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IRB: Non-English Speaking Participants

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Non-English Speaking Participants

Purpose

The purpose is to outline the policies and procedures for non-English speaking participants involved in research.

Definitions

Interpreters work live with participants. They convey (in another language) information that is spoken in English or read aloud (in another language) materials written in English. Individuals interpreting information are considered to be engaged in research activities due to their interaction with participants.

Translators work with written documents, converting them from English into another language. As they do no interact with participants, they are not considered to be engaged in research activities.

Translation Certification is a process by which an individual who is unaffiliated with the research translates documents or reviews translated documents and asserts that that the tone, meaning, and content remain consistent with the approved, English versions.

Policies

Federal regulations require that information given to a research subject or a representative of the subject “be in language understandable to the subject or the representative.” Accordingly, for research intended or likely to involve subjects who are not fluent in English, any informed consent forms, parental permission (consent) forms, child assent forms or scripts, advertisements or other subject documents must be translated into a language understood by the subjects.

The principal investigator (PI) or another research team member must be fluent in the subjects’ or representatives’ language in order to answer questions, obtain informed consent, and conduct any interventions or interactions, unless an outside interpreter will be utilized for these tasks.

Interpreters

Interpreters working with participants directly are considered to be engaged in research activities and must complete half of the basic online training courses, earning a certificate in the Human Research Curriculum only. Training must be completed through the Collaborative Institutional Training Initiative (CITI). For more information, please see the Mandatory Training policy page.

Interpreters of de-identified audio recordings do not interact with participants and are not considered to be engaged in research activities. Therefore, they are not required to complete online training.

Deaf or Hard of Hearing

As English is often not the primary language of many deaf and hard of hearing participants, they would not be expected to have high proficiency in written English. Thus, English versions of consent documents must be written at an appropriate reading level. Informed consent forms and other research materials must be approved by the Institutional Review Board or Exempt Review Committee, and then be interpreted live by an individual fluent in the particular sign language used by the participants (e.g., American Sign Language). If the interpreter is not a member of the research team, he/she will be subject to the same training policy as mentioned under the Interpreter section above.

Deaf or hard of hearing participants should be able to provide a signature on an English informed consent form after a study has been explained to them in their own language, unless a waiver of documentation of informed consent is requested and granted. Please see our Informed Consent, Parental Consent and Child Assent policy.

Procedures

When involving participants who speak a language other than English, the following procedure must be followed:

  1. The investigator must clearly describe in the application who will be recruiting participants and how.
  2. The investigator must clearly describe in the application who will be obtaining informed consent of participants and how (e.g., written form in the other language, verbal explanation, etc.).
  3. The investigator must clearly describe in the application how informed consent will be documented (e.g., signature to be collected on a form or to be waived).
  4. The investigator must clearly describe in the application who will be performing research interactions or interventions (if applicable).
  5. The English versions of the documents must first be submitted to and approved by the Institutional Review Board (IRB) or Exempt Review Committee (ERC). The readability must be appropriate for the target population.
  6. The investigator must then submit to the IRB or ERC (except for with deaf or hard of hearing participants):
    1. the documents written in the other language and
    2. a Translation Certification form. This form must be completed by an independent translator, who is not a member of the research team, and who will affirm that the translation is accurate. Please see the IRB or ERC web pages for the appropriate form.

 

 


 

Related Policies

  • Informed Consent, Parental Consent and Child Assent
  • Mandatory Training

 


 

History

12/3/2013 - Updated

 


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