research involving non-english-speaking subjects

DUKE UNIVERSITY HEALTH SYSTEM

Human Research Protection Program

RESEARCH INVOLVING NON-ENGLISH-SPEAKING SUBJECTS

7/7/2021

1. Informed Consent for Non-English-Speaking Subjects

There is an increasing need to include in research studies at Duke those subjects who may not

understand the English language. It is imperative that all subjects, regardless of their knowledge

of English, have an understanding of the study and the elements of consent that are sufficient

for deciding whether or not to participate in a research study. This means that consent must be

obtained using language that is understandable to the non-English-speaking potential subject.

This process requires either written translation and/or oral presentation in the relevant non-

English language by a person who is fluent in both English and the other language, and who

understands both cultures.

A. Acceptable Methods for the Consent of Non-English-Speaking Subjects

The DUHS IRB recognizes two methods for obtaining the consent of non-English-speaking

research subjects:

(1) Use of Translated Long Form Consent Form (preferred method)

(2) Use of Translated Short Form Consent Form

B. Use of Long Form Consent Form

This method requires translation of the English consent form by either a valid translation service

or individual(s) who are known by the Principal Investigator (PI) to be bilingual. A valid

translation service is defined as a well-established business entity or an entity that is regularly

utilized by Duke in other areas that require translation.

The IRB submission must contain the following:

(1) forward and back translations of the consent form by two different individuals (e.g.,

translators)

(2) a statement concerning the qualifications of the translators. If the translation is done

outside of a translation service, then the statement should include an attestation by

the PI that both translators are bilingual.

(3) a description of the consent process that clarifies who will do the oral presentation in

the potential subject’s spoken language and the presenter’s qualifications for the

role. The presenter must be bilingual. Ideally, the presenter will also possess

sufficient knowledge of the study to be able to address any questions concerning its

design, risks, benefits, costs, etc. However, if such an individual is not available, the

presenter may translate the potential subject’s questions to a qualified study team

member who is present and, in turn, back-translate his/her replies to the potential

subject.

(4) a description of who will sign the long form consent form. This should be signed by

the subject and the study team member obtaining consent. The consent process

should be documented to include the translator’s name and that the long form

consent form was used in the subject’s spoken language.

DUKE UNIVERSITY HEALTH SYSTEM

Human Research Protection Program

Required: two bilingual translators, oral bilingual presenter.

Exception: When conducting research in an international location and all human subjects

interaction is subject to the review of a local IRB (see the International Research Policy), the

IRB submission may contain English and local language versions of the consent form(s), in

addition to the local IRB approval notice indicating that the consent form(s) were also reviewed

by that IRB.

Other exceptions to these requirements must be prospectively approved by the DUHS IRB.

C. Use of Short Form Consent Form

This method also requires translation of the IRB-approved English consent form by either a valid

translation service or individual(s) who are known by the PI to be bilingual. Please refer to the

Short Form Consent Policy for additional information.

The IRB submission must contain the following:

(1) forward and back translations of the consent form by two different individuals (e.g.,

translators) NOTE: Not required when using the template short form Spanish

consent form posted at irb.duhs.duke.edu. The short form consent must be signed

by the subject, presenter, and a bilingual adult witness. The adult witness may be a

family member or friend of the potential subject but NOT a member of the study team

or an individual having a familial or reporting relationship to a study team member.

DUHS IRB recognizes that there may be complex studies where a bilingual clinician

with a reporting relationship to a study team member may be an appropriate witness

to ensure that the information was accurately conveyed. However, this would be an

exception to the preferred standard, and this person could not be a member of key

personnel for the study. Rationale for this should be documented in the consent

process section of the IRB application.

(2) a statement concerning the qualifications of the translators. This should include an

attestation by the PI that both translators are bilingual.

(3) a description of the consent process that clarifies who will do the oral presentation in

the potential subject’s spoken language and the presenter’s qualifications for the

role. It is required for the presenter to be bilingual. Ideally, the presenter will also

possess adequate knowledge of the study to be able to address any questions

concerning its design, risks, benefits, costs, etc. However, if such an individual is not

available, the presenter may translate the potential subject’s questions to a qualified

study team member who is present and, in turn, back-translate his/her replies to the

potential subject.

(4) an English translation of the script of the oral presentation. The script must contain

all elements required for valid consent. The PI may submit the English long form

version of the consent form as the script.

Required: two bilingual translators, oral presenter, adult witness

Exceptions to these requirements must be prospectively approved by the DUHS IRB.

DUKE UNIVERSITY HEALTH SYSTEM

Human Research Protection Program

2. Questionnaires/Surveys for Non-English-Speaking Subjects

When subjects who do not understand the English language are involved in research studies

that require responding to questionnaires or participating in surveys, it is important that those

questionnaires are translated into a language that the subjects understand. Also, it is important

that the questionnaires convey the same meaning as the original English version.

Self-administered questionnaires for non-English-speaking subjects shall be the same as for

English-speaking subjects in content and format, except that the non-English questionnaires will

be translated into the language that is understandable to the subject. The translation process

shall require one forward and one back translation by two bilingual translators either from a valid

translation service or by individuals known to the PI to be qualified to assume this role. As with

consent form translation, the research summary within the iRIS application must contain either

the name of the translation service or the names of the two individual translators accompanied

by an attestation from the PI regarding their qualifications to assume this role.

3. Focus Groups/Interviews for Non-English-Speaking Subjects

Focus groups and interviews must be conducted in a language that is understandable to non-

English-speaking subjects and must be of a format and content similar to that of the original

English versions. These activities must be conducted by an individual who: (1) is bilingual; and

(2) possesses extensive knowledge of the research study, such as a study team member. If

this is not possible, the DUHS IRB may approve a strategy where the focus group/interview is

conducted by an English-speaking study team member through a bilingual translator. Although

not required, it is recommended that the focus group/interview be audio-recorded, then

transcribed into English by a second independent bilingual translator.

4. Adverse Events, Research Questions and the Right to Withdraw

When enrolling non-English-speaking subjects into a research study, the PI must make

provisions during the course of the study for the subject to report adverse events or ask

questions in his/her spoken language. Likewise, there must be a provision for the subject to

withdraw from the study at any time by expressing verbally or in writing the wish to leave in

his/her spoken language. The IRB submission for the study should include a description of this

process.

Previous Version Date(s): 2/26/2008, 8/24/2016, 1/11/2017