Netherlands CTIS Emergency Enrollment Consent Requirements

Conditions for enrollment before consent

Mandatory. All Article 35 conditions must be addressed. The trial can use deferred consent only when:

• the participant faces a sudden life-threatening or other sudden serious medical condition
• the participant cannot receive prior information and cannot give prior consent because of the urgency
• a legally designated representative cannot provide consent within the therapeutic window
• there are scientific grounds to expect a direct clinically relevant benefit for the participant
• the trial directly relates to the condition causing the emergency
• the trial can be conducted only in emergency situations
• the participant has not previously expressed an objection to trial participation
• the trial poses no more than minimal risk and burden compared with standard treatment for the condition

The need to perform the first trial-specific action within the short therapeutic window must have a medical basis. Administrative delay, staffing or convenience is not enough.

Mixed populations

Conditional. If some people can consent before enrollment while others cannot, explain the mixed pathway and its compelling justification in the protocol. The Dutch CCMO memorandum treats this as exceptional, while the current EU Q&A allows it when the reasons are clear and Article 35 applies to those enrolled without prior consent.

Use ordinary prior consent whenever it can be obtained. Do not route all participants through deferred consent merely for operational consistency.

Required submission documents

Recruitment and consent procedure

Mandatory. Complete section 6 of the harmonised Recruitment and Informed Consent Procedure template. Explain why prior consent is impossible, how the participant or representative will be approached at the earliest opportunity, and how participant consent will be obtained if capacity returns.

If representatives or minors may be involved, also complete the relevant capacity and minor sections. The version 2.0 template becomes the only accepted version for new Part II submissions from 1 September 2026.

Protocol

Mandatory. Define the therapeutic window, first trial-specific intervention, inclusion decision, prior-objection check, capacity assessment, representative search, repeated consent attempts and maximum operational times. Explain which procedures can occur before consent and which must wait.

CCMO does not endorse a routine fixed delay such as 72 hours for every trial. The timing should reflect the clinical condition, burden and whether procedures continue. Consent must be sought without undue delay.

Dutch participant and representative documents

Mandatory. Prepare Dutch information and consent for the participant after capacity returns and for the legally designated representative while the participant remains unable to consent. Explain that enrollment occurred before consent, what has already happened, what will happen next and what choices remain.

Submit the blank authorised forms in Part II with the informed-consent documents. They are signed during conduct, not at CTIS submission. The standard Dutch IVO can be adapted, but there is no separate CCMO emergency ICF model that replaces the trial-specific design.

Initial enrollment and documentation

Before enrollment, the authorised investigator should confirm and document that the Article 35 criteria are met for that person. Check available medical records and known wishes for any prior objection to research or an intervention inconsistent with the trial.

Record why prior participant and representative consent could not be obtained within the therapeutic window. Record the emergency condition, time of eligibility, intervention and efforts to identify a representative.

Only the procedures authorised before deferred consent may be performed. The participant's ordinary clinical care must not be made dependent on later trial consent.

Obtaining consent after enrollment

Participant regains capacity

Mandatory. Inform the participant and obtain written consent for continued participation without undue delay. Explain the research already performed, data and samples collected, remaining procedures, risks and the right to decline.

The participant and researcher or authorised interviewer sign and date the Dutch form. If the participant declines, end participation and further research collection.

Participant remains unable to consent

Mandatory. Seek consent from the legally designated representative as soon as possible. The representative order and authority follow Dutch law. If the representative consents, continue the authorised trial pathway. If capacity later returns, obtain the participant's own consent.

See the Netherlands limited-capacity and legal representative consent guide for the representative documents.

Trial procedures already complete

The participant or representative must still be informed. Where no further trial participation remains, the consent discussion focuses on the study, the data and samples already obtained, and applicable rights. The protocol should distinguish this from consent needed before continuing burdensome procedures.

Refusal, withdrawal and previously collected data

If the participant or representative refuses continued participation, stop new trial procedures and data collection. Do not treat refusal as withdrawal from ordinary care.

The current EU CTR Q&A states that data lawfully gathered under Article 35 remain in the trial when all conditions were met and consent efforts were not unduly delayed. Explain this clearly rather than promising deletion of all prior data.

The person should be told how remaining samples are handled and what rights apply under the authorised protocol, consent documents and data-protection law.

Death before consent

Where a participant dies before consent can be obtained, CCMO considers that data collected under an authorised deferred-consent process may be used for the trial, provided the person had not objected while alive. The current EU Q&A likewise states that Article 35 data remain in the trial.

CCMO recommends informing the legal representative or next of kin for transparency, even though a relative no longer acts as legal representative after death. The protocol should describe this sensitive communication and the handling of any objection.

Final checks

• Every Article 35 condition is answered for the trial and each enrollment.
• The emergency is directly related to the trial question and intervention.
• The therapeutic window is medically justified.
• Prior objection is checked and respected.
• Section 6 of the harmonised procedure template is complete.
• Participant and representative Dutch documents explain prior enrollment.
• Consent attempts and capacity changes are time-stamped in source records.
• New collection stops after refusal.
• Data-retention wording matches current EU and Dutch guidance.
• Death before consent is addressed in the protocol.
• The emergency pathway is not used when ordinary prior consent is possible.

Return to the Netherlands English CTIS hub for the complete guide series.