Protocol Deviation Reporting
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 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.
The IRB recognizes that some protocol deviations pose no conceivable threat to participant safety or scientific integrity. As such, reporting is left to the discretion of the PI within the context of the guidelines below.
Only a subset of protocol deviations needs to be reported to the IRB. The IRB requires the prompt reporting of protocol deviations which are:
- Intended to eliminate apparent immediate hazard to a research participant or
- Harmful (caused harm to participants or others, or place them at increased risk of harm - including physical, psychological, economic, or social harm), or
- Possible serious or continued noncompliance
What is a serious non-compliance
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.
Examples of serious non-compliance include, but are not limited to the following:
- Deliberate or repeated failure to obtain prior review and approval of new protocols and on-going human participants research by the IRB.
- Deliberate or repeated failure to obtain or document informed consent from human participants.
- Deliberate or repeated omission of a description of serious risks of the experimental therapy when obtaining informed consent.
- Deliberate or repeated failure to limit administration of the investigational drug or device to those participants under the investigator’s supervision.
- Deliberate or repeated failure to maintain accurate study records, report changes to the research, or report unanticipated problems posing risk to subjects or others to the IRB.
- Deliberate or repeated failure to comply with the conditions placed on the study by the University, the IRB, sponsor, or the FDA.
What is continued non-compliance?
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.
Examples of continuing non-compliance include, but are not limited to the following:
- Consistently late submission of continuing review or items that require prompt reporting.
- Repeated failure to comply with IRB requirements for completion of human subjects training before initiating study procedures.
- Repeated failure to submit the required documents to the IRB.
- Repeated refusal to comply with an IRB request.
- Repeated failure to submit progress reports.