A Principal Investigator (PI) is ethically obligated to report to the Institutional Review Board (IRB) information that could affect the conduct, safety, or compliance of a research study involving human subjects.
IRBs are required to report to federal agencies serious or continuing noncompliance, unanticipated problems involving risk to subjects or others (UPIRSO), and suspensions or terminations of IRB-approved protocols.
Reporting requirement resources for PIs and IRBs are provided below:
Reportable Events Quick Guide [D109.0000]
Other Reviews section (protocol deviations, exceptions, violations)
Unanticipated Problem/Safety Reporting webpage
Reporting Requirements for Diseases and Conditions in Kentucky [E2.0000]
Relevant Standard Operating Procedures (SOPs):
Continuation and Annual Administrative Review SOP [C2.0250]
Modification - IRB Review of Changes SOP [C2.0300]
Deviations and Exceptions - IRB Review of Changes SOP [C2.0325]
Unanticipated/Anticipated Problem/Adverse Event Reporting SOP [C2.0350]
