Policy on Investigating Noncompliance and Animal Welfare Concerns

Institutional Animal Care & Use Committee
Sep 18, 2023 11:30 am

This policy describes the process that the U-M IACUC will follow when investigating reports and allegations of noncompliance or welfare concerns relating to the care and/or use of vertebrate animals and/or cephalopods.

  • Purpose

    In accordance with federal policy and law (i.e., PHS Policy and AWAR), organizations with an animal care and use program (ACUP) must establish an Institutional Animal Care & Use Committee (IACUC), and authorize it to oversee the ACUP.

    The same standards require the IACUC to provide ongoing oversight for animal activities conducted at the institution. This policy describes the process that the U-M IACUC will follow when investigating reports and allegations of noncompliance or welfare concerns relating to the care and/or use of vertebrate animals and/or cephalopods.

  • Background

    The University of Michigan’s Animal Care & Use Program (ACUP) adheres to the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (PHS Policy), the federal Animal Welfare Act and Regulations (AWAR), the Guide for the Care and Use of Laboratory Animals (the Guide), and all other applicable standards.

    Individuals utilizing live or dead vertebrate animals and/or cephalopods under the auspices of the University of Michigan (U-M) must adhere to these standards any time vertebrate animals and/or cephalopods are used for research, teaching, demonstration, and testing.

    Violations of these standards could impact the ACUP and the University in a variety of ways, including: 1) jeopardize U-M’s privilege of using animals in research, instruction, and testing activities, 2) negatively affecting U-M’s eligibility to receive grants that include animal use and activities; 3) resulting in monetary penalties (i.e., fines); and 4) leading to public accusations of not treating animals humanely.


    This policy is applicable to all animal activities conducted under the auspices of the University, and applies to all locations under the purview of the U-M IACUC.

  • Glossary Definitions

    Adverse Event

    An unexpected incident that leads to harm or endangers the well-being of animals and/or humans.

    Allegation and Report Assessment

    A review by the ACUP Compliance Committee of the available evidence/information to determine if an allegation or report is credible, specific, and meets the requirements for proceeding to an inquiry.

    ACUP Compliance Committee (ACC)

    A subcommittee of IACUC members that is chaired by an IACUC Vice-Chair. The ACC is tasked with conducting the “Allegation and Report Assessment.” The ACC includes, at minimum, an IACUC Vice-Chair, a non-affiliated IACUC member, and at least one other faculty scientific IACUC member

    An ACUO Compliance Consultant and a designated faculty veterinarian will also be part of the committee to provide support. If allegations or inquiries include a safety or hazardous materials component, a member of Environment, Health and Safety (EHS) will be added as an ad hoc consultant to the ACC. Appointment to the subcommittee is at the discretion of the ACUO Director.


    Lead by the ACC during a convened meeting of at least a quorum of the IACUC; a formal development of a factual record and the examination of that record leading to a decision to determine, for example, whether noncompliance occurred. During the investigation, the IACUC also quantifies the significance of the incident and identifies the appropriate corrective actions to be taken.

    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, including provisions of the Occupational Health and Safety Program. For more information, please see Appendix 1 of the Policy on Investigating Noncompliance and Animal Welfare Concerns.

  • Policy

    1. Allegations and Reports:

    Individual allegations and reports submitted to the IACUC for investigation through, for example, the Animal Concern Hotline, the Attending Veterinarian (AV), the IACUC Chair, or the Animal Care & Use Office (ACUO) are routed to the ACUO. An ACUO staff member initiates the assessment and, when necessary, develops the subsequent report.

    2. Allegation and Report Assessment:

    All reports submitted to the ACUO undergo a preliminary assessment of each allegation, conducted by the IACUC Chair, ACUO Director, and the AV to determine if a report is credible or meets the definition of serious noncompliance.

    1. A report is deemed credible and/or considered as a serious noncompliance when positive affirmation by any one member of the preliminary assessment group (i.e., the IACUC Chair, the ACUO Director, and/or the AV) occurs.
    2. An inquiry is initiated if the allegation or report is determined to be credible or meets the definition of serious noncompliance. Otherwise, a summary of the allegation or reports are documented with no further action being required.

    3. Inquiry:

    1. During the inquiry, an ACUO staff member gathers the relevant information about the allegation or reports and summarizes that information for the ACC. The staff member may communicate, as needed, with the PI, their animal users ULAM, and/or any other relevant individual(s).
    2. The ACC reviews reports to (1) determine if the available evidence/information is sufficient for proceeding to an IACUC investigation and, when necessary, (2) develop a recommendation to the IACUC.

    4. IACUC Investigation Process:

    1. If an IACUC investigation is to occur, the ACC will: 
      1. Provide a detailed description of the allegation and findings to the PI and the date it will be discussed by the IACUC, and
      2. Notify the PI if/when they will be required to attend the IACUC meeting to explain the circumstances and/or discuss possible resolutions to the problem. In addition, the ACC may ask others (e.g., faculty, research technicians, animal care personnel, and/or students) to attend the meeting to provide information.
      3. An ACUO staff member will notify the PI of the allegation and coordinate the logistics for them to attend the meeting when required.
    2. to initiate discussion, the ACC Chair (or a member of the ACUO) presents the formal information (i.e., the factual report) and its recommendation (i.e., a motion for the IACUC to consider) to a majority of IACUC members during a convened meeting. After the discussion and if applicable, the PI will then participate in the IACUC ongoing discussion to provide additional information regarding the case.
    3. As a result of the discussion, the IACUC members confirm whether noncompliance occurred. The case if closed if the committee determines the allegation was not considered noncompliance.
    4. If the IACUC determines an allegation is noncompliance and/or a program deficiency, the committee identifies the appropriate corrective actions to be taken, in accordance with Appendix 2. The action is formalized through a motion and committee vote. An ACUO staff member will provide formal notification to the PI. The correspondence will summarize the findings of the IACUC and, when applicable, provide IACUC-implemented corrective actions. On behalf of the IACUC, an ACUO staff member will prepare and promptly (i.e., within 30 days) provide, through the IO, a full explanation of the circumstances and actions as a written report to AAALAC, OLAW, and the USDA, as applicable.


  • Appendix 1: Guidance on Serious (Reportable) Incidents of Noncompliance

    Through Notice (NOT-OD-05-034), Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory AnimalsOLAW provides the following guidance to institutions on how to determine if an incident requires a formal report to OLAW:

    “A comprehensive list of definitive examples of reportable situations is impractical. Therefore, the examples below do not cover all instances but demonstrate the threshold at which OLAW expects to receive a report. Institutions should use rational judgment in determining what situations meet the provisions of IV.F.3 and fall within the scope of the examples below, and consult with OLAW if in doubt.

    Examples of reportable situations:

    1. 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;
    2. conduct of animal-related activities without appropriate IACUC review and approval;
    3. failure to adhere to IACUC-approved protocols;
    4. implementation of any significant change to IACUC-approved protocols without prior IACUC approval as required by IV.B.7.;
    5. conduct of animal-related activities beyond the expiration date established by the IACUC (note that a complete review under IV.C is required at least once every three years);
    6. conduct of official IACUC business requiring a quorum (full Committee review of an activity in accord with IV.C.2 or suspension in accord with IV.C.6) in the absence of a quorum;
    7. conduct of official IACUC business during a period of time that the Committee is improperly constituted;
    8. failure to correct deficiencies identified during the semiannual evaluation in a timely manner;
    9. 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;
    10. participation in animal-related activities by individuals who have not been determined by the IACUC to be appropriately qualified and trained as required by IV.C.1.f;
    11. failure to monitor animals post-procedurally as necessary to ensure well-being (e.g., during recovery from anesthesia or during recuperation from invasive or debilitating procedures);
    12. failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry);
    13. failure to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO2);
    14. failure of animal care and use personnel to carry out veterinary orders (e.g., treatments); or
    15. IACUC suspension or other institutional intervention that results in the temporary or permanent interruption of an activity due to noncompliance with the Policy, Animal Welfare Act, the Guide, or the institution's Animal Welfare Assurance.

    OLAW recognizes that there may be levels of morbidity and mortality in virtually any animal-related activity, including those associated with the care and use of animals in research, testing, and teaching that are not the result of violations of either the Policy or the Guide. OLAW offers the following examples of situations which may not meet the threshold for reporting, based on consideration of the circumstances by the IACUC.

    Examples of situations not normally required to be reported:

    1. death of animals that have reached the end of their natural life spans;
    2. death or failures of neonates to thrive when husbandry and veterinary medical oversight of dams and litters was appropriate;
    3. animal death or illness from spontaneous disease when appropriate quarantine, preventive medical, surveillance, diagnostic, and therapeutic procedures were in place and followed;
    4. animal death or injuries related to manipulations that fall within parameters described in the IACUC-approved protocol; or
    5. infrequent incidents of drowning or near-drowning of rodents in cages when it is determined that the cause was water valves jammed with bedding (frequent problems of this nature, however, must be reported promptly along with corrective plans and schedules).”
  • Appendix 2: Corrective Action Escalation

    When the IACUC has made a determination that corrective action(s) are required to minimize the potential for recurring incidents of noncompliance, the IACUC, in collaboration with other U-M units, may use, for example, a combination of formal notices, training, and when necessary, punitive measures. Actions taken will be based on the seriousness of the incident and/or the number of incidents that occur on all protocols under the direction of a PI in the previous 3 years. Regardless of this time-period, the IACUC has the option to review the compliance history of a laboratory when determining the optimal course of action.

    The tiered escalation process outlined below will be used as a general guidance and employed when incidents of noncompliance are confirmed. The mitigation measures (e.g., sanctions) will be developed to best address the nature and cause(s) of the noncompliance, so consequently the IACUC may choose to implement any of the measures outlined in the three tiers depending on the circumstances. Below are common sanctions used by the IACUC according to escalation status. All relevant correspondence and information regarding the IACUC’s decision will be relayed directly to the PI.


    1. Single incident of noncompliance:

    1. For a single incident of noncompliance with the PI having no additional noncompliant incidents associated with their research program over the previous 3 years the PI receives a formal notice from the IACUC that identifies the importance of maintaining a compliant research program and the impact incidents of noncompliance can have on U-M’s overall ACUP. If the incident had a direct, negative impact on animal welfare, the PI is required to provide an action plan to prevent recurrences.
    2. The PI is required to complete the “Self-Guided Evaluation of Animal Activities and Protocol Content Form” and discuss the completed form at a laboratory meeting within 30 days of notice from the IACUC.
    3. Any other relevant sanction(s) as determined by the IACUC.

    2. Second incident of noncompliance:

    All individuals listed as animal handlers on the protocol are required to retake the Orientation to Animal Care and Use online module within thirty days of the notice. In addition, at least one or more of the following corrective actions will be imposed:

    1. The PI is required to complete the “Self-Guided Evaluation of Animal Activities and Protocol Content Form” and discuss the completed form at a laboratory meeting within 30 days of notice from the IACUC.
    2. The PI and/or other individuals will prepare a training module that will be presented at an appropriate forum such as an ethics class or town hall meeting, or the training may be included in the ACUP Newsletter.
    3. Select procedures or an individual’s activities on a protocol can only be conducted under the supervision of an IACUC-identified individual (e.g., a veterinarian or an ACUO member, or IACUC member).
    4. The PI’s research program may be placed on probation, during which time the IACUC may mandate “for cause” post-approval monitoring (PAM) visits by ACUO staff members, with the stipulation that any additional serious noncompliant incidents identified during the probation period would result in additional corrective actions.
    5. Requirement for the PI to be physically present for select animal activities (e.g., survival surgery) and/or to conduct post-procedure observations. and the PI will then sign the relevant records to document the required oversight of the animal activities associated with their research.
    6. Requirement for the PI to submit scheduled reports to the IACUC on the status of their research program. 
    7. Any other relevant sanction(s) as determined by the IACUC.

    3. Three or more incidents of noncompliance in a 3-year period or failure to satisfy previously imposed corrective actions:

    Within 30 days of notice, all individuals listed as animal handlers on the PIs IACUC protocol(s) are required to (1) retake the Orientation to Animal Care and Use online module and (b) certify a review of all documents related to the non-compliance (e.g., the relevant policies and guidelines as identified by the IACUC) has occurred. In addition, at least one or more of the following corrective actions will be imposed:

    1. An individual’s access to the animal facilities is restricted (e.g., loss of access or supervised access only) for an IACUC-determined period.
    2. Suspension of an individual’s privilege to conduct animal activities for an IACUC-determined period.
    3. A procedure of the use of specific animals within the relevant protocol(s) is suspended for and IACUC-determined period.
    4. A protocol is suspended for an IACUC-determined period.
    5. Any other relevant sanction(s) as determined by the IACUC.

    The U-M IACUC fully supports and adheres to Federal mandates that state “No facility employee, Committee member, or laboratory personnel shall be discriminated against or be subject to any reprisal for reporting violations of any regulation or standards under the Act” (AWAR).

    U-Ms IACUC fully supports and adheres to the University of Michigan’s Standard Practice Guide (SPG) #601.90, Protection from Retaliation, which states “Retaliation against any member of the University of Michigan community who in good faith reports or participates in an inquiry or investigation into Wrongful Conduct is prohibited.”

    Any member of the U-M community or the public can report concerns of discrimination or retaliation through resources described in SPG #601.90, or through the Animal Concern Hotline (http://animalcare.umich.edu/report-animal-concerns).