Subjects who do not speak English may be unable to understand explanations of study procedures, requirements, or potential risks. They may not understand informed consent forms, and they may be unable to ask or understand answers to questions.
If non-English-speaking subjects are included in a study, written communications including informed consent forms should be translated into the subjects' languages. When informed consent forms are administered in a language other than English, then COUHES requires that the non-English version be certified as a true and accurate translation of the English version. This certification should be submitted with the application.
When information is communicated orally, or consent is obtained verbally in the subject's language, the subject and a witness should sign forms to confirm that adequate information has been provided.