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The IACUC is responsible for oversight of the animal care and use program and its components as described in the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and the Guide for the Care and Use of Laboratory Animals (Guide). Its oversight functions include an ongoing assessment of animal care and use. IACUC responsibilities include:
The IACUC membership must consist of at least 5 members and includes:
“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 IACUC monitors the animal care and use program by conducting thorough reviews of the program and inspections of the animal facilities. All PHS funded programs must conduct program reviews and facility inspections at least every 6 months. The standards in the Guideare used by the IACUC as the basis for conducting its reviews.
Facility reviews are a physical inspection of all buildings, rooms, areas, enclosures and vehicles (including satellite facilities in which animals are housed for more than 24 hours) that are used for animal confinement, transport, maintenance, breeding, or experiments inclusive of surgical manipulation. No member wishing to participate in an evaluation may be excluded from participating. The Animal Welfare Act and Regulations (AWAR) require animal study areas where regulated species are maintained for more than 12 hours to be included in the semiannual facility inspections.A Sample Semiannual Program and Facility Review Checklist is available to assist IACUC's in performing this task. OLAW encourages institutions to use or modify the document to suit the institution's needs. The last page of the checklist provides a summary page for noting and tracking deficiencies.
After review and inspection, a written report (including any minority views) is compiled and provided to the IO about the status of the program including any recommendations. The report will include a description of the nature and extent of the Institution's adherence to the Guide, any departures from the Guide, identified specifically with reasons for each departure stated. The report will note any program or facility deficiencies, distinguish significant deficiencies from minor deficiencies, and include plans and schedules for correcting each deficiency. A significant deficiency is defined as one that is or may be a threat to animal health or safety.
A sample semiannual report to the IO is available to assist IACUCs in preparing this report.Note, semiannual reports to the IO should only be submitted to OLAW if requested, or if the institution is submitting a new or renewal Animal Welfare Assurance to OLAW and is not accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International). However, if serious or continuing deviations from PHS Policy are identified, they should be reported to OLAW promptly. The next section - Reports and Recordkeeping - describes PHS Policy reporting requirements in greater detail.
The IACUC oversees the specific use of animals by formally reviewing animal use protocols and granting approval prior to the work commencing. The 2 valid methods of protocol review are either full committee review (FCR) or designated member review (DMR). (PHS Policy IV.C.2.)
FCR may only be conducted at a convened meeting with a quorum (simple majority) of members present. A majority vote of the quorum present is needed to approve, require modifications in (to secure approval), or withhold approval of a protocol. When substantive modifications are required in a protocol to secure approval, the resubmitted protocol must be reviewed using either FCR or DMR.
DMR may occur only after all IACUC members have been provided with a list of the protocols to be reviewed and have an opportunity to call for FCR. If FCR is not requested, at least one member of the IACUC qualified to conduct the review is designated by the Chair. DMR may result in approval, require modifications in (to secure approval), or request FCR. DMR may not result in disapproval.
OLAW formally recognized an alternative practice for protocol review subsequent to FCR in NOT-OD-09-035 (Guidance to IACUCs Regarding the Use of DMR for Animal Study Proposal Review Subsequent to FCR). USDA concurs with this alternative practice.
IACUC approval of proposed animal activities or significant changes to previously approved animal activities is granted after FCR or DMR. Additionally, institutions may establish and IACUCs may approve policies (e.g., guidance documents, standard operating procedures, drug formularies) for the conduct of animal activities. These policies must be reviewed by the IACUC at appropriate intervals of no less that once every 3 years to ensure they are appropriate and accurate.
The responsibilities of the IACUC regarding review and approval of proposed significant changes to animal activities can be found in the PHS Policy IV.C.1 . The IACUC has some discretion to define what it considers a significant change, or to establish a mechanism for determining significant on a case-by-case basis according to PHS Policy IV.C.1.a.-g. It is the IACUC's responsibility to clearly define and communicate its policy for determining significance to investigators. To learn more about what is considered a significant change to an animal activity that requires IACUC review, see NIH Guide Notice NOT-OD-14-126 or Significant Changes webpage.
The PHS Policyand the AWARs state that no IACUC member may participate in the IACUC review or approval of an activity in which that member has a conflicting interest (e.g., is personally involved in the activity) except to provide information requested by the IACUC. Neither recused nor excluded members may contribute to the quorum necessary to conduct IACUC business. (Lab Animal 2010: 39(6)) (PDF)
The PHS Policy 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 include consideration of the U.S. Government Principles in its review of protocols. Protocols must conform to the institution's Assurance and meet PHS Policy requirements in section IV.C.1.a.-g.
The Guide (pp. 25-26) describes specific topic areas that should be considered in the preparation of a protocol by the PI and in the review by the IACUC.The Guide (pp. 27-33) describes certain protocols that include procedures or approaches that require special consideration during the IACUC review process due to the potential for animal welfare concerns.
Monitoring of animal care and use is required by the PHS Policy. The Guide (p. 33) describes methods for continuing review to include “continuing protocol review; laboratory inspections (conducted either during regular facilities inspections or separately); veterinary or IACUC observation of selected procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments.”Continuing protocol review may consist of an annual update. “Some institutions use the annual review as an opportunity for the investigator to submit proposed amendments for future procedures, to provide a description of any adverse or unanticipated events, and to provide updates on work progress.” (Guide, p. 34) The PHS Policy determines the maximum interval between IACUC review and approval as 3 years, i.e., a complete de novo review is required at least every 3 years. The review must encompass all of the criteria in the Policy at IV.C.1.a.-g. Animal work may not be administratively extended beyond the 3-year expiration date.
“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 has a mandate to evaluate concerns regarding the care and use of animals. Concerns may be raised by staff or employees of the institution, individuals in the community, or even members of the IACUC. It is a good idea for the IACUC to develop guidelines or procedures for handling allegations of mistreatment or noncompliance before such allegations are raised. The IACUC should also be cognizant of the rights of whistleblowers under the AWA, which prohibits discrimination against or reprisal for reporting violations of regulations or standards under the AWA.
The IACUC is empowered to suspend a project if it finds noncompliance with the PHS Policy, Guide, Assurance, or violations of the Animal Welfare Regulations. Suspension may occur only after review of the matter at a convened meeting of a quorum of the IACUC, and with the suspension vote of a majority of the quorum present. Further, the IACUC must consult with the IO regarding the reasons for the suspension. The IO is required to take appropriate corrective action and report the action and the circumstances surrounding the suspension to OLAW. Because an IACUC action to suspend a project is a serious matter, the action must be reported to OLAW promptly. Additional information can be found on the Reporting Noncompliance webpage.Go to Next Section: Reports and Records