How to Submit Exception Requests
An exception is a prospective, one-time, intentional action or process that departs from the IRB approved study protocol. In essence, an exception is a prospective deviation. Exceptions require approval from the IRB prior to implementation through an Exception Request. If the same exception is requested multiple times, the IRB may require that the PI submit an amendment to the protocol.
What is an Exception?
An exception is a prospective, one-time, intentional action or process that departs from the IRB approved study protocol.
Exception Criteria
Prospective
Prospective means that the deviation is planned, and approval is sought from the IRB prior to implementation of the change. If an exception is submitted to the IRB for approval after it has already taken place, it is then considered a deviation regardless of whether sponsor or other monitoring approvals were obtained in advance.
Intentional
Intentional means that the deviation is deliberate, not accidental. An exception request will not be approved if it was unintentional. For example, if a subject is enrolled and later it is discovered that they met an exclusion criterion, this should be submitted as a deviation NOT an exception. This is because the deviation was not purposeful, nor planned in advance.
Single Occurrence
An exception is considered to be a one-time request for a single occurrence. Multiple exceptions submitted at the same time suggest a protocol modification is warranted. Each planned exception requires separate IRB approval. Multiple exceptions may adversely affect data integrity. Investigators should consider exceptions carefully.
Deviations in Clinical Research
Penn Medicine researchers conducting clinical research should also review the Office of Clinical Research Guidance entitled: Recording, Assessment, and Reporting of Deviations Guidance to Investigators Participating in Clinical Research.
Requesting IRB Approval of an Exception
All exception requests require the Exception Request application be completed in eIRB. Supportive documentation such as approval from the study sponsor, medical monitor, and other oversight entities, as applicable, should also be included in the submission. If the study is greater than minimal risk, a document list should also be included.
How to Submit in eIRB:
- Sign into eIRB.
- Search and select the protocol in which the exception request is being made.
- Scroll to the top of your protocol to quickly check the overall status.
- Once a study has an overall approved status, the Exception Requests panels will appear.
- Using the “Panel Shortcuts” on the left, scroll down and find and select the “Exception Request” tab.
- In the main protocol, within the panels for Exceptions you have the option to edit, delete, or send submission for review. This is located in the in the “Action” column and you can edit by clicking on the paper and pencil icon. The trashcan icon is to delete the submission and the arrow icon will send the Exception Submission for IRB review.
- Review the blue box instructions.
- Complete all questions and prompts. Ensure you are saving your work by selecting the “Save/Save draft” button as the page does not automatically save.
- Upload appropriate corresponding documents when applicable such as notification to the sponsor, medical monitor, or any other oversight entities.
- Click to scroll through the form and complete the required fields.
- NOTE: You will see a confirmation screen asking if you are ready to send; Click OK to send it for review. This will change the status to Submitted.
- If ready to submit, select the “Send for Review” button.
How to Submit
- Sign into eIRB.
- Search and select the protocol in which the exception request is being made.
- Scroll to the top of your protocol to quickly check the overall status.
- Once a study has an overall approved status, the Exception Requests panels will appear.
- Using the “Panel Shortcuts” on the left, scroll down and find and select the “Exception Request” tab.
- In the main protocol, within the panels for Exceptions you have the option to edit, delete, or send submission for review. This is located in the in the “Action” column and you can edit by clicking on the paper and pencil icon. The trashcan icon is to delete the submission and the arrow icon will send the Exception Submission for IRB review.
- Review the blue box instructions.
- Complete all questions and prompts. Ensure you are saving your work by selecting the “Save/Save draft” button as the page does not automatically save.
- Upload appropriate corresponding documents when applicable such as notification to the sponsor, medical monitor, or any other oversight entities.
- Click to scroll through the form and complete the required fields.
- NOTE: You will see a confirmation screen asking if you are ready to send; Click OK to send it for review. This will change the status to Submitted.
- If ready to submit, select the “Send for Review” button.
Rush Exceptions
A rush exception is an exception that needs to take place within the next 24-48 hours. If you need a rush exception, the Exception Request Application should be completed in eIRB and follow the how to submit instructions. The Exception Request Smartsheet in eIRB automatically alert the IRB to prioritize the Exception Request review to be completed by the date chosen in eIRB.
Enrolling Participants with Limited English Proficiency (LEP)
LEP persons are individuals who do not speak English as their primary language and who have limited ability to read, speak, write, or understand English. Incidental enrollment of LEP individuals requires prospective IRB approval via an exception request in some cases. Prospective IRB approval to enroll a LEP individual is not required when certain conditions are met. Guidance on the incidental inclusion of LEP individuals is linked below. Please review this guidance prior to submitting an exception request to enroll a LEP individual.