FORM – Protocol Exception Version #2.1

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. .

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:

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