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812: Report of Review Findings for Internal Reviews

Serious or continuing noncompliance identified during an Internal Compliance Review or Ongoing Quality Monitoring Project will be verbally reported immediately to the UNR RIO Director.  The chair of the IRB will be informed within five business days. 

A draft of the Report of Internal Review Findings, prepared by the QI Officer who conducted the review, will be sent to the Director of the Research Integrity Office and the chair of the IRB within twenty business days of completing the review.  The RIO Director will have five business days, or a mutually agreed upon duration, to provide an explanation of the circumstances (extenuating or otherwise) that could account for certain findings, and an acknowledgement of findings requiring correction.

Once the findings in the draft report are agreed upon by the RIO Director and QI Officer, changes, if any, will be made to the report and the final Report of Review Findings will be issued to the RIO Director. 

If a corrective action is indicated in the Final Report of Review Findings, the RIO Director will be expected to submit a corrective action plan within ten (10) business days of receipt of the Final Report of Review Findings, or on a mutually agreed upon date. The QI Officer will review the Corrective Plan within ten (10) business days of its receipt from the RIO Director to assess whether or not risks to subjects increased as a result of any of the findings.  If the QI Officer 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 RIO Director is adequate, the RIO Director will be directed in writing to implement the corrective action plan within thirty (30) calendar days.

After the QI Officer confirms that the Corrective Plan has been successfully implemented, a close-out letter will be sent to the RIO Director and to the IRB Chair(s).   The IRB will be notified on an upcoming meeting agenda.

If the QI Officer determines that non-compliance occurred but is unable to determine that it was only minor, non-continuing non-compliance, the Final Report of Review Findings and Corrective Action Plan will be reviewed by the IRB chair. 

If the IRB Chair 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 RIO Director 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. 

After the QI Officer confirms that the Corrective Plan has been successfully implemented, a close-out letter will be sent to the RIO Director.

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