Guidance

Research Participants with Limited English Proficiency, Low Literacy, Vision Impairments, or Hearing Impairments

IRBMED
Mar 2, 2022 4:45 pm

Some potential research participants may not fully comprehend written and/or verbal communication about a study because of, for instance,

  • limited English proficiency (LEP): insufficient understanding of English;
  • Illiteracy or low literacy: a reading level below that presumed by study document(s);
  • vision impairments; and/or
  • hearing impairments. 

This guidance addresses opportunities to improve information comprehension and to reduce barriers to the informed consent process.

Note: This guidance page does not address seeking consent from participants who

  • are cognitively or decisionally impaired; or
  • may be vulnerable to coercion or undue influence.

On these topics, consult HRPP Operations Manual Part 7.II and Part 11.II.A.1; and IRBMED SOPs Part 7.II

  • Background

    Informed, voluntary consent from participants is critical to the ethical conduct of human research (although for some studies it is appropriate that consent be waived or altered, or that a legally authorized representative  provides consent). Informed consent does not simply mean that a form is signed, but rather that steps are taken to assure an individual’s decision to participate is

    • based on sufficient and relevant knowledge of the study (including but not limited to the effects of study participation on the participant directly, and whether/how the study results may impact treatment or public policy in the future); and
    • a free choice by the participant, made without external pressure from the study team or others.

    Research teams are responsible for helping potential participants overcome barriers to communication, such as by providing

    • a verbal interpreter for informed consent discussion(s); and
    • study document(s) in alternate
      • language(s); and/or
      • formats (e.g., large-print format, audio recording).

    IRBMED may also require the investigator to submit a certified translation of the informed consent, or require a witness to attest that information was conveyed accurately and that the participant’s agreement was voluntary. 

  • Statement

    Researchers at Michigan Medicine should generally plan to include members of minority groups and disadvantaged groups in research, as compatible with the research design. Studies may not systematically exclude potential participants with limited English proficiency (LEP), low literacy, or vision/hearing impairments because of inconvenience in

    • translating informed consent;
    • securing an interpreter;
    • converting study documents into an alternate format; or
    • otherwise assuring a participant’s comprehension.

    Exclusion of participants with communication limitations may be appropriate when

    • the study uses instruments/surveys that have not been translated and validated in the alternate language or format; and/or
    • the scientific aim or plan does not otherwise allow for adaptation into an alternate language or format;

    It can be acceptable to exclude a single participant if it is unfeasible to adapt all subject-facing study documents, although making accommodations is more important when the study offers the prospect of direct benefit to the participant.

    When the study team can anticipate multiple potential participants unable to use the usual informed consent process, they should plan for their inclusion. A new decision aid is available to help study teams and the IRB evaluate which studies require such a plan. The protocol should include a plan to manage communications with the participants during all phases of study participation, including in-person communications, telephone calls, or email/text.  An overview of this comprehensive communication plan should be summarized in the IRBMED application. See also IRBMED SOPs Part 3.III.C.6.d.

    Justification for exclusion(s) should be included in the protocol document and referenced in eResearch question 5.5.

  • Michigan Medicine Interpreter and Translation Services

    Interpreter Services (level-2 login or VPN access required) provides medical interpreters to all clinics at Michigan Medicine, including in-person interpretation and over-the-phone interpretation. Medical interpreters are usually free of charge to both patients and providers, including for clinical trials and research activities that occur during clinical care appointments. Follow webpage instructions to schedule in-person interpretation or over-the-phone interpretation.

    Translation Services (level-2 login or VPN access required) translates written materials from one language into another when their office resources permit. Note that in recent years the office has not had resources to devote to research materials. However, researchers can inquire about availability using webpage instructions to request a translation. (Translation Services typically would charges for translating medical research materials. Researchers can request financial assistance from their departments.) 

    If seeking translation for research activity outside of the Michigan Medicine environment or for purposes not otherwise associated with a clinical care visit, consider using a strategic supplier * through U-M Procurement Services.

    * Not all strategic suppliers offer HIPAA compliant services.  If research-related translation needs include Protected Health Information (PHI), please consult with UM-ORSP regarding implementation of a Data Use Agreement before sharing protected health information outside of the Michigan Medicine covered entity.

  • Foreign language study documents

    Verification of Translation Accuracy

    Include with IRB submissions of foreign-language documents an explanation of how translation sufficiency has been assured. For example:

    1. Name and email address of the Michigan Medicine Translation Division Coordinator who facilitated the translation; OR
    2. Certification statement for the translation, including
      • A statement of the translator's qualifications, addressing the required medical/scientific/regulatory expertise (including when a study team member provides translation);
      • A statement affirming the completeness and accuracy of the document;    
      • Identification of the translated document(s) and language;    
      • The translator's name, signature, and date; OR
    3. Back-translation of the document:
      • A separate independent translator (who has no knowledge of or contact with the original text) translates the foreign-language version of the document back into English.
      • Provide name and/or agency for the translator and back-translator.

    Do not use computer programs to translate informed consent documents.

    Board assessment of translation procedures will be made on a case-by-case basis in consideration of the risks and complexity of a given study.

    Short form informed consent document (one-time or rare)

    When it is known that a non-English-speaking potential participant will be encountered and the consenting process will deviate from IRBMED approved study procedures, submit an ORIO ahead of time for “One-time and/or temporary changes” following the directions at Reporting Time-sensitive Modifications, section II.

     If an opportunity arises unexpectedly for seeking consent from a foreign language speaker that is not already accounted for in IRBMED approved study procedures, submit a “Protocol Deviation” ORIO within seven calendar days after the consent process.

    Include with the submission:

    1. How interpretation during the consent conversation was handled.
    2. Whether the participant required/will require any subsequent translation of study documents for ongoing study activity (including ‘re-consent’ if applicable), and if so, the plan for ensuring proper translation.
    3. Uploaded documents:
      • A written summary in English of the oral presentation conducted with the participant. This is usually a copy of the approved English informed consent document.
      • A copy of the 'short form' consent document written in English.
      • A 'short form' consent document written in the foreign language of the anticipated participant(s).
      • Use the IRBMED foreign-language short form templates if there is one for the anticipated language.
      • For other languages, include verification of the document’s accuracy (see heading above) in the IRBMED submission.

    If neither the Michigan Medicine Interpreting Division nor over-the-phone interpretation services can meet the needs of a potential non-English speaking participant, submit an ORIO explaining the incident within 7 calendar days of the event.

    Translating the Full Informed Consent Document

    When the investigator expects enrollment of a particular non-English speaking group, the best practice is to translate the full Informed Consent Document and other vital study documents used with participants (e.g., recruitment materials, surveys, study-related instructions).

    The investigator and/or study budget is responsible for any costs associated with the document translation.

    Submit with a new project or amendment application

    • English version of the full informed consent document(s);
    • Foreign-language version of the full informed consent document(s);
    • Supplementary information/document(s) to verify the accuracy of the translation (see heading above); and
    • As part of the protocol, a plan to manage communications with the participants during all phases of study participation, including in-person communications, telephone calls, or email/text.

    Conducting the informed consent process

    Conduct the participant's informed consent process with the appropriate study team member and a qualified interpreter fluent in English and the foreign language. Whenever feasible, consult with Interpreter Services and coordinate scheduling in advance to assure availability. If scheduling cannot be arranged in advance, availability of in-person interpretation may be limited and over-the-phone interpretation may be a suitable alternative. Family members or others may attend a consent conversation as long as there are no concerns regarding possible coercion or undue influence toward the participant. However, family members or others accompanying the participant should not be used as interpreters except at the specific request of an  individual participant, per 45 CFR 92 (separate guidance applies to research under emergency circumstances).

    Americans with Disabilities Act (ADA) defines a qualified interpreter as someone who is able to interpret effectively, accurately, and impartially, both receptively (i.e., understanding what the person with the disability is saying) and expressively (i.e., having the skill needed to convey information back to that person) using any necessary specialized vocabulary.

    1. If the participant agrees to enroll in the research study,
    2. Obtain signatures as follows:
      • DOCUMENT SIGNED BY
        English ICD
        • Appropriate study team member
        • Interpreter/Witness
        Foreign language document (short form or translated full ICD)
        • Participant
        • Interpreter/Witness
      • A study team member may serve as verbal interpreter if qualified; however, in this case a separate witness fluent in both languages must sign both documents.
      • When the foreign language interpreter is independent of the study team (e.g. Michigan Medicine Interpreter Services), the interpreter generally serves as the witness.
      • The witness’s signature attests that the consent information was accurately explained, that the participant appears to have fully understood the information, and the participant’s informed consent was given freely.
    3. The participant is given a copy of BOTH the foreign language form and signed English informed consent document (even though the participant may not understand English).
    4. Maintain copies of BOTH signed documents in the study records.
    5. Important note for Michigan Medicine studies: A complete (every page) copy of both signed consent forms should be placed in the UM medical record of participants (level-2 login or VPN required), particularly when the research intervention may affect other treatment or care (in most cases this means scanning the document into MiChart (level-2 login or VPN required)). However, doing so may not be appropriate in all cases (for example if identification of the participant might put them at risk of criminal prosecution or harm to reputation).
  • Limited Literacy, Visual Impairment and Blindness

    A  participant or Legally Authorized Representative (LAR), whether a speaker of English or another language, may be unable to read the standard-print (or screen-display) informed consent document due to illiteracy, limited literacy, or a sight impairment. Visually impaired persons are usually familiar with tools (e.g., screen reader or large-font generators) or seeking assistance from others to access written information.

    1. Whenever possible, provide a copy of the informed consent document well in advance of the consent conversation, electronically and/or in paper form, so that the participant can use appropriate tools or assistance to gain familiarity. If this would represent a deviation from the approved recruitment strategies, then report a one-time and/or temporary change using the ORIO process.
      If the participant requests the study team provide an audio recording:
      • For clinical trials and/or when the research overlaps with clinical care, the following contacts can facilitate no-cost conversion of documents into an audio format:
        Patient Civil Rights Coordinator
        Michigan Medicine
        2901 Hubbard
        Ann Arbor, Michigan 48109-2435
        MichMed_patients_rights@med.umich.edu
        Phone: 734-936-6439
        Fax: 734-347-0696
      • Several websites* can convert PDF documents (such as an IRB-finalized consent document downloaded from eResearch) into MP3 audio format at no cost. The following conversion sites are provided for your convenience; the IRBMED does not endorse any conversion service: * Be certain to validate the accuracy of the conversion process.  DO NOT share Protected Health Information, confidential information, or otherwise proprietary information with the websites.
    2. Consent materials should be presented in either an oral format using a recorded format or a study team member may read the consent document out loud.
    3. Sufficient time should be allowed for questions to be asked and answered, both by the participant and by the person obtaining consent, to ensure the participant comprehends the consent information.
    4. It is recommended that a witness not associated with the study team observe the consent process. (For studies subject to ICH-GCP, this is a requirement.)

    To document the consent process, follow guidance endorsed by the FDA and as set forth by the International Conference on Harmonisation (ICH E-6 4.8.9). If the participant verbally agrees to participate in the study:

    1. If capable of doing so, the participant signs or marks an X to signify consent.
    2. The witness signs and personally dates the consent form. By doing so the witness attests that the consent information was accurately explained, that the participant appears to have fully understood the information, and the participant’s informed consent was given freely.
    3. The person obtaining consent signs and dates the consent form.
    4. Signed copies are given to the participant.
    5. Important note for Michigan Medicine studies: A complete (every page) copy of both signed consent forms should be placed in the UM medical record of participants (level-2 login or VPN required), particularly when the research intervention may affect other treatment or care (in most cases this means scanning the document into MiChart (level-2 login or VPN required)). However, doing so may not be appropriate in all cases (for example if identification of the participant might put them at risk of criminal prosecution or harm to reputation).
  • Hearing Impairment and Deafness

    The Interpreter Services Deaf Access Program provides a broad range of services to Deaf, Deaf/Blind, and Hard of Hearing patients and their families, including sign language interpreters and video phones. Questions and comments can be directed to UMHS-deafaccess@med.umich.edu.

    Consult Americans with Disabilities Act (ADA) Communicating with People Who Are Deaf and Guide to Effective Communication for examples of, and principles for, accommodating deaf and hearing impaired participants. Recall that different types of aid or support in communication may be necessary depending on the individual’s preferences and background.

    Americans with Disabilities Act (ADA) defines a qualified interpreter as someone who is able to interpret effectively, accurately, and impartially, both receptively (i.e., understanding what the person with the disability is saying) and expressively (i.e., having the skill needed to convey information back to that person) using any necessary specialized vocabulary.

    Family members or others may attend a consent conversation as long as there are no concerns regarding possible coercion or undue influence toward the participant. However, family members or others accompanying the participant should not be used as interpreters except at the specific request of an  individual participant, per 45 CFR 92 (separate guidance applies to research under emergency circumstances).

    Conducting and documenting informed consent process

    1. Whenever possible, provide a copy of the informed consent document well in advance of the consent conversation, electronically and/or in paper form. If this would represent a deviation from the approved recruitment strategies, then report a one-time and/or temporary change using the ORIO process.
    2. Verify the individual’s preferences regarding communication before conducting the informed consent process.
    3. Sufficient time should be allowed for questions to be asked and answered, both by the participant and by the person obtaining consent, to ensure the participant comprehends the consent information.

    If a sign language interpreter is used to facilitate the informed consent process and the potential participant cannot understand spoken or written English, then conducting and documenting the informed consent process follows the same procedures as with a limited literacy participants:

    1. If capable of doing so, the participant signs or marks an X to signify consent.
    2. The witness—preferably the sign language interpreter—signs and personally dates the consent form. By doing so the witness attests that the consent information was accurately explained, that the participant appears to have fully understood the information, and the participant’s informed consent was given freely.
    3. The person obtaining consent signs and dates the consent form.
    4. Signed copies are given to the participant.
    5. Important note for Michigan Medicine studies: A complete (every page) copy of both signed consent forms should be placed in the UM medical record of participants (level-2 login or VPN required), particularly when the research intervention may affect other treatment or care (in most cases this means scanning the document into MiChart (level-2 login or VPN required)). However, doing so may not be appropriate in all cases (for example if identification of the participant might put them at risk of criminal prosecution or harm to reputation).
  • Federal Regulations and Guidance

    FDA

    Regulations - 21 CFR 50.20 21 CFR 50.25 21 CFR 50.27

    Guidance - A Guide to Informed Consent, heading “Non-English Speaking Participants” and “Illiterate English-Speaking Subjects”

    OHRP/Common Rule

    Regulations - 45 CFR 46.116(a)(3), 45 CFR 46.117(a)

    Guidance - Informed Consent of Participants Who Do Not Speak English (1995)

    Informational videos – About Research Participation (available in English and Spanish, with subtitles)

    Federal nondiscrimination provisions

    Americans with Disabilities Act (ADA)

    Affordable Care Act (ACA) – 45 CFR 92

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)

2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: larkspur@umich.edu
Last Updated: March 4, 2022 9:00 AM