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103.6a Organization Policy on Reporting

April 2016

The Organization has the responsibility to report unanticipated problems involving risks 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 regulatory agencies when required.  The Institutional Official (IO) is authorized as the individual who will submit reports when a JHM 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, OHRP, and/or FDA as applicable.

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; and,
  • The plans for continued oversight, investigation, or action.

The draft report will be finalized by the IO and the GCs.  The IO will sign the report within 20 business days of the agreed upon final revision of the report.  The final report will be submitted to 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 Office of Research Administration if the project is funded by an outside sponsor, Risk Management (if applicable), and the Principal Investigator (PI).  The IO may determine that 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.  Additionally, the IO shall also have the authority to report pursuant to this policy even an instance in which an IRB has not made a finding requiring reporting under the three cited policies, but where the IO has determined that a report should be made.

If the event involves the unauthorized use, loss, or disclosure of PHI, a copy will be sent to the HIPAA Privacy Officer. 


[1] These are:  Department of Agriculture, Department of Energy, National Aeronautics and Space Administration, Commerce Department, Consumer Product Safety Commission, Housing and Urban Development, Department of Justice, Department of Defense, Department of Education, Veterans Administration, National Science Foundation, Department of Transportation, Environmental Protection Agency, Agency for International Development, Office of Science and Technology Policy, Department of Homeland Security, Social Security Administration, and the Central Intelligence Agency.


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