Eastern Florida State College
Human Research Protection Program
Institutional Review Board (IRB) Adverse Event or Unanticipated Problem Form
Project Information:
IRB Number of Approved Research Protocol:
Title of Approved Research Protocol:
Principal Investigator:
Name of Principal Investigator:
Phone:
Sign
ature:
Email:
Dat
e:
Name of Advisor/Supervisor:
Adverse Event Information:
Adverse events must be reported to the EFSC IRB within 24 hours of knowledge of occurrence. Adverse events may be
subject to disclosure requirements under Florida Sunshine Laws.
Location of adverse event:
What was the result of the event? (Check all that apply)
Bre
ach of confidentiality or loss of records
Participant personal harm such embarrassment, discrimination, or criminal/civil litigation
Participant physical harm such as injury or sickness
Was the adverse effect related or possibly related to the research?
No Yes
Describe the event:
Notes:
Complete and email this form to irb@easternflorida.edu.
Date Received
by IRB Chair
Date of IRB Vote
(if needed)
IRB Determination
Name of Form
Last updated: 2015-04-21
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