Explanations of Type of Incident/Adverse Event

All incidents/events are reported to the IRB. Incidents/events that fall between Severe Unexpected (Possible – Definite relatedness) through Unanticipated Problems must be reported to the IRB immediately.

Expected vs Unexpected:

Expected: Disclosed in Consent Form or part of an underlying disease

Unexpected: More serious than expected or not disclosed in Consent Form

Types of Incident/Adverse Event:

1. Mild Expected

  • Transient of minimal symptoms
  • No change in activity level
  • No therapy, or only symptomatic therapy, required

2. Mild Unexpected

  • Transient of minimal symptoms
  • No change in activity level
  • No therapy, or only symptomatic therapy, required

3. Moderate Expected

  • Symptomatic
  • Moderate change in activity level
  • Specific therapy required

4. Moderate Unexpected

  • Symptomatic
  • Moderate change in activity level
  • Specific therapy required

5. Severe Expected

  • Incapacitating = >24 hours of any of the following:
  • Loss of work
  • Bed rest
  • Decreased social activities

6. Severe Unexpected

  • Incapacitating = >24 hours of any of the following:
  • Loss of work
  • Bed rest
  • Decreased social activities

7. Serious Expected

  • Life threatening or results in death
  • Requires in-patient hospitalization
  • Results in persistent or significant disability
  • Congenital anomaly or birth defect

8. Serious Unexpected

  • Life threatening or results in death
  • Requires in-patient hospitalization
  • Results in persistent or significant disability
  • Congenital anomaly or birth defect

9. Unanticipated Problems

  • Unintentional change to IRB-approved protocol that involves risk or has potential to recur
  • Deviation from the protocol taken without prior IRB review to eliminate apparent immediate hazard
  • Publication in the literature, safety monitoring report including Data and Safety Monitoring Reports, interim result or other finding that indicates an unexpected change to the risk/benefit ratio of the research
  • Breach of confidentiality
  • Any complaint of a subject that indicates an unanticipated risk or that cannot be resolved by the research staff