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Office of Animal Welfare

Reporting of Adverse Events

Purpose

To define adverse events and establish responsibility for reporting of adverse events to the Attending Veterinarian (AV).

Definitions

Adverse Event:
Any event resulting in a negative welfare impact (increased distress, pain, disease, or death) that was not explicitly described as the expected outcome within the approved IACUC protocol

Background

Animals involved in research may be subject to events that have the potential to adversely impact their health or welfare. These events must be promptly reported to the AV for review and assessment and possible subsequent reporting to IACUC and/or external oversight agencies. The Animal Welfare Act Code of Federal Regulations defines the Principal Investigator as the individual “responsible for a proposal to conduct research and for the design and implementation of research involving animals.” As such, the Principal Investigator (PI) is responsible for communicating unexpected adverse events that impact the welfare of animals used in their research.

Policy

Adverse events may be research-related (e.g., unanticipated side effect of administered substance, surgical complication, or unexpectedly deleterious phenotype) or not research-related (e.g., due to natural disasters, accidents, or mechanical failures).

Regardless of cause, all adverse events must be promptly reported to the AV. The AV will work with the reporting individual and with the Office of Animal Welfare and IACUC chair, when indicated, to determine if the adverse event meets criteria for reporting to the IACUC and/or to external oversight agencies. Adverse events that are fully described within the approved protocol may not require additional IACUC notification. Adverse events determined to require prompt reporting to OLAW (as per OLAW NOT-OD-05-034) will also be reported to the IACUC at a regularly convened meeting. Adverse events not meeting requirements for prompt reporting may be communicated to the IACUC through protocol modifications, triennial review summaries, or at semi-annual records reviews as appropriate based on the timing and/or nature of the event.

For research-related adverse events, it is the responsibility of the PI to ensure the AV is notified. Reporting of adverse events requiring clinical intervention may be delegated to veterinary staff in some cases, but the PI must ensure veterinary staff intend to report the event on the PI’s behalf.

For non-research-related events (e.g., due to natural disasters, accidents, or mechanical failures), management of the responsible department must ensure the AV is notified.

The IACUC views the failure to report an adverse event as a non-compliance, and it will be addressed by the IACUC on a case-by-case basis.

Examples of research-related adverse events and incidents requiring notification to the AV include but are not limited to:

  • Unexpected clinical signs potentially related to a protocol procedure that are not currently described in the protocol
  • Expected clinical signs related to a protocol procedure that are occurring at an increased severity or rate than stated in the protocol
  • A significant increase in morbidity or mortality related to protocol procedures (e.g., 20% death during a procedure is expected, but 40% death is occurring)
  • Phenotypes associated with transgenic animals (e.g., tumor development, neurological conditions, fertility issues, skin conditions, early death) that negatively impact the welfare of an animal, but are not stated in the protocol
  • Surgical complications such as anesthetic deaths, infections, or wound dehiscence occurring during research surgeries
  • Malfunction of equipment being used to complete a research procedure (e.g., surgical robot or anesthetic machine)

Examples of non-research-related adverse events and incidents requiring notification to the AV include but are not limited to:

  • Accidents, unrelated to the research protocol, that negatively impact animal welfare
  • Facility or weather-associated events (e.g., HVAC or power failure, flooding, fire) that negatively impact the welfare of an animal(s)
  • Frequent incidents of drowning of rodents as a result of issues with water source
  • Animal deaths known to be caused by lack of food or water access
  • Surgical complications such as anesthetic deaths, infections, or wound dehiscence occurring during clinical surgeries
  • Malfunction of HVAC during a research surgery that negatively impacts animal welfare

References

  1. OLAW NOT-OD-05-034 – Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals
  2. Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, National Institutes of Health, United States. Department of Health and Human Services. Washington, D.C., 2015.
  3. Guide for the Care and Use of Laboratory Animals. 8th ed., National Research Council. Washington, D.C., The National Academies Press, 2011.
  4. Animal Welfare Act, CFR Title 9, Chapter 1, Subchapter A, Part 1-3

Approval/Review Dates

Originally A​​​pproved: 08/21/2025
Last Reviewed/Revised by the IACUC: N/A

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