Version 07/15/11
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VALENCIA COLLEGE
Human Research Protection (HRP) Institutional Review Board (IRB)
Participant Withdrawal/Complaint Report Form
(for Internal and External Investigators)
NOTE: The form is subject to the disclosure requirements of Florida Sunshine Laws.
SECTION 1Withdrawal information to be completed by the Principal Investigator
Participant Identifier: ___________________________________________________________________
Check all that apply:
Withdrawal
Effective Date of Withdrawal: ____________________________________________________________
Reason for Withdrawal (attach additional documents if necessary):
SECTION 2 Complaint information to be completed by the Participant
Complaint
Participant Name: ____________________________________________________________
(optional)
Participant Signature: _______________________________ Date: ____________________
(or Parent/Guardian/Legal Rep)
(optional)
Description of Complaint (attach additional documents if necessary):
Participants may choose to submit the Complaint directly instead of giving it to the Investigator by mailing it
to: IRB Chair, Valencia Community College, P.O. Box 3028, Mail Code 3-32, Orlando, FL 32802.
Principal Investigators must submit Withdrawal forms to the IRB within thirty (30) working days of
occurrence or knowledge of occurrence, and must submit Complaint forms to the IRB within five (5) working
days of receipt.
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Version 07/15/11
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SECTION 3 – to be completed by the Principal Investigator
Title of Research Protocol: ___________________________________________________________________
___________________________________________________________________
Principal Investigator: ___________________________________________________________________
Address: _______________________________________________ Phone: _____________________
PI Signature: ______________________________________________ Date: _____________________
SECTION 4
Supervisor/Administrator: ___________________________________________________________________
Address: _______________________________________________ Phone: _____________________
Supervisor/Administrator Signature: ______________________________________ Date: ______________
All Participant Withdrawal Report Forms are reviewed by the full IRB for discussion and recommendation at
the next scheduled meeting. All Participant Complaint Forms are reviewed by the full IRB for discussion and
recommendation at the next scheduled meeting, or earlier.
If you have any remaining questions about Valencia’s IRB process, contact the IRB Chair at irb@valenciacollege.edu
.
THANKS!
______________________________________ ___________________
Date Received by IRB Chair or Designated Rep Date Distributed to IRB
IRB Recommendation: _______ No action at this time
Date:______________ _______ Changes to Consent Form
_______ Reconsenting
_______ Referral to (specify): _______________________________
_______ Other (specify): ___________________________________
IRB Comments:
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