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experimental animal

Institutional Animal Care and Use Committee

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.

Every institution that uses animals for federally funded laboratory research must have an Institutional Animal Care and Use Committee (IACUC). The IACUC must consist of at least one veterinarian with training in laboratory animal science and expertise in the species under consideration, at least one practicing research scientist, and at least one person not affiliated with the institution to represent community interests in proper care and use of animals. The institution typically appoints the non-affiliated member of the IACUC, much the same as it appoints the affiliated members. 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 . Institutional Animal Care and Use Committees must have a way to correct problems in animal care including fair treatment of whistleblowers.

History of IACUCs

Amendments were added to the United States Animal Welfare Act in 1970. It became law that, "Enclosures shall be constructed and maintained so as to provide sufficient space to allow each animal to make normal postural and social adjustments with adequate freedom of movement. Inadequate space may be indicated by evidence of malnutrition, poor condition, debility, stress, or abnormal behavior patterns." An indication of the state of conventional thinking at that time is illustrated by the fact that officials of the United States Department of Agriculture resisted the idea that dogs used in laboratory research should be given daily walks.

In the early 1970s, two options were available for institutions making use of warm-blooded animals for laboratory research. One way for such institutions to comply with United States animal welfare laws was to be accredited by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC). The second option was to have a local institutional animal care committee that would include a veterinarian and take responsibility for making sure that the institution conformed to all government mandated animal care rules.

In 1973 the United States Public Health Service specified that local animal care committees needed to have a minimum of three members. Institutions that did not use large numbers of animals were not required to have a veterinarian on the committee as long as a member of the committee had the training and experience in animal care that was required to care for the animals being used in that institution's research. In order to obtain government research funding, animal care committees were required to make reports documenting facilities and animal care practices.

In 1979 all institutions seeking government funding for research involving animals were required to have an institutional animal use committee, even if the institution was AAALAC-accredited. Institutions were advised to establish a research protocol review process by which the institutional animal use committee would review individual research proposals in order to confirm that proposed research would be conducted according to government-established animal care guidelines. In order to obtain government funding, institutions needed to certify that they had an animal use committee that was working to keep the institution in compliance with government-mandated animal care guidelines. Each grant application submitted to federal funding agencies had to include an explicit description of how laboratory animal use would be conducted so as to comply with animal welfare laws and guidelines.

Shortly after founding PETA, Alex Pacheco worked as a volunteer at the Institute for Biological Research in Silver Spring, Maryland. He reported violations of the Animal Welfare Act and police seized monkeys from the Institute for Biological Research. Resulting legal cases, in what became known as the Silver Spring monkeys case, eventually reached the United States Supreme Court, generating large amounts of publicity. The United States House of Representatives Subcommittee on Science, Research and Technology held hearings that eventually resulted in major changes to animal welfare laws in 1985. In 1986, newly mandated changes in United States Public Health Service policy and guidelines for animals used in research included a requirement that each institution seeking federal funding have an Institutional Animal Care and Use Committee that would make sure that animal care conformed to the Animal Welfare Act.

The National Research Council of the U.S. National Academy of Sciences provides a Guide for the Care and Use of Laboratory Animals and follows the Government principles for the utilization and care of vertebrate animals used in testing, research, and training. These documents guide the actions of local Institutional Animal Care and Use Committees. Inspections of institutions that use animals in research are conducted by the United States Department of Agriculture. Compliance of institutions with the Animal Welfare Act is measured by the results of unannounced inspections by the Animal and Plant Health Inspection Service. The results of these inspections are made available to the public through the Freedom of Information Act.

Reliability of IACUCs

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). …

… [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…

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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.

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."

References

  1. Online resources of the NIH Office of Laboratory Animal Welfare. tutorial
  2. Animal Welfare Act
  3. Historical review of animal care regulation, USDA Perspective on Environmental Enrichment for Animals by Jodie A. Kulpa-Eddy, Sylvia Taylor and Kristina M. Adams in ILAR Journal (2005) Volume 46(2).
  4. Website of the Association for Assessment and Accreditation of Laboratory Animal Care
  5. Guide for the Care and Use of Laboratory Animals
  6. Government principles for the utilization and care of vertebrate animals used in testing, research, and training
  7. Online USDA inspection reports
  8. USDA Inspector General Audit Report of APHIS Animal Care Program Inspection and Enforcement Activities, Report No. 33002-3-SF, September 2005

Further reading

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