The informed consent should not be translated into another language until the English version has been finalized by New England IRB.
If you have a subject who does not understand or is not fluent in English, please notify NEIRB and NEIRB will arrange to have the consent form translated. If you wish to use your own translation service, the translated consent form should be submitted to New England IRB in both hard copy and electronically in MS Word. The certification of the translation must also be submitted.
If the informed consent template is being translated for a multi-center study, New England IRB will issue a site-specific translated consent to each site that requests one.
If the consent form is being translated, other subject materials that will be read by subjects (subject instructions, diaries, etc.) should also be translated.