In the event that a student`s population is not English-speaking or the clinical examiner or IRB considers the approval interviews to be conducted in a language other than English, the IRB should need a translated agreement document to be prepared and ensure that the translation is correct. In accordance with 21 CFR 50.27, a copy of the consent document must be provided to each applicant. For non-English speaking subjects, this would be the translated document (from the FDA website). For human research, informed consent (with limited exceptions) is necessary both ethically and legally. As part of this requirement, information about studies must be presented “in language that is understandable to the subject.” 1-3 The Office of Human Research Protections strongly recommends providing non-English speakers with approval documents written in their own language4.4 Creating consent documents in languages other than English and ensuring that they are understandable to participants can be a major challenge. In order to document the approval process, the HRP recommendations are consistent with FDA-approved guidelines set by the International Conference on Harmonization (E-6 4.8.9). If the subject (or the law-authorized representative) orally agrees to participate in the study: Given the subjective nature of the language and the ability to communicate the same relative meaning in different ways, we used a conservative approach to identify problems with translations. Nevertheless, the examples we point out here illustrate the potential problems; some Spanish speakers may agree with our classification of certain translations as problematic. Furthermore, this assessment is not clear as to the effects of translation errors. We cannot say, for example, to what extent the omission of “please” shifts the tone of the approval form in an important way for all Spanish-speaking subjects, or the use of more technical terms and complex sentences reduces understanding of the subject; these are important areas for future research.
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