Sweden CTIS Part II Impartial Witness Consent Requirements

When an impartial witness can be used

Conditional. Use the pathway when a participant is able to make the participation decision but cannot personally write or sign.

Do not use an impartial witness merely because a participant needs an interpreter, because the participant has limited health literacy, or because a site prefers a second signature. Those situations may need other support, but they do not by themselves create the Article 29 witness condition.

Witness independence

The witness must be independent of the trial. The role is to observe the consent process and support reliable documentation that the participant's decision was expressed through the approved alternative method.

Describe how the site will select an eligible independent witness. Avoid a process that routinely uses someone whose trial role could compromise independence.

What to describe in Part II

Annex I point 62 requires relevant information when an impartial-witness procedure will be used. The Sweden-specific description should cover:

• why the participant cannot sign or write
• how the participant's own decision will be expressed
• how the independent witness is selected
• what the witness observes
• which document the witness signs and dates
• how the investigator documents the reason for using the pathway
• how the participant receives a copy of the information and consent record

The procedure and participant documents must be in Swedish for the Swedish application.

Signature logic

The witness dates and signs the informed consent when the alternative consent method is used. The person providing the information also follows the normal Article 29 signature requirement.

The witness does not replace the participant's decision. The legal function is to witness the approved method by which that decision is given and documented.

At CTIS submission, submit the blank proposed consent form and the procedure description. Do not pre-sign the witness section.

Swedish templates

No separate mandatory Swedish impartial-witness form was identified in the official sources reviewed. Add the witness statement and signature fields to the appropriate Swedish ICF when the pathway can realistically be used, and describe the process in the recruitment and informed-consent procedure.

Return to the Sweden CTIS Part II hub and use the patient-facing QC checklist to confirm that the witness pathway is not being confused with language support or legal-representative consent.