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If a researcher intends to enroll subjects who do not adequately read the English language, informed consent documents should be translated into a language comprehended by the potential subjects.
The English version of approved study documents, including informed consent documents, should be approved by the IRB before the documents are translated into languages other than English. This will avoid duplicate work in case modifications have to be made to the English versions before they are approved by the IRB.
Once the English documents have been approved by the IRB, the investigator may create documents in other language(s) intended for use. The translated documents must be approved by the IRB before they may be used. Documents are eligible for IRB approval if translated under the following policies [NOTE – Only for studies whose management has been outsourced to Western Institutional Review Board (WIRB), the applicable translation policy is that defined by WIRB]:
1) The translation may be made by a certified translator approved to conduct such business by the university. Such translations must be accompanied by a signed translator certification statement including the date of the translation. This process may be used all studies but it is required for studies involving an IDE or IND. This requirement for certified translations for FDA research involving drugs or devices is consistent with the FDA requirement that a translated document be accompanied by an "Affidavit of Accuracy”
2) The translation may be made by a “back translation” method (see below) for submission to the IRB. This process may be used for all studies that do not involve an IDE or IND.
3) The translation may be made by a qualified translator. Included in these qualifications is that the translator be fluent (i.e. can speak, read and write) in the language. The translator must attest that the translated informed consent accurately reflects the IRB-approved English informed consent and provide the date of the translation. The translator must also submit to the HSRO a signed statement describing his/her qualifications to make this translation from one specific language into another. This process may be used only for studies that are approved by the IRB as 'exempt'. [NOTE – The signed statement should define that the translation is true, accurate, and correct "to the best of my knowledge and ability".]
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