Adverse events are events or circumstances that were unintended and unanticipated at the time the project was approved by the IRB. Any illness, injury, or trauma that requires medical or psychological treatment must be reported to the IRB and to the funding agency. Even adverse events that are not related to the project must be reported.
Unanticipated Event Requiring Reporting
Is the adverse event an unanticipated problem and therefore must be reported?
- Is the adverse event unexpected?
- Is the adverse event related or possibly related to participation in the research?
- Does the adverse event suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized?
If the answer to all three questions is yes, then the adverse event is an unanticipated problem and must be reported to appropriate entities under the Health and Human Safety (HHS) regulations 45 CFR 46.103.
Unexpected Adverse Event
Any adverse event not listed in the current consent form must be reported within five (5) days.
Serious Adverse Event
Any event resulting in death, a life threatening situation, inpatient hospitalization, significant disability, or birth defect must be reported to the IRB within five (5) days of the PI’s knowledge of the event. A physician’s comment is required and must be included with the report.
Neither Serious Nor Unexpected Adverse Event
Any adverse event which is neither serious nor unexpected must be reported to the IRB within one (1) month.
- A subject is identified as being in a high risk category that was not anticipated or planned in the selection of human subjects.
- A different use of data than originally planned causes a risk of loss of privacy or confidentiality for the human subjects.
- Participant consent was waived by IRB due to minimal risk but, as the project evolves, is later determined to be necessary.
- Although not occurring within the research activity, any automobile accident involving a subject as driver still needs to be reported. If numerous accidents by subjects in the same study were reported to the IRB, they could be a result of extreme stress caused by the study.