Organization Policy on Reporting (Policy No. 103.6(a))
April 2008

The Organization has the responsibility to report unanticipated problems involving risk to subjects or others under Policy 103.6(b), serious or continuing non-compliance under Policy 103.7, and suspension or termination of approved research under Policy 113.1, to the appropriate agencies.  The Institutional Official (IO) is authorized as the individual who will submit reports when an IRB has made a determination under the three cited policies.  In cases where the IRB and IO determine that additional information is required before submitting a final report, a preliminary report may be made to the appropriate officials, supporting federal agency (as applicable), OHRP, and FDA (as applicable), within one month of the IRB’s determination.

A draft preliminary or final report will be prepared for review by the IO and General Counsels (GCs).  The draft report will contain the following information:

• The nature of the event
• The findings of the organization
• The actions taken by the organization and IRB, including plans to protect the rights and welfare of the participants
• The reasons for the organization’s and IRB’s actions
• The plans for continued oversight or investigation or action.

The draft report will be finalized by the IO and the GCs.  The IO will sign the report within 20 days of the agreed upon final revision of the report. The final report will be submitted to the OHRP if the research is conducted, funded, or overseen by DHHS; to FDA, if the research is regulated by FDA; and to other agencies that are signatories to the Common Rule [1] , if the research is conducted, funded or overseen by that agency. A copy of the report will be sent to the reviewing IRB, ORA if the project is funded by an outside sponsor, Risk Management (if applicable), and the PI.  The IO may determine the report should be provided to the Director of the department in which the PI is appointed as faculty and the Dean of the School of Medicine.  If the event involves unauthorized use, loss, or disclosure of PHI, a copy will be sent to the HIPAA Privacy Officer.