5.5 Non-English Consent

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CARILION CLINIC INSTITUTIONAL REVIEW BOARD
Standard Operating Guidelines
Title: 5.5: Informed Consent Process: OBTAINING CONSENT FROM NON-ENGLISH
SPEAKING SUBJECTS
Original Date: April 2009
Date of Last Revision:
Primary Sponsor: Department of
Approved By: Director of Biomedical and
Biomedical and Research Ethics
Research Ethics
Objective:
To describe the process researchers and their staffs should use to obtain and document
informed consent from subjects who are non-English speakers and require an interpreter and
translated consent materials.
General Description:
The governing principles of human subject research -- respect for persons, beneficence, and
justice -- require that researchers not exclude subjects based solely on their inability to read,
speak or understand English. Investigators need either to communicate directly with subjects,
or to provide a reliable alternative to ensure that:

Study participation is voluntary , as indicated by free and truly informed consent (respect for
persons); and

Study schedules, procedures, and risks are accurately communicated , and subjects have
ongoing opportunities to express concerns and ask questions, in order to minimize risks to
subjects (beneficence); and

There are fair procedures and outcomes in the selection of research subjects so that risks
and benefits of research are shared in society (justice).
Federal regulations enforced by the Office for Human Research Protections (45 CFR 46.116)
and the Food and Drug Administration (21 CFR 50.20) state that informed consent "shall be in
language understandable to the subject or the representative," and 45 CFR 46.117, along with
21 CFR 50.27, describe how the informed consent is to be documented.
Procedure:
There are two methods for obtaining and documenting informed consent for research subjects
who do not read, speak, or understand English:
1. The preferred method is to provide consent forms written in the subject's language.
2. For the occasional and unanticipated non-English-speaking subject, an alternative "short
form" method is allowed [21 CFR 50.27(b)(2) and 45 CFR 46.117(b)(2)].
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Informed consent is an ongoing process throughout a study. For non-English speakers, the
investigator should address the means for providing continued, qualified interpretive services.
Use of Translated Consent Documents
The IRB strongly encourages the use of a written consent document that has been translated
into a language understandable to the subject and which contains all necessary elements for
obtaining legally effective informed consent. In addition, other written materials used in the
consent process should be translated into a language understandable to the subject.
As part of the IRB application process, investigators should estimate the likely proportions of
non-English-speaking-people who may be encountered as eligible subjects for a proposed study
and make plans to have the consent form and other materials translated.
The cost of translating written consents is the investigator's responsibility. These costs may be
quite high, particularly for large studies where multiple translations are needed and/or studies
with relatively complex consent information that may require additional time by a skilled
professional. Investigators should include the costs of written translations as well as medical
interpreter services on grants and contracts. Industry sponsors are often willing to pay the costs
of translating consent forms.
The IRB will accept documents translated by Manzana Publications and Program Services or the
Roanoke Office of Refugee and Immigration Services. These groups are approved by the office
of the Vice President of Administration/Regulatory. If languages cannot be translated by these
groups, contact the office of the VP of Administration/Regulatory for further help.
Use of “Short Forms”
The IRB also permits oral presentation of informed consent information in conjunction with a
short form written consent document and a written summary of what is to be presented orally.
The short form notes that elements of informed consent have been presented orally.
When the short form is used with subjects who do not speak English:



The oral presentation and the short form written consent document should be in a language
understandable to the subject;
The IRB-approved English language informed consent document may serve as the
summary;
The witness should be fluent in both English and the language of the subject.
At the time of the consent discussion:



The short form document should be signed and dated by the subject (or, if the subject lacks
decision making capacity, by the subject’s legally authorized representative);
The summary (such as the English language informed consent document) should be signed
and dated by the person obtaining consent as authorized in the protocol;
The short form document and the summary (or English language informed consent
document) should be signed and dated by a witness. When the person obtaining consent is
assisted by a translator, the translator may serve as the witness.
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The IRB must approve the English version of the short form, the translated version of the short
form and the summary of information that will be presented to the subject, including the
English language informed consent document.
Ethical and Legal Considerations
As part of each consent discussion, investigators have an ethical and legal obligation to assess
the subject's understanding of the consent information to ensure that the consent is truly
"informed." When the investigator and subject do not share a language, the investigator must
depend on the accuracy of the translated consent documents and the working relationship with
the medical interpreter. The investigator's familiarity with the subject's culture ("cultural
competency") or lack of familiarity affects the communication.
Working Effectively With Medical Interpreters
The medical and technical information discussed during the initial consent discussion, as well as
ongoing, study-related information, can be very complex and should be communicated to nonEnglish speaking-subjects through an interpreter with training and understanding in medical
terminology. In addition, an individual with a professional commitment to maintain strict
confidentiality should handle the private medical issues discussed with subjects.
The field of medical interpretation is evolving and although protocols are being developed,
standardized practices do not exist. Investigators may want to discuss some or all of the
following topics with the interpreter before participating in an interpreter-mediated consent
discussion.




If the English version of the consent form is orally interpreted for the alternative "short
form" method, how will the interpreter incorporate cultural considerations into the
consent information?
How transparent will the interpreted conversation be? With three people communicating
(subject, investigator and interpreter), will everything said by each person be
translated?
How will the investigator and interpreter determine whether the subject truly
understands the consent information?
Informed consent is an ongoing process. How will the investigator ensure that the
subject will understand ongoing study-related communication? If the subject has
questions about continuing in the study, how will that be communicated to the
researchers?
This SOG was adapted from material on the web site for the University of Virginia Health Sciences IRB.
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