In the event of reading difficulties, what ensures understanding?

• A. The sponsor provides a translation.
• B. The participant signs without understanding.
• C. An impartial witness is present during the informed consent discussion.
• D. The consent is not required.

Answer: (C)

When a participant has reading difficulties, ensuring understanding during the informed consent process hinges on having an impartial witness present during the consent discussion. The impartial witness is there to confirm that the information was explained in a way the participant could understand and that the participant’s consent is given freely and without coercion. This witness is independent from the research team, helping to protect the participant’s rights and confirming that understanding was attempted and documented. Translation or reading aloud can support understanding, but the witness provides independent verification that the discussion occurred and that the participant understood the risks, benefits, and voluntary nature of participation. Signing without understanding is not acceptable, and consent is still required.