Source: Office for Protection from Research Risks
(OPRR)
November 9, 1995
| TO: |
Professional Staff
Division of Human Subject Protections, OPRR |
| FROM: |
Director
Division of Human Subject Protections, OPRR |
| |
|
| SUBJECT: |
OBTAINING AND DOCUMENTING INFORMED CONSENT OF
SUBJECTS WHO DO NOT SPEAK ENGLISH |
Department of Health and Human Services regulations for the protection
of human subjects require that informed consent information be presented
"in language understandable to the subject" and, in most situations,
that informed consent be documented in writing (45 CFR 46.116
and 46.117).
Where informed consent is documented in accordance with 46.117(b)(1),
the written consent document should embody, in language understandable
to the subject, all the elements necessary for legally effective
informed consent. Subjects who do not speak English should be presented
with a consent document written in a language understandable to
them. OPRR strongly encourages the use of this procedure whenever
possible.
Alternatively, 46.117(b)(2)
permits oral presentation of informed consent information in conjunction
with a short form written consent document (stating that the elements
of consent have been presented orally) and a written summary of
what is presented orally. A witness to the oral presentation is
required, and the subject must be given copies of the short form
document and the summary.
When this procedure is used with subjects who do not speak English,
(i) the oral presentation and the short form written document (see
sample attached) should be in a language understandable to the subject;
(ii) the IRB-approved English language informed consent document
may serve as the summary; and (iii) the witness should be fluent
in both English and the language of the subject.
At the time of consent, (i) the short form document should be signed
by the subject (or the subject's legally authorized representative);
(ii) the summary (i.e., the English language informed consent document)
should be signed by the person obtaining consent as authorized under
the protocol; and (iii) the short form document and the summary
should be signed by the witness. When the person obtaining
consent is assisted by a translator, the translator may serve as
the witness.
The IRB must receive all foreign language versions of the short
form document as a condition of approval under the provisions of
46.117(b)(2).
Expedited review of these versions is acceptable if the protocol,
the full English language informed consent document, and the English
version of the short form document have already been approved by
the convened IRB.
It is the responsibility of the IRB to determine which of the procedures
at 46.117(b)
is appropriate for documenting informed consent in protocols that
it reviews.
Melody H. Lin, Ph.D.
Attachment: Sample Short Form Consent Document For Subjects Who
Do Not Speak English.
cc: Gary B. Ellis, Ph.D.
SAMPLE SHORT FORM WRITTEN CONSENT DOCUMENT
FOR SUBJECTS WHO DO NOT SPEAK ENGLISH
THIS DOCUMENT MUST BE WRITTEN IN A LANGUAGE UNDERSTANDABLE
TO THE SUBJECT
Consent to Participate in Research
You are being asked to participate in a research study.
Before you agree, the investigator must tell you about (i) the
purposes, procedures, and duration of the research; (ii) any procedures
which are experimental; (iii) any reasonably foreseeable risks,
discomforts, and benefits of the research; (iv) any potentially beneficial
alternative procedures or treatments; and (v) how confidentiality
will be maintained.
Where applicable, the investigator must also tell you about (i) any
available compensation or medical treatment if injury occurs; (ii) the
possibility of unforeseeable risks; (iii) circumstances when the investigator
may halt your participation; (iv) any added costs to you; (v) what
happens if you decide to stop participating; (vi) when you will be
told about new findings which may affect your willingness to participate;
and (vii) how many people will be in the study.
If you agree to participate, you must be given a signed copy of this
document and a written summary of the research.
You may contact ____name____ at ___phone number__ any
time you have questions about the research.
You may contact ____name____ at ___phone number__ if
you have questions about your rights as a research subject or what
to do if you are injured.
Your participation in this research is voluntary, and you will not
be penalized or lose benefits if you refuse to participate or decide
to stop.
Signing this document means that the research study, including the
above information, has been described to you orally, and that you
voluntarily agree to participate.
| ___________________________ |
____________ |
| signature of participant |
date |
| ___________________________ |
____________ |
| signature of witness |
date |
|
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