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.
TITLE OF PROTOCOL:
1. Person Requesting Use of Short Form
2. Is the person requesting the short form the contact person to be listed on the short form?
No. Indicate the person’s name and phone number.
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?
Yes. Indicate number of times and dates the short form has been used below.
Number of times 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.
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
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
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:
Short Form Request (03-05-13) Page of