What should an investigator include in the consent forms for studies involving illiterate persons?

Including a signature block for an impartial witness in consent forms for studies involving illiterate persons is essential. The presence of an impartial witness ensures that the person who is unable to read and write is adequately informed about the study, its risks, benefits, and procedures. This requirement is in line with ethical standards, which prioritize the protection of vulnerable populations, ensuring that consent is given voluntarily and with a clear understanding of what participation entails.

An impartial witness serves as a third party who can confirm that the consent process was followed properly. They help verify that the illiterate participant was given the appropriate information and that they understood it, which is crucial for maintaining ethical research practices. The witness's signature also adds a layer of accountability and transparency, which is particularly important in trials involving individuals who may not have the ability to fully comprehend written materials.

While other elements like a detailed description of study procedures or potential outcomes are important for informed consent, they do not address the unique needs of illiterate participants in the same direct manner as having an impartial witness. The investigator's signature alone does not fulfill the ethical requirements needed to ensure that consent is valid in such cases.