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Short form request


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__________________________________________________________________________

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)  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.

2)  Identify the individual/commercial interpretation/translation service that translated the short form:      

5. 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
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
autoshape 2


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) Page of


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