On a recent monitoring visit, the coordinator asked an IMARC monitor if the study sponsor could have their consent translated into Spanish. However, the site had one caveat – their IRB also required a “back translation” of the translated consent. Why would the IRB require this back translation?
Back translation is the process of having the consent translated into another language, and then having a separate (typically non-affiliated) party who is unfamiliar with the original consent and the study itself, translate the translated consent back into English. The back translated consent can then be compared with the original English consent to ensure there were no mishaps in translation and that the translated consent shares the same meanings as the original.
Why would an IRB require a back translated consent? As stated in section 50.20 of the federal regulations , "The information that is given to the subject or the representative shall be in language understandable to the subject or the representative”. IRBs are required to guarantee that all information given to subjects as part of informed consent is in accordance with the regulations (section 56.109).
Further instruction by the FDA was included in the Guide to Informed Consent - Information Sheet, published by the FDA in 1998, which notes “When the study subject population includes non-English speaking people or the clinical investigator or the IRB anticipates that the consent interviews will be conducted in a language other than English, the IRB should require a translated consent document to be prepared and assure that the translation is accurate.” How the IRBs ensure accurate translation is not specified, but rather left to each individual IRB.
In the monitor’s experience, the majority of IRBs require that a consent is translated by a qualified translator. Some may require the translator be certified or that the translator provide documentation certifying that the translation is consistent with the IRB-approved consent. Requiring back translation makes sense because while the IRB may have documentation that the translator was qualified, unless they speak that specific language, they can’t guarantee that the consent was translated accurately. With back translations, they are able to verify this by comparing the back translated consent to the English consent, which should be nearly identical. Additionally, translating a document can be tricky – each language has its own nuances. Having two people review the consent reduces the chances of incorrect language being added.
Have you had any experience with back translated consents? Are they an efficient way to assure the translation is accurate or a useless step? Tell us your thoughts in the comments below.
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