Norway CTIS Impartial Witness Consent Requirements

When a witness is used

Conditional. Article 29 requires an impartial witness when a participant or representative is unable to write and consent is recorded through an appropriate alternative means. ICH E6(R3) also describes the witness process when the participant or representative is unable to read.

Do not use a witness merely because the participant speaks another language. Provide information in a language the person understands and use a qualified interpreter where needed. A person who lacks consent capacity needs the legally designated representative pathway, not a witness alone.

Witness eligibility

The witness must be independent of the trial and unable to be unfairly influenced by people involved in it. Avoid members of the study team, people subordinate to the investigator and anyone with a conflict in the participant's decision.

Record the witness's name, role and relationship to the participant. If the discussion is remote, document how the witness attended the complete discussion and how identity and signatures were verified.

Consent procedure

Provide the approved Norwegian information in an accessible manner. When the participant or representative cannot read, read and explain the form and all other relevant information. The impartial witness should be present for the entire discussion.

Allow questions and adequate decision time. Confirm that the information was apparently understood and that consent was freely given. The information-giver and consent-taker must follow Norway's recruitment rules, including avoiding consent by the treating physician where the dependent relationship could compromise voluntariness.

Signatures and witness attestation

Mandatory when the pathway is used. The participant or representative signs and dates if capable. Where the person cannot write, record consent through an appropriate alternative means in the witness's presence. The witness signs and dates the consent record.

The witness attestation should confirm that the information was accurately explained, apparently understood and that consent was freely given. The investigator or delegated site staff member who conducted the consent discussion also signs and dates. Give the participant or representative a copy of the completed record.

The form uploaded at CTIS submission remains blank. Include the witness fields and procedure in the approved version before sites use it.

Document and submission checks

• Use Norwegian for the participant information and consent form used in Norway.
• Keep the participant's decision separate from the witness attestation.
• Do not describe the witness as consenting on behalf of the participant.
• Explain any interpreter role separately from the witness role.
• Match alternative signature and electronic-consent methods to the approved procedure.
• Protect the witness's personal data in the public CTIS version.

Use the Norway patient-facing document QC checklist before submission. If the person lacks legal capacity, use the limited-capacity and representative-consent guide. Return to the Norway CTIS hub for all guides.