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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 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.
