AARHPP

Protocol Deviations

A protocol deviation is ANY departure from the defined procedures and treatment plans as outlined in the protocol version submitted and previously approved by the Institutional Review Board (IRB). Protocol 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.

Protocol deviations are unplanned and/or unintentional events. Any changes in the research protocol during the period, for which the IRB approval has already been given, may not be initiated without submission of an amendment for IRB review and approval.

Am I required to submit all protocol deviations to the IRB?

The IRB recognizes that some protocol 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.

As such, reporting is left to the discretion of the PI within the context of the guidelines below:

    The University of Utah IRB requires researchers to submit protocol deviations which are
  1. Intended to eliminate apparent immediate hazard to a research participant (such as changing the dose of a medication due to possible toxicity); or
  2. Harmful (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
  3. Possible serious or continued noncompliance (such as a deviation that has happened previously and is now being repeated).

Protocol Deviations that meet the above criteria must be promptly reported.

What does "prompt" reporting mean?

  • Prompt reporting means that the report must be submitted as soon as possible after the PI learns of the event, but in all cases within 10 working days. The deadline for reporting begins at the time the investigator learns of the event. If the report is submitted late, a written explanation of its tardiness must accompany the report.

What are the consequences for late reporting?

  • Researchers are required to submit the report as soon as possible after the PI learns of the event, but in all cases within 10 working days. Late reports may be reviewed for non-compliance.
  • When in doubt, it is better to submit a Deviation Report allowing the IRB to make the determination rather than failing to submit a report that should have been submitted.

How do I promptly report a deviation to the IRB?

  • The investigator reports a deviation by completing and electronically submitting an ERICA Report Form application.

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 a UP, or evaluated for possible serious or continuing non-compliance.

What is “serious non-compliance”?

  • Serious non-compliance is an act or omission to act that resulted in increased physical, psychological, safety, or privacy risk that compromised the rights and welfare of research participants.

What is “continuing non-compliance”?

  • 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, VA Handbook 1200.5 or the policy, requirements, and determinations of the IRB governing human subject research.

Where can I find more information?