When research activities will be conducted in a language other than English, in addition to reviewing and approving all protocol materials in English, the IRB must approve the use of translated consent materials (e.g. consent forms to be signed by participants, and consent scripts used with verbal consent processes). In order to approve the use of translated consent materials, the IRB must know the name and qualifications of the individual/service translating the written materials and verbal consent process. In addition, if a translator is used for any other portion of the research, their qualifications must be reviewed and approved by the IRB. This information must be included in Section I of the Research Plan. If the name and qualifications of the translator is not known when the researcher submits the initial application, the researcher must submit an amendment with that information (along with the translated consent materials, if they have not already been submitted). Translator qualifications must be approved by the IRB before translated information is conveyed to participants.
It is common for researchers to be required to revise consent materials during the IRB review and approval process. Therefore, researchers may provide translated consent materials in their initial IRB application, or may provide them after the English version of the consent materials have been approved.
When research is conducted in a language for which no written version exists, the researcher is expected to explain this in relevant sections of the Research Plan, and to provide translator information as described above.