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Back Translation for Quality Control of Informed Consent Forms
By David Grunwald,
CEO of Global Translations,
davidg[at]global-translation-services.com
and
Norman M. Goldfarb,
Managing Partner of First Clinical Research,
ngoldfarb[at]firstclinical.com
https://www.gts-translation.com/
http://www.firstclinical.com/
Become a member of TranslationDirectory.com at just
$12 per month (paid per year)
FDA
regulations and ICH guidelines both require that "the
information that is given to the subject or the representative
shall be in language understandable to the subject
or the representative." 1, 2 Obviously, if an Informed
Consent Form (ICF) is written in a language that the
subject does not understand, it must be translated
into a language the subject does understand.
ICFs are highly technical documents, so careful translation
by certified medical translators is essential. Translation
errors can change the meaning of important content,
causing potential subjects to receive inaccurate information.
They can also confuse meaning, so the ICF is more
difficult to understand.
Many
professional translation companies and independent
translators are well-qualified to translate ICFs.
However, even with certified medical translators,
errors can occur because:
- Translation
is more of an art than a science.
- Translators
are unlikely to specialize in the specific medical
condition under study.
- Time
and money are usually limited.
In a normal translation process, the translator translates
the document; an editor then reviews the translation
and makes corrections. A more robust process includes "back-translation", whereby a second translator translates
the foreign language ICF back to the original language.
The back translator must have excellent command of
the foreign language as well as being a native English
medical translator, and perform a more literal translation
than normal. The original and back-translated versions
of the ICF can be compared side-by-side by the original
authors of the document or the IRB. Back-translation
addresses the first two causes of error cited above,
but at the cost of money and time.
Table
1 presents three paragraphs from a fictional English-language
ICF along with two unedited and one edited translation
into Spanish. Table 2 presents the respective translations
back into English.
Comparing
the unedited back translations to the original text
reveals:
- As
indicated by the highlighted words, both translations
include substantive changes. Some of these changes,
such as deleting the word "experimental" or adding
the word "suffering", change the meaning in important
ways. Others, such as changing "hair growth" to
"capillary growth" are medically incorrect. Others,
such as "experimental blood", make no sense.
- Spanish
and English have different grammatical structures,
so the numerous changes in wording and phrasing
may or may not reflect changes in readability.
- The
error rate suggests that quality control is essential.
- The
translations have entirely different errors. The
errors in a specific translation are thus unpredictable.
The
edited translation (2a) makes numerous phrasing changes,
but corrects none of the substantive changes. Table
3 describes the substantive changes. It demonstrates
that back-translations are not definitive, but can
be used to identify possible problems for review.
Even this small amount of data illustrates three different
reasons why back translations may differ from the
original text:
- Translator
changed the meaning in the forward-translation.
- Translator
changed the meaning in the back-translation.
- Literal back-translation
of correct forward-translation appears to be error
The
amount of data in this experiment is far too small
to reach any definitive conclusions. It does, however,
suggest that:
- Back-translations
are valuable tools, but cannot replace editors.
- It
may be essential for ICF authors to read the back-translations.
- A
larger, more definitive, experiment would be worthwhile.
Back-translation
increases the cost of translation by about 80%. A
typical $800 ICF translation charge would thus increase
to about $1,400. In addition, it takes time to make
the necessary comparisons and correct errors. However,
given the importance of accurate translations, the
additional investment is more than justified.
Some
Institutional Review Boards (IRBs) require back-translation
of ICFs. For example:
"The Principal Investigator must translate the consent
form if subjects expected to be enrolled are not fluent
in written English. A completely translated copy of
the informed consent and a complete back-translation
done by two qualified translators must be submitted
to the IRB before the translated ICF is approved."
3
(The
ambiguity in this text reinforces the message that
writing errors are easy to make. Does one translator
do the forward-translation and another the back-translation,
or do the two translators work together as a team
on both translations?)
Because
quality control personnel at translation companies
are unlikely to speak every language their company
translates, back-translation can also play an important
role in identifying qualified translators.
Table
1. Translations to Spanish
| Original |
Translation 1 |
Translation 2 |
Translation
2a
(edited) |
| You
are being asked to participate in this study
because you have been diagnosed with alopecia
(hair loss) of the scalp. The purpose of this
study is to determine if an experimental "study
drug," a patch containing capsaicin, is safe
and effective when given to people with your
condition. An experimental drug is one that
has not received approval by the U.S. Food
and Drug Administration (FDA). |
Se
le ha pedido que participe en este estudio
porque le han diagnosticado alopecia (pérdida
del cabello) del cuero cabelludo. La finalidad
de este estudio es determinar si el "fármaco
experimental" de este estudio, un parche que
contiene capsaicina, es seguro y eficaz cuando
se administra a personas que padecen su afección.
Fármaco experimental es aquel que aún
no ha sido aprobado por la Administración
de Drogas y Alimentos de Estados Unidos (Food
and Drug Administration, FDA). |
Se
lo invita a participar es este estudio por
que se lo ha diagnosticado con alopecia (pérdida
del cabello) en el cuero cabelludo.
El propósito de este estudio es el de determinar si el "medicamento
en estudio", un parche de capsaicin,
es seguro y eficaz cuando suministrado a personas
con su condición. Un medicamento experimental es un medicamento que no ha recibido la aprobación
de la Administración de Alimentos y
Medicamentos de Estados Unidos (FDA, por sus
siglas en inglés). |
Se
lo invita a participar en este estudio por
que se le ha diagnosticado alopecia (pérdida
del cabello) en el cuero cabelludo. El propósito de este estudio es el de determinar si el "medicamento
en estudio", un parche de capsaicin,
es seguro y eficaz cuando se le administra
a personas con su condición. Un medicamento experimental es un medicamento que no ha recibido la aprobación
de la Administración de Alimentos y
Medicamentos de Estados Unidos (FDA, por sus
siglas en inglés). |
| Capsaicin
is a man-made version of a peppery substance
found in chili peppers. Low-concentration
capsaicin creams and patches are available
without prescription for controlling pain
from arthritis (swelling of the joints), back
pain and painful muscle soreness. However,
it is unknown if the experimental patches
containing 10 to 20 times higher concentrations
of capsaicin will be helpful in reversing
alopecia. It is also unknown if any hair growth
that results from treatment will be temporary
or permanent. |
La
capsaicina es una versión sintética
de una sustancia picosa que se encuentra en
los pimientos. Existen cremas y parches con
bajas concentraciones de capsaicina, de venta
sin receta, para el control del dolor causado
por la artritis (inflamación de las
articulaciones), dolor de espalda y fuerte
dolor muscular. Sin embargo, no se sabe si
los parches experimentales que contienen 10
a 20 veces la concentración de capsaicina
serán útiles para revertir la
alopecia. Tampoco se sabe si el crecimiento
de cabello que pueda producirse a raíz
del tratamiento será temporal o permanente. |
Capsaicin
es una versión fabricada por el hombre,
de una sustancia picante que se encuentra
en los chiles. Se pueden adquirir cremas
y parches con baja concentración de
capsaicin sin receta médica, para la
artritis (inflamación de las articulaciones),
el dolor de espalda y los dolores musculares.
Sin embargo, se desconoce si los parches experimentales
con concentraciones de capsaicin entre 10
y 20 veces mayores servirán para revertir
la alopecia. Asimismo se desconoce si el crecimiento
capilar que resulte del tratamiento será
temporal o permanente. |
Capsaicin
es una versión, creada por el hombre,
de una sustancia picante que se encuentra
en los chiles. Se pueden adquirir cremas
y parches con baja concentración de
capsaicin sin receta médica para combatir
el dolor causado por la artritis (inflamación
de las articulaciones), el dolor de espalda
y los dolores musculares. Sin embargo, se
desconoce si los parches experimentales, que
contienen concentraciones de capsaicin entre
10 y 20 veces mayores, servirán para
revertir la alopecia. Asimismo se desconoce si el crecimiento capilar resultante del tratamiento
será temporal o permanente. |
| If
you qualify for the study, you will come in
for two visits. At the first visit, we will
measure your vital signs (blood pressure,
heart rate, breathing rate and temperature),
perform a physical exam, photograph your scalp,
and take your medical history. We will collect
a blood sample to measure the level of harontin
in your blood. Harontin is a natural hormone
associated with hair growth. We will collect
approximately 2 tablespoons of blood. You
will be asked to rate any discomfort or pain
you have before, during and after the study
patch application. |
Si
califica para el estudio, vendrá a
dos consultas.
En
la primera consulta se tomarán sus
constantes vitales (presión arterial,
frecuencia cardiaca, frecuencia respiratoria
y temperatura), se le hará un examen
médico, se tomará una fotografía
de su cuero cabelludo y se obtendrá
su historia clínica.
Obtendremos
una muestra de su sangre para determinar el
nivel de harontin. El harontin es una hormona
natural asociada con el crecimiento del cabello.
Obtendremos aproximadamente 2 cucharadas de
sangre. Le pediremos que nos diga cuál
es el nivel de dolor que tiene, durante y
después de la aplicación del
parche del estudio. |
En
el caso de que usted califique para participar
en el estudio, deberá presentarse a
dos visitas médicas.
En la primera visita, mediremos sus señales vitales (presión
arterial, ritmo cardiaco, ritmo respiratorio
y temperatura), realizaremos un examen físico,
tomaremos una fotografía de su cuero
cabelludo y haremos una historia clínica.
Haremos una extracción de sangre para medir
el nivel de la harontonina en su sangre. La harontonina es una hormona
natural que se asocia con el crecimiento capilar. Le
extraeremos aproximadamente 2 cucharadas de
sangre.
Se le pedirá que evalúe el nivel de
molestia o dolor que siente antes, durante
y después de la aplicación del
parche en estudio. |
En
el caso de que usted cumpla con los requisitos
para participar en el estudio, deberá
presentarse a dos visitas médicas.
En
la primera visita, mediremos sus señales
vitales (presión arterial, ritmo cardiaco,
ritmo respiratorio y temperatura), realizaremos
un examen físico, tomaremos una fotografía
de su cuero cabelludo y redactaremos su historia
clínica. Haremos una extracción de sangre para medir
el nivel de harontonina en su sangre. La harontonina es una hormona
natural asociada al crecimiento capilar. Le
extraeremos aproximadamente 2 cucharadas de
sangre.
Se le pedirá que evalúe el nivel de
molestia o dolor que siente antes, durante
y después de la aplicación del
parche en estudio. |
Table 2. Original and Back Translations
| Original |
Back Translation 1 |
Back
Translation 2 |
Back
Translation 2a
(edited) |
| You
are being asked to participate in this study
because you have been diagnosed with alopecia
(hair loss) of the scalp. The purpose of this
study is to determine if an experimental "study
drug," a patch containing capsaicin, is safe
and effective when given to people with your
condition. An experimental drug is one that
has not received approval by the U.S. Food
and Drug Administration (FDA). |
You
have been asked to participate in the study
because you have been diagnosed with alopecia
(hair loss) of the scalp. The purpose of this
study is to determine whether the "experimental blood" of the study, a patch which contains
capsaicin, is safe and efficacious when administered
to persons suffering
from your condition. An experimental drug
is one which has not been approved by the
United States Food and Drug Administration
(FDA). |
You
are invited to participate in this study because
you have been diagnosed with alopecia (hair
loss) on the scalp.
The purpose of this study is to determine
if the _
"medication under study", a capsaicin
patch, is safe and effective when provided
to persons with your condition. An experimental
medication is one that has not received the
approval of the Food and Drug Administration
of the United States. |
You
are invited to participate in this study because
you have been diagnosed with alopecia (hair
loss) on the scalp. The purpose of this study
is to determine if the _
"medication under study", a capsaicin patch,
is safe and effective when administered to
people with your condition. An experimental
medication is a medication that has not received
the approval of the Food and Drug Administration
of the United States (FDA). |
| Capsaicin
is a man-made version of a peppery substance
found in chili peppers. Low-concentration
capsaicin creams and patches are available
without prescription for controlling pain
from arthritis (swelling of the joints), back
pain and painful muscle soreness. However,
it is unknown if the experimental patches
containing 10 to 20 times higher concentrations
of capsaicin will be helpful in reversing
alopecia. It is also unknown if any hair growth
that results from treatment will be temporary
or permanent. |
Capsaicin
is a synthetic version of a spicy substance
which is to be found in hot peppers. There
are creams and patches with low concentrations
of capsaicin, which are sold without a prescription,
for the control of pain caused by arthritis
(joint inflammation), shoulder pain and severe muscular pain. However, it is not known
whether the experimental patches, which contain
10 to 20 times the concentration of capsaicin,
will be useful for reversing alopecia. Nor
is it known whether the hair growth which
may be produced as a result of the treatment
will be temporary or permanent. |
Capsaicin
is manmade version of a spicy substance found
in hot peppers. Creams and patches with a
low concentration of capsaicin can be purchased
without a medical prescription, for arthritis
(swelling of the joints), back pain and muscle
pain.
However, it is unknown if experimental patches with
capsaicin concentrations 10 to 20 times stronger
will serve to reverse alopecia. It is also
unknown if the capillary growth resulting from treatment
will be temporary or permanent. |
Capsaicin
is a version of a spicy substance created
by man that is found in chili peppers. Creams
and patches with a low concentration of capsaicin
can be purchased without a medical prescription,
to fight off pain caused by arthritis (inflammation
of the joints), back pain and muscular pain.
However, it is not known if the experimental
patches, which contain concentrations 10 and
20 times higher of capsaicin, will help to
reverse alopecia. Neither is it known if the
capillary growth resulting from treatment will be temporary or permanent. |
| If
you qualify for the study, you will come in
for two visits. At the first visit, we will
measure your vital signs (blood pressure,
heart rate, breathing rate and temperature),
perform a physical exam, photograph your scalp,
and take your medical history. We will collect
a blood sample to measure the level of harontin
in your blood. Harontin is a natural hormone
associated with hair growth. We will collect
approximately 2 tablespoons of blood. You
will be asked to rate any discomfort or pain
you have before, during and after the study
patch application. |
If
you qualify for the study, you will come to
two consultations. At the first consultation,
your vital signs will be taken (blood pressure,
heart rate, respiration rate and temperature),
you will be subjected to a medical examination, a photograph of your scalp will be taken
and your clinical history will be recorded.
We will take a sample of your blood in order
to determine the level of harontin. Harontin
is a natural hormone associated with hair
growth. We will take approximately 2 spoonfuls of blood. We will ask you to tell
us the level
of pain you experience during and after
the application of the study patch. |
If
you qualify to participate in the study, you
shall come for two medical
visits. At the first visit, we will measure
your vital signs (blood pressure, heart rate,
respiratory rate and temperature), perform
a physical examination, take a photograph
of your scalp and complete a medical history.
We will take a blood sample to measure the
level of harontonina
in your blood. Harontonina
is a natural hormone that is associated with
capillary growth. We will take approximately 2 tablespoons of blood.
You will be asked to evaluate the level of
discomfort or pain that you feel before, during
and after the patch under study is applied. |
In
the event that you meet the criteria for participating
in this study, you shall go to two medical
appointments. In the first appointment, we
will measure your vital signs (blood pressure,
heart rate, respiratory rate and temperature),
perform a physical exam, take a photograph
of your scalp and prepare your medical history.
We will take a blood sample to measure the
level of harontonina
in your blood. Harontonina
is a natural hormone associated with capillary growth. We will take approximately 2 tablespoons of blood.
You will be asked to assess the level of discomfort
of pain that you feel before, during and after
applying the patch under study. |
Table 3:
Translation 2a Substantive Changes
| Change |
Comments |
| Changed
"experimental 'study drug'" to "medication under
study". |
"Medication
under study" does not fully communicate the
concept of "experimental drug". The change was
made in the forward-translation. |
| Changed
"hair" to "capillary. |
"Capillary"
in English means "a very small blood vessel."
In Spanish, "capilar" not only means a very
small blood vessel, but it also means "related
to the hair." The forward-translation was correct. |
| Changed
"visits" to "medical appointments". |
Most
clinical research is not "medical care". The
subject may, for example, receive a placebo.
Calling visits "medical appointments" may increase
the subjects' therapeutic misconception. The
change was made in the forward-translation. |
| Changed
the term "harontin" to "harontina". |
The
change was made in the forward-translation.
Translators could not find this term in any
of the medical dictionaries, so they substituted
it with a name that had a more Spanish flavor. |
| Changed
"discomfort or pain" to "discomfort of pain" |
The
concept is lost that pain may be so minor as
to be classified as mere discomfort. The forward-translation
was correct; the change was made in the back-translation. |
References
1 45
CFR 46.116
2 ICH
Subpart B Section 50.20
3 Boston
University Medical Center IRB Policies and Procedures
last accessed 1/16/05 at http://www.bumc.bu.edu/www/bumc/irb/Images/pp_infconsent.htm
_____________________________________
David
Grunwald is CEO of Global Translations, a provider
of translation services to the clinical research industry.
Contact him at (866) 280-9038 or davidg@global-translation-services.com.
Norman M. Goldfarb is Managing Partner of First Clinical
Research, a provider of a clinical research best practices
consulting, training, implementation and research
services. Contact him at (650) 465-0119 or ngoldfarb@firstclinical.com.
This
article was originally published in Journal of Clinical
Research Best Practices, Vol. 2, No. 2, February 2006.
www.FirstClinical.com
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