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Guidelines for Adverse Events
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Guidance on Reporting & Reviewing Adverse Events


This section focuses on developing a plan to handle events and reporting if something happens.

Plan to Handle Events
For studies that are beyond minimal risk, the UHSRC asks researchers to prepare a plan that would address what the Principal Investigator would do if an adverse event occurred. Please see Sample Adverse Events Protocol PDF (right column of this page).

Reporting if Something Happens
To explain adverse events and when/how one would report these happenings to the UHSRC, please see Guide for Reporting Adverse Events PDF, Emergency Experimenter Protocol PDF and the Adverse Event Reporting iForm (right column of this page).

A Guide for Reporting Adverse Events to the UHSRC
With an Emphasis on Non-Medical Research

These guidelines are adapted from those drafted by the Department of Health and Human Services Office of Human Research Protections, tailoring them to the types of studies we see most often at EMU (i.e., non-medical research). Some examples have been lifted verbatim from the OHRP guidelines . See Related Links (left column of this page) for a more thorough discussion of the OHRP guidelines on reporting of Adverse Events and Unanticipated Problems.

"Adverse events" are unanticipated problems involving risks to participants or others. Adverse events should be reported to the UHSRC if the event was
  • Unexpected.
  • Related to (but not necessarily caused by) study participation.
  • The research places subjects or others at a greater risk of harm than was previously known or recognized.
Adverse events occur most commonly in the context of biomedical research, although on occasion, adverse events can occur in the context of social and behavioral research.
Adverse events may be the result of:
  • The interventions and interactions used in the research.
  • The collection of identifiable private information in the research.
  • An underlying disease, disorder, or condition of the subject.
  • Other circumstances unrelated to the research or any underlying disease, disorder, or condition of the subject.

There are several broad categories of Adverse Events and Unanticipated Problems that should be reported to the UHSRC:
  1. Adverse events that are serious, unexpected, and related or possibly related to participation in the research.
  2. Serious adverse events that are expected in some subjects, but are determined to be occurring at a significantly higher frequency or severity than expected.
  3. Other unexpected adverse events, regardless of severity, that may alter the IRB’s analysis of the risk versus potential benefit of the research and, as a result, warrant consideration of substantive changes in the research protocol or informed consent process/document.
  4. In addition to the three limited subsets of adverse events described above, there are other types of events that occur during the conduct of human subjects research that represent unanticipated problems but are not considered adverse events. In other words, harm to a subject need not occur in order for an event to be an unanticipated problem


Use Only Adobe Reader 7.1 or Later for Interactive PDF Forms.

Human Subjects
Adverse Events Reporting
iForm (549K)
PDF
Human Subjects
Guide for Reporting Adverse Events
Guidelines (73K)
PDF



Human Subjects
Adverse Events Protocol
Example (90K)
PDF
Human Subjects
Emergency Experimenter Protocol
Example (82K)
PDF

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Content Posted 12/10/2012 | Design Posted 04/17/2012