Are you submitting a consent form and/or other study materials in a language other than English?
The IRB has special requirements for investigators doing research in non-English-speaking populations. If the PI anticipates enrollment of non-English speakers at the time of initial submission, the PI must submit translated copies of consent forms, study information sheets, brochures, diaries, and any other items that will be provided to subjects. The submission must also include a certification of translation, which documents the name and credentials of the person or company doing the translation and confirms the documents are an accurate translation. Submissions that don’t include these items will result in a contingency.