Office for the Protection of Research Subjects (OPRS)
Institutional Review Board
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
To Be Completed By the Investigator UIC Protocol #:
Date Application Completed: For OPRS Use Only
Application Document Version #: Assigned IRB:
I. Research Title:
A. Principal Investigator
Name (Last, First) Degree(s) University Status/Title
Mailing Address E-mail Address
Phone Number Fax Number M/C
The protocol exception request represents:
An exception to the protocol to allow the enrollment of or modification of procedures for a single
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
Complete section B.
1. Subject(s) Study Identification Code
(Do not provide any subject identifiers. Instead, use a coded identifier like the one used in study
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. .
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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.
1. Research is currently stopped due to a:
Lapse in approval
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
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
Signature of PI: Date:
Printed Name of PI:
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