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Protocol Deviations

A deviation is ANY departure from the defined procedures and treatment plans as outlined in the protocol version or application version submitted and previously approved by the Institutional Review Board (IRB). Deviations have the potential to place participants at risk and can also undermine the scientific integrity of the study thus jeopardizing the justification for the research.

Deviations are unplanned and/or unintentional events. Any changes in the IRB-approved research protocol should not be initiated without submission of an amendment for IRB review and approval.  If such changed are initiated before IRB approval for the change is given, a deviation has occurred.

 

Criteria for Reporting Deviations

The University of Utah IRB requires researchers to submit deviations that meet one or more of the following criteria:

  • Intended to eliminate apparent immediate hazard to a research participant (such as changing the dose of a medication due to possible toxicity);
    or
  • Caused possible harm to participants or others, or places them at increased risk of harm - including physical, psychological, economic, or social harm, such as a breach of confidentiality;
    or
  • Possible serious or continued non-compliance (such as a deviation that has happened previously and is now being repeated).
    • Serious non-compliance is an act or omission to act that resulted in significant harm (physical, psychological, safety, or privacy) or significantly increased the possibility of harm to the rights and welfare of research participants.
    • Continuing non-compliance is a pattern of repeated actions or omissions to act that suggests a future likelihood of reoccurrence and that indicates a deficiency in the ability or willingness to comply with Federal regulations, VHA Handbooks or the policy, requirements, and determinations of the IRB governing human subject research.

The IRB recognizes that some deviations pose no conceivable threat to participant safety or scientific integrity. For example, when the subject misses a clinic visit and the only available re-schedule date is outside the study visit window but no study procedures or medication doses are missed. In this case, the subject may not incur possible harm from a missed dose or missed procedures meant to maintain or evaluate the subject's safety and welfare.  As such, reporting is left to the discretion of the PI within the context of the guidelines above. Though a deviation may not pose a conceivable threat or possible harm, it may represent possible continuing non-compliance.

VA RESEARCH: The criteria for VA research differs from University policy.  For more information about reporting non-compliance for VA research, visit Research Conducted at Veterans Affairs.

 

How to Report a Deviation

The Investigator must consider each deviation and decide whether or not it meets the reporting criteria above.

Criteria Are Met:

Report the deviation using the Report Form in ERICA.  The Report Form must be submitted promptly, within 10 working days from the time the investigator learns of the deviation. NOTE: The Report Form must be submitted within 5 working days for VA research. 

    1. Open the study in ERICA.
    2. Click on the Report Forms tab.
    3. Click on the File a Report Form button.
    4. Indicate Deviation as the type of report.
    5. Complete the report form entirely.
    6. Attach any supporting documentation to the report form in the indicated sections.
    7. If you are submitting an amendment in conjunction with the report, link the report form to the amendment in the "Report Forms" section of the amendment application.
    8. Submit the report form to the IRB for review.

Criteria Are Not Met:

    1. Document in the research record how the deviation does not meet the reporting criteria.
    2. Log the deviation such that it can be evaluated in the future if other deviations occur.

 

What are the possible consequences for deviating?

The deviation is evaluated to determine if it had a significant effect on the participant’s rights, safety, or welfare, or corrupted the integrity or the resultant scientific data. After the review, the deviation may be completed, returned to the PI to be re-submitted as an unanticipated problem, or evaluated for possible serious or continuing non-compliance.

 

What are the consequences for late reporting?

Researchers are required to submit the report as soon as possible after the PI learns of the deviation, but in all cases within 10 working days (5 days for VA research). If the report is submitted late, a written explanation of its tardiness must accompany the report. Late reports may be reviewed for additional non-compliance.

When in doubt, it is better to submit the deviation, allowing the IRB to make the determination rather than failing to submit a report that should have been submitted.

 

Where can I find more information?