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Washington State University

Reporting Events & Deviations

Reportable events, unanticipated problems, deviations

In any study, promptly report the following to the IRB

Adverse events or unanticipated problems

Submit an IRB/HRPP Reporting Form if anything unplanned happens during research that could negatively affect the research or a human participant. Such events may include the following:

  • Unanticipated problems involving risks to subjects or others (UPIRSO), and
  • Any untoward or unfavorable medical occurrence in a human subject, whether or not considered related to the subject’s participation in the research

Deviations

Submit an IRB/HRPP Reporting Form  if any member of the research team does not follow the approved protocol. A deviation includes any change, divergence, or departure from the study design or research protocol procedures that:

  • Is under the investigator’s control, and
  • Has not been approved by the IRB and/or the sponsor