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OBTAINING AND DOCUMENTING INFORMED CONSENT OF
SUBJECTS WHO DO NOT SPEAK ENGLISH
The
Department of Health and Human Services (DHHS) regulations
( 45
CFR 46.116 and 45
CFR 46.117) and FDA regulations ( 21
CFR 50.25 and 21
CFR 50.27) require that informed consent information
be presented in language understandable to the subject,
and in most situations, that informed consent be documented
in writing. Investigators should carefully consider the
ethical/legal ramifications of enrolling a subject when
there is a language barrier. If subjects do not clearly
understand the consent document or freely ask and receive
answers to their questions, then their consent will not
be truly informed and may not be legally effective. Thus,
subjects who do not speak English must be provided with
BOTH a:
- written
consent document in a language understandable to them,
AND
- translator
fluent in both English and the subject's spoken language
Depending
upon the research, the written consent document can be
either: (I.) a translation of the entire English version
of the Partners Human Research Committee (PHRC) approved
consent document; or (II.) a translation of the so-called
"short form."
I.
USING A WRITTEN TRANSLATION OF THE ENTIRE ENGLISH VERSION
OF THE PHRC-APPROVED CONSENT DOCUMENT
Use
of a written translation of the entire PHRC-approved English
version is always preferred. If researchers can reasonably
expect that more than an incidental number of subjects
speaking the same non-English language will be enrolled
(for example, if the investigator is targeting a non-English
speaking group), translation of the entire English version
is strongly recommended. The PHRC must approve all translated
versions of the consent form and recommends that the translation
be done by a certified translator from Interpreter Services.
However, the PHRC will consider, on a case-by-case basis,
allowing other translators to perform this function with
verification that the translation is an accurate and acceptable
presentation of the entire English version.
II.
USING A WRITTEN TRANSLATION OF THE "SHORT FORM"
CONSENT DOCUMENT
Investigators
cannot always anticipate the interest of a particular
non-English speaking individual and provide him/her with
a translation of the entire PHRC-approved English version
of the informed consent document in a timely manner. Under
these circumstances, a translation of the "short
form" (which attests that the elements of consent
have been presented orally) can be used to document informed
consent in writing. When a "short form" is used
to document informed consent, the consent process must
include oral presentation of the entire English version
of the consent form in language understandable to the
potential subject.
The
informed consent process for enrolling subjects using
the "short form" consent document is outlined
below. ALL of the following requirements (1, 2,
3 and 4) must be completed:
- A
translator must orally present the entire PHRC-approved
English version of the consent form to the subject in
a language understandable to him/her, and the subject
must be given a written translation of the "short
form" consent document to read;
-
The entire consent process must be witnessed by an individual
who is fluent in both English and the language understandable
to the subject. The translator may serve as the witness;
-
The PHRC-approved English version of the consent form
must be signed by the investigator authorized by the
PHRC to obtain consent and the witness to the consent
process, and the translated "short form" must
be signed by the subject and the witness to the consent
process (see 2 above); AND
-
The subject must be given copies of both the PHRC-approved
English version of the consent form and the translated
version of the "short form" consent document.
The original signed English version with the original
signed "short form" attached should be placed
in the subject's research record and a copy of both
placed in his/her medical record, if appropriate.
The
PHRC recommends that the translator come from the pool
of experienced translators at Interpreter
Services, however will consider on a case-by-case
basis allowing other individuals to serve in this capacity.
For questions about obtaining translation services (written) for your research study contact: MGHTranslations@partners.org, or for interpreter services (oral) contact: MGHInterpreters@partners.org.
III.
"SHORT FORM" CONSENT DOCUMENT AND TRANSLATIONS
INTO COMMONLY ENCOUNTERED LANGUAGES
Below
are PHRC approved "short form" consent documents.
All other translations of the "short form" must
be submitted to the PHRC for approval. The consent documents
are available as "PDF" files and can be printed
with Adobe Acrobat.
For
more information about short form consent documents and
obtaining consent, please visit the links below:
FDA: A Guide to Informed Consent, 1998 Update
OHRP
Memorandum: Obtaining and Documenting Informed Consent
of Subjects Who Do Not Speak English, 11/09/95
Short Form Consent Versions:
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