Translation

Per federal regulations, the consent process and documents as well as study-related documents (e.g., survey instrument, medical release forms) for participants not fluent in English must be presented in a language (preferably native) understandable to them. If it is expected that participants who do not speak English will be enrolled in a study, translated documents should be made available.

PIs will need to list the language(s) in which the research will be conducted on the protocol and indicate whether a member of the research team is fluent in the language of the potential participants so that questions or concerns of the participants may be appropriately addressed.

The IRB must approve non-English language versions of written or oral consent documents and all survey instruments as a condition of approval under 45 CFR 46.117(b)(2) paying careful attention not only to the accuracy of the translation, but the level of understanding of the subject population, as well as any cultural elements specific to the population. For specific requirements, please refer to the IRB Translation Policy and Procedures manual.