Is an English consent document acceptable when enrolling non-English-speaking subjects?
Study participants must be given a copy of the consent to be used as a reference document and to reinforce their understanding of the study. Regulations require that the consent document must be in language understandable to the participant. When the prospective participant is fluent in English, the consent document should be in English. However, when the participant is non-English-speaking, the PI should submit a translated consent form for IRB review along with a certification from the translator that the English and non-English versions are the same. While a translator may be used to facilitate conversation with the participant, routine ad hoc translation of the consent document may not be substituted for a written translation.
