A Guide to the Institutional Animal Care Program

Responsibilities

The Institutional Animal Care and Use Committee (IACUC) plays a crucial role in overseeing an institution’s animal care and use program. This oversight is mandated by the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and detailed in the Guide for the Care and Use of Laboratory Animals (Guide). The IACUC’s primary function is to ensure the ethical and humane treatment of animals involved in research, testing, and training within the institution. This responsibility involves continuous evaluation and improvement of all aspects of the animal care and use program. Key responsibilities of the IACUC include:

Semiannual Program Review: At least twice a year, the IACUC must comprehensively review the institution’s entire program for humane animal care and use. This goes beyond just checking facilities; it involves assessing policies, procedures, animal husbandry, veterinary care, and personnel training to ensure they meet established standards.
Semiannual Facility Inspections: Complementary to program reviews, the IACUC conducts semiannual inspections of all animal facilities, including any satellite facilities. These inspections are physical walkthroughs to verify compliance with regulations and guidelines in areas like housing, sanitation, environmental control, and equipment maintenance.
Reporting to the Institutional Official (IO): After each semiannual review and inspection, the IACUC is required to prepare a detailed report for the Institutional Official (IO). This report summarizes the IACUC’s evaluations, highlights any deficiencies found, and provides clear recommendations for program improvement. The IO is ultimately responsible for the animal care program at the institution and relies on the IACUC’s report for informed decision-making.
Reviewing Animal Welfare Concerns: The IACUC serves as a central point for addressing any concerns related to animal welfare within the institution. This includes establishing mechanisms for reporting concerns, investigating allegations of animal mistreatment or noncompliance, and ensuring appropriate corrective actions are taken.
Recommendations to the Institutional Official: The IACUC’s role is advisory, and it actively makes recommendations to the IO on all aspects of the animal program. These recommendations can cover facility upgrades, policy revisions, personnel training enhancements, or any other area that could improve animal welfare and program effectiveness.
Protocol Review and Approval: A critical responsibility of the IACUC is to review and approve all research protocols involving vertebrate animals before the research can commence. This protocol review ensures that proposed animal use is ethically justifiable, scientifically necessary, and aligns with animal welfare regulations and institutional policies.
Review of Significant Changes: Beyond initial protocol approval, the IACUC must review and approve any significant changes to previously approved animal activities. This ensures that modifications to research protocols are also ethically sound and do not negatively impact animal welfare. Defining what constitutes a “significant change” is also a responsibility of the IACUC.
Authority to Suspend Activities: In situations of serious noncompliance or when animal welfare is severely compromised, the IACUC has the authority to suspend any animal activity. This power underscores the IACUC’s role as an enforcement body, ensuring adherence to regulations and ethical standards. Suspension is a serious action that requires careful deliberation and reporting to the IO and relevant oversight agencies.

Membership

To effectively carry out its diverse responsibilities, the IACUC is required to have a diverse membership of at least five individuals, encompassing a range of expertise and perspectives. This composition is designed to ensure comprehensive and balanced oversight of the animal care program. The mandatory members include:

Veterinarian: A Doctor of Veterinary Medicine (DVM) with specific training or experience in laboratory animal science and medicine is a cornerstone of the IACUC. This veterinarian holds direct or delegated authority and responsibility for all animal-related activities at the institution. Their expertise is crucial for ensuring animal health, providing veterinary care guidance, and advising on animal welfare best practices.
Practicing Scientist: A scientist with hands-on experience in research involving animals is essential to the committee. This member brings the researcher’s perspective to the IACUC, understanding the scientific necessity of animal use and contributing to the evaluation of research protocols from a scientific validity standpoint, while also being mindful of ethical considerations.
Non-Scientific Member: To broaden the perspective beyond the scientific and veterinary fields, the IACUC must include a member whose primary concerns lie in a nonscientific area. This could be an ethicist, a lawyer, a member of the clergy, or someone from a similar background. This member is crucial for raising ethical and societal considerations related to animal research, ensuring a balanced and holistic review process.
Unaffiliated Member: To provide an external perspective and ensure public accountability, the IACUC must include at least one member who is not affiliated with the institution in any way, except for their IACUC membership. This individual represents the interests of the community and the public’s broader concerns about animal welfare in research. They bring objectivity and independence to the committee’s deliberations.

Semiannual Program Reviews and Facility Inspections

The Guide for the Care and Use of Laboratory Animals defines an animal care and use program broadly: “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, p. 11)

The semiannual program reviews and facility inspections are the primary mechanisms through which the IACUC actively monitors and evaluates the institution’s animal care and use program. These evaluations are mandated for all programs funded by the PHS and are conducted at least every six months. The Guide serves as the fundamental standard against which the IACUC measures the program’s adequacy and effectiveness.

Facility inspections are comprehensive physical assessments of all locations where animals are housed for more than 24 hours. This includes all buildings, rooms, areas, enclosures, and even vehicles used for animal confinement, transport, maintenance, breeding, or experimental procedures, including surgical manipulations. It’s critical that all IACUC members are allowed to participate in these evaluations, ensuring a thorough and multi-faceted assessment. Furthermore, the Animal Welfare Act and Regulations (AWAR) stipulate that animal study areas housing regulated species for over 12 hours must also be included in these semiannual facility inspections, highlighting the broad scope of these reviews.

To aid IACUCs in conducting these essential reviews, resources like the Sample Semiannual Program and Facility Review Checklist are available. This checklist, provided by the Office of Laboratory Animal Welfare (OLAW), offers a structured framework for IACUCs, which can be adapted to fit the specific needs and context of each institution. The checklist also includes a summary page designed for documenting and tracking any identified deficiencies, facilitating corrective action planning and follow-up.

Semiannual Report to the Institutional Official

Following the semiannual program review and facility inspection, the IACUC is responsible for compiling a comprehensive written report for the Institutional Official (IO). This report serves as a formal communication of the IACUC’s findings and recommendations. It must include a description of the institution’s adherence to the Guide, explicitly noting any departures from the Guide and providing clear justifications for each departure. If there are differing opinions within the IACUC, any minority views must also be included in the report to ensure a balanced representation of the committee’s deliberations.

A crucial aspect of the report is the identification and categorization of any program or facility deficiencies. The IACUC must distinguish between significant deficiencies, which pose a potential threat to animal health or safety, and minor deficiencies. For each deficiency identified, the report must include concrete plans and realistic timelines for corrective action. This demonstrates the IACUC’s proactive role in ensuring continuous program improvement.

To assist IACUCs in preparing these detailed reports, OLAW provides a sample semiannual report to the IO. This template offers a structured format and guidance on the essential elements that should be included in the report.

It’s important to note that semiannual reports to the IO are typically submitted to OLAW only under specific circumstances: if OLAW requests them, or if the institution is submitting a new or renewal Animal Welfare Assurance to OLAW and is not accredited by AAALAC International (Association for Assessment and Accreditation of Laboratory Animal Care International). However, any serious or ongoing deviations from the PHS Policy must be reported to OLAW promptly, regardless of the routine reporting schedule. Further details on PHS Policy reporting requirements are available in the section on Reports and Recordkeeping.

Protocol Review

The IACUC’s oversight extends to the specific ways animals are used in research. This is achieved through a rigorous protocol review process. Before any animal work can commence, researchers must submit detailed animal use protocols to the IACUC for review and approval. There are two recognized methods for protocol review: Full Committee Review (FCR) and Designated Member Review (DMR), as outlined in the PHS Policy IV.C.2..

Full Committee Review (FCR): FCR requires a convened meeting of the IACUC with a quorum, which is a simple majority of the members. Decisions on protocol approval, modifications, or withholding approval are made by a majority vote of the quorum present. If significant modifications are required for protocol approval, the revised protocol must undergo either FCR or DMR for final approval. FCR is particularly important for protocols that raise significant ethical or animal welfare concerns, or when there is substantial disagreement among committee members.

Designated Member Review (DMR): DMR offers a more streamlined review process for protocols that are considered less complex or pose minimal risk. Before DMR can be initiated, all IACUC members must be provided with a list of protocols slated for review and given the opportunity to request FCR if they deem it necessary. If no FCR is requested, the Chair designates at least one qualified IACUC member to conduct the review. DMR can result in protocol approval, required modifications (followed by approval), or a request for FCR. Importantly, DMR cannot result in protocol disapproval; protocols that cannot be approved through DMR must be forwarded to the full committee for FCR.

OLAW has formally recognized an alternative practice for protocol review following FCR, detailed in NOT-OD-09-035 (Guidance to IACUCs Regarding the Use of DMR for Animal Study Proposal Review Subsequent to FCR). The USDA also concurs with this alternative approach.

In addition to protocol-specific reviews, IACUCs can also approve institutional policies, such as guidance documents, standard operating procedures (SOPs), and drug formularies, to standardize and guide animal activities. These policies must be reviewed by the IACUC at least every three years to ensure they remain current, accurate, and effective.

The PHS Policy IV.C.1 details the IACUC’s responsibilities in reviewing and approving significant changes to animal activities. The IACUC has the authority to define what it considers a “significant change” or establish a process for determining significance on a case-by-case basis, as per PHS Policy IV.C.1.a.-g. Clear communication of the IACUC’s policy on significant changes to investigators is crucial. NIH Guide Notice NOT-OD-14-126 and the Significant Changes webpage provide further guidance on this topic.

To maintain objectivity and prevent conflicts of interest, the PHS Policy and AWARs prohibit IACUC members from participating in the review or approval of activities in which they have a conflicting interest, except to provide information requested by the IACUC. Recused or excluded members cannot be counted towards the quorum required for IACUC business (Lab Animal 2010: 39(6) (PDF)).

The PHS Policy also endorses the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training” (U.S. Government Principles). The IACUC is expected to consider these principles during protocol review. Protocols must adhere to the institution’s Animal Welfare Assurance and meet the specific requirements outlined in PHS Policy section IV.C.1.a.-g..

The Guide (pp. 25-26) outlines specific topics that Principal Investigators (PIs) should address when preparing protocols and that the IACUC should consider during review. Furthermore, the Guide (pp. 27-33) identifies certain types of protocols that necessitate special consideration during IACUC review due to a higher potential for animal welfare concerns.

Post-approval Monitoring

Ongoing monitoring of animal care and use is a fundamental requirement of the PHS Policy. This post-approval monitoring ensures that animal activities continue to comply with approved protocols, regulations, and ethical guidelines throughout the duration of the research project. The Guide (p. 33) describes various methods for continuing review, including:

Continuing Protocol Review: This can involve annual updates from investigators, providing an opportunity to submit proposed amendments, report adverse or unanticipated events, and update on research progress.
Laboratory Inspections: These inspections can be integrated into regular facility inspections or conducted separately, focusing on specific laboratories or research areas to observe animal handling, experimental procedures, and adherence to protocols.
Veterinary or IACUC Observation: Direct observation of selected procedures by veterinary or IACUC staff or members provides real-time assessment of animal welfare and protocol compliance during experimental manipulations.
Animal Care Staff Observation: Animal care, veterinary, and IACUC staff and members are all expected to be vigilant in observing animals daily for any signs of distress, illness, or deviations from expected behavior, and to report any concerns.
External Regulatory Inspections and Assessments: Institutions are also subject to external inspections by regulatory bodies, such as USDA and AAALAC International, which provide an additional layer of oversight and accountability.

The PHS Policy sets a maximum interval of 3 years between complete IACUC reviews and approvals. A full review, encompassing all criteria in Policy IV.C.1.a.-g., is required at least every three years. Animal work cannot be administratively extended beyond this 3-year expiration date, emphasizing the importance of regular and thorough re-evaluation.

Addressing Animal Welfare Concerns

Establishing clear and effective mechanisms for reporting and addressing animal welfare concerns is a critical responsibility for institutions and IACUCs. As the Guide emphasizes, “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, p. 23).

The IACUC is mandated to evaluate all concerns related to animal care and use, regardless of the source. Concerns may be raised by institutional staff, employees, community members, or even IACUC members themselves. Proactive IACUCs develop clear guidelines and procedures for handling allegations of mistreatment or noncompliance before such allegations arise. These guidelines should outline the steps for reporting concerns, the process for investigation, and the procedures for implementing corrective actions.

IACUCs must also be aware of whistleblower protections under the Animal Welfare Act (AWA). The AWA prohibits discrimination or reprisal against individuals who report violations of regulations or standards under the AWA, encouraging open and honest reporting of animal welfare concerns without fear of retaliation.

Suspension of Animal Activities

The IACUC holds significant enforcement power: the authority to suspend an animal activity if it finds noncompliance with the PHS Policy, Guide, Animal Welfare Assurance, or violations of the Animal Welfare Regulations. This power is reserved for serious situations where animal welfare is demonstrably at risk or when there is significant noncompliance with regulations.

Suspension can only occur after a formal review of the matter at a convened meeting of the IACUC with a quorum present. A majority vote of the quorum is required to suspend an activity. Following a suspension vote, the IACUC must consult with the Institutional Official (IO) to discuss the reasons for the suspension and the necessary corrective actions. The IO is ultimately responsible for taking appropriate corrective action and is required to report the suspension and the circumstances surrounding it to OLAW.

Because IACUC-initiated suspension of a project is a serious event with significant implications, it must be reported to OLAW promptly. Further information on reporting noncompliance, including suspensions, can be found on the Reporting Noncompliance webpage.