Yes, if potential participants are non-English speaking or the clinical investigator or IRB
anticipates that the consent interviews will be conducted in a language other than English,
the IRB should require investigators or sponsors to prepare translated consent documents.
FDA recommends that the IRB review, and if appropriate, approve procedures for
ensuring that the translations will be prepared by a qualified individual or entity.
However, FDA will not provide translations of the statement. We have written the
required statement to use simpler language and do not believe that the statement will pose
translation difficulties.