Purpose

To describe the process and expectation for timely reporting and evaluation of adverse events.

Background

Activities involving animal subjects may occasionally result in an adverse event or unexpected complication which may compromise animal welfare. The ARC has developed this policy to meet the obligations of our Animal Welfare Assurance with the Office of Laboratory Animal Welfare (OLAW), our registration with the United States Department of Agriculture (USDA), and our AAALAC International continuing accreditation requirements.

Definition

For this policy, "Adverse Event" is defined as a health-related event that harms[1] an animal covered by an ARC-approved protocol and meeting one of the following conditions:

  1. The event is research-related but not described in the protocol or is occurring at a rate or severity higher than indicated in the protocol; or
  2. The event is not research related but results from a facility, physical plant, equipment, or personnel failure, malfunction, or mistake.

Examples of adverse events that should be reported include, but are not limited to:

  • Unexpected clinical signs, potentially related to a protocol procedure, not currently described in the protocol or occurring at increased severity or rate.
  • A significant increase in mortality related to protocol procedures, not currently described in the protocol or occurring at increased severity or rate.
  • A high rate of surgical complications such as anesthetic deaths, infections, or wound dehiscence.
  • Previously unknown phenotypes associated with transgenic animals (e.g., tumor development, early death) that negatively impact animal welfare.
  • Protocol deviations, departures or mistakes made by the research team inconsistent with the approved protocol resulting in harm to the animals.
  • Facility or weather-associated events (e.g., HVAC or power failure, flooding, fire) that negatively impact the welfare of an animal.

Policy

All adverse events as defined above are to be reported to the DLAM clinical veterinary staff in a timely manner (e.g., preferably within 72 hours, or sooner depending on severity) to ensure adequate veterinary care, minimize the effect on animal welfare, and identify ongoing trends. Following preliminary assessment of the event, and implementation of actions to ensure animal care, the research team or veterinary staff will notify the ARC of the event through the ARC administrative office.

The ARC will evaluate shared information on adverse events and may contact relevant parties for more information if needed. Reporting to external agencies may be necessary depending on the type of event; this will be coordinated by the ARC administrative staff.

If there is a question about the need for reporting, DLAM clinical veterinarians or the ARC administrative staff can provide guidance for the research team.

[1] "Harm" has occurred when an event impacts the welfare of an animal, leading to pain/distress, morbidity, and/or death.

Approved 2/13/23