Guideline for Reporting of Adverse Events and Unexpected Outcomes and Injuries

Animals involved in research may be subject to events that have the potential to adversely impact their health or welfare. These events must be reported promptly to the Animal Care and Use Committee (IACUC) for assesment.

If you have concerns regarding the welfare and care of research animals, please see our guidance regarding Reporting Concerns.

Definitions

  • Adverse Event - An unexpected incident that negatively affects the health or welfare of animals.
  • Unexpected Outcome - An unexpected result of IACUC-approved animal activities. Examples of IACUC reportable unexpected outcomes may include, and are not limited to:
    • Animal morbidity or mortality occuring at a higher frequency than expected.
    • Unanticipated debilitating defects discovered after created or breeding genetically modified animals.
  • Injury -  Unexpected injuries that results from accidents or IACUC-approved activities.
  • Expected Outcome - An anticipated result of IACUC-approved animal activities. For example, a certain percentage of morbidity or mortality may be expected with a particular procedure, such as a surgery or disease model. These outcomes do not need to be reported to the IACUC if they fall within the anticipated frequency of occurrance and the procedures are conducted as approved in the Animal Use Protocol (AUP).
  • Minor concerns – the animal is in distress, but not in a life-threatening situation. Examples might be: an animal which has been unable to obtain food or water for a short period of time, minor wounds, a suture or staple missing from an incision but the incision remains closed.
  • Extreme emergency – the animal needs immediate intervention/euthanasia. Examples might be: uncontrollable bleeding, continuous seizures, fractures, extreme dehydration, and severe self-mutilation resulting in open wounds.

Guidance

In the event of an unanticipated animal injury, illness, or research outcome that impacts animal welfare, Animal Care staff will attempt to contact the Principal Investigator (PI). The PI must post emergency contact information in his/her lab(s), updating it as changes in personnel occur.

PIs or research personnel should immediately notify the veterinarian or animal care staff of any unanticipated animal injury, illness, or research outcome that impacts animal welfare. Prompt notification is essential to prevent unnecessary pain or distress as well as to prevent the spread of any disease.

Euthanasia decisions will typically be made by the Pricipal Investigator in consultation with the Attending Veterinarian however, some events may require immediate action by the Animal Care Staff or the Attending Veterinarian to protect animal heath and welfare.

Procedures For Animal Care Staff

  • During normal working hours (8:00 a.m.–5:00 p.m.), Animal Care staff will contact the PI via all available contact numbers and email address provided by the PI.
  • If after 30 minutes there is no response by phone or email, Animal Care staff will contact the Attending Veterinarian or Alternate Veterinarian. The Veterinarian will take appropriate action.
  • If this is an extreme emergency, Animal Care staff will contact the Attending or Alternate Veterinarian and then call the PI. The Attending or Alternate Veterinarian or their representative will take appropriate action. Animal Care staff will notify the PI by email of action taken by the Veterinarian.

Procedures For PI or Research Personnel

  • Contact a member of the animal care staff or the veterinarian in the vivarium or call one of the emergency numbers posted on the vivarium office door.
  • The PI may wish to treat or euthanize the animal based on the severity of the situation and its effect on the research. The veterinarian or the animal care staff should be notified of this decision as soon as possible.
  • As soon as possible after resolution, the event must be reported, in writing, to the IACUC at iacuc@olemiss.edu. Please include the relevant protocol number, a brief description of the event, and how it was handled.

Procedures for the IACUC

  • Once an adverse event or unexpected outcome has been reported to the IACUC office, the IACUC Research Compliance Specialist notifies the IACUC Executive Committee (IEC). The IEC consists of the IACUC Chair, the AV, the Executive Director for Research Integrity, and Compliance, and one additional IACUC voting member.
  • The IEC reviews the reports and determines if the event/outcome constitutes an animal welfare concern. If the event/outcome is not an animal welfare concern, the event/outcome and resolution are reported at the next convened IACUC meeting.

The Attending or Alternate Veterinarian or their representative will take immediate action, irrespective of the above procedures, when he/she feels that the life of the animal is in jeopardy or if the animal appears to be experiencing undue pain or distress.

References:

The Guide, pg. 46 
AWAR §2.31,d,vi; §2.31,d vii