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The Common Rule requires reporting of certain unanticipated problems that occur in the course of conducting research. This tutorial explains what these requirements are for reporting to the Office for Human Research Protections (or OHRP). To report incidents to other Common Rule agencies, investigators and IRBs should seek advice from the respective funding agency directly. For HHS-funded nonexempt human subjects research, the Common Rule requires that each IRB must establish and follow written procedures to ensure prompt reporting of any unanticipated problems involving risks to subjects or others to the IRB, OHRP, and other relevant officials. Reporting unanticipated problems is a responsibility that both investigators and IRBs share. Typically, investigators are the first to become aware of a potential unanticipated problem that might need reporting. This commonly happens in the course of conducting the research or as a result of information they receive from co-investigators, spons
