Institutional Animal Care and Use Committees are of central importance to the application of laws to animal research in the United States. Most research involving laboratory animals is funded by the United States National Institutes of Health or other federal agencies. The NIH Office of Laboratory Animal Welfare has been directed by law to develop policies that describe the role of Institutional Animal Care and Use Committees.[1]
Every institution that uses animals for federally funded laboratory research must have an Institutional Animal Care and Use Committee (IACUC). Each local IACUC reviews research protocols and conducts evaluations of the institution's animal care and use which includes the results of inspections of facilities that are required by law.[2]
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The history of IACUCs evolved from the history of regulation of animal welfare in the USA. Prior to 1963, regulation was conducted solely by investigators, and research laboratories had inconsistent animal care policies and standards of care. A group of veterinarians formed the Animal Care Panel and began work in 1961, and in 1963 they published the first edition of "The Guide for the Care and Use of Laboratory Animals", referred to hereafter as the Guide. Subsequent editions of the Guide were supported by NIH and published by the Institute of Laboratory Animal Research branch of the National Academy of Science. Currently, the Guide is in its eighth edition.[1]
An accreditation committee was formed in 1963, and it was independently incorporated from the ACP. Its name was AAALAC, the American Association for the Accreditation of Laboratory Animal Care. In 1996 this committee changed its name to the "Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC)"
A series of reports on poor animal welfare in the USA led to a major article in Life magazine in 1966. Thus catalyzed, Congress created the Animal Welfare Act (1966), which named the USDA the responsible agency. It inspected animal use facilities, but did not inspect or regulate individual laboratories.
In 1971, the Animal Welfare Act was revised, and compliance by institutions could be achieved through an animal care committee, or via AAALAC accreditation. Compliance required adhering to the Guide, the Animal Welfare Act, and an additional set of "Principles for the Use of Laboratory Animals". In 1979, PHS policy took over and required an animal care committee for each animal-using grantee institution, and expanded the species covered to include all vertebrates. The animal care committee had to include five members with expertise to regulate animal welfare at that institution, one of which must be a veterinarian.
The term IACUC was formally introduced in 1986 with an amendment to the Animal Welfare Act and corresponding changes in PHS policy. Although much of the animal welfare law comes from the Animal Welfare Act which is enforced by the USDA, the full set of regulations over IACUCs comes from PHS Policy. Inspections of animal use facilities needed to done twice per year. The modern composition of IACUCs was established.[2]
The IACUC must consist of at least 5 members appointed by the institution. The appointed members must be qualified to regulate animal care at that institution. The IACUC must include a veterinarian with expertise in the species used at the institution. Another member must be a practicing scientist experienced in animal research. Another must have primary concerns that are in nonscientific areas. Another must have no relation with the institution except for serving on the IACUC. One member can fulfill more than one prerequisite, but the committee must still consist of at least 5 members.[3]
Each local IACUC reviews research protocols and conducts evaluations of the institution's animal care. The evaluations include inspections of all animal use facilities every six months.[3] The IACUC reports to the NIH Office of Laboratory Animal Welfare (OLAW) annually, and is issued an animal welfare assurance number by OLAW without which no federallly funded use of animals in research may occur. The IACUC is required to report significant noncompliance with animal use protocols to OLAW, as well as IACUC actions taken to correct the noncompliance.[4]
Each animal use protocol (AUP) must be reviewed by full IACUC committee each three years or more often. The protocol must cover at least these points:
In review, the IACUC is required to ensure that the proposed work falls within the OLAW Animal Welfare Assurance, and that the following points are covered:
Institutional Animal Care and Use Committees must have a way to correct problems in animal care including fair treatment of whistleblowers who report animal welfare violations on USDA species.[6]
The actions of the IACUCs are subject to inspection by multiple agencies. PHS staff and advisors may inspect any PHS awardee at any time to verify adherence to PHS policy.[7] The APHIS branch of the USDA conducts surprise inspections of institutions that use species covered by the Animal Welfare Act up to every six months. These inspections verify compliance with the Animal Welfare Act, which is a subset of the PHS policies governing IACUCs.[8] AAALAC inspects facilities for accreditation at least every three years. Accreditation also requires an annual report to AAALAC.[9]
The central importance of Institutional Animal Care and Use Committees means that animal care and use is fundamentally dependent on the application of the Guide for the Care and Use of Laboratory Animals regulations by an institution’s committee. It has been suggested that one measure of the success of the IACUC system is the reliability of protocol approvals between institutions. In other words, would a protocol for animal use, approved by the IACUC at one institution, be approved at another institution? This question was addressed specifically by researchers Plous and Herzog in 2001:[10]
Over the past 20 years, the reliability of scientific peer-review judgments has been a topic of frequent debate and scrutiny. However, one area of peer review that has not received much empirical investigation is the system that protects animal subjects from research risks. At most research institutions, studies involving animal subjects must be approved by an Institutional Animal Care and Use Committee (IACUC). … … [W]e conducted a study of randomly selected IACUCs from U.S. universities and colleges. Seventy committees were drawn from a master list of 916 IACUCs maintained by the U.S. Office for Protection from Research Risks. Of these 70, 50 agreed to participate in the study…. In all, 494 of 566 voting members (151 females and 343 males), or 87% of those approached, took part in the study.
Each IACUC was asked to submit its three most recently reviewed protocols involving animal behavior, including the committee's decision on whether to approve the research in question. All information identifying the investigator or institution was then removed from the protocols, and each protocol was randomly assigned to be reviewed a second time by another participating IACUC. Voting members of the second committee were sent packets containing three masked protocols with a request to review the protocols and to send us a completed evaluation anonymously in a prepaid envelope.
Once we received reviews from individual committee members, the IACUCs were asked to meet as a group and render a final evaluation for each of the three protocols. Committees were asked to follow their standard operating procedures and to discuss the protocols as they would any other research proposal.
Protocol evaluations from the originating committee and from the second committee were not significantly related to one another…. This absence of a relation was found not only across the full set of 150 protocols, but for relatively invasive research involving procedures such as electric shock, food or water deprivation, surgery, and drug or alcohol research…; for protocols involving euthanasia …; and for protocols in which the reviewing IACUC expected animals to experience a significant amount of pain…. Thus, regardless of whether the research involved terminal or painful procedures, IACUC protocol reviews did not exceed chance levels of intercommittee agreement…
The Plous and Herzog work was criticized by some in the animal research community as drawing false conclusions because IACUCs rely on knowing the experience of the investigators and staff. The Plous and Herzog study compared responses of in-house IACUCs, who knew the investigators and staff, with blinded IACUCs, who did not know the investigators and staff. The blinded IACUCs did not necessarily have expertise in the species or procedures under consideration, or with the forms used to submit the protocol, and most of the lack of agreement between the two IACUC ratings were requests for more information.[11]
A September 2005 Audit Report issued by the Office of Inspector General for the United States Department of Agriculture also spelled out problems with the reliability of IACUC oversight. The Audit Report goes on at length regarding the failure of IACUCs to effectively review protocols and ensure compliance with federal Animal Welfare laws:
"Some IACUCs are not effectively monitoring animal care activities, protocols, or alternative research methods. This situation exists because (1) the IACUCs are only required to conduct facility reviews on a semiannual basis, (2) IACUCs experience a high turnover rate, and (3) some members are not properly trained. In very few cases, the facilities are resistant to change, showing a general disregard for APHIS regulations. As a result, the facilities are not conducting research in compliance with the AWA or, in some cases, not providing humane conditions for research animals."[4]