Office of the Institutional Review Board

Exception

Exception


Forms:

 

 

Policy/Guidance:

  • Use the Decision Tree to help you evaluate the departure
  • A one-time, intentional action that departs from the IRB approved protocol for a single subject. An exception is identified before it occurs and is under the control of the investigator.
  • Single subject exceptions may not be initiated without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.
  • Example: (but are not limited to): enrollment of a single subject who does not meet all eligibility criteria for a study, but the investigator and sponsor have agreed this subject should be enrolled.
  • Refer to the Modifications and Amendments Policy and Procedure

 

UPDATED: 1/8/2016

Always download the forms from the IRB website to ensure you are using the most current versions.
Hard copy submissions are not accepted.

Note: These forms are to be downloaded and saved to your computer and then opened in Microsoft Word (Click the Examplepicture for an example). If you are experiencing problems downloading a form from our page, and using an alternate browser has not helped (i.e., Chrome, Firefox, Internet Explorer), please call the Office of the IRB at 210-567-8250.