Reporting Unanticipated Problems and Adverse Events

• Unanticipated problems involving risks to subjects or others must be reported to the IRB within 3 days.

• Adverse events that are anticipated, related or possibly related to study participation, and considered moderate to severe, must be reported to the IRB within 30 days.

 

I. What are unanticipated problems?
 

Unanticipated problems (UPs) include any incident, experience, or outcome that meets all of the following criteria:

• unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;

• related or possibly related to participation in the research (in this guidance document, possibly related means 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.  For example, breach of confidentiality is considered to place subjects at risk, but is only unanticipated if it was not described as a risk in the consent form.
 

II. What are adverse events?
 

An adverse event is any untoward or unfavorable occurrence in a human subject, temporally associated with the subject’s participation in the research.  Adverse events encompass both physical and psychological harms.   

Attribution: Adverse event attribution will fall into one of the following categories:

• related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research);

• unrelated events are those that could in no way be attributed to study participation.  These events are not reportable.

Severity: Adverse event severity will fall into one of the following categories:

• Mild: Event results in transient discomfort; does not influence performance or functioning; does not require intervention or treatment; does not limit or interfere with daily activities; expected to resolve quickly with no physical, psychological, social, or economic consequences.

• Moderate:  Of sufficient severity to make the patient uncomfortable; may include worsening of conditions present at the onset of the study; treatment of symptom(s) may be needed; expected to resolve but short term physical, psychological, social, or economic consequences are possible.

• Severe:  Event results in significant symptoms that prevents normal daily activities; may require hospitalization or invasive intervention.  Long term physical, psychological, social, or economic consequences are possible.

 

Policy approved February 15th 2011.

Unanticipated problems and Adverse Event Reporting Chart