What is an unanticipated problem?
Any information, event, or activity that at the time of its occurrence is either (1) unexpected; or (2) unforeseeable based on the information that was proposed or previously provided to the IRB. The Campus IRB is required to report unanticipated problems causing serious harm to subjects to federal and institutional officials. In an effort to be proactive, to further protect subjects, the Campus IRB requires investigators to report all unanticipated problems and adverse events to the IRB for a determination of what should be reported to federal or institutional officials. Please contact the Campus IRB if you believe an unanticipated problem has occurred.
Related Questions
- In the case of a potential unanticipated problem involving risks to participants or others, when is the principal investigator expected to report this occurrence to the IRB?
- What if an unanticipated problem is determined by the researcher not to meet the criteria for UPIRTSO?
- Who makes the assessment of whether an unanticipated problem constitutes a UPIRTSO?
