Guidance for Consenting Participants with Accessibility Needs

For research participants with limited English proficiency, low literacy, vision impairments, or hearing impairments

Institutional Review Board

Overview

A thorough informed consent process is an essential part of ethical human subjects research. Informed consent is more than just providing a signature; it is the process through which participants can make a fully informed decision on whether or not they want to participate in the study free from external pressure or coercion. 

Some potential participants may not be able to read or access a standard written informed consent document; however, it is unethical to exclude participants based solely on their inability to read or understand an informed consent document. It is the PI's responsibility to ensure that potential participants can fully understand the informed consent materials, which can include offering translated documents, alternative formats, and/or additional resources.

If a participant requires accommodation in order to understand the informed consent materials, then the accommodation may also come into play in other aspects of the study. If a translation, alternative format, and/or an interpreter is required for the informed consent process, then the same accommodation may be required for the rest of the study materials, such as surveys or interview questions.  

Potential participant groups that may require additional resources or alternative formats for informed consent materials include (but are not limited to) the following:

  • Non-English-speaking persons/persons with limited English proficiency (LEP)
  • Persons who are illiterate/persons with low literacy
  • Deaf and/or Hard of Hearing (HoH) persons 
  • Blind persons/persons with visual impairments

If your study specifically targets or likely includes participants from any of these groups, then your IRB submission must include the process for consenting these specific participants. Select from the drop-down options below to view additional guidance on ensuring your informed consent process and materials meet the needs of each potential participant group.

Non-English-Speaking & Limited English Proficiency (LEP)

When working with potential participants who are non-English-speaking or only speak limited English, the best method is to provide a copy of the informed consent document that has been translated into their preferred language. If no one on your study team speaks the potential participant’s language, then you will also need a qualified interpreter to assist with answering questions and ensure comprehension during the consent process.

Translating Materials

When beginning the IRB submission process, you only need to submit English-language copies of the consent document and study materials, and you can let the IRB know that you intend to add translated copies. The translated copies can be added later as a modification request or as part of requested changes for final approval. This will prevent you from having to update the translated copies if your written materials require revision.

The IRB does not require researchers to use a specific translation service. However, ETSU does offer translation services through the Language and Culture Resource Center. Google Translate is never an appropriate translation method. Any translations must be from a reliable resource to ensure accuracy of information. The study submission will ask that the translation and/or interpreter be identified and their qualification specified.

Interpreters

Potential participants may have further questions after reading the translated documents. If no one on the research team speaks that language, then the PI is responsible for providing a qualified interpreter to answer questions during the consent discussion. The interpreter should also sign the informed consent document on the interpreter/witness signature line.

Friends or family members may attend the consent conversation as long as there are no concerns regarding potential coercion. However, friends or family members should not be relied on as the interpreter unless the participant specifically requests it.

If your study involves a remote/asynchronous consent process (such as an online survey) and no one on the study team speaks the potential participant’s language, then the PI must still have arrangements in place to quickly respond to individuals who reach out with questions or concerns.  

Illiteracy or Low Literacy

When enrolling subjects who cannot read the consent materials due to illiteracy or low literacy, it is recommended to read the consent materials aloud to the potential participant. Allow plenty of time for the participant to ask questions; the person obtaining consent should also ask the participant questions to ensure that the participant fully understands the information. It is also advised to have an impartial witness observe the consent process.

Signatures

If the participant is able, they can sign their name on the consent document or mark an X to indicate their consent. If using an impartial witness, then the witness should also sign and date the consent form to attest that the information was explained to and understood by the participant.

Deaf and/or Hard of Hearing

When enrolling subjects who are Deaf or Hard of Hearing (HoH), keep in mind that American Sign Language (ASL) is a separate language from English. Deaf or Hard of Hearing Persons whose primary language is ASL may not be able to read study materials written in English.  

Whenever possible, it is recommended to have a qualified interpreter attend the informed consent discussion. If this is absolutely not possible, then it is recommended to provide the potential participant with a copy of the informed consent document in advance, so that they have extra time to read the materials and ask questions.  

Interpreters

The best method for working with Deaf or HoH participants is to use a qualified interpreter. Interpreters can be requested through the ETSU Office of Disability Services. When working with an interpreter, the participant can sign the consent form if able, or they can mark an X. The interpreter should also sign and date the form as a witness to attest that the information was explained to and understood by the participant.

Friends or family members may attend the consent conversation as long as there are no concerns regarding potential coercion. However, friends or family members should not be relied on as the interpreter unless the participant specifically requests it.  

Blindness or Visual Impairment

For potential participants who are legally blind or visually impaired, oral presentation of the informed consent materials is appropriate. Be sure to allow sufficient time for the participant to ask questions. The person obtaining consent may also need to ask questions to ensure that the participant understands the material.

If the participant is unable to personally sign the consent form, then it is recommended to have an impartial witness observe the consent process and then sign attesting that the informed consent process took place and the participant understood and agreed to participate. With IRB approval, you may also use video/audio recording of the informed consent process to document the participant's consent. Because the recording would serve as documentation, it would need to be maintained and retained with the study records for the required period of time.