Deviations
Description
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 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 changes are initiated before IRB approval for the change is given, a deviation has occurred. Sometimes the deviation is the result of an act or omission to act by the PI or research team; but, it is also possible that the deviation is the result of an act or omission to act by a participant. For example, a participant did not follow the instructions provided by the study team from the protocol and thus data collection was not possible, this still represents a deviation from the protocol.
Criteria for Reporting Deviations
The UIUC 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);
- 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;
- 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 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 study visit and the only available re-schedule date is outside the study visit window but no study procedures are missed. In this case, the subject may not incur possible harm from a 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.
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. The Report Form must be submitted promptly, within 10 working days from the time the investigator learns of the deviation.
- Complete a Report Form application (link to Form)
- Be sure to review the instructions carefully. Not all sections need to be completed based on the type of information you are submitting.
- Submit the completed Report Form via email. Be sure to include any supporting documents with the application to explain the event.
- If you will be making changes to the study based on the information you are reporting, an amendment will be needed. In the amendment application, be sure to state that you are submitting it based on a report form. In the report form application, be sure to state that you are submitting an amendment as part of your corrective and preventive action plan.
Criteria Are Not Met:
- Document in the research record how the deviation does not meet the reporting criteria.
- Log the deviation such that it can be evaluated in the future if other deviations occur.
Related Documents
Related FAQs
- What are the possible consequences for deviating?
- What are the consequences for submitting possible non-compliance late?
- Once my project is determined exempt, do I need to do anything else with the application?