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IG001: Identifying and Reporting Unanticipated Adverse Events, Noncompliance, and Concerns

IACUC Guideline Number: IG001, Approved By: IACUC, Approval Date: 8/14/2025, Version: 7

The use of animals in research, teaching, or testing may occasionally result in an unanticipated adverse event or noncompliance, which may ultimately compromise animal welfare by causing or increasing the risk of pain and/or distress, morbidity, or death of the animal subject. 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, Michigan State University (MSU) must have a mechanism for reporting 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 to provide the highest quality animal care.

Monitoring, reporting, and managing animal-related events help the IACUC assess whether changes are needed to reduce further risks. Reporting even a single incident can reveal broader issues, support a culture of care, identify trends, guide resource allocation, and align with MSU’s commitment to continuous improvement in animal and human welfare.

If you’re unsure whether an incident should be reported, please contact the IACUC Chair, Director, or Attending Veterinarian (AV) for guidance.

Definitions:

Unanticipated Adverse Events: unexpected incidents that lead to harm, endanger, or negatively impact the health and welfare of animals used in research, teaching, testing, or production, or endanger or harm the humans participating in the animal care and use program. These events must be reported to the IACUC and include animal-related issues, facility-related issues, and animal care activities. To see a list of examples, see Appendix A.

Noncompliance: the failure to comply with applicable federal, state, or local laws or regulations, and/or IACUC protocols, SOPs, Guidelines, or Policies. These incidents are to be reported to the IACUC and may involve deviations in protocols, animal care orders, or facility operations. To see a list of examples, see Appendix A.

Anticipated Events (NOT REQUIRED TO BE REPORTED): an anticipated event involving animals (clinical, physiological, and/or behavioral signs of pain or distress) that are expected to cause more than momentary pain or distress and have been described and approved in the animal use protocol. These events do not need to be reported to the IACUC 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. To see a list of examples, see Appendix A.

Concerns: matters regarding the health or well-being of an animal, as well as any aspect of the MSU animal care and use program that may require attention, evaluation, and/or action. These concerns may relate to animal care, facility conditions, or personnel conduct. To see a list of examples, see Appendix A.

Process:

All adverse events or noncompliance that directly impact or pose an imminent risk to animal welfare are to be reported immediately to veterinary staff to ensure prompt care and prevent further harm.  These urgent concerns should be communicated directly (by phone or email) to the Campus Animal Resources (CAR) or Farms veterinary staff for immediate review and professional input. Once veterinary care has been provided, a summary of the incident shall be reported within 24 hours to the IACUC, AV, and PI via email at iacuc@msu.edu. The IACUC and AV will collaborate with the reporter to determine any additional actions needed for resolution.

Adverse events or noncompliance that do not directly impact or pose an imminent risk to animal welfare should be reported to the IACUC, AV, and PI within 48 hours. This preliminary report should include the nature of the event, how the event and animal welfare were monitored or addressed, and what immediate and/or long-term steps are being taken or considered to prevent reoccurrence of the event. If the preliminary report is not complete or more time is needed, include this and a suggested timeline in the report.

It is the expectation of MSU that all animals for which it is responsible receive the best possible care. Any concerns regarding animals can be reported as an identified individual or anonymously.

Any concerns about animals should be reported to any of the following:

Animal Concerns Contacts (Regular Hours)
Contact Unit/Person Phone Email
The faculty member, department chair, or farm/facility manager Numbers and contact information can be found on signage in animal facilities and laboratories.
Campus Animal Resources (CAR) Veterinary Staff 517-353-5064 CARvets@msu.edu
MSU Farms Veterinarian 517-432-4242 ORRS.DL.MSUFarmVet@msu.edu
Veterinary Teaching Hospital 517-719-7124  
Institutional Animal Care and Use Committee Office 517-432-8103 iacuc@msu.edu
Animal Concerns Contacts (After Hours)
Contact Unit/Person Phone Email
Attending Veterinarian and CAR Veterinary Staff 517-884-8527 CARvets@msu.edu
MSU Farms Veterinarian 517-977-6014 ORRS.DL.MSUFarmVet@msu.edu 
Animal Concerns Contacts (In Case of Emergency)
Phone
911

Authority/References

  1. Under the AWAR (2.31,c,4), the IACUC must “review and, if warranted, investigate concerns involving the care and use of animals at the research facility.
  2. The PHS Policy (IV, B,4) states the IACUC must “review concerns involving the care and use of animals at the institution.”
  3. The Guide (p.23) states “responsibility for review and investigation of [animal welfare] concerns rests with the IO and the IACUC” and (p.34) states that the IACUC should have “regular review of adverse or unexpected experimental outcomes affecting the animals.”
  4. NIH/OLAW’s Frequently Asked Questions (FAQ) G.8. states that “The IACUC must consider allegations of noncompliance or animal welfare issues as concerns that must be addressed in accordance with relevant PHS Policy provisions and Animal Welfare Regulations.”
  5. AAALAC Rules of Accreditation (Section 2.g.) states “The accredited unit shall promptly notify AAALAC International of significant adverse events relating to the animal care and use program.”
  6. OLAW Guidance Reporting Noncompliance website: https://olaw.nih.gov/guidance/reporting-noncompliance.htm

Appendix A: Examples of Events, Noncompliance, and Concerns

Adverse Event Examples:

  1. Unanticipated events (i.e., an event that is not approved in the protocol, SOP, or Farm Description and Operating Guidelines) that would result in more than slight or momentary pain or distress and would normally be treated with pain- or distress-relieving intervention or medication. Examples include:
    • Failure to ensure the death of animals after euthanasia procedures.
    • A significant increase in mortality related to protocol procedures that are not described in the protocol, or mortality incidences occurring at increased severity.
  1. The event exceeds the conditions or outcomes of normally accepted veterinary medical or surgical care. Examples include:
    • Anesthetic complications beyond what would be considered normal.
    • Failure to carry out veterinary orders (e.g., treatments).
  1. The event is not research-related but results from a facility, environmental, physical plant, equipment, shipping, or personnel failure, malfunction, or mistake. Examples include:
    • A restraint device or other equipment causing serious injury to an animal.
    • Power outage that results in changes to environmental conditions for a prolonged period or temperature/humidity excursions outside of Guide
    • Animal(s) develop sores on their feet caused by the cage flooring.
    • 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.
    • Chronic failure to provide space for animals in accordance with recommendations of the Guide unless the IACUC has approved a protocol-specific deviation from the Guide based on written scientific justification.
  1. Significant animal rights activities. Examples include:
    • Protests
    • Break-ins
    • Property damage.

Noncompliance Examples:

  • Conduct of animal-related activities without appropriate IACUC review and approval.
  • Failure to adhere to IACUC-approved protocols and procedures.
  • Implementation of any significant change to IACUC-approved protocols without prior IACUC approval.
  • Conduct of animal-related activities beyond the animal use protocol expiration date established by the IACUC.
  • Participation in animal-related activities by individuals whom the IACUC has not determined to be appropriately qualified and trained as required by IV.C.1.F.
  • Failure to monitor animals post-procedurally as necessary to ensure well-being.
  • Failure to correct deficiencies identified during the semiannual evaluation in a timely manner.

Anticipated Event Examples:

  • Conditions or outcomes that are within normally accepted veterinary medical or surgical care parameters.
  • Slight or momentary pain or distress that would not normally require professional medical treatment in humans.
  • Animal death or illness from spontaneous disease when appropriate quarantine, preventive medical, surveillance, diagnostic, and therapeutic procedures were in place and followed.
  • Animal death or injuries related to manipulations that fall within parameters described in the IACUC-approved protocol or Description and Operating Guidelines or considered common to the species-specific production system.

Concern Examples:

  • Improper or inhumane treatment of animals.
  • Conditions that jeopardize the health or well-being of animals. (i.e., natural disasters, accidents, mechanical failures, etc.)
  • Adequacy of the facility housing animals.
  • Failure to carry out veterinary orders (i.e., treatments).