Reporting a Problem or Adverse Event

Unanticipated problems involving risks to participants or others must be reported to the IRB as well as appropriate institutional officials, and regulatory agencies when applicable.

An unanticipated problem may or may not involve direct harm to participants. Unanticipated problems that result in direct harm to participants are Adverse Events.

An unanticipated problem is generally an event that is:

• considered to be unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and the characteristics of the subject population being studied;
• related or possibly related to participation in the research (e.g, 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.

An adverse event is any event that occurs during the research and as a result of the research participation and results in physical, psychological, or social harm to participants. Adverse events occur more commonly in the context of biomedical research, although adverse events can occur in the context of social and behavioral research.

Investigators are required to report adverse events promptly to the IRB. The IRB evaluates the adverse events report to determine whether the study may continue. Complete the Adverse Event Report in Niner Research detailing the problem(s).

A serious adverse event is one that results in death, is life threatening, results in hospitalization, results in disability/incapacity, or jeopardizes the subject’s health such that medical or surgical intervention are needed to prevent the outcomes listed previously. A serious adverse event must be reported to the IRB within 5 calendar days of the Investigator becoming aware of the event.

The death of a research subject must be reported by telephone to the IRB immediately (i.e., within 48 hours) upon becoming aware of the information.

Unanticipated problems involving risks to participants or others should be reported to the IRB within 14 calendar days of the investigator becoming aware of the problem.

Cat Runden 704-687-1871, IRB Manager

Tyler Forgette 704-687-8341, IRB Specialist