Subjects who have limited English proficiency should be presented with an authorization in a language understandable to them that includes all required elements and statements for use and/or disclosure of their PHI. Persons with limited English proficiency are individuals who do not speak English as their primary language and/or who have a limited ability to read, speak, write, or understand English.

For research involving targeted populations that have limited English proficiency, the use of a written translation of the approved long form consent/authorization document is required. The translated consent/authorization must be approved by the IRB.

If the IRB approves the use of a short form consent, researchers should either use the Spanish translation of the stand-alone HIPAA Authorization for Spanish speakers, or in all other cases request an altered authorization to permit an oral presentation of the HIPAA authorization elements, without signed authorization from the subject or their LAR. Researchers should provide a written summary of what will be discussed. See Enrolling Participants with Limited English Proficiency for more information.