What must an investigator do if they expect illiterate subjects to enroll in studies often?

When an investigator anticipates enrolling illiterate subjects in a study frequently, it is necessary to incorporate a signature block for an impartial witness in the consent process. This approach is essential for ensuring that the rights and welfare of participants are protected.

An impartial witness serves as a neutral party who can observe the consent process, confirm that the participant understands the nature of the study, and verify that they freely agree to participate. This is particularly important for illiterate participants, who may not be able to read the consent document or fully comprehend written information. The presence of an impartial witness ensures that the consent obtained is ethical and aligns with regulatory requirements, supporting participant autonomy and informed decision-making.

In this context, other options may not adequately address the specific needs of illiterate participants or fail to maintain a standard of ethical practice. For instance, a written request for consent or a standardized consent form presumes the participant's ability to read, which may not be the case. Focusing solely on verbal consent without the presence of a witness might increase the risk of misunderstanding or coercion, further underscoring the importance of having an impartial witness present.