Finland Impartial Witness Consent Requirements

This is a variation of the main consent process

Start with the Finland Patient Information and Consent Requirements guide. The participant receives the same trial information, prior discussion, decision time and opportunity to ask questions. Only the method of recording the person's consent changes.

Conditional. Use an impartial witness because the consenting person cannot write. A witness is not automatically required because a participant speaks another language, has limited literacy or uses an interpreter. Those circumstances need an understandable consent process, while the witness pathway applies when the written signature cannot be provided.

Witness eligibility

Select a person independent of the trial and free from influence by people involved in it. The witness must be able to observe the full consent process and understand what they are attesting. Avoid study-team members and anyone whose interests could compromise impartiality.

Document the witness's identity, relationship to the participant, independence and role. The Part II procedure should state who checks eligibility and what happens when no suitable witness is available.

An interpreter and an impartial witness perform different functions. The interpreter enables communication. The witness attests to the consent process and alternative record. If one person might perform both roles, justify the arrangement and confirm language ability, independence and the approved procedure. Using separate people is clearer when feasible.

Required documents and procedure

Prepare:

• the ordinary Finnish and/or Swedish Participant Information Sheet
• an Informed Consent Form with the approved alternative-record and witness fields
• the Recruitment and Informed Consent Procedure describing the trigger, witness selection, communication method, understanding check and record
• translated participant documents and interpreter arrangements when the person does not speak Finnish or Swedish

Finland does not publish a separate national witness form. Adapt Tukija's consent template and the EU procedure form to the approved alternative means.

Consent discussion and signatures

The witness should be present for the consent discussion and observe that the information is accurately explained, apparently understood and voluntarily accepted. The qualified study-team member must still conduct the prior interview and verify understanding.

Record the participant's or representative's consent through the approved alternative method. The impartial witness signs and dates the consent document. The person who conducted the consent discussion also signs and dates it. Add the participant's mark or other record when feasible and approved, without implying a conventional signature was possible.

Give the participant or representative a copy of the consent document or record. Archive the original. Do not sign the blank CTIS submission version.

If the person lacks decision-making capacity rather than only the ability to write, use the Finland limited-capacity and legal representative guide. A witness cannot replace the legally designated representative.

Run the final document through the Finland patient-facing document QC checklist and return to the Finland CTIS hub for related consent variations.