Policy on Investigating Noncompliance and Animal Welfare Concerns
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.
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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.
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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 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 have the potential to jeopardize U-M’s privilege of using animals in research, teaching, demonstration, and testing activities.
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Glossary Definitions
Adverse Event
An unexpected incident that leads to harm or endangers the well-being of animals and/or humans.
Related Terms:ReportAllegation
A reported concern that may potentially be an incident of noncompliance, an unanticipated adverse event, or a circumstance that may endanger the well-being of an animal and/or human. The report may be a written or oral communication to any ACUP staff member.
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 the IACUC Vice-Chair. The ACC is tasked with conducting the initial assessment of an allegation or report and fulfilling the purpose of the Policy on Investigating Noncompliance and Animal Welfare Concerns. The ACC includes, at minimum, the 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 will be added as an ad hoc consultant to the ACC. Appointment to the subcommittee is at the discretion of the ACUO Director and terms are for one year.
Inquiry
Inquiry is an official period used to collect information associated with an allegation or report. The purpose of the inquiry is to decide if an allegation or report warrants an IACUC investigation. If a determination is made to proceed to an investigation, the ACC must notify all involved parties, including, when possible, the individual(s) who reported the allegation.
Investigation
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.
Report
Reports are verbal or written notices of concern relating to aspects of the U-M Animal Care & Use Program. Reports are not limited to allegations of noncompliance and may be associated with, for example, an adverse event.
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.
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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. The ACUO initiates an ACC assessment and the development of a subsequent report.
2. Allegation and Report Assessment:
- Upon receipt: the ACC performs 1) a preliminary assessment of each allegation; and 2) provides a summary of the allegation to the IACUC Chair, ACUO Director, and the AV.
- The IACUC Chair, ACUO Director, 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.
- An inquiry process is initiated if at least one member of the ACC determines the allegation or report is credible or meets the definition of serious noncompliance. Otherwise, a summary of the findings is communicated to the IACUC during the next scheduled meeting as a matter of information.
3. Inquiry Process:
- During the inquiry, the ACC collects the necessary information required to determine if an allegation or report warrants a formal IACUC investigation.
- The ACC will communicate, as needed, with the PI, his/her animal users, ULAM, and/or any other relevant individual(s).
- If an IACUC investigation is to occur, the ACC will also determine whether the PI 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 staff, and/or students) to attend the meeting to provide information.
- The ACC, through the ACUO Associate Director of Compliance, will also file preliminary reports with relevant agencies (e.g., the Office of Laboratory Animal Welfare (OLAW), USDA, DoD, AAALAC).
4. IACUC Investigation Process:
- During a convened meeting of a majority of IACUC voting members, the ACC presents its inquiry findings.
- 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.
- Once the investigation is completed, the ACC, through the ACUO, will provide formal notification to the PI. The correspondence will summarize the findings of the IACUC and, when applicable, provide IACUC-implemented corrective actions.
- The IACUC, through the IO, will promptly (i.e., within 30 days) provide a full explanation of the circumstances and actions as a written report to AAALAC, OLAW, and the USDA, as applicable. The report will be prepared by the ACUO and ACC.
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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 Animals, OLAW 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:
- 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;
- conduct of animal-related activities without appropriate IACUC review and approval;
- failure to adhere to IACUC-approved protocols;
- implementation of any significant change to IACUC-approved protocols without prior IACUC approval as required by IV.B.7.;
- 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);
- 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;
- conduct of official IACUC business during a period of time that the Committee is improperly constituted;
- failure to correct deficiencies identified during the semiannual evaluation in a timely manner;
- 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;
- 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;
- 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);
- failure to maintain appropriate animal-related records (e.g., identification, medical, husbandry);
- failure to ensure death of animals after euthanasia procedures (e.g., failed euthanasia with CO2);
- failure of animal care and use personnel to carry out veterinary orders (e.g., treatments); or
- 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:
- death of animals that have reached the end of their natural life spans;
- death or failures of neonates to thrive when husbandry and veterinary medical oversight of dams and litters was appropriate;
- 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
- 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).”
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Appendix 2: Corrective Action Escalation
Ensuring animal welfare and maintaining program compliance is a shared responsibility, and U-M depends on everyone to do their part. For example, animal researchers must adhere to their approved protocols, maintain required records, and help to ensure the health and well-being of their animals.
The institution has taken action to minimize or eliminate incidents of noncompliance. U-M will use, for example, a combination of formal notices, training, and when necessary, punitive measures to mitigate incidents of noncompliance with governing standards. Actions taken to minimize occurrences of noncompliance 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.
The following mitigation measures will be employed when incidents of noncompliance are confirmed. Since PIs are ultimately responsible for ensuring their animal activities are conducted in accordance with governing standards and their IACUC-approved protocols, the IACUC will direct any relevant correspondence and actions directly to the PI.
1. Single incident of noncompliance:
- A single incident of noncompliance with the PI having no additional noncompliant incidents associated with his/her research program over the past 3 years, and that incident having no direct negative impact on animal welfare. 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.
- A single incident of noncompliance with the PI having no additional noncompliant incidents associated with his/her research program over the past 3 years, and that incident having a direct negative impact on animal welfare. 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. In addition, the PI is required to provide an action plan to prevent reoccurrences.
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:
- 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.
- 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).
- The PI’s research program may be placed on probation, during which 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.
- Requirement for the PI to be physically present for select animal activities (e.g., survival surgery), and for he/she to conduct post-procedure observations and sign the relevant records to ensure he/she is overseeing the animal activities associated with his/her research.
- Requirement for the PI to submit scheduled reports to the IACUC on the status of his/her research program.
- Any other relevant sanction as determined by the IACUC.
3. Three or more incidents of noncompliance or failure to satisfy previously imposed corrective actions:
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:
- An individual’s access to the animal facilities is restricted (e.g., loss of access or supervised access only).
- Suspension (indefinitely or for a defined time period) of an individual’s privilege to conduct animal activities.
- The suspension of a procedure within a protocol.
- Suspension (for a defined time period) of an approved protocol.
- Any other sanction as determined by the IACUC.
Questions?
For questions, additional detail, or to request changes to this policy, please contact the Office of the Assistant Vice President for Research, Director of the Animal Care & Use Office at acuoffice@umich.edu or (734) 763-8028.