Guideline #13

Policy on Category E Protocols

1. References: AWA, Guide for the Care and Use of Laboratory Animals: Eighth Edition.

2. Purpose/Scope: The purpose of this policy is to provide information to principal investigators who may request approval for Category E proposals.

3. Definition: Category E is a USDA pain category that is defined as “Pain or distress or potential pain or distress that is NOT relieved with anesthetics, analgesics, and/or tranquilizer drugs or other methods for relieving pain or distress.”

4. Category E protocols require robust scientific justification in the IACUC proposal, and must consult with the AV prior to submitting any Category E proposal to the IACUC for consideration.

5. Legal, regulatory, and ethical guidelines require that animal pain and distress be minimized in any experiment. For these reasons, investigators are encouraged to euthanize animals used in potentially fatal experiments prior to the actual death of the animal if experimental validity will not be compromised. These objectives assume that investigators can differentiate between animals that are found morbid (i.e. affected with disease and illness), and those that are found moribund (i.e. in the state of dying).

6. All attempts must be made to ensure that endpoints are humane and scientifically justified in the IACUC proposal. In certain studies, such as those that expect severe disease, prevention of suffering of the animals may include increased monitoring frequency, use of parameters that may predict endpoints (such as body temperature in sepsis studies), and identification of clinical endpoints that occur prior to death or prolonged suffering of the animal such as respiratory distress, neurologic signs, or severe clinical infections resulting in an inability to eat or drink, or distress or discomfort that cannot be (for scientifically justified reasons) alleviated with the use of NSAIDS, opioid drugs, or other methods of pain relief (i.e. euthanasia).

LAST REVIEWED AND ADOPTED BY THE IACUC: September 17, 2020