Bulgaria CTIS Part II Emergency Enrollment Consent Requirements

When emergency enrollment may be used

Conditional. Article 35 allows information and consent to be obtained after the decision to include the participant only when all required conditions are met.

The core conditions are:

• the urgency is caused by a sudden life-threatening or other sudden serious medical condition
• the participant cannot provide prior informed consent or receive prior trial information
• there are scientific grounds to expect a direct clinically relevant benefit for the participant
• it is not possible within the therapeutic window to provide the required information and obtain prior consent from the legally designated representative
• the investigator is not aware of a previously expressed objection to trial participation
• the trial relates directly to the medical condition causing the emergency and can be conducted only in emergency situations
• the trial poses minimal risk and minimal burden compared with standard treatment for the condition

If any of these conditions is absent, the Article 35 deferred-consent pathway should not be used.

What the Part II document set should explain

The protocol and participant-facing documents should describe the emergency pathway consistently. The application should make clear:

• why prior consent cannot be obtained within the therapeutic window
• what trial intervention may occur before consent
• how the investigator checks for known prior objections
• who will be approached for consent after the intervention
• how soon information and consent will be sought
• what happens if the participant regains capacity
• what happens if the participant or representative refuses continued participation
• how data already obtained under the emergency pathway will be handled under Article 35 and applicable data-protection rules

The BDA does not publish a separate national Bulgaria emergency-consent template in its current Part II document list.

Bulgarian patient-facing documents

Mandatory for the Bulgaria consent set. Participant information and ICF documents used for the later consent process should follow the BDA's Bulgarian-language rule and be accompanied by the Bulgaria version in English.

The current BDA list does not state a separate language exception for emergency enrollment. Do not assume that an emergency protocol allows English-only participant materials for the subsequent consent process.

Consent after the first intervention

Mandatory. Following an Article 35 intervention, informed consent to continue participation must be sought without undue delay.

For an adult who can consent, seek consent from the participant. If the participant is temporarily unable to consent, the legally designated representative may be approached, but the participant's own consent to continue must be obtained as soon as the participant becomes capable.

For minors or incapacitated subjects, seek consent from the legally designated representative without undue delay and provide information to both the participant and representative as soon as possible. Apply the Bulgaria-specific minor or adult representative rules in addition to Article 35.

The Bulgaria minor consent and assent guide and Bulgaria limited-capacity participant guide explain those national pathways.

Consent and signature logic

Once informed consent is being obtained under the normal Article 29 process, the participant or legally designated representative and the person conducting the consent interview sign and date the consent. Apply any additional Bulgaria-specific signatures for minors or an independent witness when those conditions are present.

Do not create a retrospective signature date that suggests the participant consented before the emergency intervention. The record should distinguish the Article 35 enrollment decision from the later informed-consent event.

Later refusal or withdrawal

Mandatory. If the participant or representative does not give consent after the emergency intervention, stop further participation that requires consent. Article 35 also requires the person to be informed of the right to object to the use of data obtained from the clinical trial.

The consent document should explain this without promising deletion of all data in circumstances where applicable law permits retention or use. Keep the wording aligned with the sponsor's data-protection documentation.

Good Clinical Practice documentation

The site should be able to show why the emergency pathway was used for the individual participant and when subsequent consent was sought. The protocol should define the process clearly enough that investigators do not make a new regulatory interpretation at the bedside.

If an independent witness is needed during the later consent discussion because the participant or representative cannot read or cannot write, use the Bulgaria impartial witness consent guide.

For the complete country guide library, return to the Bulgaria CTIS hub.