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If a site enrolls a subject who cannot read and understand English, does the informed consent document need to be translated into the subject’s native language?

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If a site enrolls a subject who cannot read and understand English, does the informed consent document need to be translated into the subject’s native language?

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Yes. The informed consent document must be provided in a language understandable to the study subject. For more information, please see Translations and Safeguards for Vulnerable Subjects.

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