The role of attending the informed consent process if the subject or legal representative cannot read is associated with which role?

• A. Independent Ethics Committee
• B. Impartial Witness
• C. Principal Investigator
• D. Sponsor Monitor

Answer: (B)

When a subject or their legally authorized representative cannot read, an impartial witness must be present during the informed consent discussion. This person observes that the information is explained, confirms that the subject understands the study and agrees to participate, and signs to attest that the consent was given under proper conditions. The witness should be independent of the trial team to avoid conflicts of interest and to protect the subject’s rights. The principal investigator remains responsible for obtaining consent, but the impartial witness provides an additional layer of protection and verification. Other roles, like those overseeing the study or monitoring activities, do not serve this witnessing function.