1. ADVERSE EVENT or PROBLEM
Federal documents and professional literature interchangeably refer to a “problem” or an “adverse event” as any undesirable physical or psychological experience to or within a human subject participating in research (note-. FDA regulations define adverse events as any undesirable experience associated with the use of a medical product in a patient).
2. INTERNAL VS EXTERNAL
Federal guidance differentiates between problems/ events that are “internal” (i.e. experienced by a research subject enrolled at a site under the jurisdiction of the University of Miami IRB for either multicenter or single center research projects) or “external” (i.e. experienced by subjects enrolled at a site external to the jurisdiction of the University of Miami IRB or in a study for which UM is not the coordinating center.
An event is “related” if it is likely to have resulted from participation in the research study
4. SERIOUS ADVERSE EVENT
Federal regulations consider an adverse event to be serious when medical or surgical intervention is required to prevent any of the following:
A life-threatening situation
Prolongation of existing hospitalization
A persistent or significant disability/incapacity, or congenital anomaly/birth defect
Pursuant to federal regulations, adverse events that do not result in death or are not life threatening or require hospitalization should also be considered serious adverse events when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
An event is unanticipated if it was unforeseeable at the time of its occurrence (i.e. it is not consistent with the current Investigator’s Brochure; or if an Investigator’s Brochure is not required or available, the event should be considered unanticipated if its specificity or severity is not consistent with the risk information described in the investigational plan or elsewhere in the IRB application. Note- if adverse events occur at a greater frequency, severity or duration that was previously anticipated, these events should be considered “unanticipated” and must be promptly reported.
6. UNANTICIPATED PROBLEMS INVOLVING RISK TO PARTICIPANTS OR OTHERS
This defines any event that was:
Places subjects or others at a greater risk of physical or psychological harm than was previously known or recognized
Examples of such unanticipated problems include but are not limited to:
Breach of confidentiality
Loss of research data stored without encryption
Any change to the protocol made without prior review even if done to eliminate an apparent immediate hazard to subjects
Subject complaints that indicate unexpected risks
NOTE: Unanticipated problems involving risk to participants or others should be reported to the IRB regardless of whether the problems occur during the study, after study completion, after participant withdrawal or after study closure.