International Council for Harmonisation (ICH) E6 Practice Exam

The recommendation from the ICH indicates that if a subject is illiterate, having an impartial witness present during the informed consent discussion is vital. This approach ensures that the consent process is conducted in an ethical manner, safeguarding the rights and welfare of the participant.

An impartial witness can help ensure that the subject understands the information presented and that the consent process is transparent and free from coercion or undue influence. They serve as a safeguard to verify that the subject's decisions are made based on comprehensive understanding rather than misunderstanding or manipulation.

This consideration is particularly essential in trials involving vulnerable populations, where the ability to fully comprehend clinical trial materials may be compromised. The presence of an impartial witness helps uphold the integrity of the informed consent process, aligning with ethical standards in clinical research.

In contrast, relying solely on a legally acceptable representative, submitting consent via email, or having the investigator verbally explain consent may not provide the same level of protection and oversight for the subject’s comprehension and autonomy.