When To Translate Informed Consent Forms
If English speakers struggle to understand the language of Informed Consent Forms, imagine the difficulty that exists for people with limited English proficiency (LEP). The US Food and Drug Administration (FDA) (21 CFR 50.25 and 21 CFR 50.27) and the US Department of Health and Human Services (45 CFR 46.116 and 45 CFR 46.117) both require Informed Consent Forms be translated for all LEP patients.
Sometimes a short form of the informed consent form may be translated and given to the participant in place of the full version of the Informed Consent Form. A short form translation should only be given when there is little risk and a direct benefit to the participant in the study or procedure.
Informed Consent Form Translations Must Be Coordinated to a Patient’s Level of Understanding
Regulations state that Informed Consent Forms must be in a language that the participant understands. This means it must be written clearly in plain language. When translated, ICFs must also be in plain language in the target language. This means that having a high level surgeon or specialist doctor perform the translation is not necessarily the best choice. The usual choice is to have the Informed Consent Form translated by a translator experienced in medical translation.
Informed Consent Form Translations Almost Always Require A Certificate Of Accuracy
In most instances the Institutional Review Board (IRB) must review and approve all translated versions of an informed consent form before it is used in a study. As part of the review and approval process and in order to satisfy most IRBs, Informed Consent Form translations must be submitted along with a certificate of translation accuracy. The Certificate of Translation Accuracy verifies that certified linguists were used and that a process (preferably a certified process) was employed while performing the translation.
Back Translation Is Sometimes Required
Back translations are often done when translating Informed Consent Forms to assure that the translation is accurate. If a clinical trial is complicated or has associated risk, the Informed Consent Form should undergo back translation as part of the translation process. Back translations provide an additional quality assurance step. Back translation involves taking the translated version of the Informed Consent Form and then having a separate independent translator (who has no knowledge of or contact with the original text) translate it back into the original language. A project manager will then assess the two versions to see if they are consistent and that nothing was lost in translation. Forward and back translations should all be performed by qualified translators, and sometimes both the forward and back translations are required to be submitted to the Institutional Review Board (IRB).
