Study related documents (e.g., the informed consent document, the HIPAA authorization, a survey) must be presented in a language understandable to the subject. Two methods of translation are acceptable to the HSPP/IRB. The preferred method is that the document be translated by a professional translation service that will attest to the accuracy of the translation. The second is the use of back-translation into English. In this scenario
- the English version of the document is translated into the foreign language,
- the name and credentials of the individual who did the translation are provided to the IRB by the investigator,
- another individual who has not seen the English version of the document translates the foreign language document back into English,
- this individual provides his/her name, credentials and a statement that s/he has not seen the original English version to the IRB via the investigator,
- both English versions of the form and the foreign language version are submitted to the IRB for review, and
- the IRB will compare both English versions of the documents.
If the IRB determines the translation is accurate the foreign language document will be approved for use.
The informed consent process must also be conducted in a language understandable to the subject and may therefore require the use of a translator. The translator may be a family member or friend of the subject, an employee of the institution or may be hired by the principal investigator.
Obtain Approval of English Versions First
Although you are not required to do so, you may want to obtain approval of the English version of your documents before you go through the process of having them translated. In this manner, if the IRB requires changes to the English version in order to secure approval, you will not have to go through the translation process again. If you plan to obtain approval for the English version documents first you should indicate this on the IRB Application Checklist that translated documents will be submitted for approval via a request for addendum/modification before they are used with subjects.
The PI is responsible for covering the cost of the translation. The cost of the translation will not be incurred by the subjects.