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"The IRB works with investigators from across the university to protect the individuals who participate in research conducted by members of the NSU community."

Unanticipated Problem and Adverse Event Reporting

Unanticipated problems, adverse events (AE) and serious adverse events (SAE) must be reported to the IRB in a prompt manner by investigators. The IRB has established definitions, a reporting process, and policy related to unanticipated problems and adverse events that is available on the policies page.

1. Unanticipated Problems are considered to include any incident, experience, or outcome that meets all of the following criteria:
   • Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related outcomes, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
   • Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research; and
   • Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
2. Adverse Events are any unanticipated problems involving risks to subjects or others that do not fall into the different categories under Serious Adverse Events (SAEs). For example:
   • Breach in confidentiality that may present a risk to a subject.
   • A participant’s complaint of an unanticipated risk that cannot be resolved by the research staff
   • Change to the research protocol that may result in unanticipated risks
   • Rash
3. Serious Adverse Events are defined as follows:
   • Cancer
   • Death
   • Congenital Anomaly/Birth Defect
   • Hospitalization Required
   • Life Threatening Event
   • Overdose
   • Significant or Persistent Disability/Incapacity

Unanticipated problems and adverse events must be reported to the IRB within 5 working days. Serious adverse events must be reported to the IRB within 24 hours.

Unanticipated problems, adverse events, and serious adverse events are to be reported using the:

• Unanticipated Problems and Adverse Event Report Form
• Unanticipated Problems and Adverse Event Report Form