Denmark CTIS Part II Emergency Enrollment Consent Requirements

When Article 35 can be used

Conditional. and narrowly defined. Denmark's 2026 VMK emergency-trial guidance requires the application to show all of the following Article 35 elements.

The situation is genuinely urgent

It must be impossible to obtain prior informed consent because of a sudden life-threatening or other sudden serious medical condition. The protocol should explain why the intervention cannot be postponed and describe the relevant therapeutic window.

Direct clinically relevant benefit is scientifically plausible

There must be scientific grounds to expect that participation has the potential to provide a direct clinically relevant benefit resulting in a measurable health improvement, reduction in suffering, improvement in health or diagnosis of the participant's condition.

Prior consent cannot be obtained within the therapeutic window

The participant or legally designated representative cannot receive the full prior information and provide consent in time for the necessary intervention.

No known prior objection

The investigator must not be aware that the participant previously objected to trial participation. Danish practice requires the protocol to describe how prior objections will be checked, such as relevant information in the medical record.

The trial directly concerns the emergency condition

The trial must be directly related to the condition causing the emergency and be of a type that can only be conducted in that emergency setting. Article 35 cannot be used as a general shortcut when an ordinary prospective consent process would be possible.

Risk and burden are minimal compared with standard treatment

The trial must impose minimal additional risk and burden compared with the standard treatment of the emergency condition. VMK asks for a realistic risk assessment addressing how the experimental pathway differs from normal care and how additional burdens will be minimized.

If minors or incapacitated adults are included, the application must also satisfy the specific CTR safeguards for those populations.

What the Part II application should describe

The emergency consent section should explain:

• the medical emergency and therapeutic window
• why prior information and consent cannot be obtained
• why the trial cannot be conducted outside the emergency setting
• the expected direct clinically relevant benefit
• the risk and burden comparison with standard care
• how prior objections will be checked
• how the emergency situation is identified and documented
• which participant categories may be included
• which legally designated representatives apply to each category
• when and how subsequent consent will be sought
• how every attempt to obtain subsequent consent will be documented
• what happens if subsequent consent is refused or cannot be obtained

Danish legally designated representatives

Denmark defines the representative by participant category.

Adult without capacity and not under guardianship. Subsequent surrogate consent is obtained from both the nearest relative and the trial guardian. The consent is valid only when written consent from both has been obtained.

Minor. Consent is obtained from the holder or holders of parental authority. If parental authority is joint, both must consent. If a 15 to 17 year old is able to consent at the time consent is sought, the young person's own consent is also obtained. If the young person later regains the ability to consent, obtain that consent then.

Adult under guardianship. The legal guardian provides consent if the scope of the guardianship includes authority to consent to research participation.

The trial guardian is an independent physician who protects the participant's interests and has relevant knowledge of the field. VMK's emergency guidance states that the trial guardian must not be part of the trial team or otherwise have conflicting interests.

Subsequent consent after emergency inclusion

Mandatory. After inclusion without prior consent, informed consent to continued participation must be sought as soon as possible and without undue delay from the participant or the applicable legally designated representative.

There is no single fixed Danish number of hours that fits every emergency trial. The sponsor should state how the requirement will be met in the actual clinical pathway and provide an estimate for when consent-seeking starts for the different participant groups.

Written and oral information must be provided. The participant or representative should have an opportunity to ask questions and receive appropriate time to consider the decision given the clinical circumstances.

The standard Danish rule on the person giving oral information also applies. The information and consent process is handled by a duly qualified physician with Danish authorisation, and the same physician gives the oral information and receives the consent.

If consent is refused or cannot be obtained

If subsequent consent is not obtained, the participant cannot continue in the clinical trial. From that point, trial treatment, trial-specific activities and new data collection must stop. New access to the medical record for trial data collection also stops.

VMK's guidance states that data collected up to the point when consent is refused or cannot be obtained may continue to be used, subject to the applicable CTR and data-protection framework. The participant or representative should be informed about the possibility of objecting to use of already collected data under data-protection rules.

The protocol and Part II material should describe this pathway before the trial starts.

Language and document set

Prepare the emergency participant and representative information in Danish for the normal Danish population. Add validated translations where a participant or representative does not understand Danish.

The document set may need separate information and consent forms for:

• a participant who regains capacity
• nearest relative
• trial guardian
• parental authority holder or holders
• capable 15 to 17 year old
• legal guardian where applicable

Use the Denmark limited-capacity guide and Denmark minor consent guide for the underlying representative logic. Return to the Denmark CTIS hub for other Part II requirements.