The Principal Investigator is responsible for submitting to the IRB ongoing reports of events that may adversely affect the safety of participants or the conduct of the research, and any information relevant to the conduct of the approved research. The types of events and information that may need to be reported to the IRB include, but are not limited to:
- Adverse Events
- Deviations and Incidents
- Updated Study Safety Information
An unanticipated problem is an event or outcome that meets the following criteria: 1) unexpected; 2) related or possibly related to participation in the research; and 3) places subjects or others at a greater risk of harm than was previously known or recognized. All unanticipated problems need to be reported to the IRB via webIRB, though not all adverse events, violations, incidents or deviations are unanticipated problems.
For examples, please see the guidance document Reporting of Unanticipated Problems, Including Adverse Events as well as Protocol Violations, Deviations and Incidents and the Reporting of Updated Study Safety Information.
For questions, please contact OHRPP staff.