Limited English Proficiency Overview

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.

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Interpreters

Interpreters facilitate spoken and sign language communication between speakers who use different languages. Unless the study team includes bilingual personnel who are able to communicate effectively in a participant’s non-English language, the study team must use the services of an interpreter fluent in both English and the language understood by the LEP participant. Interpreters may provide services in person, by phone, or via videoconferencing. For information about interpreter resources, see Resources for oral interpretation and written translation.

When is an Interpreter Needed?

• For studies occurring within UW Health facilities, study teams should rely on the “Interpreter Required” field in the Health Link record. If this field in a patient’s record indicates that an interpreter is required, study teams should use an interpreter, and IRB requirements regarding participants with LEP apply. For studies involving children, use an interpreter if the child or the parent(s) require one.
• For studies occurring within other health care facilities (e.g., Meriter), study teams should familiarize themselves with and follow those facilities’ policies regarding when an interpreter is needed.
• For all other studies, study teams should use an interpreter when a participant requests one, and also in situations where, based on interaction with a participant, the study team feels that an interpreter is needed for effective communication.

Who can serve as an interpreter?

• Studies occurring within UW Health facilities requires the use of interpreters deemed qualified by the UW Health Interpreter Services Department. If UW Health patients and/or their representatives feel strongly that a family member or friend should be used in lieu of a qualified medical interpreter, UW Health reserves the right to have a qualified medical interpreter present to ensure accurate communication of information between the study team and patients. See UW Health Policy 3.3.4, “Interpreter Services and/or Language Assistance” for details.
• For studies occurring within other health care facilities (e.g., Meriter), study teams should familiarize themselves with and follow those facilities’ policies regarding who may serve as an interpreter.
• For all other studies, the use of professional interpreters or bilingual staff is strongly encouraged, and is required for research that is more than minimal risk or is sensitive. Use of a professional interpreter will help to minimize risks of misunderstanding. Use of a family member or friend of the participant/representative to interpret is discouraged, even for minimal risk or non-sensitive research. Study teams should provide justification in their IRB application or protocol for any plan to use a family member or friend of the participant/representative to interpret.

See Resources for oral interpretation and written translation for more information.

Role of an interpreter

An interpreter’s role in the research setting is to facilitate communication between the study team and the participant by conveying what the study team says in a language the participant understands. It is the study team’s responsibility to present the information they want the participant to know, in a manner that is understandable to participants. Study teams should not ask an interpreter to independently interpret a written document such as a consent form. Instead, the study team member responsible for conducting the informed consent discussion should orally present information about the study, using the consent form as a guide, while the interpreter communicates what the study team member says to the participant and what the participant says to the study team member. For detailed guidance on conducting a consent discussion, see HRP-090-SOP: Informed Consent Process for Research.

Bilingual Study Personnel

If the study team includes personnel who are fluent in a language understood by the participant with LEP, and whose roles include recruiting, obtaining informed consent, or interacting with participants, they may communicate directly with those participants with LEP without an interpreter.

• UW Health allows communication without an interpreter only for personnel who are qualified as bilingual by the Manager of Interpreter Services (see UW Health Policy 3.3.4, Interpreter Services and/or Language Assistance for more information).
• UW Health bilingual personnel are not allowed to serve as interpreters for other staff.

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Informed Consent Processes for Participants with LEP

Individuals with limited English proficiency must receive informed consent information in a language understandable to them, using a consent process that allows for effective exchange of information between the potential participant and the research team, and (when applicable) documents the participant’s agreement to take part in a study. Study teams should follow the detailed, step-by-step guidance in HRP-090-SOP: Informed Consent Process for Research for conducting a consent process with individuals who have LEP and the guidance in HRP-091-SOP: Written Documentation of Consent when documenting informed consent.

Understandable consent information may be provided to participants with LEP using a written translation of the study-specific “long form” informed consent document, or a “short form” process to document informed consent. For studies with an approved waiver of documentation of consent, the IRB may approve an oral consent process in the participant’s language using a consent script.

Written Translation of Long Form Consent Documents

“Long form” consent refers to a study-specific, written informed consent document that includes all applicable regulatory elements (see HRP-314-WORKSHEET: Criteria for Approval).

The IRB requires written translation of the long form consent document into the relevant non-English language(s) when a study team:

• Is recruiting participants likely to speak and read a non-English language and to have LEP.
• Has conducted a short form consent process three times in the same language.

The IRB encourages written translation of the long form consent document when a study team:

• Encounters an eligible participant with LEP and the enrollment window allows time to translate the long form and have it approved by the IRB before the consent process occurs.
• Uses a short form consent process to obtain initial informed consent for a study with multiple visits. The long form consent may be translated into the participant’s preferred language and provided to the participant after enrollment.
• For FDA regulated studies, FDA Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors advises fully translating the long form consent document, either before the consent process takes place, or after a short form consent process is used.

The IRB must approve translated long form consent documents prior to their use, via a change of protocol. See IRB approval required prior to enrolling individuals with limited English proficiency.

Short Form Consent Documentation

With “short form” consent documentation, a research team presents study-specific consent information to a potential participant orally through an interpreter and in the presence of a witness, basing the presentation on a written summary (usually the approved English long form consent document). The “short form” is a brief document in the participant’s language that outlines the elements of informed consent to be covered during the consent discussion; it is not study specific. The participant with LEP documents consent by signing the short form. See HRP-317-WORKSHEET: Short Form of Consent Documentation for details.

The IRB may approve a short form consent process if, when designing the study, the study team does not know if they will encounter potential participants with LEP, or cannot predict the languages needed, and the study team explains why it would not be feasible to translate the long form consent document if they encounter a potential participant with LEP.

Requirements and Resources for Short Form Consent Documents

The IRB must approve a study’s use of short form consent documentation prior to its use. If not approved at a study’s initial review, the study team can add a short form process via a change of protocol. (See IRB approval required prior to enrolling individuals with limited English proficiency.)

• The short form consent process requires the presence of a witness and has specific signature requirements. For details, see HRP-317-WORKSHEET: Short Form of Consent Documentation, HRP-090-SOP: Informed Consent Process for Research, and HRP-091-SOP: Written Documentation of Consent. Also see “Addressing witness requirements” below.
• Translated short form consent documents are posted in the UW IRB’s Toolkit Library. Studies approved by the IRB to use a short form consent process may use these translated documents without additional IRB approval; these short forms do not need to be uploaded in ARROW.
• Studies approved by the IRB to use a short form process may also use translated short forms from WCG IRB and the University of Utah, which are available in a wide range of languages. These short forms need to be submitted for UW-Madison IRB approval only if they will be used with participants who lack consent capacity, in which case the signature lines need to be modified to accommodate an LAR signature. Translated short forms from a source not included above must be submitted for IRB approval prior to use.
• For any translated short forms from a source other than UW IRB’s Toolkit Library, the English-language long-form consent provided to participants as a summary must include contact information for the study team and the HRPP’s confidential compliance phone line (see the UW’s English short form under “Who can I talk to?” for example language).
• A study may use the short form process up to three times for the same language. Prior to conducting another consent discussion in that language, the study team should submit a change of protocol including the translated long form consent document and revising the consent process to describe using the translated consent form with speakers of that language. Once approved, the translated consent document should be provided to any active participants who speak that language, for their reference. The study team may continue using the short form process with participants who speak a different language.

Addressing Witness Requirements for the Short Form Consent Process

When a short form process is used, an impartial witness must be present during the entire consent discussion. See HRP-090-SOP: Informed Consent Process for Research for a definition of the witness’s role in the consent process.

Guidance from the Office of Human Research Protections (OHRP) and the FDA states that the witness should be fluent in English and in the LEP participant’s language and should be independent of the study team. An interpreter who interprets the consent process in person may also serve as the impartial witness.

Unless the IRB has approved a waiver of signed consent for the study, the witness signs the short form and the written summary (usually, the English long-form consent document). However, when an interpreter participates remotely by phone or video, the interpreter is unlikely to be able to sign the consent documents. In cases where an interpreter does not sign as the witness:

• A bilingual family member or friend may serve as the impartial witness if the study is no more than minimal risk, does not involve a medical intervention, and does not involve sensitive information.
• Another individual independent of the study team may witness the consent discussion. If this witness is not bilingual, the witness should confirm with the participant (through the interpreter) that their questions were answered.

HIPAA requirements and participants with limited English proficiency

See Authorization & Participants with Limited English Proficiency for guidance on obtaining HIPAA authorization.

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Resources for Oral Interpretation & Written Translation

Within UW Health Facilities:

• Only interpreters who are deemed qualified by the UW Health Interpreter Services Department are authorized to interpret at UW Health. UW Health Interpreter Services provides interpreters free of charge for faculty within SMPH and/or recruiting UW Health patients within UW Health facilities. Interpreters may be in-person or via phone or video conferencing. To request an interpreter, contact Interpreter Services through one of the options listed here.
• UW Health allows communication without an interpreter only for personnel who are qualified as bilingual by the Manager of Interpreter Services (see UW Health Policy 3.3.4, Interpreter Services and/or Language Assistance for more information). UW Health bilingual personnel are not allowed to serve as interpreters for other staff.
• Written translations of long form consent documents and other subject-facing materials into Spanish may be arranged through Interpreter Services for a cost. Interpreter Services can provide a quote for translating documents.

When Not in UW Health Facilities or For Translations Other Than Spanish:

• For purchases of interpreter or translation services that will cost $5,000 or less on a study, investigators may use any vendor they choose and may pay for those services through a number of mechanisms (e.g., purchase order, P-card, direct pay).
• Purchases of services that will cost more than $5000 for a study require use of vendors contracted with the Wisconsin Department of Administration (DOA). DOA offers interpreters and translators that can be accessed by UW employees, including for medical-related interpretations and translations. These vendors may be used for purchases regardless of cost ($5000 or less, as well as more than $5000).
• Use of interpreters or translators for studies covered by HIPAA and that will include PHI must be subject to a Business Associate Agreement (BAA). Many DOA vendors have entered into BAAs. This information can be found on the “Vendor Information Sheets” as described below.

How to Find Translators and Interpreters Who Are Approved Vendors:

• The vendors listed here have contracted with UW-Madison for American Sign Language services, but many also offer interpreter and translation services for other languages. Because the UW contract is for American Sign Language, if used for languages other than ASL, these vendors may ONLY be used at this time for interpreter and translation purchases costing $5,000 or less.
• To find DOA contracted vendors, go to VendorNet, and click on “Contracts” at the top of the page. Using the “Keyword or Number” search function, search for “interpreter” or “translation.” This will yield lists of vendors categorized by in-person interpretations, telephone interpretations, video remote interpretations, or written language translations. After selecting the type of service you want (e.g., Telephone Interpretation Services), you will see a list of available vendors.
  • Review the Contract Applicable To information to ensure it can be used by UW System and its campuses.
  • Near the bottom of the page, there is a Documents section that includes a link for “Vendor Information Sheets”. This excel spreadsheet has a tab for each vendor, and provides specific information on how to access services, what languages are offered, whether there is a BAA in place, and whether medical and scientific interpretations or translations are available.
  • As noted above, because these are contracted vendors, they may be used for purchases regardless of cost ($5,000 or less, or more than $5,000).
• If you believe your purchase will exceed $5,000 and you wish to use a vendor not contracted for such services, contact a UW Procurement Specialist for assistance.

Vendor Agreements:

Any purchase orders or other written contacts with vendors, even for those listed above, must be signed by UW’s Purchasing Services. For questions, please contact a UW Procurement Specialist.

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