Reportable Adverse Incident Guidance

To help ensure that animals used in research and teaching activities receive humane care, use, and treatment in accordance with the highest ethical standards, laws, regulations, and policies, the Institutional Animal Care and Use Committee (IACUC) must be made of aware of any: 

noncompliance (defined as serious or continuing noncompliance with the PHS Policy, serious deviations from the provisions of the Guide, or any deviation from an approved IACUC protocol.

Reportable adverse events include conditions that jeopardize the health or well-being of animals, including natural disasters, accidents, and mechanical failures, resulting in actual harm or death to animals

Here are definitions to help you choose which category to report an incident or noncompliance:

Higher than expected mortality: An increase in the percentage of mortality as a direct result of protocol procedures (e.g., protocol predicts 15% death during a surgical procedure expected, but 30% death is occurring).

Unexpected death of an animal. An animal dies either as a result of an approved procedure (e.g.,  death during anesthesia*, administration of a drug) or an animal dies due to illness or injury unrelated to a protocol procedure (e.g., infectious disease, injury caused by aggression). 

Unexpected euthanasia of an animal. This does not include euthanasia as part of the protocol or for criteria for moribundity that are reasonably expected as part of the protocol procedures and are listed on the protocol (e.g., development of a tumor in mice known to spontaneously develop tumors).

Unexpected clinical signs. An animal develops clinical signs as a result of an approved procedure (e.g., administration of a drug causes unexpected diarrhea) or due to illness or injury unrelated to a protocol procedure. This does not include clinical signs that are reasonably expected as part  of the protocol procedures and are listed on the protocol (e.g., frequent urination in animals with diabetes).

Observation of a new negative phenotype in transgenics. Negative phenotypes may be observed when strains are acquired from a new source, two strains are crossed, or a transgenic strain is developed. Negative phenotypes include early mortality, spontaneous development of tumors, neurological conditions, blindness, skin conditions, reduced fertility, etc.

Reportable Event: A condition that jeopardizes the health or well-being of animals. This includes accidents,  mechanical failures, and natural disasters that results in harm or death to animals.

Drowning/ wet cage: Frequent incidents of drowning or near-drowning of rodents in cages as a result of issues with water source.

Transportation Incident: Accident during animal transport resulting in either an injury (animal is treated or  euthanized), or death.

Non-Compliance: Conducting animal-related activities without appropriate IACUC review and approval or Failure to adhere to the standards set forth by the USDA Animal Welfare Act and Animal Welfare Regulation and the NIH Guide for the Care and Use of Laboratory Animals.

Other. The incident does not fit one of the above categories, or you are unsure which category to choose.