|IACUC Policy:||Reporting Adverse Events|
|Policy #||IBT-208.00||IACUC Approval:||March 24, 2014|
The IACUC is under federal mandate to monitor all research activities related to animal use. To assist the IACUC in fulfilling this requirement, all suspected Adverse Events should be reported in a timely manner to the Attending Veterinarian. The Attending Veterinarian will determine if the event is reportable.
The requirements specified in this policy for reporting Adverse Events applies to all vertebrate animal species used in Institutional facilities, under the jurisdiction of the Texas A&M Health Science Center IACUC.
Reporting Adverse Event is the responsibility of the Principal Investigator, all animal users, staff, technicians and anyone concerned with the welfare of research animal(s).
Adverse Event is the occurrence of an unforeseen event that negatively impacts the welfare of research animal(s), involving pain, distress, and/or death of the animal. By definition, Adverse Events are not identified as potential risks or outcomes in the approved IACUC animal protocol.
Examples of events that are required to be reported as Adverse Events
A. Animal death or illness from spontaneous disease not related to activities approved on an AUP.
B. Unexpected animal death or injuries related to approved animal activities (ie-allergic reactions, broken limbs, complications during or recovering from surgery, sudden death). Unexpected death includes an increased number of deaths over what was stated in the approved protocol.
C. Death due to equipment failure or natural disaster.
D. Conduct of animal-related activities without appropriate IACUC review and approval (i.e.- implementing protocol amendments prior to obtaining approval)
Examples of events that are not required to be reported as Adverse Events
A. Injury/illness unrelated to approved procedures and being treated by a clinical veterinarian.
B. Death or morbidity of animals described as expected in the approved IACUC protocol.
After consultation with the attending veterinarian, the IACUC needs to be notified of the adverse event within 24 hours of observing the event. The investigator must file an adverse event from through the iRIS system.
The IACUC will investigate the event and determine if any changes to the protocol are required or if the event should be reported.
Dr. David Brammer
Program for Animal Resources
Office of Research Compliance
- Animal and Plant Health Inspection Service, USDA. US Animal Welfare Act (AWA 1990) and Regulations (PL-89-544, as amended, 7USC Ch. 54) 2008. CFR Title 9, Subchapter A - Animal Welfare. U.S. Government Printing Office, Washington, D.C.
- National Research Council. Institute for Laboratory Animal Research. 2011. Guide for the Care and Use of Laboratory Animals. Public Health Service, Bethesda, MD.
- Public Health Service Policy on Humane Care and Use of Laboratory Animals http://grants.nih.gov/grants/olaw/references/phspol.htm.
- Silverman, Jerald, et.al. 2000. The IACUC Handbook: The Basic Unit of an Effective Animal Care and Use Program. Baltimore, MD.
- ARENA/OLAW Institutional Animal Care and Use Committee Guidebook, 2nd Ed. 2002.
Version 00 - Initial Approval: March 24, 2014