Reviewing and Resolving Noncompliance in Animal-Related Matters

Policy

The Institutional Animal Care and Use Committee (IACUC) is charged with reviewing and, when necessary, investigating animal-related matters such as welfare concerns, adverse events, facility incidents, and unexpected animal losses. Such animal-related matters may involve the failure of a principal investigator (PI) to comply with federal, state, or local laws or regulations or campus policies. The IACUC must investigate such events and ensure the implementation of suitable corrective measures and disciplinary actions to prevent their recurrence.

Responsibility

The PI holds the ultimate responsibility for all animal use activities described in an approved IACUC protocol. This accountability extends to any actions executed or neglected by personnel listed on an approved IACUC protocol, irrespective of the PI’s awareness of these actions. The policy below outlines the procedures the IACUC will follow to evaluate animal-related activities and determine instances of noncompliance. Should noncompliance be determined, the PI will be subject to corrective and/or disciplinary measures.

Definitions

Noncompliance: This refers to unintentional or intentional failure to adhere to applicable federal, state, or local laws or regulations, IACUC policies/guidelines/standard operating procedures, or procedures described in an approved IACUC protocol.

Minor noncompliance: This typically occurs when a policy violation has minimal risk of harm to animals or researchers and does not compromise the IACUC’s authority or function. Reporting minor noncompliance to oversight entities external to the IACUC is not necessary, although the PI may need to implement corrective actions or otherwise face possible IACUC sanctions.

Serious noncompliance: This involves any event that negatively impacts an animal’s welfare and/or directly violates federal standards regulating animal activities. These standards include provisions of the Animal Welfare Act and Regulations, the Guide for Care and Use of Laboratory Animals (the Guide), the Guide for the Care and Use of Agricultural Animals in Research and Teaching (the Ag Guide), and the Occupational Health and Safety program, or conducting animal procedures without first obtaining IACUC approval. Serious noncompliance necessitates reporting to the Institutional Official (IO) and may require further reporting to federal agencies and accrediting bodies. Serious noncompliance will likely lead to additional corrective actions for the PI and possible IACUC or institutional disciplinary actions, potentially jeopardizing the PI’s ability to participate in ongoing and future animal activities.

Repeated noncompliance: This involves recurring instances of noncompliance (minor and/or serious) involving the same PI. The IACUC will consider all noncompliance events over the last three years when evaluating a PI’s compliance history. Repeated noncompliance requires reporting to the IO and may necessitate reporting to federal agencies and accrediting bodies. Repeated noncompliance may lead to additional corrective actions for the PI and possible IACUC or institutional disciplinary actions, potentially jeopardizing the PI’s ability to participate in ongoing and future animal activities.

Corrective actions: These are remediation steps intended to prevent recurrence of noncompliance. Corrective actions may be proposed by PIs in consultation with the IACUC, the IACUC Chair, and/or Attending Veterinarian (AV) outlining how noncompliance resolution will be achieved.

Disciplinary actions: These are measures imposed on a PI by the IACUC when noncompliance has occurred. Disciplinary actions are aligned with the severity of the noncompliance incident and intended to bring the PI back into compliance with regulatory requirements, ethical standards, or institutional policies.

Background

The University of Illinois at Urbana-Champaign maintains standards to comply with federal laws associated with the United States Department of Agriculture (USDA) and the Office of Laboratory Animal Welfare (OLAW), as well as performance-based guidelines established by the Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) as a voluntary accrediting body. The University’s Animal Assurance adheres to the Public Health Service (PHS) policy on Humane Care and Use of Laboratory Animals (PHS Policy), Animal Welfare Act and Regulations (AWAR), and the Guide and Ag Guide. All individuals using animals in research and teaching must follow the standards set forth in these regulatory and guidance documents, along with adhering to internal policies and procedures, except where specifically approved to deviate from them in the IACUC protocol. When the University becomes aware of potential noncompliance, comprehensive investigation and possible corrective actions and sanctions may be necessary to protect animal welfare, personnel, university funding, and research and teaching activities.

The IACUC has developed this policy to establish clear and consistent guidance on assessing and managing potential noncompliance involving animals. As situations vary considerably across contexts, determinations are made case-by-case based on the facts and circumstances, including whether self-reporting or voluntary corrective actions occurred, or any other relevant considerations. It is recognized that isolated instances of noncompliance can occur as the result of simple or minor errors with no willful intent to circumvent applicable requirements. As such, the IACUC has the discretion to determine whether a full investigative process and formal corrective measures are warranted.

This policy is not intended to eliminate the ability of an investigator to immediately correct a simple or minor oversight or error in conjunction with the IACUC or the University’s Animal Care Program (ACP). Rather, this policy is intended to address compliance issues that, in the determination of an IACUC and in specific cases, the institutional official (IO), go beyond simple or minor oversight. The processes described in this policy reflect best practices in animal compliance and strive to balance due diligence, fairness, and transparency (Hansen et al., 2017). This includes maintaining strict confidentiality of details involved in noncompliance determinations, elimination of conflicts of interest among all parties, and clear and written communication from the IACUC.

All animal welfare concerns, adverse events, facility incidents, and unexpected animal losses are taken seriously by our institution. This policy applies to situations within the IACUC purview when an animal-related issue has been identified. Anyone concerned with an animal's welfare or who is aware of potential noncompliance with animal care protocols, policies, rules, regulations, or laws, should report that concern and/or potential noncompliance to the IACUC and/or ACP as soon as possible using the following resources: https://go.illinois.edu/AnimalWelfareReport

Procedure

If it is determined that an urgent safety or welfare concern exists, the campus AV, or their designee, may expeditiously intervene to ensure animal welfare standards are maintained. The AV has the authority delegated by the IO and the IACUC to assess and treat the animal, remove it from an experiment, institute appropriate measures to relieve pain or distress, or perform euthanasia, if necessary. The AV also has the authority to halt an experiment until it can be determined that the activity may be safely resumed.

Preliminary Assessment

Upon receiving a report of potential noncompliance, the IACUC Office, in collaboration with ACP veterinarians, will perform a preliminary assessment. This assessment may include:

• Correspondence with the principal investigator (PI) of the applicable IACUC protocol(s) to verify the report and obtain in writing the PI’s plan for preventing future noncompliance,
• Ad hoc inspections of animal use areas,
• Interviews with the PI, students, and/or lab and facility staff to gather pertinent information and context.

The IACUC Office will also verify funding source(s) of the relevant protocol to determine the external reporting obligations.

All information associated with an open case will be maintained in confidence and captured in an animal incident tracking report for internal use within the IACUC Office. The findings of the preliminary assessment will be discussed with the PI and their response will be considered in making an initial IACUC determination, which may lead to the following:

• Dismissal of the allegation (i.e., an unsubstantiated claim)
• IACUC/ACP recommended actions being implemented by the PI
• Immediate corrective action as implemented by the AV, IACUC Chair, or IO (required in cases of urgent safety or welfare concerns)
• Further inquiry by the IACUC Office

Regardless of the initial assessment, all issues related to potential noncompliance will be reviewed during a convened meeting of the IACUC and will be documented in the meeting minutes.

Determination of Noncompliance

Following deliberation of the preliminary assessment and PI response at a convened meeting, the IACUC will determine whether a full investigation is necessary. If warranted, the IACUC Chair or Vice-Chair will charge a subcommittee to ensure thoroughness in the investigative phase. The ad hoc investigative subcommittee will comprise IACUC members, possibly supplemented by IACUC Specialists, independent domain experts, and consultants to ensure diverse and unbiased viewpoints. The IACUC subcommittee will compile a formal report to be shared with the full committee and discussed at a convened IACUC meeting. Importantly, all information and documents generated during the review and investigation of potential noncompliance will remain confidential.

Upon concluding an IACUC assessment or investigation, a convened quorum of the IACUC will deliberate and vote on the following questions:

1. Incident Classification: Is this incident noncompliance (Yes, No, Tabled)?
   1. Yes: Noncompliance is substantiated, and a subsequent vote will determine the degree of noncompliance (minor, serious, repeated)
   2. No: Noncompliance was not substantiated, and the incident is closed. However, any animal welfare issues unrelated to noncompliance may still be addressed by the IACUC.
   3. Tabled: Discussion on the matter will pause but must resume by the end of the next convened meeting for appropriate resolution.
2. Issue Resolution: Is the issue satisfactorily resolved (Yes, No, Tabled)?
   1. Yes: The matter will be closed without a corrective action plan.
   2. No: A corrective action plan must be developed and implemented by the PI, in consultation with the IACUC.
   3. Tabled: Additional information is needed before official IACUC action can be taken, but the matter must be addressed by the end of the next convened meeting.
3. Preventative Measures: Are programmatic changes needed to prevent further occurrences (Yes, No, Tabled)?
   1. Yes: An IACUC subcommittee will be charged by the IACUC Chair to address the matter for future consideration by the IACUC.
   2. No: No further actions are necessary.
   3. Tabled: Additional information is needed before official IACUC action can be taken, but the matter must be addressed by the end of the next convened meeting.

Following the IACUC meeting(s) where these questions are resolved, the IACUC Chair, Vice-Chair, or Director will relay committee findings in writing to the PI. Responsibilities to communicate with a PI may be delegated to others as appropriate. Such communication will occur regardless of whether noncompliance was substantiated to ensure every report is followed through. Communication regarding minor noncompliance may be included in the body of an email. The communication will include a summary of findings, corrective actions recommended/required by IACUC/ACP, disciplinary actions imposed by the IACUC, and applicable PI response deadlines.

If serious or repeated noncompliance is substantiated, an IACUC action letter will be emailed to the PI from the IACUC Chair or Director. The action letter will detail the noncompliance determination, disciplinary actions imposed by the IACUC, and applicable PI response deadlines. Depending on the circumstances, the PI’s unit head/chair/director, Associate Dean of Research (or equivalent), members of the Office of the Vice Chancellor for Research and Innovation, AV, and IO may also receive the IACUC action letter.

Disciplinary Actions

The IACUC may impose disciplinary actions that align with the severity of the incident and the PI’s responsiveness and cooperation. For actions that include the suspension of an activity (i.e., any action or procedure that involves animals used in research and teaching), a majority vote of a quorum of the IACUC is required at a convened meeting. A quorum is constituted when the number of committee members with voting privileges exceeds half of the total membership by one. The goal of disciplinary actions is to bring the PI and the institution back into compliance with all applicable standards for the care and use of animals in research and teaching. Depending on the circumstances, the IACUC may impose one or more of the following disciplinary actions:

Actions managed by the IACUC/ACP

1. Formal Notification: The IACUC will send a formal notification to the PI emphasizing the importance of maintaining standards in animal compliance.
2. Enhanced Monitoring: ACP veterinarians and/or members of the IACUC or IACUC Office will enhance monitoring of animal activities, including direct observation of personnel performing animal procedures or routine reporting of applicable records.
3. Increased Review Frequency: The frequency of de novo IACUC protocol review may be increased (e.g., annual review instead of every 3 years).
4. Reporting Noncompliance: Noncompliance will be reported to Federal and/or accrediting entities in correspondence sent by the IO.
5. Protocol Suspension/Termination: The IACUC may suspend or terminate a protocol if it is determined that the PI is not adhering to approved activities.
6. Revocation of Privileges: Animal use privileges may be suspended or revoked permanently for the PI and/or any protocol personnel found to be directly and willfully implicated in serious or repeated noncompliance.
7. Other Actions: The IACUC may determine other actions, including those in response to preventing future incidents and addressing animal welfare concerns.

Actions requiring PI effort

1. Mandatory Training: The PI and others included on the protocol(s) associated with the noncompliance must complete mandatory training.
2. Written Response: The PI must provide a written response addressing the noncompliance and describing a plan to prevent recurrence.
3. Direct Engagement: The PI is invited to engage directly with the IACUC as a guest at a convened monthly meeting.
4. Protocol Knowledge Assessment: Applicable protocol personnel must undergo a protocol knowledge assessment via written or verbal formats.
5. Protocol Amendment: Amendments to IACUC protocols involving animal care and use, or development of standard operating procedures designed to mitigate or prevent adverse outcomes at the root of the noncompliance. These must be reviewed and approved by the IACUC before implementation.
6. Post-Approval Monitoring: The implementation or increased frequency of post-approval monitoring with established expectations for a PI to provide updates to the IACUC for review at a convened meeting.
7. Professional Development Training: The PI and/or protocol personnel found to be directly and willfully implicated in serious or repeated noncompliance must complete intensive professional development training with a focus on compliance.

Inherent in the IACUC determination of whether an animal-related issue constitutes noncompliance is the committee's acknowledgment that the situation may require reporting to external regulatory entities, as specified in the Reporting Adverse Events policy. If the IACUC determines that noncompliance should be reported to federal or accrediting agencies (i.e., OLAW, USDA, and/or AAALAC) or funding sources, a report detailing the determination and correction of the noncompliance will be written by the IACUC Chair, IACUC Director, or the campus Attending Veterinarian. Written reports to federal/accrediting agencies and/or funding sources will be sent by the IO and co-signed by the IACUC Chair.

Appeal of IACUC Decisions

While the AWAR, PHS Policy, and relevant compliance guidance documents do not explicitly describe or require an appeal process, the right to appeal is a fundamental principle of fairness. An individual may officially appeal to rectify perceived prejudicial errors in the IACUC investigation process, challenge the application of pertinent regulations or guidelines, and/or dispute disciplinary actions deemed to be unjustly imposed.

Any resolution reached by the IACUC during an officially convened meeting, in accordance with parliamentary procedure, can only be reversed by the IACUC itself; there is no further appeal process. This includes disciplinary actions imposed because of a noncompliance determination and decisions made during the IACUC appeal process. Any disciplinary actions imposed by the IACUC will remain in place during the appeal process.

An appellant must express intention to appeal an IACUC decision through written correspondence to the IACUC Chair or Director within two weeks of receiving an official IACUC notification. A written appeal must be provided by the appellant to the IACUC Chair or Director within three weeks of receiving the official IACUC notification, and the written appeal must identify specific IACUC actions being appealed and provide a clear explanation as to why these should be altered or expunged from the record. In addition to the written appeal, an appellant may request to make a direct appeal to the IACUC. If requested by the appellant, they will be invited to attend a convened IACUC meeting as a guest and will be allotted 15 minutes of uninterrupted time to present their appeal, after which they will be excused.

Appeals will be deliberated at a convened monthly IACUC meeting following the receipt of a written appeal, and after the appellant has been excused following their in-person appeal (if they choose to give one). The IACUC will evaluate the information put forth by the appellant and decide whether to amend any aspect of the original decision. An appeal decision will be made at a meeting convened after the one in which the appeal was initially discussed, and the IACUC will notify the appellant in writing within 2 weeks of that decision.

References

• Public Health Service Policy on the Humane Care and Use of Laboratory Animals.
• Animal Welfare Regulations, 9 CFR, Part 2, Subpart C , § 2.31.
• UIUC Campus Administrative Manual (CAM) policy on the Care and Use of Animals in University-sponsored Activities (RP-12)
• Hansen BC, Gografe S, Pritt S, et al. Ensuring due process in the IACUC and animal welfare setting: considerations in developing noncompliance policies and procedures for institutional animal care and use committees and institutional officials. FASEB J. 2017; 31:4216-4225. doi:10.1096/fj.201601250R