A deviation is an unintentional action or process that departs from the IRB approved study protocol that is identified retrospectively (after the event occurred). Deviations can be categorized as minor or major.

Major Deviations

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, human research university policies that may:

·         have the potential to adversely affect subject safety; OR
·         increases risks to participants; OR
·         adversely affects the integrity of the data; OR
·         violates the rights and welfare of participants; OR
·         affects the subject’s willingness to participate in research.

These deviations require expedited reporting because they require an assessment by the IRB. Submitting a major deviation that requires separate review requires use of the most recent version of the  Deviation Report Form (Click here to download)
 
Minor Deviations

Minor protocol deviations should be summarized at continuing review. These are deviations that patently do not meet the criteria outlined above.

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” page about exception requests for more information.

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

After completing the submission form, please print and send to the IRB office with one copy of each required supporting document. PI signature is required for all paper submissions.

How should I report deviations with my continuing review?

If your study experienced some minor deviations during the year that did not require immediate reporting, you may submit a summary of those events with your continuing review. Please note the following when drafting the summary:

  • The document may be in the form of narrative summary or a deviation log,
  • The summary must include all of the following information:
  1. When each deviation occurred
  2. A description of each deviation
  3. If and when the deviations were previously reported to the IRB
  4. Any corrective actions put in place in response to each deviation
  5. Assessments of each deviation to determine the following:

          - Were subject rights, welfare, or willingness to participate adversely affected?

          - Was the scientific integrity of the study adversely affected?,

          - Did the deviation have the potential to affect the safety of subjects?

Who Do I Contact With Questions?

For questions about the content of your Deviation submission, please reach out to:

Jessica Yoos

Dave Heagerty

Patrick Stanko

Tracy Ziolek