IG002: IACUC Review Process of Animal Welfare Concerns, Adverse Events, and Noncompliance

IACUC Guideline Number: IG002, Approved By: IACUC, Approval Date: 8/14/2025, Version: 4

Purpose

This guideline establishes procedures for the review and investigation of concerns, adverse events, and noncompliance reported to the Institutional Care and Use Committee (IACUC) at Michigan State University (MSU) regarding animals used for teaching, research, and outreach or any aspect of the animal care and use program at MSU. This guideline also establishes criteria used to determine if these reports must be submitted to any external entity or regulatory agency.

Definitions

Adverse Event: unexpected incidents that lead to harm or endanger the well-being of animals and humans at a research institution.
Animal Care and Use Program: compromises all activities conducted by and at an institution that have a direct impact on the well-being of animals, including animal and veterinary care, policies and procedures, personnel and program management and oversight, occupational health and safety, IACUC functions, and animal facility design and management.
Concern: concerns or deficiencies regarding animal welfare or any aspects of the MSU animal care and use program. This includes but is not limited to: proper treatment of animals, adequacy of the facility housing animals, or deviation from approved protocols.
Noncompliance: the failure to comply with applicable federal, state, or local laws or regulations, and/or IACUC protocols, amendments, procedures, SOPs or Policies.
Minor Noncompliance (as defined in the Guide for the Care and Use of Animals): a deviation from approved procedures, regulations, or guidelines that does not pose a significant potential for causing harm to the health or safety of an animal or to personnel working with animals.
Serious Noncompliance (as defined in the Guide for the Care and Use of Animals): a deviation from approved procedures, regulations or guidelines that poses, or may pose, a significant potential for causing harm to the health or safety of an animal or to personnel working with animals.
Continuing noncompliance: an action of either minor or serious noncompliance occurring repeatedly or without efforts to correct the noncompliance.
Report: reports are verbal or written notices of concern relating to aspects of the MSU animal care and use program or may be associated with an adverse event, concern, or noncompliance.

Procedures:

A. General Information

Any person having concerns about the treatment of research or teaching animals at MSU is strongly encouraged to report these concerns or perceived noncompliance to any of the following: IACUC Chair, IACUC Director, Attending Veterinarian (AV), Research Liaison, any IACUC member, IACUC staff, Facility Manager, or veterinary staff, who in turn will inform the IACUC office.
Detailed guidance on identifying and reporting adverse events, noncompliance, and concerns can be found in IG001.

B. Initial Assessment of Report

Once a report or concern is received, a preliminary assessment of the situation will be made by the AV, the IACUC Chair or Vice Chair, and/or the IACUC Director. If necessary, they may consult with the IAUCUC Oversight Committee. The AV, IACUC Chair, and IACUC Director acts on behalf of the IACUC in conducting an initial review of all reports. During this preliminary period, information may be gathered in order to make a complete assessment. [An exception will be made when the concern involves one of the aforementioned and/or they are not available for consultation.]

Notes:

If a concern presents a potential immediate animal health or welfare risk, the AV or designee will assess the situation and take any action determined to be, in their professional judgment, appropriate to alleviate unnecessary pain and distress in animals. The AV or designee, the Institutional Official (IO), or the IACUC Chair may ask a Principal Investigator (PI) to cease procedures in process if cessation is determined to be in the best interest of the animals. All reasonable attempts to receive input from pertinent individuals and the PI should be exhausted before such a decision is made.
Reports of an urgent nature may require an immediate response from the IACUC Office.

After careful deliberation, these individuals involved in the preliminary assessment or the IACUC Oversight Committee will determine a course of action deemed to be in the best interest of the welfare of the animals and to determine the seriousness of the alleged event, concern, or noncompliance. If necessary, the Associate Vice President for Research Regulatory Support (AVPRRS) will be included in such deliberations; otherwise, they will be apprised of the situation as expeditiously as possible. Following this initial assessment, the aforementioned individuals may:
- Dismiss the allegation as unsubstantiated and notify the PI that no further action is required.
- Require that the PI provide a written response to the event report.
- Determine that the report constituted a minor noncompliance or adverse event and notify the PI what, if any, further action is required.
- Require that the PI submit a corrective action plan for minor noncompliance or adverse event; when a corrective action plan is requested for these issues, the matter is considered resolved if 1) the plan submitted by the PI is acceptable to the IACUC; and 2) the actions outlined in the plan have been completed; and/or
- Move to conduct a formal investigation, especially of a serious or continuing noncompliance or adverse event, to a subcommittee of the IACUC, which also may include ad hoc individuals with relevant expertise. In cases of a formal investigation by the subcommittee, the IACUC retains responsibility to ensure that the investigation is conducted in an appropriate and legal manner. The full IACUC will be notified of investigations as soon as possible, but no later than the next regularly scheduled meeting.

C. IACUC Formal Investigation of Concern, Adverse Event, or Noncompliance

The investigation process will be determined by the IACUC members assigned to the investigation subcommittee. The process may include: interviews and written documents from relevant parties involved in or with knowledge of the reported concern or noncompliance; visits to the laboratory for inspections; and/or a review of pertinent records, which may include inspection reports, animal health records, the animal use protocol, facility access reports, or video monitoring equipment. If necessary, the IACUC will seek expertise (e.g. Departmental, Human Resources, Legal Services) to ensure that investigations and actions are properly conducted and follow due process.
The subcommittee will compile a report which includes all of the relevant documentation pertinent to the investigation, the results of interviews, the conditions of the animals and of their environment, and the result of record reviews. The report should include conclusions regarding the substance of the concerns in light of the requirements of the AWRs, PHS Policy, The Guide, and institutional policies and procedures, and recommended actions, if appropriate.
The subcommittee will present their findings at a convened IACUC meeting for discussion. After consideration of all information, the IACUC may:
- Determine that corrective actions taken by the PI or relevant group are sufficient;
- Determine the concern was unsubstantiated, however related aspects of the animal care and use program require further review.
- Determine no action needs to be taken as the concern or event was unsubstantiated.
- Require additional corrective actions such as:
  - Protocol amendments.
  - Continued monitoring of research.
  - Retraining or mentoring of the PI, personnel in the laboratory, or other relevant personnel.
  - Periodic reporting to the IACUC; or
  - Restrictions of research activities, facility access, and/or use of research data.
- Suspend the PI’s animal research protocol(s) and/or animal activities.
- Require additional information and to extend the investigation. If further investigation is required, a quorum of the IACUC must review the additional information.
The IACUC will notify the PI or the party in which the concern was about, in writing, of the outcome of the investigation and actions. In addition, the outcome may be communicated to the reporter of the concern, unless it was made anonymously.
PIs may submit written statements requesting reconsideration of the IACUC decision.

Notes:

All investigations and actions will be conducted in accordance with appropriate federal, state, and University legal and policy standards.
Every attempt will be made to protect the rights of both the complainant and others involved in investigations. Protections to ensure confidentiality will include, but are not limited to, allowing reports and complaints to be made anonymously as well as withholding names from written and oral reports.
The IACUC informs the IO of all IACUC decisions regarding serious or continuing issues of noncompliance. The IO may impose additional sanctions above and beyond those recommended by the IACUC.

External Reporting:

A. OLAW:

Reporting to OLAW is required if the incident meets the reporting criteria established by OLAW and that animal activity is funded by the PHS (NIH, FDA, CDC), NSF, NASA, or VA, as outlined in our PHS Assurance.
Required reporting includes: serious or continuous noncompliance with the PHS Policy, serious deviations from the Guide, and suspension of animal activities by the IACUC will be reported to OLAW.
- NOT-OD-05-034 will be used as a guideline for reporting threshold.
Reports must be sent to OLAW promptly, with a written report due within 90 days.

B. USDA:

Reporting to the USDA is required if the incident meets the reporting criteria established by the USDA and involves an AWA-covered species.
Required reporting includes: failure to adhere to a plan and schedule for correction that results in a significant deficiency remaining uncorrected and suspension of a protocol involving AWA-covered species.
Reports must be sent to the USDA within 15 days.

C. Department of Defense (DoD) / Animal Care and Use Review Office (ACURO):

Reporting to the DoD / ACURO is required if the incident meets the reporting criteria and the animal activity is funded by the DoD.
Required reporting includes: significant deficiencies, noncompliance, change in AAALAC status, socially sensitive matters, adverse events, and protocol suspensions.
Reports must be sent to ACURO within 5 business days.

D. AAALAC International:

Prompt reporting to AAALAC Int’l is necessary if the incident meets the reporting criteria as established in their managing and reporting adverse events
Required reporting includes: inadequate veterinary care, inappropriate euthanasia, noncompliance or significant adverse events resulting in animal harm or death, and substantiated external reports of welfare concerns.
Events that are reported that do not meet the promptly reportable criteria, such as protocol violations which had the potential to compromise animal welfare, unapproved use of animals, or other significant adverse events not previously reported as required by the Rules of Accreditation, will be reported to AAALAC via the Annual Report only.

Animal Care Program Office of Research Regulatory Support