A copy of the IRB-approved English short form translated into the language in which the subject is fluent.
The UCSD IRB-approved English short form has been translated into the following languages:
A copy of the IRB-approved study consent (long form).
A copy of the UCSD "Experimental Subject's Bill of Right" translated into the language in
which the subject is fluent. The UCSD "Experimental Subject's Bill of Right" has been
translated into the following languages:
If the procedures for using the short form were not previously approved, a revised Research
Plan to clearly and specifically outline the procedures that will be used to obtain consent
using this method.
These procedures should also address the ongoing process of "informed" consent and the need for
providing continued, qualified interpretive services. These four documents require IRB
approval before using the short form to obtain consent.
In addition, the following persons need to be present at the time short form consent is being
The following signatures are required if the potential participant agrees to enroll in the study:
The potential participant.
The person obtaining consent.
A qualified interpreter.
A family member or close personal friend of the participant is not considered a qualified
interpreter. The qualified interpreter may be present physically or by some other means, for
example by phone or video conference. Note that the interpreter may also serve as the witness
only if the interpreter can sign the appropriate documents (see below).
The witness is an adult who is conversant in the language of the presentation. The witness
should be an impartial third party, not otherwise connected with the clinical investigation
(for example, clinical staff not involved in the research or a patient advocate) and not be
the person obtaining the consent. The purpose of the witness is generally to attest to the
voluntariness of the subject's consent and the adequacy of the consent process by ensuring
that the information was accurately conveyed and that the subject's questions were answered.
The participant signs and dates the translated short form and the translated "Experimental
Bill of Right"
The person obtaining the consent signs and dates the IRB-approved study document
The witness signs and dates the translated short form and the IRB-approved study consent
Copies of all the documents are provided to the participant.
Once the participant has been consented, the English version of the IRB-approved study consent
must be translated into the language in which the participant is fluent. The translated
document must be submitted for approval by the IRB (typically using expedited procedures), and
provided to the participant as soon as possible but no more than one month after the
participant's initial consent.
The short form method should be used only for the occasional and unexpected enrollment of
non-English speaking participants.