Version 07/15/11
VALENCIA COLLEGE
Human Research Protection (HRP) Institutional Review Board (IRB)
IRB Adverse Event/Unanticipated Problem/Increased Risk Report Form
(for Internal and External Investigators)
IRB Number of Currently-Approved Research Protocol: ________________________________________
Title of Currently-Approved Research Protocol: _______________________________________________
_______________________________________________
SECTION 1
Principal Investigator (PI): ___________________________________________________________________
Address: _______________________________________________ Phone: _____________________
PI Signature: _______________________________________________ Date: _____________________
Supervisor/Administrator Signature: _____________________________ Date: _____________________
SECTION 2
Investigators must report all adverse events that were not included in protocol, consent, or program
materials, including:
• unexpected adverse events where participants are exposed to a reportable event – an actual harm is not
required (e.g., breach of confidentiality, loss of records or computer-based participant information, loss of
employability, loss of insurability, criminal or civil litigation, embarrassment, humiliation, discrimination,
stigmatization);
• serious adverse events (e.g., resulted in death, was/is life threatening, required hospitalization, resulted in
persistent or significant disability or incapacity, any medical event that requires treatment to prevent any of
the previous medical outcomes); and
• expected adverse events of moderate or greater severity associated with the research study.
Adverse events must be reported to the IRB within five (5) working days of occurrence or knowledge of
occurrence
. All Adverse Event/Unanticipated Problem/Increased Risk Report Forms are subject to the
disclosure requirements of Florida Sunshine Laws and are reviewed by the full IRB for discussion and
recommendation at the next scheduled IRB meeting, or earlier.
Check one: Initial Report Follow-up Report
Location of Adverse Event: ___________________________________________________________________
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