A deviation is an unintentional action or process that departs from the IRB approved study protocol that is identified retrospectively (after the event occurred). All study teams should record, assess and develop corrective actions for all deviations that occur during the conduct of the research study. Deviations should be assessed in the context of the protocol and the IRB reporting criteria to determine whether expedited IRB reporting is required.
Deviations can be categorized as major or minor. This categorization will affect IRB the reporting criteria:
Major deviations require separate expedited reporting to the IRB within 10 business days of their discovery.
A major deviation is a deviation from the IRB approved protocol, human research regulations, or human research university policies that adversely affects
- the rights of participant, OR
- the welfare of participants, including actual or potential substantive harm, OR
- the scientific integrity of the study
These deviations require expedited reporting because they require an assessment of noncompliance by the IRB. Additionally, a breach of confidentiality should also be reported in an expedited manner, as this involves a deviation from the approved confidentiality plan.
Submitting a major deviation that requires separate review requires use of the most recent version of the Deviation Report Form (Click here to download) - Updated 7/2022
Minor protocol deviations are deviations that patently do not meet the criteria outlined above. If there is any uncertainty surrounding the deviation, please submit to the IRB in an expedited fashion for IRB assessment. Even if a deviation is minor and not submitted for expedited review it should still be recorded in the study files to document:
- when each deviation occurred
- a description of the deviation
- the PI assessment of the deviation in context of the IRB expedited reporting criteria
- any corrective actions put in place in response to each deviation or to prevent it from happening again
Please note that if an investigator knows in advance that the protocol will be deviated from for any reason, an exception request should be submitted prior to implementation of that altered process. Please note that exception requests submitted after implementation will be considered deviations regardless of prior approval from sponsors or medical monitors. Please see the How to Submit: Exception Requests for more information.
NOTE: The IRB may use its discretion in determining whether an event meets the definition of noncompliance, serious noncompliance, or continuing noncompliance. Likewise, the IRB may use its discretion in determining whether noncompliance is reportable to internal or external entities.
Penn Medicine researchers conducting clinical research should also reivew the Office of Clinical Research Guidance entitled: Recording, Assessment, and Reporting of Deviations Guidance to Investigators Participating in Clinical Research
Steps for creating a Deviation in HSERA
1. After completing the submission form, save it to your desktop. PI signature on the form is NOT required when submitting in HSERA
2. Go to HSERA.
3. In the blue menu on the left side of your screen look for "Create" under "My Submissions".
4. After clicking "Create" you will be brought to a new screen where the various electronic application types are available. Click "Deviation"
5. After clicking "Deviation" you will be brought to a screen with a list of all HSERA studies for which you are listed as either PI, Co-PI or Study Contact (note that Key Personnel cannot create submissions). Check to make sure your filter is clear. Then enter the protocol # you wish to make a Deviation for and click "Filter".
6. After clicking "Filter" with the specific protocol number entered, you should see one entry with columns showing the PI name, Submission date, Title, and a Select column - click the white and yellow "Select" button.
7. After clicking the "Select" button you will be taken to the first page of the Deviation submission
- Page 1 requires that users answer questions similar to those questions in the downloaded form that you already completed in Step 1. The IRB will refer to your attached form – NOT the electronic answers on page 1 of the Deviation application. Currently the system requires responses to all questions on page 1. You should fill in accurate dates for the first 2 questions. Fill in all text boxes with “NA” or “0” or “See attached” to get through this section quickly (In the future the system will be updated to remove these questions and provide an area to attach your completed form). All the relevant information that the IRB requires will be provided in your attached form. When you get to the end of page 1, click “Next”
- Page 2 of the Deviation application is where you attach your completed form (from Step 1). You can attach as many documents as necessary in this section.
- Once the completed Deviation form and supplemental documentation are attached to the application, go to the bottom of the page and click “I accept” – your Deviation submission is now complete.
To Submit a Deviation for a Paper Study
How should I report deviations with my continuing review?
For all greater than minimal risk research, A summary of major deviations will be required at Continuing Review.
Requirements for submitting minor deviations at the time of continuing review are contingent upon the protocol specific plan for monitoring and quality control.
Please see How to Submit: Continuing Review for guidance and instructions prior to submitting your continuing review.
Who Do I Contact With Questions?
For questions about the content of your Deviation submission, please reach out to: