- 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
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 picture 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.