The Principal Investigator or their representative is responsible for submitting an incident report to KEP. The reporting time that KEP recommends varies depending on the nature of the issue being reported. KEP uses the following references.
Researchers can submit reports at any time, which means the review process can occur outside of the regular cycle.
Researchers who wish to apply for a report will need to submit the following documents:
Documents should be sent to the email address email@example.com with the subject: Unanticipated Event Report – (protocol number)
KEP recommends researchers to include the following information when reporting adverse events as unanticipated issues to KEP:
An unanticipated problem is a problem that unexpectedly involves a risk to the research subject or others. An event may be classified as an unanticipated problem if:
Important to highlight here is the concept of risk. Risk is the possibility or potential of harm or loss, but not necessarily the occurrence of harm or loss itself.
An adverse event is any event that includes physical and psychological harm to a human subject, including abnormal signs, symptoms, or illness. Adverse events may or may not be related to the subject’s participation in the study.
The relationship between these two can be explained with the Venn Diagram below.
KEP requires researchers to report events in area B (unanticipated adverse events) and area C (unanticipated problems that are not adverse events) that occur during the study.
An unanticipated adverse event is an event that meets the definition of an adverse event and an unanticipated problem.
An adverse event may be considered unanticipated if it occurs in at least one subject participating
in the study, and its nature, severity, or frequency is not consistent with any of the following:
Example of unanticipated adverse events under this definition is as follows:
Adverse events may be caused by one or more of the following:
In general, adverse events caused by number (1) will be considered related to participation in the research, while adverse events caused solely by number (2) or number (3) will be considered unrelated to participation in the research.
For example, a student receiving bullying from other students as a result of participating in a research study on dyslexia is an adverse event related to participation in the study because the event is indeed caused by the procedures that require students with specific characteristics to be involved in the study. Whereas if a subject with a bipolar disorder experiences depressive symptoms while participating in a study on perceptions of beauty products (a topic that has nothing to do with the subject’s underlying condition) , it is not considered an adverse event related to participation in the study because the event is a result of the subject’s underlying illness, disorder or condition.
An adverse event is considered to place a subject or other person at greater risk of harm than previously known if an adverse event has the potential to cause a risk of harm that is higher in nature, severity, or frequency than identified on the research protocol.
This type of adverse events can be divided into 2 (two) types of events:
KEP defines an emergency adverse event as any event that:
Non-emergency adverse events are adverse events that do not fall under Emergency Events but still have the potential to cause a higher risk of physical or psychological harm than previously known.
The following are examples of unanticipated events that may be categorized as non-emergency events, but are not limited to: