91´ÎÔª

Investigating Animal Welfare Concerns and Noncompliance

Number: IACUC-POL-026

Responsible Office: IACUC along with the Office of Research and Creative Scholarship (ORCS) 

Applies to: Principal Investigators Conducting Animal Research or All animal research and teaching protocols involving live vertebrate animals  

1. Purpose

The Institutional Animal Care & Use Committee (IACUC) is required to provide ongoing oversight of animal activities conducted at 91´ÎÔª (UM) in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals and the Animal Welfare Act and Animal Welfare Regulations. 

The (IACUC) will investigate concerns involving the care and use of animals used in teaching or research. This includes claims by the public or anonymous complaints concerning any aspect of the animal care and use program or by employees or students who report alleged instances of animal abuse, violation of approved protocols or standard operating procedures, use of animals not covered by approved protocols, violation of any animal-related regulation or standard (such as the Animal Welfare Act, Public Health Service Policy, or UM IACUC policy), or complaints regarding the care received by animals housed in UM laboratory animal facilities.   

2. Definitions 

Respondent: the person against whom an allegation is directed or who is the subject of an animal welfare or noncompliance proceeding. 

Complainant: the person who initiates a formal animal welfare or noncompliance complaint. 

Serious noncompliance: Serious noncompliance is any noncompliant event that has a negative impact on the welfare of an animal and/or human, and/or is in direct conflict with federal standards governing animal activities or university policies. 

Examples of serious violations (this list is not intended to be exhaustive)  

• Use of animals without an IACUC approved protocol 

• Disregard for animal pain and suffering 

• Improper euthanasia 

• Improper surgical techniques or experimental treatments 

• Exposing humans or animals to substantial and unnecessary risks 

• Knowingly providing false or inaccurate information to LAR or IACUC 

3. Allegations and Reports  

Individual allegations and reports submitted to the IACUC for investigation through, for example, the Animal Welfare Concern Form, , the Attending Veterinarian (AV), IACUC Manager or the IACUC Chair, are routed to Office of Research and Creative Scholarship (ORCS) and the IACUC Chair, in consultation with relevant subject matter experts, will determine if an allegation is credible and meets the definition of serious noncompliance.  

The IACUC Chair, Associate VP of ORCS and or the AV will take immediate action to ensure the welfare of any animal or human associated with the allegation. This action may include the immediate suspension of animal activities and or an individual’s ability to conduct animal activities until, at minimum, an investigation is conducted. 

1. An inquiry process is initiated if:  
   1. The allegation was made in good faith 
   2. The alleged conduct affects animal welfare and or meets the definition of serious noncompliance 
   3. The allegation is sufficiently credible and specific to identify potential animal welfare issues and/or evidence of noncompliance. 
2. If an inquiry is unwarranted, a summary of the findings and rationale is communicated to the IACUC.   

4. Animal Welfare Allegations and Concern, Inquiry Process 

The purpose of the inquiry is not to reach a conclusion about whether animal welfare issues and or noncompliance occurred or who was responsible but is a process of gathering information and initial fact-finding to determine whether an allegation or animal welfare issue warrants an investigation. An investigation is warranted if (1) there is a reasonable basis for concluding that the allegation affects animal welfare and (2) preliminary information-gathering and preliminary fact-finding from the inquiry indicates that the allegation may have substance. 

The IACUC Chair may appoint a subcommittee to conduct the initial assessment of an allegation or Animal Welfare Concern. Members with direct involvement or conflict of interest with the reported incident will not be appointed.  

5. Notification of Respondent  

The IACUC Chair will inform the respondent that an allegation of animal welfare concern has been made against them, provide the respondent with a written summary of the allegation, and explain the investigation process for addressing the allegation. The IACUC Chair will make reasonable efforts to notify the respondent of the allegation in a face-to-face meeting, which may be attended by a representative of the dean’s office. 

6. Investigation of Suspected Animal Welfare Concerns 

If an investigation is warranted, ORCS and the IACUC Chair will investigate the concern and or appoint an IACUC subcommittee as an investigation team and an investigation team lead, as appropriate; members with direct involvement or conflict of interest with the reported incident will not be appointed 

1. The investigation will include reviewing the initial concern documentation, interviewing involved personnel, observing the animals, housing and experimental environment, reviewing any pertinent records with appropriate subject matter experts, as applicable to the reported concern. 
2. An investigation report will be prepared and submitted with findings and recommended corrective/preventative actions to the IACUC Chair. Recommended corrective/preventative actions will apply only operational processes and procedures. Personnel-related corrective action will not be captured through this procedure. In this case, Human Resources and/or Legal Counsel will be contacted by the Associate VP of ORCS. Upon acceptance of the investigation report, the IACUC Chair will review the report and recommended actions with the IACUC at a convened meeting. The report is finalized through a motion and a vote of a quorum. 

When the investigation deems that animal welfare has been affected and or noncompliance has occurred with university policies or federal regulations, the report shall include: 

1. A summary of the records and evidence reviewed during the investigation. 
2. Identification of university policies or federal violations under which noncompliance occurred 
3. A description of the noncompliance violation and whether the violation resulted in any adverse events. 
4. Corrective actions that should be implemented to avoid animal welfare issues and or noncompliance in the future and a reasonable date by which the corrective actions will be implemented.  

7. Determination of Noncompliance and Corrective Actions 

When the IACUC determines that noncompliance with federal regulations, university policy, or approved animal use protocols has occurred, the Committee will evaluate the nature and severity of the violation and determine appropriate corrective actions. 

Factors Considered 

1. In determining the appropriate corrective action(s), the IACUC may consider: 
2. The extent to which the incident(s) were self-reported, 
3. Proactive corrective actions taken in response to the incident(s), 
4. Whether the incident(s) represent a continuing or repeated violation, 
5. Whether the incident(s) constitute a minor or significant deficiency, 
6. The extent to which animal welfare was jeopardized, and 
7. The length of time between incidents of noncompliance. 

Corrective Actions 

• The IACUC may impose corrective actions to address the violation and facilitate compliance. Examples of possible corrective actions include, but are not limited to: 
• Retraining of personnel, 
• A letter from the Institutional Official (IO) or IACUC Chair to the Principal Investigator (PI) outlining the violation and requiring a corrective action plan,
• Requiring the PI to appear before the IACUC, 
• Notifying the PI’s unit head or dean, 
• Mandating changes to animal care procedures (e.g., additional analgesics, increased monitoring), 
• Requiring modification of a protocol, 
• Assigning oversight or monitoring of protocol activities, 
• Suspending or revoking specific personnel from performing animal work, or 
• Suspending some or all activities under the protocol.  

8. Notification and Implementation 

When a formal determination of noncompliance is made, the IACUC Chair will notify the involved individual(s) in writing of the violation and any required corrective actions. If corrective actions are required, the individual(s) will be provided with a timeline for implementation and may work with the IACUC and Chair to adjust the corrective plan if deemed appropriate by the Committee. In cases where noncompliance is ongoing or poses an immediate risk to animal welfare, the IACUC may suspend the research activity without delay. Depending on the severity of the violation, the Institutional Official, Provost’s Office, the PI’s Department Head, College Dean, and the Office of Sponsored Programs may be notified. Serious or continuing noncompliance will also be reported to OLAW, USDA (if applicable), and any relevant funding agencies, as required.  

9. Confidentiality and Whistleblower Protections 

, Governance and Organization, Section 211, MUS Compliance and Reporting Hotline, explicitly prohibits retaliation or discrimination against anyone who reports a violation of LAR or IACUC standards, procedures, rules, or protocols. Similarly, individuals named in or connected to a complaint are prohibited from engaging in reprisals. Any act of retaliation or reprisal in the context of IACUC complaint procedures constitutes a violation of IACUC standards and may result in the loss of privileges or access to the animal care and use facilities under UM IACUC oversight. 

The confidential nature of the complaint and violation procedures must be respected by all parties involved. 

10. Reporting Noncompliance 

Reporting Noncomplaince to OLAW 

If the IACUC determines any incident qualifies as a significant noncomplaince, the IACUC 
Office will submit a preliminary report to OLAW via phone or email. When the responsible party 
completes the corrective action plan, the IACUC Office will draft a final report to OLAW 
providing the required information and summarizing the incident, findings, and resolution. 
The final report will be sent to the IO for approval and signature, and the final signed report will 
be sent electronically to OLAW.   

Reporting Noncomplaince to AAALAC 

It is AAALAC's expectation that they should be informed of the results of animal welfare concern 
investigations and any subsequent corrective measures. 

Reporting Noncomplaince to USDA

The IACUC must report any suspensions of USDA-covered animal activities to the USDA. 

All documents will be retained by the IACUC Office per UMs Record Retention Policy.  

11. References 

1. Office of Laboratory Animal Welfare, National Institutes of Health, US Department of Health and Human Services. . 2015. Public Health Service, Bethesda, MD. 
2. National Research Council. Institute for Laboratory Animal Research. 2011. . Public Health Service, Bethesda, MD. 
3.  
4. Animal and Plant Health Inspection Service, USDA. . July 2023. CFR Title 9, Subchapter A - Animal Welfare. U.S. Government Printing Office, Washington DC. 
5. Office of Laboratory Animal Welfare (OLAW), Office of Extramural Research. . 24 February 2005. 
6. , Governance and Organization, Section 211, MUS Compliance and Reporting Hotline.  

12. Review, Approval and Version History 

Policy approval/version information

Version	Date	Description of Changes	Approved By
1.0	September 7, 2005	Initial policy creation	IACUC
2.0	September 13, 2017	Review	Heivilin
3.0	August 21, 2025	Review and rewrite	Hicks