Version: 9/1/12
Saint Louis University
Institutional Review Board (IRB)
GUIDELINES FOR STUDIES INVOLVING NON-ENGLISH SPEAKING
SUBJECTS
A. Introduction
When investigators enroll non-English speaking (or limited English proficiency)
subjects, and materials are being distributed to those subjects in their native
language (non-English), the IRB requires that both an English version and the
non-English versions of materials be submitted to the IRB for review.
Materials may include, but are not limited to:
 Questionnaires
 Recruitment Materials (Flyers, Newspaper Ads, Brochures, etc.)
 Consent Documents
Federal regulations1 require that informed consent information be presented “in a
language that is understandable to the subject.” The consent process involves all
communication with the subject about their participation in a research study.
Communication with subjects should be conducted by a translator (who agrees to
serve in this capacity) or a member of the research team who is fluent in both
English and the non-English language native to the subject.
B. Submission to the IRB
1. How and when to submit translated materials to the IRB
Study materials translated into the non-English language of the subject(s)
must be submitted to the IRB. In most cases, it is in the best interest of the
investigator to submit these materials after the English version receives IRB
approval. The protocol should note that non-English study materials will be
translated from IRB approved English versions of study materials. Please
note that if the IRB requests modifications to the original submissions, the
translated materials may also be affected (i.e., it will be necessary to verify
that the changes have been made in the translated materials).
If a non-English speaking subject population is being added, or the materials
are submitted after the English versions are approved, materials must be
submitted with an Amendment in eIRB.
The submission to the IRB must specify who will be available to offer verbal
translations to the non-English speaking subjects at the time of consent to
participate in the study and any study visits. For further explanation see
section C below.
1
DHHS 45CFR46.116-117 and FDA 21CFR50.20
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Version: 9/1/12
2. To obtain IRB approval of non-English consent forms and study
materials
a. All English study materials (those distributed to subjects) must be
translated to non-English language of the subject population.
b. The materials must be translated by a certified or qualified
translator (i.e. a person native to the language of the subject,
spoken non-English language for X years, or teaches the language,
etc.). The qualifications and contact information of the translator
should be included in the consent section of the eIRB application..
NOTE: If a professional (paid service) is used for original
translation of materials, step c (the verification process) may be
waived. Please attach a copy of the documentation from the paid
service to confirm the translation.
c. The non-English study materials must be reviewed and verified by
a second person (the verifier) prior to IRB submission if not
originally translated by a professional or paid service. The verifier
can not be the same person who provided original translation. The
verifier should check for consistency between both non-English and
English versions of study materials. The verifier does not have to
do a “word for word” back translation. The verifier must complete
and sign the verification form (see sample in Appendix 1). The
translated documents must be approved by the IRB before they are
used for the study.
NOTE: If the research team cannot identify a verifier, the IRB may
be able to identify a service or individual who may provide this
service. See section D below, Local Resources.
3. Modification to study materials after the study has received initial
IRB approval
If modifications are needed to study materials being distributed to non-English
speaking subjects (e.g. consent form), an Amendment in eIRB must be
submitted to the IRB along with the revised copy of both English and NonEnglish versions of the document. Only the changes to the materials need to
be verified by a translator, and the verification form along with revised study
materials should be completed and submitted to the IRB (changes should be
tracked, shaded or highlighted in yellow.
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C. Obtaining and Documenting the Consent Process
The IRB also requires that an individual fluent in the subject’s non-English
language be available to verbally translate during study activities. This individual
may or may not be a part of the research team. The application to the IRB must
explain who will be available to conduct translations if a non-English speaking
subject is involved in study activities (see examples below). A detailed
explanation should be provided on the consent tab of the application and other
sections where appropriate.
These activities may include, but are not limited to:
 Obtaining and documenting consent
 Answering questions about the study
 Follow-up interactions with the subjects
 Re-consenting of subjects if necessary
When obtaining informed consent from a non-English speaking subject, there are
two options for documenting the informed consent.
1. IRB Approved Translated Consent Form - If non-English speaking
subjects are expected to be involved in research activities, then a full
translated consent form should be used. The process for IRB approval of
translated study materials is explained in section B above.
2. Short Form with a Written Summary- If a non-English subject is
encountered and qualifies to be enrolled in the study, and the investigator
does not have ample time to have a translation of the full consent form
completed, a short form may be used. A short form2 is permitted for use
with a written summary that meets the required elements of the informed
consent*or an oral translation of the full consent form. The short form
states that the required elements of informed consent have been
presented orally (See English Short Form Version). The short form must
be written in the native language of the subject.
A witness to the oral presentation is required. The witness must be fluent
in both English and the language of the subject. The IRB shall approve a
written summary of what is to be said to the subject or the representative.
*Note: the IRB approved English version of the consent document may
serve as the summary.
At the time of obtaining informed consent using a short form,
a. The short form document should be signed by the subject (or the
subject’s legally authorized representative).
2
OHRP requirements – http://www.hhs.gov/ohrp/policy/ic-non-e.html; FDA requirements -
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=50.27
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Version: 9/1/12
b. The summary (e.g. the English consent document) should be
signed by the person obtaining consent as authorized under the
IRB approved protocol.
c. When the person obtaining consent is assisted by a translator, the
translator may serve as the witness.
d. The witness shall sign both the short form and the summary (e.g.
the English consent document).
e. The subject must be given copies of the short form document and a
written summary of what was presented orally.
3. The IRB has several translated short form consents available here.
D. Local Resources
Below is a list of a few local paid translation services located in the St. Louis
area. Note: This is not an exhaustive list of all services located in the St. Louis
area, but rather, is a list provided as a courtesy to investigators who may need a
starting point in locating translation services. The IRB is not responsible for the
quality of these services. For complete listings of professional translation
services, see the local yellow pages.
Language Solutions Inc
699 West Woodbine Ave.
St. Louis, MO 63122
http://www.languagesolutions.net
International Institute St. Louis
http://www.iistl.org/trans_interpretations.html
The Language Access Metro Project (LAMP)
http://www.lampagency.com/services.html
If you are unsuccessful locating a translation service, the IRB may be able to
assist you with locating a translator. Some SLU affiliates may be able to do
translation verifications. Please contact the IRB if you need a referral. The IRB
cannot guarantee that these individuals will be available.
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Version: 9/1/12
APPENDIX 1
Verification Form- Cut and paste the following template on your department
letterhead. This form should be completed by the verifier and attached with
submission to the IRB.
SAMPLE
VERIFICATION OF TRANSLATED MATERIALS
DATE: __________________________
IRB#:
___ ___________________
TO:
_____[verifier]______________
PI:
_______________________
__________________________
FROM: [PI or study personnel]
__________________________
Dear Foreign Language Reviewer:
Enclosed are copies of materials in both English and [name language]. The
Saint Louis University Institutional Review Board (IRB), the Board that is
responsible for protecting the welfare of human subjects recruited to participate
in research, requires review of these materials to verify that the foreign language
corresponds with the English wording. If you have comments or suggestions for
changes to the translated materials, please note them on the attached materials.
If you have any questions, please contact the Principal Investigator of this study
at [enter PI’s phone number and email] If you have any questions for the IRB,
please call the IRB office at 314-977-7744 or email IRB@slu.edu.
Thank you for your assistance!
Please respond within 1 week from the date above. If you need additional
time, please contact our office.
I have reviewed the enclosed materials and (please check one of the following):
______
I believe the materials presented in the foreign language
correspond with the English version.
______
I have comments or suggestions for changes to the translated
materials. See attached.
________________________________
Signature of reviewer (verifier)
_______________
Date
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