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 a modification 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.

The IRB will consider translator qualifications on a case by case basis. Please provide the IRB with enough detail about the translator's qualifications for the IRB to make a determination that the translator has appropriate qualifications. The IRB review will consider what medical background, if any, would be appropriate based on the risks and complexities of study activities. 

Who is a qualified translator?

Using a professional translation service or a certified translator is ideal but not always possible. The following are some general considerations regarding appropriate translator qualifications:

• The translator should be fluent in the languages they are translating to/from and should not need to rely on tools such as Google translate. 
• When the study involves jargon or scientific/medical terminology, the translator should have sufficient understanding of those terms to provide an accurate translation. For example, someone with no medical background should not be asked to translate a complicated clinical trials consent form if they need to have a good understanding of medical terminology in order to provide an adequate translation of the informed consent details.
• The Principal Investigator (PI) of the study is ultimately responsible for ensuring participants are appropriately consented and understand the information provided to them during the consent process. The PI will need to be familiar with the translator's qualifications and determine that the translator is qualified and able to provide an accurate translation understandable 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.