The following guidelines apply when translating study-related documents into non-English languages. For translation resources, see the Resources for oral interpretation and written translation section. For detailed guidance on informed consent, see Informed consent processes for participants with limited English proficiency.

• The IRB must review and approve each non-English language study document prior to its use.
• To avoid extra costs and delays, it is advisable to obtain IRB approval for the English version of study documents before translating them.
• Study documents must be translated by a reliable source (e.g., professional translators or bilingual staff). For studies that involve more than minimal risk to participants, especially those that include medical treatment and/or procedures, researchers should use a professional translation service with appropriate expertise.
• The IRB may request a back-translation process by an individual not associated with the research to confirm the accuracy of the translated document.
• The study team must provide the credentials (qualifications, skills or experience for carrying out this role) of the individual(s) or service(s) used to translate study documents (and back translate, if applicable).