Membership

The membership of the IACUC includes:

• at least five members;
• one veterinarian with training or experience in laboratory animal science and medicine, who has direct or delegated authority and responsibility for activities involving animals at the institution;
• one practicing scientist experienced in research with animals;
• one member whose primary concerns are in a nonscientific area (e.g., ethicist, lawyer, member of the clergy); and
• one member who is not affiliated with the institution other than as a member of the IACUC.

The USDA Animal Welfare Regulations intend that the individual not affiliated with the facility provide representation for general community interests in the proper care and treatment of animals. The 1996 Guide further specifies that the nonaffiliated member should not be a laboratory animal user.

Semiannual Program Reviews and Facility Inspections

The IACUC monitors the animal care and use program by conducting thorough reviews of the program and inspections of the animal facilities. These program review and facility inspections must occur at six-month intervals, or semiannually. The standards in the Guide are used by the IACUC as the basis for conducting its evaluations and inspections.

The program review encompasses institutional policies and responsibilities (lines of authority and reporting channels), IACUC membership and functions, and IACUC record keeping and reporting procedures. It should also include a review of the adequacy and appropriateness of the veterinary medical care program, the training program for personnel, and the occupational health and safety program.

The facility review is 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. The Animal Welfare Regulations apply to animal study areas where animals are maintained for more than 12 hours (applicable only to species covered by the Regulations).

The IACUC submits documentation of its program evaluation and facility inspections, including any recommendations, in semiannual reports to the Institutional Official. These reports describe 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 Program and Facility Review Checklist is available to assist IACUCs in performing this task. OLAW encourages institutions to make use of this checklist or to develop one of their own.

Note that the semiannual IACUC reports to the Institutional Official 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 the Guide or PHS Policy are identified, they should be reported to OLAW promptly. The next section - Reports and Record Keeping - describes PHS Policy reporting requirements in greater detail.

Protocol Review

The IACUC oversees the specific use of animals by formally reviewing protocols, either at a convened meeting of a quorum (simple majority), or through the use of designated reviewers.

The use of designated reviewer(s) may occur only after the entire IACUC is provided with a list of the protocols to be reviewed, and each member provided an opportunity to call for full committee review of any protocol. If full committee review is not requested, at least one member of the IACUC, designated by the chair and qualified to conduct the review, may review the protocol and have the authority to approve, require modifications, or request full committee review.

The criteria that the IACUC considers in its review of protocols are delineated at IV.C.1.a.-g. of the PHS Policy. These criteria must be applied initially, i.e., before an animal activity begins, and at appropriate intervals, but at least once every three years.

Significant changes to a protocol after it has been approved require further review by the IACUC. It is useful for IACUCs to develop guidelines for investigators in order to eliminate potential ambiguity about what constitutes a significant change. Examples of the kinds of changes that are generally considered significant are changes:

• in the objectives of a study;
• from nonsurvival to survival surgery;
• in the invasiveness of a procedure or discomfort to an animal;
• in species or in the approximate number of animals used;
• in the Principal Investigator;
• in anesthetic agent(s), or the use or withholding of analgesics (not intended to limit the clinical judgment of the veterinarian in treating individual animals); or
• in the method of euthanasia.

Addressing Animal Welfare Concerns

The IACUC has a mandate to evaluate concerns regarding the care and use of animals at the institution. 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 whistle blowers under the AWA, which prohibits discrimination against or reprisal for reporting violations of regulations or standards under the AWA.

Suspension of Animal Activities

The IACUC is empowered to suspend a project if it finds violations of the PHS Policy, Guide, Assurance, or 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 Institutional Official regarding the reasons for the suspension. The Institutional Official 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.

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