Must informed consent documents be translated into the written language native to study subjects who do not understand English?
The signed informed consent document is the written record of the consent interview. 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 study subject population includes non-English speaking people so that the clinical investigator or the IRB anticipates that the consent interviews are likely to be conducted in a language other than English, the IRB should assure that a translated consent form is prepared and that the translation is accurate. A consultant may be utilized to assure that the translation is correct. A copy of the translated consent d
Related Questions
- 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?
- Must informed consent documents be translated into the written language native to study subjects who do not understand English?
- Can subjects undergo screening or study procedures prior to giving written informed consent?
