Informed Consent for Non-English Speakers: Tips for Translation Success
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of non-English speakers for U.S.-based and global
clinical trials is on the rise. As a result of this,
foreign language translation becomes a critical component
of clinical trials management. If done right, translations
can play an important role in meeting global product
demands. Otherwise, mistakes from poorly done translations
can result in product delays, cost overruns, or, even
worse, contribute to malpractice or product liability
you planning to enroll non-English speaking subjects
in a U.S.-based or global clinical trial? If so, you
will need to translate informed consent forms (ICF)
into the native languages of those individuals to
satisfy the requirements of the FDA and/or various
directives governing clinical trials in foreign countries.
on the practices of leading clinical research companies
and its own experience, Global Language Solutions
(GLS), a full-service translation company delivering
solutions in over 100 languages, offers the following
tips for a successful ICF translation:
Know the regulations. Among different documents
given to a research subject, the informed consent
form is, arguably, the most important document.
Its wording is carefully monitored by the federal
government and IRB institutions. According to the
Office for Human Research Protection (OHRP), obtaining
consent from subjects who do not speak English must
be in the language understandable to the subject,
and in most cases, be documented in writing.
Readability ensures informed consent. The
consent obtained from subjects who do not understand
the information in the ICF means that it was not
truly “informed”. The Journal of the American Medical
Association demonstrated in studies in 1995 and
1999 that the number of Spanish speakers who had
difficulty understanding written instructions was
almost double of the English speakers presented
with the same instructions. Readability helps to
ensure informed consent. Aim for the recommended
4-8th grade reading level of the ICF by using “plain
English” and, whenever possible, replacing legalese
and scientific terms with simpler terms or by explaining
them in the text.
Remain consistent between the original ICF and its
translation. In order to protect the subject’s
rights, the translated version of the consent must
preserve the original document’s content and style.
This includes everything from font size and footer
information to descriptive non-medical terms, if
that’s what was used in the source document. For
example: “high blood pressure” should not be translated
All words are not created equal. Use precise
translation equivalents for key ICF terminology
to avoid critical and costly mistakes. For example:
“replacement dose” is not the same as “additional
dose” and “study” or “research” does not equal “treatment”.
Translators are not lawyers. Make sure
translators don’t “play lawyer” and modify key sections
of the translated ICF (i.e. Risks, Compensation
or other sections). Stick to the wording of the
original ICF. Since you may not be familiar with
the language the ICF is being translated to, make
sure you communicate this to your translation provider
upfront. If you receive pushback from your language
service provider, see tip #8.
Me, myself and I. Make sure that Statement
of Consent section is translated in first person
(“I”, “me”, “my”), not second person (“you”, “your’),
as in the rest of the ICF. We have seen some translations
where that very important section of the ICF was
incorrectly translated in second person.
Use translation memory (TM) tools. Translation
memory (TM) software analyzes repetitive text in
the source documents and then queries a translation
memory database to identify previously translated
segments. TM tools ensure consistency of terminology,
expedite future ICF revisions, and reduce translation
costs. These tools should not be confused with Machine
Translation (MT) software, which is unusable for
Turn to professionals. You’ve heard the
saying: “Do what you do best and outsource the rest.”
Since translation is most likely not your core competency,
you’re probably in the market for a professional
translation provider. Ensure your vendor has experience
in this vertical, understands the regulations and
nuances of ICF translation, and can supply a reputable
client list with references.
Global Language Solutions
Language Solutions (GLS) is a full-service translation
company delivering solutions in over 100 languages
to increase its clients’ multicultural and international
market share. The company’s expertise includes translation
of product labeling, instructions for use (IFUs),
,manuals, informed consent forms, protocols, advertisements,
IVRS scripts, and more. For additional information,
or call +1-949-798-1400.
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