Institutional Review Board (IRB)
RETROSPECTIVE PROTOCOL VIOLATION REPORT
SUBMISSION INFORMATION: A Retrospective Protocol Violation report must be
completed when a protocol violation has occurred regardless of whether or not it
involved additional risk to subjects. Protocol violations are deviations from protocol
procedures which have not been prospectively reviewed and approved by the IRB.
Note: Per requirements of 45CFR46.103(b)(4) and 21CFR56.108(a)(3)(4), changes in
approved research cannot be initiated without IRB review and approval unless
necessary to eliminate apparent immediate hazards to the subject or provide important
information germane to informed consent.
SUBMISSION DEADLINE: The Retrospective Protocol Violation report must be
submitted to the IRB within five (5) business days after discovery of the violation.
SUBMISSION DOCUMENTS: Submit one (1) original and one (1) copy of this form.
SECTION I
1. Identifying Information
Approved IRB Protocol number:
Subject Identification Number:
Principal Investigator:
Department:
Campus Zip:
Phone:
2. Certification of Investigator:
I certify that I have been made aware of the event(s) outlined in this report and will
insure that an appropriate plan to minimize the occurrence of protocol violations in
the future will be implemented. In addition, my signature certifies that I understand
and accept the obligations to protect the rights and welfare of research subjects in
this study, as detailed in the IRB Application.
Signature of Investigator
Date
Academic Research & Services Building 3000 / 987830 Nebraska Medical Center / Omaha NE 68198-7830
402-559-6463 / FAX 402-559-3300 / Email: irbora@unmc.edu / http://www.unmc.edu/irb
Protocol Violation report (12-20-06)
page 1 of 2
SECTION II
Instructions: Each required subpart must be titled using boldface subheadings as
described below and addressed independently in the listed sequence without reliance
on information covered under other subparts. Please include sufficient information to
facilitate an effective review by the IRB. All abbreviations and terms not part of common
usage should be defined and simplified language should be used as much as possible.
Pages should be numbered.
1. Protocol Violation:
a. When did the protocol violation occur (mm/dd/yr)?
b. When did the PI become aware of the protocol violation (ie., how long
after the occurrence of the violation)?
c. Describe the specific protocol violation.
d. Describe any additional risks to which the subject was exposed as a result
of this violation. Note: The exposure of a subject to risk does not necessarily
imply that an adverse event occurred. Risk is defined as the possibility of
harm.
e. Describe the outcome of the violation. Note: Outcome may include such
actions as, removal of the subject from the study or from some aspect of the
data analysis, increased follow-up of the subject or treatment.
2. Subject Notification: Was the subject notified of the protocol violation? If no, then
provide justification.
3. Avoidance of Violation: Describe how future protocol violations of this sort will be
avoided.
Academic Research & Services Building 3000 / 987830 Nebraska Medical Center / Omaha NE 68198-7830
402-559-6463 / FAX 402-559-3300 / Email: irbora@unmc.edu / http://www.unmc.edu/irb
Protocol Violation report (12-20-06)
page 2 of 2