Denmark CTIS Part II Impartial Witness Consent Requirements

When an impartial witness is used

Conditional. Use the CTR Article 29 witness pathway when the participant or legally designated representative is able to make the informed decision but cannot write the consent in the normal manner.

Do not use an impartial witness to replace a legally designated representative when the participant lacks decision-making capacity. Those are different pathways. Use the Denmark limited-capacity consent guide when the issue is incapacity rather than inability to write.

Likewise, emergency inclusion without prior consent is governed by Article 35, not by the witness rule. Use the Denmark emergency enrollment guide for that situation.

What the Part II procedure should describe

Annex I requires relevant information when consent witnessed by an impartial witness is planned. Describe:

• why the participant or representative cannot use the normal written-signature process
• what alternative method will be used to give and record consent
• how the impartial witness will be selected
• how the witness will be present for the consent process
• what will be recorded in the source documentation
• how the final ICF or consent record will be retained

The European Commission CTR Q&A states that details of the process should be recorded and the informed consent form kept as evidence.

Witness signature and dating

Mandatory. when this pathway is used. Under Article 29, the witness signs and dates the informed consent document when the participant or representative is unable to write and consent is recorded by appropriate alternative means.

The person performing the information interview also signs and dates the consent. In Denmark, that person must be a duly qualified physician with Danish authorisation. The same physician gives the oral information and receives the consent. If the physician is not the principal investigator, a written agreement with the principal investigator is required.

The participant or representative receives a copy of the document or record by which consent was given.

Who can act as an impartial witness?

The CTR requires an impartial witness but does not create a Denmark-specific named profession or national witness form in the current VMK CTR consent-form library. The safest Part II approach is to define the witness as a person independent of the decision and able to attest that the alternative consent process was carried out as described.

Do not assign someone whose role creates a conflict with the participant's interests. The application should make the independence rationale understandable to the ethics assessor.

Participant information does not become optional

The witness pathway changes how consent is documented. It does not remove the information requirements.

The participant or representative still receives understandable written information and the oral information interview. Adequate time should be allowed to consider participation, and understanding should be checked.

If the person does not understand Danish, the Danish translation rule also applies. Provide validated written translations of the PIS and ICF into a language the person understands to the same degree and arrange suitable oral language support.

Submission timing

The witness-adapted consent form and procedure are submitted blank in Part II when the pathway is expected to be used. The actual participant, witness and physician signatures are obtained during trial conduct when consent is given.

If the need arises unexpectedly after authorisation, assess whether the approved documents and procedure already permit the alternative means. If not, determine the appropriate CTIS modification route before implementing a new consent process unless an urgent safety situation requires otherwise.

Use the Denmark CTIS hub for the full set of country guides.