How To Submit Deviations
A deviation is an unintentional action or process that departs from the IRB approved study protocol that is identified retrospectively (after the event occurred). Study teams should keep a log of all deviations to record, assess, and develop corrective actions 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 reporting to the IRB is required.
Deviations can be categorized as major or minor. This categorization is dependent on the IRB reporting criteria. A major deviation is a deviation from the IRB approved protocol, regulations, or university policies that may constitute serious noncompliance. A minor deviation is a deviation that patently does not meet the criteria for serious noncompliance. Serious noncompliance is noncompliance that may adversely affect the following:
- the rights of participant, OR
- the welfare of participants, including actual or potential substantive harm, OR
- the scientific integrity of the study
Criteria for Serious Noncompliance
The PI should review the deviation and its root cause as well as the factors outlined below. Corrective actions to rectify the incident, and preventative actions to avoid the deviation from happening again, should also be considered. The assessment and corrective actions with associated rationale should be documented.
Adverse Impact on Welfare of Participants
Assess whether the finding may have potentially had adverse impact on participant welfare. Welfare may be defined as safety, physical integrity, or mental integrity. Assess whether there was potential for harm and whether actual harm occurred. Assess the severity of the potential or actual harm.
Adverse Impact on Rights of Participants
Assess whether any participants rights were violated as a result of the finding. This assessment should also include an assessment of the participant’s willingness to participate and whether they participant is able to be informed of the issue. If the deviation involved consent noncompliance, assess whether re-consent is possible.
Adverse Impact on Scientific Integrity
Assess whether the finding may have an adverse impact on the study results including whether the data collected can be used, the overall scientific value of the trial and/or the reliability of the results. The IRB recommends consultation of a statistician when findings involve substantial missing data.
When to Submit Deviations
When to submit deviations is dependent on the categorization of the deviation, as outlined below.
Major deviations should be submitted to the IRB within 10 days of their discovery via a deviation submission. The Word deviation form should be utilized to present the deviation, root cause, and corrective actions to the IRB. For all greater than minimal risk research, a summary of major deviations is required at Continuing Review. Click Learn More below for continuing review deviation summary requirements.
Forms & Templates
Minor deviations do not need to be reported to the IRB, but the IRB may request to review minor deviations at its discretion. Therefore, minor deviations should be documented within the study records. Keeping a deviation log is best practice. Click Learn More for a deviation log template.
Office of Clinical Research Guidance on Deviations
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
Exception Requests versus Deviations
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.
How To Submit a Major Deviation
Below are instructions for how to submit a major deviation.
- Download the Deviation form from the IRB Forms page.
- Complete the form. PI Signature on the form is NOT required when submitting in HSERA. The PI signs off electronically in HSERA.
- Sign in to HSERA.
- On the Blue left side Menu click “Create” under “My Submissions”
- On the next screen choose “Deviation”
- 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”.
- When the appropriate study appears in the list, click the select button on the far right.
- 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.
- Download the Deviation form from the IRB Forms page.
- After completing the submission form, have it signed by the PI, and scan it.
- Compile electronic versions of any other documents relevant to the deviation as well. Please do not send PHI to the IRB. Ensure any participant materials are redacted.
- Email the signed Deviation form and any other documents to the IRB PO box so that the closure submission may be reviewed electronically.
IRB Review Process
The IRB will assess the deviation and the proposed corrective and preventative actions. The IRB may ask questions to clarify the root cause and details of the deviation. The IRB may request changes to corrective and preventative actions or study documents. The IRB will determine whether the deviation may constitute serious noncompliance, continuing noncompliance, or an unanticipated problem. It is important to note that most deviations do not result in determinations of serious noncompliance, continuing noncompliance, nor an unanticipated problem. In very rare cases, the IRB could terminate approval of the research to ensure the welfare of human research participants are protected.