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

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.

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 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.

Interpreter Services (level-2 login 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 interpretation.

Translation Services (level-2 login 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 charge 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 University-wide 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.

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 (level-2 login required) 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.

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.

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.

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 (level-2 login required) 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.

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.

In nearly all instances, IRBMED expects researchers to utilize the services of impartial, professional interpreters to facilitate the bilingual consent discussion. However, in keeping with the Belmont Report’s emphasis on equitable subject selection, as well as in the spirit of other federal provisions, such as regulations governing federally-funded medical care (45 CFR 92), potential participants’ adult family members or friends may act as interpreters if the services of a professional cannot reasonably be obtained. In all instances, especially those involving nonprofessional interpreters, researchers should clearly explain to those serving as interpreters the importance of conveying all information as fully and accurately as possible.

If the participant agrees to enroll in the research study,

1. Obtain signatures as follows:

   • DOCUMENT	SIGNED BY
     English ICD	Appropriate study team member Witness (may be interpreter)
     Foreign language document (short form or translated full ICD)	Participant Witness (may be interpreter)

   • 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.
2. 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).
3. Maintain copies of BOTH signed documents in the study records.
4. 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 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 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 require that every consent document utilized in a bilingual consent process bear the signature of a witness unaffiliated with the study team. The witness’s signature indicates that they observed an oral informed consent process based on the information within an IRB-approved informed consent document (either in the potential participant’s own language or, in a short form consent procedure, in English) and facilitated by an interpreter. The informed consent process involves both conveyance of the information within the consent document and, in most cases, discussion and question and answer between potential participant and researcher.

The signature of the witness does not attest to any of the following, all of which are responsibilities of the researcher:

• The accuracy and/or completeness of the researcher’s descriptions and explanations, either within the consent document or during the consent discussion
• The researcher’s compliance with federal regulations, institutional policies, and/or other requirements
• The accuracy and/or completeness of the potential participant’s understanding of the information presented to them, both within the consent document and during the consent discussion
• The potential participant’s decision whether to take part in the research, free of undue influence or coercion by the researcher or other parties.

In sum, the role of the witness is to observe and formally acknowledge that an oral informed consent process took place, not to attest to its regulatory, legal, or ethical quality. In a bilingual consent process, this role necessitates fluency in both languages. For this reason, the interpreter tasked with facilitating the bilingual consent process is most often asked to sign the consent materials in the role of witness.

Signature: As indicated above in this guidance, Michigan Medicine Interpreter Services (or the non-UM vendors they contract with) provides interpretation services to all clinics at Michigan Medicine for both in-person and remote (e.g., over-the-phone) interpretation. When this service is provided in person, the interpreters (when acting as a witness) will sign the informed consent documents as indicated above in the table. When this service is provided remotely, signature can be obtained via accepted electronic platforms (SignNow, etc.). However, when it is not possible to obtain electronic signature of the interpreter who is acting in the role of a witness, IRBMED accepts the following method in lieu of the traditional (wet or electronic) signature:

• In Section 13 of the informed consent template, on the witness line, the researcher indicates on the first name (if the full legal name will not be provided) and employee ID of the interpreter and the vendor services (internal or external[name of the vendor]).

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
     [email protected]
     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:
     • https://www.zamzar.com/
     • https://audio.online-convert.com/convert/pdf-to-mp3
     • https://anyconv.com/pdf-to-mp3-converter/

     * 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 (“What should be considered when enrolling subjects with low literacy and numeracy?”) 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 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 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).

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 [email protected].

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).

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.
   • If a sign language interpreter should be involved, whenever feasible, consult with Interpreter Services’ Deaf Access Program and coordinate scheduling in advance to assure availability. An on-call sign language interpreter is available to meet needs on weeknights, weekends, and holidays.
   • If written materials are preferred, ensure a Computer Assisted Real-time Transcription (CART) or similar device will be available.  Consult with Interpreter Services to secure CART services.
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).

FDA

Regulations – 21 CFR 50.20, .25, .27

Guidance – Informed Consent

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)