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Adverse Events

A page within IACUC

PURPOSE:

The purpose of this policy is to provide guidance for determining when and how adverse events/ unexpected outcomes impacting animal welfare should be reported.

BACKGROUND:

The use of animals in research or teaching may occasionally result in an adverse event or unexpected outcome which may compromise animal welfare. To meet the obligations of our assurance to the Office of Laboratory Animal Welfare (OLAW), our registration with the United States Department of Agriculture (USDA), and our AAALAC International continuing accreditation requirements, the University of Wisconsin – La Crosse must have a mechanism in place for reporting these events in a timely manner. The Institutional Animal Care and Use Committee (IACUC), in its oversight of animal care and use, must ensure there is a clear path to report these events in order to provide the highest quality animal care.

Since adverse events/unexpected outcomes may also necessitate the need to provide clinical care to affected animals, this policy also covers guidelines for reporting clinical emergencies. Consultation with veterinary staff is almost always required, with the possible exception of clinical treatments that are approved on the IACUC protocol to be performed by protocol personnel.

DEFINITIONS:  

  • Adverse events/unexpected outcomes: An adverse event/unexpected outcome is defined as an unforeseen event that impacts the welfare of an animal leading to pain/distress, morbidity, and/or death of the animal. These events may also have an impact on personnel health and safety. Examples of adverse events/unexpected outcomes include, but are not limited to:
  1. Animal morbidity or mortality rates inconsistent with, or occurring at a higher frequency than, the expected outcomes of the activities (surgery, disease model, etc.) listed on the approved protocol.
  2. Animals developing unexpected clinical signs as result of an approved procedure, or due to illness or injury unrelated to a protocol procedure.
  3. Unforeseen events such as an equipment failure or a natural disaster that leads to abnormal harm, or that causes obvious distress not scientifically justified and approved in the protocol
  • Expected outcomes: An expected outcome is an already anticipated result of approved protocol 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 if they fall within the anticipated frequency of occurrence and protocol personnel are following the animal monitoring procedures and humane endpoint determinations as outlined in the protocol.
  • Clinical Emergency: A clinical emergency is any animal welfare issue that requires immediate clinical treatment to provide relief from pain/distress or prevent an imminent risk of pain/distress, morbidity, or mortality. It can be the result of an adverse event/ unexpected outcome, and may affect a single animal or a group of animals.

POLICY:

All adverse events/unexpected outcomes must be reported immediately to the Attending Veterinarian (AV) (see Reporting Clinical Emergencies below). Within 48 hours of discovery, a preliminary report should be submitted to the AV, IACUC Chair and/or Office of Research and Sponsored Programs (ORSP). This preliminary report can be conveyed by various methods (phone call, email, text, etc.). The supervisor (e.g. Principal Investigator) is responsible for submitting the preliminary report within 48 hours only if veterinary staff were not previously contacted. The AV, IACUC Chair, and/or ORSP will contact the relevant parties for more information, if needed, and determine if a full report should be submitted using the “Report of Adverse Event/Unexpected Outcome” form.

Reporting Clinical Emergencies: Animals found injured, sick, morbid, or deceased by protocol personnel during routine daily checks or other activities should be promptly reported to the AV, this includes off-hours on weekdays, weekends, holidays, and shutdown periods. Emergency veterinary contacts should be posted and kept up to date in all animal use areas. Individuals should first make reasonable efforts to separate animal(s) from any immediate danger (e.g. malfunctioning equipment, aggressive animals, environmental hazards, etc.) as they are able, without endangering themselves. Veterinary staff must be consulted prior to providing clinical care unless clinical treatments to be provided by protocol personnel are approved procedures on the IACUC protocol.

Reporting Concerns: Any concerns regarding animal welfare can also be reported anonymously: https://www.uwlax.edu/iacuc/reporting-concerns/

Relevant Regulations and References

  1. Guide for the Care and Use of Laboratory Animals, National Research Council, 2011.
  2. Animal Welfare Act and Animal Welfare Regulations, United States Department of Agriculture, 2018.
  3. AAALAC International Reporting Requirements.

Adoption Date: 4/26/23
Amended: 5/31/23
Reference minutes: TBD