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809: IRB Review of Report Findings and Corrective Action Plan

The Final Report of Review Findings with the Corrective action plan will be sent to the IRB chair and RIO director to assess whether or not risks to subjects increased as a result of any of the findings. The appropriate next level of review is determined by and at the discretion of the IRB chair and RIO director.

If the Rio Director and/or IRB Chair determine that 1) risks to subjects did not increase, and 2) only minor, non-continuing non-compliance, if any, occurred, and 3) the corrective action plan provided by the PI is adequate and likely to satisfy the noted deficiencies, the PI will be directed in writing to implement the corrective action plan within thirty (30) calendar days.

If the Rio Director and/or IRB Chair determine that non-compliance occurred but are unable to determine that it was only minor, non-continuing non-compliance, the Final Report of Review Findings and Corrective Action Plan may be reviewed by a designated sub-committee of the IRB or sent to the full IRB for review at a scheduled meeting.

In the event that the Final Report of Review Findings and Corrective Action Plan is reviewed by a designated sub-committee of the IRB and the sub-committee determines that 1) risks to subjects did not increase, and 2) only minor, non-continuing non-compliance, if any, occurred, and 3) the corrective action plan provided by the PI is adequate, the PI will be directed in writing to implement the corrective action plan within thirty (30) calendar days.

If the designated sub-committee of the IRB cannot determine that only minor, non-continuing non-compliance occurred, the Final Report of Review Findings and Corrective Action Plan will be sent to the full IRB at a scheduled meeting.

Once the Final Report of Review Findings has been reviewed and a Corrective Action Plan approved, the PI will be directed in writing to implement the corrective action plan within no more than thirty (30) calendar days.  A shorter term for implementation may be appropriate when quick action is necessary to protect research participants. 

The PI must notify the QI Officer once the action plan has been successfully implemented or completed.

Through review or discussion of the PI's notification of completion of the correction action plan, the QI Officer or other RIO staff confirms that the Corrective Action Plan has been successfully implemented and sends a close-out letter to the PI. The IRB will be notified on an upcoming meeting agenda.

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