103.6a Organization Policy on Reporting

August 2020

The Organization has the obligation to report certain findings and determinations of the JHM IRBs to the appropriate regulatory agencies when required. These are IRB findings of unanticipated problems presenting risks to subjects or others and of serious or continuing non-compliance (see Policy on Prompt Reporting of Reportable Events) and determinations that a research study must be suspended or terminated (see Policy on Suspension or Termination of IRB Approved Research).

The Institutional Official (IO) is authorized as the individual who will submit reports when a JHM IRB has made a determination under the 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 by OHSR Compliance staff 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 IRB and/or the organization;
  • The actions taken by the IRB and/or the organization, including plans to protect the rights and welfare of the participants; and,
  • Any plans for additional oversight, investigation, or corrective and preventative 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/or 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 or agency, Risk Management (if applicable), the Principal Investigator (PI), and the IND or IDE sponsor-investigator if applicable. If the event involves the unauthorized use, loss, or disclosure of PHI, a copy will be sent to the HIPAA Privacy Officer.

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 cited policies, but where the IO has determined that a report should be made. The IO shall also have the authority to report at his or her discretion an IRB finding where the research is not funded or regulated by DHHS, FDA, or other signatory agencies to the Common Rule.

[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.