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

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.

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 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 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 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 12 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]).

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. To access CART services, contact:
     Patient Civil Rights Coordinator
     Michigan Medicine
     2901 Hubbard
     Ann Arbor, Michigan 48109-2435
     [email protected]
     Phone: 734-936-6439
     Fax: 734-347-0696
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).