Subjects who have limited English proficiency should be presented with informed consent information in a language understandable to them that includes all the required and additional elements for disclosure. 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 document is required. With prior IRB approval, a short form consent documentation process is available for documenting consent when an individual with limited English proficiency is encountered unexpectedly and an IRB-approved translated long form consent document is not available. If unexpected enrollment of these subjects happens repeatedly, the IRB may require translation of the long form consent document / translation of the long form consent should be considered. Review the HRP-317 – WORKSHEET: Short Form of Consent Documentation.

  • Written translation of long form documents: The IRB must review and approve all non-English language versions of long form consent documents for a particular study prior to use.
    • For long form consent document translations, the investigator may wish to delay translation service until IRB approval is granted for the English version to avoid extra translation costs. The IRB must have all versions of the research materials (e.g., recruitment informed consent form(s), instruments) in both English and Non-English on file.
    • The translation of a consent document must be made by a reliable source.
    • The IRB may request verification of a back-translation process by an individual who is not associated with the research to confirm the accuracy of the translated document.
    • The investigator must provide the credentials (qualifications, skills or experience for carrying out this role) of the individual(s) or service(s) that were used to translate (and back translate, if applicable) the consent documents.
  • Written translation of short form documents:
    • If you will use the translated short forms posted in the Toolkit Library, you do not need to submit these forms for IRB approval.
    • Translated short forms from the following sites also do not need to be submitted for IRB approval, unless the study is approved for subjects lacking consent capacity (in which case, you should submit the short form to the IRB):
    • Translated short forms not from the IRB website or the other approved sites above must be submitted for IRB approval prior to use.
    • If you are not using a translated short form from UW’s Toolkit library, you must include within the English summary that is provided to participants contact information for the study team and the HRPP’s confidential compliance hotline (see the UW’s English short form under Who can I talk to? for example language).
  • Short form consent documentation process: The short form documentation process may be used when an individual with limited English proficiency is encountered unexpectedly, and no translated long form is available. For this process the following are required:
    • Include potential enrollment of participants with limited English proficiency in your protocol or IRB application at the time of initial submission to the IRB.
    • Submit a change of protocol application in ARROW for IRB review. You can submit this as an expedited change, as long as there’s no increased risk and the change meets criteria in HRP-313 – Worksheet – Expedited Review for a minor modification to previously approved research. The change of protocol application and revised protocols/applications should describe safeguards and accommodations for the added population(s) as well as the consent process for the population. If the change is time-sensitive, please indicate this in the change workspace when submitting and email AsktheIRB@hsirb.wisc.edu to inform the IRB of the forthcoming time-sensitive submission.
    • Oral presentation of the research in a language understandable to the subject or the subject’s Legally Authorized Representative (LAR) by an interpreter
    • A short form consent document in the subject’s or LAR’s language
    • A written summary of the information that is presented orally (the IRB-approved English language long form consent document may serve as a summary).
    • If HIPAA applies to the study, oral presentation of HIPAA authorization elements, as well as a request for Altered Authorization to present the information orally and not obtain signature from the subject or subject’s LAR. (except no altered authorization is needed when using the stand-alone HIPAA Authorization that has been translated to Spanish). See: Authorization & Participants with Limited English Proficiency.
    • A witness fluent in both English and the language of the subject or subject’s LAR is present for the oral presentation. The witness is someone who is not involved in the research. When the person obtaining consent is assisted by a qualified interpreter or translator, that individual may serve as the witness if they are not involved in the research.
  • Signatures required for the short form consent documents:
    • The subject or representative signs and dates the short form consent document.
    • The individual obtaining consent signs and dates the summary.
    • The witness to the oral presentation signs and dates the short form consent document and the summary.
    • Copies of the signed and dated consent document and summary are provided to the subject or representative.

For more information, refer to HRP 090-SOP-Informed Consent Process for Research, HRP 091-SOP-Written Documentation of Consent, and HRP-317-WORKSHEET-Short Form of Consent Documentation.