__________________________________________________________________________
NEBRASKA’S HEALTH SCIENCE CENTER
OFFICE OF REGULATORY AFFAIRS (ORA)
Institutional Review Board (IRB)
SHORT FORM REQUEST
Instructions: Use of a short form written consent document is permissible in accordance with HHS
regulations at 45 CFR 46.117(b)(2) and FDA regulations at 21 CFR 50.27(b)(2) when 1) a subject/LAR who
cannot understand English is unexpectedly encountered, 2) there is not sufficient time to develop and obtain
IRB approval for a standard consent form written in language understandable to the subject/LAR, and 3) there is
sufficient prospect of direct therapeutic benefit if the individual is permitted to enroll in the research. The short
form is not a substitute for a complete fully translated consent form when it is anticipated that a significant
number of subjects will be non-English speaking. Use of a short form is restricted to enrollment of no more than
two subjects per language in a given protocol.
To utilize a short form, this request must be completed and submitted to the Office of Regulatory Affairs prior to
consent of the non-English speaking subject/LAR.
DATE:
IRB #:
TITLE OF PROTOCOL:
PI NAME:
1.
Person Requesting Use of Short Form
Name:
Phone:
Email:
2.
Is the person requesting the short form the contact person to be listed on the short form?
Yes
No. Indicate the person’s name and phone number.
Name:
Phone:
3.
Anticipated Date of Consent of the Prospective Subject/LAR:
4.
Identification of Short Form
A.
I am requesting the use of the following IRB-approved short form:
Arabic
French
Russian
Spanish
Croatian
Hmong
Somali
Vietnamese
B.
I am requesting the use of a short form in another language that has not received IRB
approval. Language:
1)
2)
5.
A translated short form, based upon the IRB-approved English version of the short
form, has been developed and is now submitted for IRB review and approval.
Identify the individual/commercial interpretation/translation service that translated the
short form:
Subject’s Legal Status
A.
I am requesting the use of a short form to enroll an adult
B.
I am requesting the use of a short form to enroll a minor
Short Form Request (03-05-13)
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6.
Has a short form in this language been previously used in this protocol?
No
Yes. Indicate number of times and dates the short form has been used below.
Number of times used:
Date(s) used:
7.
Requirements for IRB approval:
A non-English speaking potential subject/LAR has been unexpectedly encountered.
There is not sufficient time to develop and obtain IRB approval of a translated complete consent form.
There is sufficient prospect of direct therapeutic benefit to the potential subject.
An interpreter is available:
A qualified member of the study staff; Name:
Official TNMC, CH&MC, or study site hospital interpreter/translator; Name:
A qualified employee of the UNMC, UNO, TNMC or CH&MC; Name:
A commercial interpretation/translation service; Identify
Family member of subject will serve as the interpreter. Please list reason:
A witness is available who will be present during the oral presentation of the consent form. Note: The
interpreter may serve as the witness as long as the interpreter is not the designated study personnel
obtaining consent.
Certification:
I understand that the complete IRB-approved consent form must be verbally interpreted into a language
understandable to the subject. Throughout the process, the subject/LAR must be asked for feedback to
determine an understanding of the research and his/her/subject’s rights as a research subject.
The subject/LAR and the witness will sign and date the short form. The person obtaining consent and the
witness will sign and date the English version of the complete consent form(s). A copy of all signed and
dated documents will be given to the subject/LAR. The process of consent will be fully documented and
maintained on file which includes the following:
 The time over which the process of consent was conducted;
 The name and contact information of the interpreter;
 The name and contact information of the witness.
Person Requesting Use of Short Form
Date
FOR OFFICE USE ONLY
Expedited Review
Use of an IRB-approved short form
Use of a short form in this language is approved for this subject.
Date of expiration:
Use of a short form in this language is not approved. A fully translated consent
form
must be developed and submitted for full IRB review and approval prior to enrollment of any
subjects speaking this language.
Use of a short form in this language is not approved. Short form(s) previously used
Use of a short form in this language is not approved. There is adequate time to develop and
obtain IRB approval for translated complete consent form
Use of a short form in this language is not approved. There is insufficient prospect of direct
therapeutic benefit
Other:
IRB CHAIR/DESIGNEE
Use of a new short form
The new short form is based upon the UNMC IRB approved English short form template. This
short form is approved. Date of expiration:
IRB CHAIR/DESIGNEE
Short Form Request (03-05-13)
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