Institutional Animal Care and Use Committee - Reliability

Reliability

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:

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). … … 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 invalid 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 non-blinded and blinded IACUC ratings took the form of requests for more information.

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 document described failure of some 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."