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The organization requires consent materials to be written in language that will be understandable to the participant population(s). For research conducted in the U.S., the JHM IRB will require principal investigators who will recruit known populations of non-English speakers to have consent materials translated into the language most commonly used by the target study population. For research conducted in other countries, the JHM IRB will require the PI to the document when English is not the primary language. In such cases, the PI must provide the translated consent materials in the local language(s).
The investigator may submit both the English version of the informed consent document and any translated informed consent documents needed for the study along with a Certificate of Translation. However, since any changes made by the JHM IRB to the submitted English version of the informed consent document must be included in the translation of the informed consent document, investigators are advised to have the translation completed after JHM IRB approval of the English version of the informed consent document.
The JHM IRB will accept translated documents from consultants or other individuals who provide certification of their expertise in the specific language.