Protocol Deviations

The IRB defines a protocol deviation as:  an incident involving non-compliance with the approved protocol, but typically does not have a significant effect on subjects’ rights, safety or welfare, or the integrity of the study.

Investigators are required to report to the IRB the following using the Protocol Deviation Report Form when discovered during the course of research and no later than 5 working days after their occurrence:

  1. Protocol deviations that may affect the safety of research participants
  2. Protocol deviations that have the potential to recur
  3. Any change to the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research participant
  4. Any publication in the literature, safety monitoring report, interim result, or other finding that indicates an unexpected change to the risks or potential benefits of the research

The Chair of the IRB or a designated member reviews all reports.  If the IRB Chair determines that the event did not represent an unanticipated problem involving risks to participants or others, the chair signs and dates the report and the report is approved.  If the IRB Chair or designated member determines that an event might represent an unanticipated problem involving risks to participants or others, and related to the investigation, the event is reviewed at the next convened IRB meeting.  The IRB votes to determine whether the event is an unanticipated and related problem involving risks to participants or others.   

If IRB determines that an event is an unanticipated and related problem involving risks to participants or others, it will consider the following actions:

  1. No action 
  2. Modification of the research protocol 
  3. Modification of the information disclosed during the consent process 
  4. Additional information provided to past participants 
  5. Notification of current participants (required when such information may relate to participants’ willingness to continue to take part in the research) 
  6. Requirement that current participants re-consent to participation 
  7. Modification of the continuing review schedule 
  8. Monitoring of the research  
  9. Monitoring of the consent  
  10. Suspension or termination of the research  
  11. Referral to other organizational entities (e.g., legal counsel, risk management, or institutional official)