Instructions For Using A Short Form Consent Document Definitions

instructions for using a short form consent document definitions: * short form consent: an abbreviated written consent document

Instructions for Using a Short Form Consent Document
Definitions:
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Short Form Consent: An abbreviated written consent document
stating that the elements of consent have been presented orally.
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If enrollment of non-English speaking participants is planned
in a research study, an IRB-approved translation of the
written informed consent document should be provided to
prospective participants. (Translations should be made by a
reliable source.)
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Summary: A brief overview of the information that is presented
orally to the research participant that is attached to the short
form each time it is used. The IRB-approved English language
informed consent document may serve as the summary.
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Translation: Informed consent information must be presented in a
language understandable to the prospective participant or the
participant’s legally authorized representative. Translation may
be provided by VUMC Interpretive or Translation services. For
information regarding interpretive services at VUMC, please
contact 322-7378 or visit www.vanderbilthealth.com.
For English Speaking Participants:
The Short Form Consent document may be utilized in conjunction with an
oral presentation of the informed consent information and a written
summary of what is presented orally. The English Short Form should be
used with participants who are unable to read and whose primary
language is English. (Please note that Surrogate Consent Procedures
should be employed for participants with impaired decision-making
capacity.)
When the English Short Form is used:
a. The informed consent information must be presented orally in
conjunction with a short form consent document. A witness to the oral
presentation is required. The witness should be fluent in English. The
participant must be given copies of the short form consent document
and the IRB approved English consent form.
b. At the time of consent:
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the short form consent document should be signed by the
participant or the participant's legally authorized
representative;
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the English consent form should be signed by the person obtaining
consent as authorized under the protocol or research plan.
For Non-English Speaking Participants:
A translated Short Form Consent document may be provided to
non-English speaking participants, in conjunction with an oral
presentation of the informed consent information and a written summary
of what is presented orally.
When a non-English Short Form is used:
a. The informed consent information must be presented orally by a
qualified translator in conjunction with a short form consent document
(written in the participant’s language). A witness to the oral
presentation is required. The witness should be fluent in English and
the language of the participant. The participant must be given copies
of the short form consent document and the IRB approved English
consent form.
b. At the time of consent:
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the short form consent document should be signed by the
participant or the participant's legally authorized
representative;
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the English consent form should be signed by the person obtaining
consent as authorized under the protocol or research plan; and
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the short form document and the English consent form should be
signed by the interpreter. When the person obtaining consent is
assisted by a translator, the translator may serve as the witness.
c. Ideally, participants who do not speak English should be presented
with a consent document written in a language understandable to them
as soon as available. Although the PI should strive to present a
consent document written in a language understandable to the
non-English speaking participant, this is only strongly encouraged by
OHRP. It is acceptable per the federal regulations to use oral consent
with a short form and a copy of the English version consent.