Often referred as an Unanticipated Problem. An unanticipated problem may be either an actual harmful or unfavorable occurrence or any development that potentially increased the likelihood of harm occurring in the future. Assessment Criteria:
- Unanticipated Severity: The nature, severity, or frequency of the event(s) or information was NOT expected, given descriptions in the study documents or the characteristics of the subject population being studied.
- Related: There is a reasonable possibility that the procedures involved in the research caused the problem.
- Increased Risk: The event(s) or information suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (including physical, psychological, economic, or social harm).
