To Be Completed By the Investigator

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					                                                        Office for the Protection of Research Subjects (OPRS)
                                                                                 Institutional Review Board
                                                                                            FWA# 00000083

                                                                                           203 AOB (MC 672)
FORM - Protocol Exception                                                               1737 West Polk Street
                                                                                       Chicago, IL 60612-7227
                                                                       Phone: 312 996-1711 Fax: 312 413-2929
Version: 2.1                                                            www.research.uic.edu/protocolreview/irb
Date: 05/25/2012



To Be Completed By the Investigator                      UIC Protocol #:
Date Application Completed:                              For OPRS Use Only
Application Document Version #:                          Assigned IRB:




I. Research Title:

II. Personnel
A. Principal Investigator
 Name (Last, First)                                    Degree(s)              University Status/Title

 Department                                                                   College

 Mailing Address                                                              E-mail Address

 Phone Number                               Fax Number                        M/C




III. Information
The protocol exception request represents:
      An exception to the protocol to allow the enrollment of or modification of procedures for a single
      subject.
          Complete section A.
      An exception to the protocol to allow the enrollment of or modification of procedures for small number
      of subjects (justification for why an amendment cannot be submitted is required.)
          Complete section A.
      An exception to allow currently enrolled subjects to continue some or all research activities during a
      lapse in IRB approval or suspension. Enrollment of new subjects is not allowed, except in
      extraordinary circumstances.
          Complete section B.
A.
 1.     Subject(s) Study Identification Code
        (Do not provide any subject identifiers. Instead, use a coded identifier like the one used in study
        records.)

 2.     Description of the Exception: Describe the exception and justify why the exception is needed.
        Attach a copy of the sponsor/funding agency/coordinating site approval for the exception. If the
        study involves an investigational drug, biologic or device, provide FDA approval for the exception. .




Page 1 of 2                                                                  OVCR Document #0280
          FORM – Protocol Exception                                                     Version #2.1


 3.    Risks and Benefits: Briefly discuss the impact of the exception on the risks and benefits to the
       individual subject. Note whether the exception affects the validity of the study.

 4.    Informed Consent: Indicate whether the exception will be discussed with the subject. If so,
       describe how the exception will be presented to the subject. Attach any written materials or script
       of oral presentation to be provided the subject.



B.
 1.    Research is currently stopped due to a:

          Lapse in approval
          IRB suspension

  2.    Research activities
          Requesting to continue all research activities in the IRB approved protocol
           Requesting to continue only the following activities from the IRB approved protocol
            List:

3. List below for each subject their coded identification (ID) and the over-riding safety concerns or
   ethical issues justifying why it is in their best interest to continue participation in the requested
   research activities (Do not provide any subject identifiers. Instead, use a coded identifier like the one
   used in study records.)

Subject Coded ID                                        Justification for Protocol Exception




IV. Investigator’s Signature
As Principal Investigator, my signature indicates that the information contained in this report is accurate
and complete.


Signature of PI:                                                            Date:


Printed Name of PI:




Page 2 of 2                                                                 OVCR Document #0280

				
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