Is an English consent document OK when enrolling non-English-speaking subjects?
Study subjects are given a copy of the consent to be used as a reference document to reinforce their understanding of the study and, if desired, to consult with their physician or family members about the study. In order to meet the requirements of 21 CFR 50.20, the consent document must be in language understandable to the subject. When the prospective subject is fluent in English, and the consent interview is conducted in English, the consent document should be in English. However, when the majority of anticipated study subjects are non-English-speaking people, and it is anticipated that the consent interviews are likely to be conducted in a language other than English, the PI should submit a translated consent form for IRB review. A copy of the translated consent document must be given to each appropriate subject. While a translator may be used to facilitate conversation with the subject, routine ad hoc translation of the consent document may not be substituted for a written transla
