Denmark CTIS Part II Limited-Capacity Participant and Legal Representative Consent Requirements

Adults without capacity who are not under guardianship

Mandatory. when this population is included. Danish guidance identifies the nearest relative and a trial guardian as the persons who give surrogate consent for an adult without capacity who is not under guardianship. Both written consents are required for the surrogate consent to be valid.

The nearest relative is determined by the participant's actual relationship and circumstances, not by a sponsor-defined contact hierarchy. Danish guidance gives examples including spouse or cohabiting partner, direct-line relatives and siblings, and in some situations another family member or friend with regular close contact.

The trial guardian is a physician who safeguards the participant's interests and is independent of the investigator's interests and the clinical trial. The physician should have relevant knowledge of the research area. The Part II material should explain how this person is selected and how the role remains independent.

VMK publishes a CTR consent form for the nearest-relative and trial-guardian pathway.

Adults under guardianship

Conditional. Where an adult is under legal guardianship, the guardian can give surrogate consent only if the scope of the guardianship includes authority to consent to participation in research.

Do not assume that the existence of a guardian automatically covers clinical-trial consent. The site should confirm the mandate before relying on the guardian's signature.

Information for the participant

The fact that a representative gives legal consent does not remove the participant from the information process. Provide information adapted to the participant's capacity and understanding as far as possible.

The participant's present wishes must be respected. Danish ethics guidance states that surrogate consent cannot justify conducting research against the participant's will. Refusal can be verbal or expressed by behaviour, body language or resistance to procedures.

The Part II package should therefore describe how the investigator will assess and respect objection or dissent during trial conduct, not only at the first consent meeting.

Representative information and documents

Prepare information that enables each required representative to understand the trial, the participant's expected burden, risks and potential benefit, alternatives where relevant, the right to withdraw, data and record access, and biological-sample handling.

For the nearest-relative plus trial-guardian route, make the two roles distinct. The trial guardian is not a substitute for the relative, and the relative is not a substitute for the independent physician when both are required.

The blank forms submitted through CTIS are reviewed as application documents. The representatives sign when consent is actually obtained.

Consent physician requirements

The oral information and receipt of consent in Denmark must be handled by a duly qualified medical doctor with Danish authorisation. The same physician performs both steps. If that physician is not the principal investigator, a written agreement with the principal investigator is required.

This national rule applies to the representative consent process as well as the standard adult pathway, subject to any additional procedure authorised for the particular vulnerable population.

Objection, withdrawal and re-consent

Mandatory. If the participant objects to participation or a trial procedure in a way that represents a genuine current refusal, do not rely on the surrogate's signature to override that refusal.

Mandatory. when capacity returns. If the participant regains the ability to understand the trial and make the decision, obtain the participant's own informed consent for continued participation as soon as the person is able to receive the information and consent. The protocol and Part II procedure should explain how this transition will be recognized and documented.

For a participant initially enrolled under the Article 35 emergency exception, the subsequent-consent timing has additional rules. Use the Denmark emergency enrollment guide.

Language and translations

Representative information and participant information should be in Danish for the normal Danish-speaking pathway. If the participant or a required representative does not understand Danish, provide validated written translations of the PIS and ICF into a language they understand to the same degree and arrange appropriate language support for the oral conversation.

The sponsor is responsible for translation quality. The investigator remains responsible for confirming understanding.

Use the Denmark CTIS hub for the full Part II guide set.