Short Form Consent for Non-English Speaking Participants

The IRB Policy Committee has approved a policy on use of the short form consent process for non-English speaking participants.  For more information on the use of short form consent for non-English speaking participants, see HRPP policy Short Form Informed Consent.

The Short Form Consent may be used when all of the following apply:

1. The participant or legally authorized representative does not speak or understand English,
2. The participant or legally authorized representative speaks only a language(s) that was not anticipated in the study population or location (i.e., “unexpectedly encountered”),
3. An appropriately translated consent form in the participant’s language has not been approved by the IRB, and
4. There is not adequate time for preparation and IRB review and approval of a translated consent form.

When the short form consent is used, an interpreter provides an oral translation of the complete English language informed consent, and a witness fluent in both English and the language understood by the prospective participant (typically the interpreter if the interpreter is not the person obtaining consent) must be present. The process includes special signature requirements, and the participant must receive signed and dated copies of all documents. Following use, the investigator must obtain an IRB-approved translation of the full informed consent document(s) and provide the document(s) to the enrolled participant within a reasonable time, usually within 90 days following use of the short form. (Refer to the policy for additional information.)

Investigators should carefully consider whether sufficient resources exist to assist with questions the participant may have during the informed consent process or during participation in the research before enrolling a non-English speaking participant using the short form consent process.

The short form consent is available in the following languages:

• English (for reference only)
• Arabic
• Cebuano
• Chinese (Simplified)
• Chinese (Traditional)
• French
• German
• Japanese
• Khmer
• Korean
• Laotian
• Nepali
• Russian
• Somali
• Spanish
• Swahili
• Vietnamese

These translations are available in part through funding from The Ohio State University Comprehensive Cancer Center. Upon demonstrated need, additional translations of the short form consent may be provided by ORRP. To recommend additional languages, please contact ORRP.

Regulatory Guidance

• Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English (OHRP)
• Informed Consent for Non English Speaking Subjects (FDA Information Sheet)