Austria Emergency Enrollment Consent Requirements

When emergency enrollment may be used

Article 35 allows information and consent to be obtained after the decision to include a participant only when all of its conditions are met. The emergency situation must arise from a sudden life-threatening or other sudden serious medical condition that prevents prior information and consent.

The protocol must define the emergency situation and justify the pathway. Prior consent cannot be obtained from the participant within the therapeutic window, and a legally designated representative cannot provide prior consent within that window. The investigator must not be aware of a previous objection to trial participation.

The trial must directly relate to the medical condition causing the emergency and must be of a type that can be conducted only in emergency situations. The CTR also requires the applicable potential direct benefit and minimal-risk and minimal-burden conditions relative to standard treatment.

Do not use an emergency-consent section merely because recruitment is time-sensitive or the site expects practical difficulty contacting a representative.

Part II documents to prepare

Mandatory. Describe the emergency informed-consent procedure in the Part II informed-consent procedure documentation. Annex I of the CTR requires the sponsor to explain the procedures used where informed consent cannot be obtained before participation.

Mandatory in Austria. Submit a post-hoc Patient Information Sheet and Informed Consent Form for the participant to receive when capacity returns.

Conditional. If the participant remains unable to consent and a legally designated representative becomes available, prepare the representative information and consent document. Use the Austria limited-capacity and legal-representative guide for the representative pathway.

Conditional for minors. Where the emergency participant is a minor, the Article 35 process must be read together with Article 32 and Austria's minor rules. Use the Austria minor consent and assent guide for the age-specific documents.

All Austrian participant-facing documents are German. Certified translations are required for planned participants or representatives who do not sufficiently understand German.

Deferred and subsequent consent

Mandatory. After the first emergency intervention, informed consent to continue participation must be sought without undue delay. For participants who are not minors or incapacitated, the CTR requires consent from the participant or legally designated representative, whichever can provide it sooner. If a representative gives consent while the participant remains incapacitated, the participant's own consent to continue must be obtained as soon as the participant becomes capable.

The Austrian post-hoc ICF should make the sequence clear. Explain what has already happened, what continuing trial procedures are proposed, risks and benefits, the right to refuse continued participation and how previously collected data are handled.

Later refusal or withdrawal

If the participant or representative does not consent to continued participation, the CTR requires them to be informed of the right to object to the use of data obtained in the trial. Do not present deferred consent as automatic confirmation of enrollment.

Austrian law contains a specific emergency data rule. If an Article 35 trial ends for the participant, or the participant dies, before the delayed informed consent can be obtained, section 41(3) AMG permits the data already processed and the results of any autopsy to be used for the purposes of that clinical trial.

For participants who do consent and later withdraw from the trial, apply the ordinary Austrian withdrawal rules. New study-purpose data collection through study visits, follow-up visits or re-contact should not continue after full withdrawal, apart from applicable safety-reporting obligations.

Signatures and record keeping

Once consent can be obtained, the ordinary Article 29 signature requirements apply. The participant or legally designated representative and the person conducting the consent interview sign and date the consent record. Austrian national guidance uses wet ink or qualified electronic signature for informed consent.

The emergency inclusion decision, reason prior consent could not be obtained, absence of a known prior objection and the timing of subsequent information and consent should be documented in the trial records in a way that supports the approved protocol procedure.