An impartial witness should be present during the entire informed consent discussion when:

An impartial witness is required when a legally acceptable representative (LAR) or the subject themselves cannot read. The witness ensures that the information is presented accurately and that the consent process is conducted ethically. The witness also signs the consent form to confirm that the subject or representative understands the study details.

GCP guidelines require an impartial witness to be present to confirm that the consent information is correctly conveyed and understood when the subject or LAR cannot read.

"An impartial witness is required when the subject or legally acceptable representative is unable to read, ensuring the consent process is transparent and ethically sound."

Objectives:

Protect the rights of individuals with literacy challenges.

Maintain ethical standards in the consent process.