Study teams are strongly encouraged to design their research to include participants with limited English proficiency (LEP). Including those with LEP will improve the generalizability of the research and provide equitable opportunities to participate in research, especially if the research offers potential direct benefit to participants. Studies recruiting from the community at large are encouraged to recruit and enroll a diverse population, including those with LEP, and provide appropriate support for those who choose to participate.

Note: For the purposes of this guidance on LEP, “participants” includes both study participants and their legally authorized representatives.

IRB Approval Required Prior to Enrollment

To ensure appropriate support and consent processes for participants with LEP, study teams may only enroll these individuals if their approved IRB application or protocol describes including participants with LEP.

Studies that are not initially designed to include participants with LEP may add this population using a change of protocol. The change of protocol application and revised protocol/application should include the information described in the “Information to include in IRB applications / protocols” section below. Changes of protocol adding participants with LEP may be submitted for expedited review as long as there are no increased risks and the change overall meets criteria in HRP-313 – Worksheet – Expedited Review for a minor modification to previously approved research. If the change is time-sensitive, indicate this when submitting and email AsktheIRB@hsirb.wisc.edu to inform IRB staff of the forthcoming time-sensitive submission.

Accommodations and Safeguards

To protect participant rights and welfare and successfully conduct research activities, studies enrolling participants with LEP should:

• Develop plans for effective communication between participants and the study team before, during, and after study visits, including ways for all participants to reach the study team outside of scheduled study contacts and (when applicable) to get medical help in the event of a study related illness or injury.
• Plan and budget for translation of study documents and other related costs.
• Identify how to provide interpreters or bilingual staff throughout study participation.
• Plan appropriate informed consent processes for LEP participants.
• Determine availability of translated standardized assessments or develop methods that enable participants to complete assessments not available in their language.
• Identify any other study-specific accommodations needed to enable full participation in study activities.

Information to Include in IRB Applications / Protocols

This section describes a list of concepts that should be addressed; please review the guidance on pages about interpreters, translations, and informed consent to understand the requirements themselves.

• When using the non-protocol-based application, select “Participants with limited English proficiency” in the Special Populations section. For non-exempt studies, describe the plan for ensuring participants’ understanding of consent information under Q2 on the Consent Overview page. Complete the Limited English Proficiency Consent page; identify how you will translate the consent and other participant-facing materials, and the translator’s qualifications. If HIPAA applies to the study, see HIPAA Processes and Documentation.
• When using a protocol-based application, describe in the study protocol the inclusion of LEP participants; how the study team will ensure adequate communication with participants throughout the study, including use of interpreters; how written study materials such as questionnaires, medication diaries, or sample collection instructions will be made accessible to LEP participants; and the consent and consent documentation process(es) to be used with LEP participants. See sections 6.0, 8.0, and 9.0 in the HRP-503 Biomedical Protocol Template for additional guidance. If HIPAA applies to the study, see HIPAA Processes and Documentation.
• Obtain IRB approval for English-language study documents (e.g., recruitment materials, informed consent form(s), instruments like questionnaires) before translating them into other languages. Translated documents may be submitted with a change of protocol after initial IRB approval of a study. Translated documents must be approved by the IRB before they can be used.