How do I report unanticipated harm to research participants?
If a research subject
suffers an injury and/or some type of harm related to the subject’s
participation in the research, you must submit a report to the IRB within 48
hours.
If a participant in
your research experiences an unanticipated adverse event that is associated
with the person’s participation in the study, the IRB must be notified
immediately. An unanticipated adverse
event means a physical or psychological reaction that was previously unknown
and was not expected on the basis of available data or experience. Notify the IRB in writing by completing the Report of Unanticipated
Harm and/or Injury during Research form. Be sure to complete the
entire form, obtain the necessary signatures, and include a detailed
description of the injury or harm.
The Report of Unanticipated
Harm and/or Injury during Research form is located in the Forms drop-down menu at the top of the web page.