Unanticipated Event Form - the Office for Responsible Research

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IOWA STATE UNIVERSITY
Institutional Animal Care and Use Committee
Unanticipated Event Form
Unanticipated Event: Any happening not consistent with routine expected outcomes that results
in any unexpected animal welfare issues (death, disease, or distress) or human health risks
(zoonotic diseases or injuries). Human injuries should be reported by completing a First Report
of Injury form via AccessPlus. If you are having a significant number of deaths, and even though
it does not relate to “noncompliance,” it should be reported to the IACUC. An example would be
a significant loss of life due to a disease outbreak, a natural disaster, or an equipment failure.
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Investigators should report unanticipated events to the Attending Veterinarian (AV) within 24 hours of the
occurrence. The AV can be reached at 515-509-7264 or msauer@iastate.edu.
When indicated by the AV, investigators should submit this completed form to the IACUC Administrator
(iacuc@iastate.edu) within 7 days of the occurrence so that the IACUC can help assure that the problems
are addressed in a timely manner and that potential pain and distress for the animal(s) have been addressed.
A signed version of the UE form should also be submitted. Depending on circumstances, non-timely
submission of this form may lead to potential noncompliance.
If “Yes” is selected for Question 8 below, the investigator should submit the modification form within 14
days of the occurrence to iacuc@iastate.edu.
Principal Investigator:
Email:
Department:
Telephone:
Project Title:
IACUC Log #:
1. Event Date:
2. Location of Event:
3. Severity of Event:
Moderate
4. Is this event related to the research?
Related
Possibly Related
Severe
Fatal
Not Related
5. Description of the event (include cause, outcome):
6. Description of how the event was managed:
7. Provide a description of the corrective and preventative actions taken to ensure this type
of event does not occur in the future:
8. Does this event necessitate a change in the protocol?
Yes
No
If “Yes,” please complete and submit to the IACUC administrator the “Continuing Review
and/or Modification Form” located on the Forms page of the IACUC website.
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Office for Responsible Research
Revised 08/12/15
Page 1 of 2
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Signature of Principal Investigator
_____________________
Date
ORR USE ONLY (check all that apply):
Consultation with IACUC Chair Int:
Date:
Copy sent to IACUC for their information;
filed with protocol—no further action required Int:
Date:
Forward to IACUC for review and action Int:
Date:
Write to PI with concerns/schedule PAM visit Int:
Date:
Per IACUC: Categorize as an adverse event (AE) Int:
UE Closed
___________________________________
Signature
Date:
______________
Date
______________________________________________________________________________
Office for Responsible Research
Revised 08/12/15
Page 2 of 2
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