Poland Emergency Enrollment Consent Requirements

Article 35 is an exception, not a general deferred-consent option

Conditional. Use the emergency pathway only if all Article 35 conditions apply. A protocol cannot defer consent merely because an emergency department is busy, a participant is difficult to contact or the study intervention is more convenient to give immediately.

The conditions include all of the following:

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

All conditions must be reflected in the protocol rationale. A single statement that the trial is an emergency study is not enough.

What the Part II dossier must explain

Annex I of the Clinical Trials Regulation requires the application to describe the emergency consent procedure and how urgency will be identified and documented. The European Commission's Recruitment and informed consent procedure template v2.0 has a dedicated emergency section for this purpose.

For Poland, the procedure should explain:

• the clinical circumstances that trigger the Article 35 pathway
• who confirms that the participant cannot provide prior consent or receive prior information
• why a legally designated representative cannot be informed and consent within the therapeutic window
• how any known prior objection is checked
• how the emergency decision and timing are documented
• which Polish participant or representative documents are used after the intervention
• how consent for continued participation is sought without undue delay
• what happens if the participant regains capacity
• what happens if subsequent consent is refused

The procedure should match the protocol exactly. Avoid an ICF that describes a broader emergency pathway than the protocol or a protocol that omits operational steps present only in a site manual.

Documents to prepare for Poland

Mandatory where the emergency pathway applies. Prepare Polish-language documents for the people who will be approached after the initial intervention. The exact set depends on the study population and expected recovery pathway.

Common documents include:

• a Polish participant information and informed consent form for continued participation
• a Polish legally designated representative information and consent form where incapacitation may continue
• a capacity-appropriate participant information document where the participant cannot yet make the legal decision but can understand some trial information
• the Recruitment and informed consent procedure describing the Article 35 process
• a re-consent pathway for a participant who later becomes able to consent personally
• any relevant pregnancy, privacy, sample or optional secondary-use material

Do not use an unsigned "emergency consent form" as if it created prior consent. Article 35 permits the initial inclusion decision under strict conditions and then requires subsequent informed consent for continued participation.

Polish language requirements

Mandatory. The European Commission's July 2026 language table marks translated patient-facing documents submitted in Part II as requiring the national language for Poland. Prepare the post-enrollment participant and representative documents in Polish for the Poland Part II dossier.

If emergency circumstances make normal reading difficult, the approved process may use an appropriate oral explanation in addition to the written document. That does not remove the need to provide the required information and document the subsequent consent properly.

Initial enrollment before consent

The decision to include the participant is taken at the time of the first intervention and must follow the approved protocol. The investigator should document why the Article 35 conditions were satisfied at that point.

The emergency exception does not create a period of unrestricted participation. It permits the first intervention under the defined conditions. Afterward, the study team must move promptly to the standard informed-consent framework for continued participation.

If the investigator is aware that the participant previously objected to trial participation, the emergency route cannot be used for that participant.

Subsequent consent without undue delay

Mandatory. After the intervention, informed consent under Article 29 must be sought for continued participation.

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

For other participants, the investigator seeks consent without undue delay from the participant or the legally designated representative, whichever can validly provide it sooner. Information is given as soon as possible to the participant or representative, whichever is sooner.

The site procedure should translate this legal requirement into an operational sequence. Define who is contacted, what document is used, how failed contact attempts are recorded and how the participant is approached if capacity returns.

For continuing incapacity, use the Poland limited-capacity and legal representative consent guide to align the subsequent consent route.

Re-consent if capacity returns

Conditional. If a legally designated representative initially consents to continued participation and the participant later regains capacity, the procedure should provide for the participant to receive the full information and make their own decision.

The European Commission v2.0 template specifically asks sponsors to explain re-consent where a participant regains capacity after consent was initially obtained from the legally designated representative. Track this prospectively rather than relying on an investigator to notice it informally.

Use the current authorised Polish adult PIS and ICF or a dedicated re-consent version that contains the same required information and clearly records the participant's personal decision.

Later refusal or withdrawal

If subsequent informed consent for continued participation is not obtained, do not treat the emergency inclusion as ongoing consent. Apply the protocol and applicable withdrawal rules for discontinuing trial participation and handling data already collected.

The participant or representative should receive clear information about what happens if consent is refused after the emergency intervention. Avoid wording that suggests the person must continue because the first intervention has already occurred.

Any continued follow-up that is not necessary for immediate safety should be supported by the applicable consent and data-protection framework described in the approved documents.

Signatures and dating

The Poland CTIS submission contains the blank controlled Polish documents. Signatures are obtained after the emergency intervention when the Article 29 consent process can occur.

The written informed consent for continued participation is dated and signed by the person conducting the consent interview and by the participant or legally designated representative, as applicable. Provide a copy of the informed-consent documentation.

If the person giving consent cannot write, the Poland impartial witness consent guide explains the current Polish NKB position on the one-witness CTR pathway.

Compensation, insurance and participant rights

Emergency enrollment does not remove the standard Poland participant protections. The post-enrollment information should explain the Clinical Trials Compensation Fund and mandatory civil liability insurance in the same way as the standard Poland consent package.

Do not hide compensation or withdrawal rights in an emergency-specific appendix. A participant or representative deciding whether to continue needs the full Article 29 information needed for an informed decision.

Use the Poland patient-facing document QC checklist to compare the emergency sequence across protocol, procedure and ICF. Return to the Poland CTIS Part II guide hub for the complete country package.