When is a translation needed?

If a sponsor or site anticipates any non-English speaking individuals will participate in a Quorum Review IRB approved protocol, then translation of the informed consent document and participant recruitment material(s) into a language understandable to the individual is required. This requirement is in compliance with applicable regulations which state that an informed consent document should be in an understandable language to the subject (or authorized representative). Also, before a site requests translation of study documents, the site must confirm the sponsor/protocol allows enrollment of non-English speaking participants.