consent and receive prior trial information.

Mandatory. There are scientific grounds to expect a direct clinically relevant benefit for the participant.

Mandatory. It is not possible within the therapeutic window to provide all prior information to and obtain consent from the legally designated representative.

Mandatory. The investigator is not aware of a previously expressed objection to trial participation.

Mandatory. The trial relates directly to the emergency medical condition and can only be conducted in emergency situations.

Mandatory. The trial poses minimal risk and minimal burden compared with the standard treatment of the condition.

If one of these conditions is absent, the Article 35 pathway should not be presented as available.

What Lithuania expects in Part II

The national recruitment and consent procedure should explain:

• why prior consent is impossible in the defined emergency
• how the urgency is recognised
• how the situation and eligibility for emergency enrollment are documented
• how the investigator checks for any known prior objection
• why a representative cannot be reached within the therapeutic window
• what information is given as soon as possible after the intervention
• who seeks consent to continue
• what happens if the participant or representative refuses later consent

Lithuania's national Part II recommendation provides a section for this emergency pathway. No separate mandatory Lithuania-specific emergency ICF template was identified in the national Part II materials reviewed for this guide.

Documents to prepare

Mandatory when Article 35 is used. Prepare a Lithuanian recruitment and informed consent procedure that fully describes the emergency process.

Conditional. Prepare a post-intervention participant ICF for the subject once the subject is capable of receiving information and deciding.

Conditional. Prepare a legally designated representative version where the protocol population may remain incapable and representative consent is required.

For minors, the later consent pathway must also match Lithuania's parent and child rules. Use the Lithuania minor consent and assent guide.

For adults with ongoing incapacity, use the Lithuania limited-capacity guide.

Subsequent consent must be obtained without undue delay

After the emergency intervention, informed consent to continue participation should be sought without undue delay.

For minors and incapacitated participants, the investigator seeks consent from the legally designated representative and gives the participant and representative the required information as soon as possible.

For other adults, consent should be sought from the participant or the legally designated representative, whichever can validly provide it sooner. If a representative consents first, the participant's own consent must be obtained as soon as the participant becomes capable.

The later ICF should clearly explain what has already happened, what continued participation involves and the person's right to refuse further participation.

Later refusal or withdrawal

If the participant or representative does not consent after the emergency intervention, the Regulation requires them to be informed of the right to object to the use of data obtained from the clinical trial.

The consent package should distinguish:

• stopping further trial participation
• treatment needed for clinical care
• use of data already obtained
• the right to object where Article 35 applies

Do not use standard withdrawal text if it does not describe the emergency-enrollment situation accurately.

Signature logic

At CTIS submission, the emergency consent forms are submitted blank.

After the intervention:

• the participant signs when capable of consenting
• the legally designated representative signs where the law requires representative consent
• the person conducting the consent interview signs and dates the record
• re-consent is obtained from the participant when capacity returns
• refusal or objection is documented

The Lithuania impartial witness guide applies if the participant or representative can consent but cannot write.

Final emergency-consent QC

Before submission, confirm:

• every Article 35 condition is reflected in the protocol
• the Part II consent procedure explains the actual operational pathway
• the emergency is not treated as a blanket consent waiver
• prior objections are addressed
• subsequent consent is sought without undue delay
• participant and representative versions are available for the expected population
• later refusal and data objection are explained
• all Part II documents are in Lithuanian

Use the Lithuania patient-facing QC checklist for the final cross-document review.