Federal regulations and UAMS IRB practices require informed consent information to be in language understandable to the subject. While there has been much debate about what, exactly, “understandable to the subject” means, we generally assume it to mean that people who don’t speak English well should have consent information presented to them in a language they do understand.
But what about HIPAA authorizations? Many studies that involve a consent process also involve protected health information, for which a HIPAA authorization must be signed if you’re getting written consent. While the short form consent process is available for consenting, there’s no equivalent short-form process for getting HIPAA authorizations signed.
We’ve received confirmation that the HIPAA authorization form itself does NOT have to be in a language understandable to a non-English-speaking subject. Therefore, it is appropriate for the translator presenting the consent information to also present the HIPAA information based on the approved English-language consent HIPAA form. The subject can then sign the English-language HIPAA form.