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.
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 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.
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 use of the most recent version of the Exception Request Form from the IRB Forms page. 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.
The Exception Request Form should include the following information:
- A description of the exception including references to the current protocol, and associated rationale for deviating;
- Proposed date of the exception, declaration of time sensitivity and rationale;
- Clarification as to why the action is a single occurrence and why the protocol doesn’t require modification, or explanation that a future modification is planned;
- Plans for communicating the exception to subject;
- Assessment of increased risk involved in the exception;
- Assessment of subject benefit from the exception; and
- Assessment of impact of the exception on data integrity
How to Submit
Download the Exception Request Form and complete it. The form does not require signature when submitting within the HSERA system.
Log into In HSERA.
Under “My Submissions” in the blue column on the left side of the screen choose “Create”.
On the next page select “Exception”.
On the next page Search for and select the relevant protocol.
Complete all text box fields on page 1 with “See attached Form” then click “Next” at the bottom of the page (the application will eventually be updated to remove these fields and replace them with an area to attach your completed form)
Attach the completed exception request form and supportive documents (document list, other approvals, etc.) by clicking the green “attach form” button. After all your documentation has been attached, click the blue “I accept” button.
After clicking “I Accept” the application will be sent to the Principal Investigator (PI) for approval (if the PI was not the person who created it). Once the PI approves the submission it will be received by the IRB for review.
If your study is older than the HSERA system and is documented on paper, follow the steps below.
Download the Exception Request Form and complete it.
Obtain the PI’s signature on the form. Scan it for submission.
Submit the form and supporting documentation to the IRB PO Box.
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 Form, rationale for rush review, and supporting documentation should be emailed to the IRB. All Rush Exception requests should be emailed to the IRB Director and Associate Directors.
In the case of rush exceptions, it may not be feasible to obtain Principal Investigator’s (PI) signature on the form. In these situations, please include an email from the PI approving the exception request as a supporting document. Please be sure to CC the PI on your exception request email to the IRB.
When submitting a rush exception via email for an HSERA study, a formal submission of the exception through HS ERA is required after the exception request has been processed. Attach all the documents along with the approval that was provided via email.
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.