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 untoward or unfavorable occurrence in a human subject, including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. Adverse events include both 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. Adverse events may be expected or unexpected.

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.

Reporting

Complete the Adverse Event Report in Niner Research detailing the problem(s).

Unanticipated problems that are serious adverse events should be reported to the IRB within five (5) calendar days of the investigator becoming aware of the event. Investigators are strongly encouraged to submit a preliminary report within 48 hours of learning about the Serious Adverse Event with a formal report submitted within the five calendar day timeline. 

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.

Any other Unanticipated problem involving risks to participants or others should be reported to the IRB within fourteen (14) calendar days of the investigator becoming aware of the problem.  Investigators are strongly encouraged to submit a preliminary report within five (5) days of learning about the Unanticipated Problem with a formal report submitted within the fourteen calendar day timeline.

All other events should be reported to the IRB within fourteen (14) calendar days of the investigator becoming aware of the problem.  Investigators are strongly encouraged to submit a preliminary report about the event with a formal report submitted within the fourteen calendar day timeline.  *Investigators should not include identifiable information in the report.

Cat Runden 704-687-1871, IRB Manager

Tyler Forgette 704-687-8341, IRB Specialist