Sweden CTIS Part II Emergency Enrollment Consent Requirements

Conditions for emergency enrollment

Conditional. Article 35 can be used only when the trial is directly related to the medical condition causing the emergency and the protocol cannot practicably use ordinary prior consent.

The CTR conditions include that:

• the participant faces a sudden life-threatening or other sudden serious medical condition
• the participant is unable to provide prior informed consent and prior information
• there are scientific grounds to expect a direct clinically relevant benefit
• it is impossible within the therapeutic window to provide all prior information and obtain consent from a legally designated representative
• the trial is directly related to the condition causing the emergency
• the trial could not be carried out comparably in a non-emergency setting
• the intervention poses only the permitted level of risk and burden compared with standard treatment under Article 35

Do not label a recruitment process as deferred consent merely because obtaining ordinary consent is inconvenient.

What to submit in Part II

Prepare a Swedish description of the emergency consent procedure. It should explain:

• the clinical circumstances that trigger the pathway
• how inability to consent is assessed
• why a representative cannot be reached within the therapeutic window
• who makes and documents the enrollment decision
• what information can be provided before the first intervention
• how the participant or representative is approached afterward
• what happens if continued participation is refused
• what happens to already collected data if consent is not given

Annex I point 62 specifically expects emergency consent procedures to be described in Part II.

Subsequent consent

After the first intervention, informed consent for continued participation must be sought as soon as possible.

For minors or adults without decision-making capacity, the participant and legally designated representative should be informed as soon as possible and consent obtained from the representative according to the applicable population rules.

For other participants, Läkemedelsverket states that the participant or representative should be informed as soon as possible, depending on which can be reached first. If the representative gives the first subsequent consent, the participant's own consent should be obtained as soon as the participant becomes able to consent for continued participation.

If consent is not given, the person must be informed about the right to object to use of the data already collected.

Who obtains consent in Sweden

The Swedish normal rule is that a licensed physician or licensed dentist conducts the consent interview and obtains consent. Läkemedelsverket can permit another healthcare professional where special reasons exist.

The authority specifically gives emergency treatment during ambulance transport as an example of a situation in which a different healthcare professional might be proposed. The sponsor must justify why this is necessary in the protocol. Do not assume the emergency context automatically creates the exception.

Participant-facing documents

Prepare the Swedish documents needed for the realistic post-emergency pathways, including:

• participant information and consent once the participant can decide
• representative information and consent where applicable
• minor and guardian documents if minors are enrolled
• limited-capacity documents if that population is included

The first intervention may precede these signatures only when Article 35 applies. Later procedures follow the approved subsequent-consent logic.

Return to the Sweden CTIS Part II hub and cross-check the limited-capacity guide or minor guide when those populations can enter through the emergency pathway.