The Institutional Animal Care and Use Committee (IACUC) plays a vital role in ensuring the ethical and humane treatment of animals used in research, testing, and training within institutions. This guide provides a detailed overview of the institutional animal care program, its responsibilities, and key components, serving as an essential resource for institutions, researchers, and anyone involved in animal welfare in research settings.
The IACUC operates under the guidelines set forth by the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and is further informed by the Guide for the Care and Use of Laboratory Animals (Guide). These regulations and guidelines are designed to ensure a comprehensive and ethical approach to animal care within research institutions.
Core Responsibilities of the IACUC
The IACUC is entrusted with several critical responsibilities aimed at overseeing and continuously improving the animal care and use program within an institution. These responsibilities are crucial for maintaining ethical standards and regulatory compliance.
Program Review and Facility Inspection:
At least twice a year, the IACUC must conduct thorough reviews of the institution’s animal care and use program. This encompasses all aspects of animal well-being, including veterinary care, housing, policies, procedures, personnel training, and facility management. Alongside program reviews, the IACUC also inspects all animal facilities, including satellite facilities, to ensure they meet the standards outlined in the Guide. These inspections cover all areas where animals are housed for more than 24 hours, assessing the physical environment and operational practices.
Reporting and Recommendations to the Institutional Official (IO):
Following each semiannual review and inspection, the IACUC prepares a detailed report for the Institutional Official (IO). This report summarizes the IACUC’s evaluations, highlights the institution’s adherence to the Guide, identifies any departures from these guidelines, and pinpoints both significant and minor deficiencies. Crucially, the report includes clear recommendations for program improvements, facility upgrades, or personnel training enhancements. The IACUC is also responsible for bringing any animal welfare concerns to the IO’s attention and proposing necessary corrective actions.
Protocol Review and Approval:
A fundamental responsibility of the IACUC is the review and approval of all research protocols involving animals before any research can commence. This process ensures that all proposed animal use is ethically justifiable, scientifically necessary, and aligns with animal welfare regulations. The IACUC also reviews and approves any significant changes to ongoing animal research activities, ensuring continuous oversight and ethical compliance. Furthermore, the IACUC is empowered to suspend any animal activity if serious concerns regarding animal welfare or regulatory non-compliance arise.
IACUC Membership: Ensuring Diverse Perspectives
To effectively fulfill its oversight responsibilities, the IACUC requires a diverse membership, comprising at least five individuals with varied expertise and perspectives. This multidisciplinary composition is essential for a balanced and comprehensive review of animal care and use. The mandatory members include:
- Veterinarian: A Doctor of Veterinary Medicine with expertise in laboratory animal science and medicine. This veterinarian has direct responsibility for the institution’s animal care programs.
- Practicing Scientist: An experienced researcher who actively conducts research involving animals. This member brings practical research experience to the committee.
- Non-Scientist Member: An individual whose primary concerns lie in a nonscientific area, such as ethics, law, or theology. This member provides an important ethical and community perspective.
- Unaffiliated Member: A member who is not affiliated with the institution other than their role on the IACUC. This individual represents broader community interests and ensures external oversight.
Semiannual Reviews and Facility Inspections: A Deeper Look
The semiannual program reviews and facility inspections are cornerstones of the institutional animal care program. These processes are not mere formalities but are in-depth evaluations designed to ensure the highest standards of animal care and use.
“An animal care and use program … comprises 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.” (Guide)
The IACUC utilizes the Guide as the primary standard for conducting these comprehensive reviews. Facility inspections are physical examinations of all locations where animals are housed for more than 24 hours, encompassing buildings, rooms, enclosures, and vehicles, including satellite facilities. These inspections cover areas used for animal confinement, transport, breeding, maintenance, and experimentation, including surgical areas. All IACUC members are entitled to participate in these evaluations, ensuring a thorough and inclusive review process. It’s also important to note that the Animal Welfare Act and Regulations (AWAR) mandate that animal study areas housing regulated species for over 12 hours must also be included in these semiannual inspections.
To aid IACUCs in conducting these reviews, resources like the Sample Semiannual Program and Facility Review Checklist are available. This checklist, provided by the Office of Laboratory Animal Welfare (OLAW), serves as a valuable tool, which institutions can adapt to their specific needs. A crucial component of this checklist is a summary page designed for noting and tracking any identified deficiencies, ensuring accountability and follow-up.
Semiannual Reporting to the Institutional Official: Transparency and Accountability
Following the rigorous semiannual review and inspection, the IACUC compiles a formal written report for the Institutional Official (IO). This report is a critical document that ensures transparency and accountability within the institutional animal care program. It includes not only the IACUC’s findings but also any differing opinions or minority views from committee members, fostering open communication and diverse perspectives.
The report details the extent to which the institution adheres to the Guide, specifically noting any deviations and providing justifications for each departure. It clearly distinguishes between significant and minor deficiencies identified in the program or facilities, and, importantly, it outlines concrete plans and timelines for rectifying each deficiency. A significant deficiency is defined as any issue that poses a potential threat to animal health or safety, highlighting the IACUC’s focus on critical welfare concerns.
To assist IACUCs in preparing these comprehensive reports, a sample semiannual report to the IO is available as a helpful template. It’s important to note that these semiannual reports are typically submitted to OLAW only upon request or when an institution is submitting a new or renewal Animal Welfare Assurance and is not accredited by AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). However, any serious or ongoing non-compliance issues with PHS Policy must be reported to OLAW promptly, underscoring the IACUC’s role in ensuring regulatory adherence and ethical conduct.
Protocol Review: Ensuring Ethical Animal Use in Research
The IACUC’s oversight extends to the specific use of animals in research through a rigorous protocol review process. This process is central to ensuring that all animal research is conducted ethically and in accordance with established guidelines. Protocols detailing proposed animal use must be reviewed and approved by the IACUC before any research activities can begin.
There are two recognized methods for protocol review:
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Full Committee Review (FCR): This method involves a review at a convened meeting where a quorum (more than half of the members) is present. Decisions on protocol approval, modifications, or withholding approval are made by a majority vote of the quorum. If significant modifications are required for protocol approval, the revised protocol must undergo further review, either through FCR or Designated Member Review (DMR).
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Designated Member Review (DMR): DMR can be implemented only after all IACUC members have been given a list of protocols slated for review and have had the chance to request FCR. If no FCR is requested, a qualified IACUC member, designated by the Chair, conducts the review. DMR can result in protocol approval, require modifications for approval, or necessitate FCR. Importantly, DMR cannot result in protocol disapproval, ensuring a higher level of committee scrutiny for protocols that may face rejection.
OLAW has formally acknowledged an alternative practice for protocol review following FCR, detailed in NOT-OD-09-035, which the USDA also concurs with. This guidance pertains to using DMR for reviewing modifications to animal study proposals after initial FCR.
IACUC approval, whether through FCR or DMR, is mandatory for all proposed animal activities and significant changes to previously approved activities. Institutions may also establish, and IACUCs may approve, policies like standard operating procedures and drug formularies to guide animal activities. These policies are subject to periodic review, at least every three years, to ensure their continued relevance and accuracy.
Defining what constitutes a “significant change” to animal activities is at the IACUC’s discretion, as outlined in PHS Policy IV.C.1.a.-g. The IACUC is responsible for clearly communicating its definition of significant change to researchers. NIH Guide Notice NOT-OD-14-126 and the Significant Changes webpage provide further clarification on this topic.
To maintain impartiality and ethical integrity, IACUC members with a conflicting interest in a protocol (e.g., personal involvement in the research) are prohibited from participating in the review or approval process, except to provide information when requested by the IACUC. Recused or excluded members also do not count towards the quorum required for IACUC meetings.
The PHS Policy strongly supports the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training” (U.S. Government Principles). IACUCs are expected to consider these principles during protocol reviews. All protocols must adhere to the institution’s Animal Welfare Assurance and comply with PHS Policy requirements detailed in section IV.C.1.a.-g..
The Guide (pp. 25-26) outlines specific areas that Principal Investigators (PIs) should address when preparing protocols and that the IACUC should consider during review. Furthermore, the Guide (pp. 27-33) discusses specific types of protocols that require extra scrutiny during IACUC review due to potential animal welfare concerns.
Post-Approval Monitoring: Continuous Oversight of Animal Welfare
Ongoing monitoring of animal care and use is a mandatory aspect of the PHS Policy. This continuous oversight is essential to ensure that approved protocols are implemented as intended and that animal welfare is consistently maintained throughout the research process.
The Guide (p. 33) describes several methods for post-approval monitoring, including:
- Continuing Protocol Review: Regular updates and reviews of ongoing protocols.
- Laboratory Inspections: Inspections conducted during routine facility inspections or separately, focusing on specific laboratory practices.
- Veterinary or IACUC Observation: Direct observation of selected procedures by veterinary or IACUC staff.
- Animal Observation: Routine observation of animals by animal care, veterinary, and IACUC personnel.
- External Regulatory Assessments: Inspections and assessments by external regulatory bodies.
Continuing protocol review often involves annual updates, allowing investigators to submit proposed amendments for future procedures, report any adverse or unexpected events, and provide progress updates. While protocols are initially approved for a maximum of 3 years under PHS Policy, a complete review encompassing all policy criteria is required at least every three years for ongoing projects. Animal work cannot be extended beyond this 3-year approval period without undergoing a full review and re-approval.
Addressing Animal Welfare Concerns: A Proactive Approach
“The institution must develop methods for reporting and investigating animal welfare concerns, and employees should be aware of the importance of and mechanisms for reporting animal welfare concerns.” (Guide)
The IACUC is mandated to evaluate and address any concerns related to animal care and use. These concerns can originate from various sources, including institutional staff, community members, or even IACUC members themselves. It is highly advisable for IACUCs to proactively develop clear guidelines and procedures for handling allegations of mistreatment or noncompliance before such situations arise. Furthermore, the IACUC must be aware of whistleblower protections under the AWA, which safeguards individuals who report violations of animal welfare regulations from discrimination or reprisal.
Suspension of Animal Activities: Ensuring Accountability and Compliance
The IACUC holds the significant authority to suspend an animal activity if it identifies noncompliance with the PHS Policy, Guide, Animal Welfare Assurance, or Animal Welfare Regulations. This power underscores the IACUC’s role in enforcing regulatory compliance and ensuring animal welfare.
Project suspension can only occur after a formal review at a convened IACUC meeting with a quorum present, and a majority vote from the quorum is required to enact the suspension. Following a suspension decision, the IACUC must consult with the Institutional Official (IO) to discuss the reasons for suspension and necessary corrective actions. The IO is then obligated to take appropriate corrective measures and report the suspension and its circumstances to OLAW. Given the serious nature of suspending a research project, such actions must be reported to OLAW promptly, highlighting the IACUC’s critical accountability to regulatory bodies. More information on reporting noncompliance can be found on the Reporting Noncompliance webpage.
This guide provides a foundational understanding of the institutional animal care program and the critical role of the IACUC. By adhering to these guidelines and continuously striving for improvement, institutions can ensure the highest standards of ethical and humane animal care in research.
