Adverse Events

New findings are unexpected problems whose nature, severity, and frequency are not described in the information provided to the IRB or to participants. Examples include unexpected complications in a subject, missteps in the consent documentation, or breaches of confidentiality. Adverse events should be reported to the IRB within 10 working days using the Adverse Events Form. Sometimes a study must be suspended to ensure subjects' safety.

The report of the event should discuss:

• the facts of the case, including the date and a description of the subject;

• whether the event is related to the study's procedures or drugs or to the subject's underlying disease or condition;

• the steps that have been taken to address the problem;

• whether the event is likely to recur; and whether the event provides new information about the study's risks that should be conveyed to participants, in a revised consent form.

These reports usually receive expedited review, but in some cases the full IRB is involved.

The University's policies on adverse events are based on Food and Drug Administration regulations. According to the FDA, a "serious adverse drug experience" with respect to human clinical experience includes "any experience that suggests a significant hazard, contraindication, side effect, or precaution," including "any experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose." An "unexpected adverse experience" is any adverse experience whose nature, severity, and frequency of risk are not described in the information provided for IRB review or in the consent form.

(See 21 CFR 312.32 [4-1-92])