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.
Assessing Deviations
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
Major deviations should be submitted to the IRB within 10 business days of their discovery via a deviation submission. The submission should describe the deviation, root cause, and corrective and preventative 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.
Minor Deviations
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 to be directed to the Penn Medicine OCR website for a protocol 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
All deviations that require expedited reporting to the IRB should be submitted in eIRB. This includes studies that were originally approved through paper submissions and previously submitted deviations via email. All paper submissions must be transitioned to electronic studies in eIRB by the study team.
Steps for submitting in eIRB
- Sign into eIRB.
- Search and select the protocol in which the deviation occurred.
- Utilizing the Panel Shortcuts menu on the left, scroll down to find and select the “Protocol Deviations” tab.
- Select the blue “Add Deviation” button within the submission. If more than one deviation has occurred, separate deviations submissions should be added.
- 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.
- If the corrective action plan requires any participant-facing materials such as telephone scripts, these must be reviewed by the IRB and can be uploaded in the deviation submission under “Please note: If an addendum consent form …”
- Deviations do not get routed within eIRB to the PI for review and approval before submission to the IRB. Therefore, by selecting the “Attestation By Person Submitting” button the submitter is confirming that the deviation has been reviewed by the PI and all necessary documentation for reviewing the deviation is being submitted to the IRB for review.
- If ready to submit, select the “Send for Review” button.
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.