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Office of Research and Innovation
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Adverse Event Reporting

Report to IRB within 48 hours via Cayuse
If it’s unexpected, possibly related to research, or increases risk → Report it

Why This Matters

Despite careful planning, things do not always go as expected in human subjects research. Adverse events and unanticipated problems can occur in any type of study. Prompt reporting protects research participants, supports investigators, and ensures compliance with federal regulations and university policy.
As a Principal Investigator (PI), you are responsible for identifying and reporting these events to the Institutional Review Board (IRB).

What Is an Adverse Event?

According to the Office for Human Research Protections (OHRP), an adverse event is:
Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign, symptom, or disease temporally associated with the subject’s participation in the research, whether or not it is considered related to the research.
  • Adverse events may be physical or psychological.
  • The event does not need to be proven related to the research to require reporting.
  • Adverse events may affect research participants or others (e.g., research staff).

What Is an Unanticipated Problem?

An unanticipated problem is an incident, experience, or outcome that meets all three of the following criteria:

1. The event is unexpected given:

  • The research procedures described in the IRB-approved protocol and informed consent, and

  • The characteristics of the participant population being studied.

2. Related or Possibly Related to the Research
There is a reasonable possibility that the event may have been caused by the research procedures.
3. Indicates Greater Risk Than Previously Known
The event suggests the research places participants or others at greater physical, psychological, social, or economic risk than was previously recognized.
An adverse event occurs in oneor more subjects. 1. Is the adverse event unexpected in nature, severity, or frequency? 2. Is the adverse event related to participation in the research? 3. Does the adverse event suggestthat the research places subjects orothers at a greater risk of physical orpsychological harm than waspreviously known or recognized? NOTE: If the adverse event is serious, the answer is always “YES”. Report the adverse event as anunanticipated problem under 45 CFR part 46 The adverse event is not an unanticipated problem and need not be reported under 45 CFR part 46 NO NO NO YES

The following are illustrative examples and are not exhaustive:
  • An accident during a treadmill or exercise study
  • Loss or theft of datasheets containing personally identifiable information
  • Emotional distress or breakdown during a psychological interview
  • Illness following participation in a food taste or nutrition study
  • A parent raising concerns about their child’s assent in an education study
  • A broken vial of blood creating a biohazard risk to research staff
Not all adverse events occur directly to the participant—some may pose risks to researchers, staff, or others.

Once reported, the IRB will evaluate the event based on:
  • How unexpected the event was
  • How likely it was related to the research
  • The seriousness of the harm or potential harm
This review may result in:
  • Reassessment of the study’s risk/benefit ratio
  • Required changes to research procedures
  • Revisions to the informed consent or assent process
  • Additional safeguards for participants
Prompt reporting helps the IRB and university research community respond appropriately while allowing research to continue safely.