2nd Edition 2002 arena/olaw institutional Animal Care and Use Committee Guidebook

A.1. Timeline, Background and History

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A.1. Timeline, Background and History


1950 Formal establishment of Animal Care Panel.

1963 First edition of the Guide for the Care and Use of Laboratory Animals (Guide) developed by the Animal Care Panel.
1965 Incorporation of the American Association for the Accreditation of Laboratory Animal Care (AAALAC).
1966 Congress passed the Laboratory Animal Welfare Act (PL 89-544) and the USDA was named the responsible agency.

  1. Animal Care Panel changed its name to the American Association

for Laboratory Animal Science (AALAS).

  1. NIH Policy on Humane Care and Use of Laboratory Animals for PHS Supported Institutions.

1971 USDA promulgated standards known as Subpart F, Stolen Animals (AWA).

  1. First Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals.

1974 Public Responsibility in Medicine and Research (PRIM&R) established.

  1. PHS Policy required each animal-using grantee institution to have a PHS Assurance and a committee to maintain oversight of its animal care program.

1979 USDA promulgated standards known as Subpart E, Identification of Animals (AWA).

  1. First PRIM&R Animal Care and Use meeting.

1985 U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training promulgated.

    1. Health Research Extension Act (P.L.99-158) passed by Congress.

1985 Animal Welfare Act Amendments passed by Congress.

1986 Applied Research Ethics National Association (ARENA) established.
1986 PHS Policy revised.
1989 USDA promulgated regulations (known as Parts 1 and 2) implement-ing the 1985 AWA amendments.

  1. The structure of the Office for Protection from Research Risks (OPRR) was changed to establish a Division of Animal Welfare.

1990 USDA promulgated standards known as Subpart B, Registration and Subpart C, Research Facilities (AWA).

1991 USDA promulgated standards known as Part 3. In addition, amend-ments were made to Part 2: Regulations in Subpart A, Licensing and Subpart D, Attending Veterinarian and Adequate Veterinary Care. (AWA).

  1. First Institutional Animal Care and Use Committee Guidebook was developed by a committee under the auspices of the Applied Research Ethics National Association (ARENA) and OPRR.

  1. 7th Edition of the Guide for the Care and Use of Laboratory Animals revised by an ILAR committee and published by the NRC.

1996 AAALAC became the Association for the Assessment and Accredita-tion of Laboratory Animal Care International.

  1. OPRR Division of Animal Welfare was separated from OPRR and became the Office of Laboratory Animal Welfare (OLAW), NIH.

2002 ARENA/OLAW Institutional Animal Care and Use Committee Guide-book. Second edition.

Background and History
Prior to the middle of the 20th century the responsibility for animals used in research in the United States was placed directly in the hands of the researchers and the quality of animal care and animal welfare varied tremendously among research institutions. Even within the same school or institution, research laboratories had inconsistent animal care policies and standards of care.
In 1961, a group of veterinarians working for research institutions in the Chicago area formed the Animal Care Panel (ACP). The ACP appointed a committee charged with establishing animal care and use guidelines for research facilities. Their product was the publication of the first edition (1963) of the Guide for the Care and Use of Laboratory Animals (referred to in this document as the Guide). Subsequent editions of this publication were supported by the NIH and developed under the auspices of the Institute of Laboratory Animal Resources (ILAR), which was subsequently renamed the Institute for Laboratory Animal Research. The National Academy Press, under the auspices of the National Research Council, published the most recent (seventh) edition in 1996. This single document serves as the primary source of laboratory animal care and use standards and guidelines in the United States. The 1996 edition has been translated and published in six languages, and over 400,000 copies have been distributed throughout the world.
In 1963, the ACP saw a need to evaluate the standards of animal care and use practiced in research institutions based on the Guide, and appointed an Animal Accreditation Committee. This Committee soon determined that it should function independently of the ACP, and in 1965 incorporated in the state of Illinois as the American Association for the Accreditation of Laboratory Animal Care. This independent accrediting agency changed its name in 1996 to the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).
Prior to 1966, no U.S. federal law addressed laboratory animal welfare. Local humane societies actively promoted responsible treatment of pets and farm animals. Concurrently, the scientific community was improving the quality of animal care and well-being in the research laboratory. During this time the increasing need for dogs and cats in research was partially fulfilled by animal dealers who obtained these animals in various ways and sold them to research laboratories. A series of articles and news reports

on animal neglect, abuse and pet theft by animal dealers culminated in a 1966 major article and photographs in Life magazine. The article suggested a need for regulation and a system of enforcement, especially for dogs and cats used in research. Catalyzed in part by this article, the Laboratory Animal Welfare Act, the first version of what is now known as the Animal Welfare Act (AWA), was passed by Congress in 1966 (Public Law 89-544) establishing legal standards for laboratory animal care and use for the first time in this country. The United States Department of Agriculture (USDA) was named the responsible agency for implementing and enforcing this new law and it promptly began promulgating regulations. Research laboratories and dealers were required to register or license their facilities and undergo inspection by USDA personnel who were authorized to issue citations for non-compliance. These early inspections did not extend into the research laboratory where animal care and use remained under the direction of the research investigator. A number of amendments to the Animal Welfare Act have led to regulations that now include animal transportation, marine mammals, and animals in the research laboratory. However, the USDA regulations currently exclude common laboratory rats (Rattus norvegicus) and mice (Mus musculus), birds, and farm animals used in production agriculture research.

All Public Health Service (PHS) policies on this subject evolved from the 1971 National Institutes of Health (NIH) Policy, “Care and Treatment of Laboratory Animals.” That policy referenced several NIH and PHS state-ments on appropriate care and humane treatment of laboratory animals, among them the Guide. It introduced the animal care committee as a means of local assurance of good animal care and use.
The 1971 NIH Policy required institutions or organizations using warm-blooded animals in research or teaching supported by NIH grants, awards or contracts to "assure the NIH that they will evaluate their animal facilities in regard to the maintenance of acceptable standards for the care, use and treatment of such animals." The institution could show that it was either accredited by a recognized professional laboratory animal accrediting body (AAALAC) or had established an animal care committee to carry out that assurance function. The minimum number of committee members was not stated, but at least one member had to be a Doctor of Veterinary Medicine. Guidelines for the committee included the Guide, all applicable portions of the AWA, and an appended set of Guidelines known as the "Principles for the Use of Laboratory Animals." The committee was

required to inspect the institution’s animal facilities at least once a year and report its findings and recommendations to responsible institutional officials. Records of activities and recommendations were required to be available for inspection by NIH representatives.

The first PHS Policy regarding animal care and use replaced the NIH policy on July 1, 1973 and continued to accept AAALAC accreditation in lieu of an institutional committee. The January 1, 1979 revision of the PHS policy required each animal-using grantee institution to have "a committee to maintain oversight of its animal care program” and expanded the definition of animal to include all vertebrates. The revised policy also required an institution to submit an Assurance statement to the Office for Protection from Research Risks (OPRR), now the Office of Laboratory Animal Welfare (OLAW), that it is committed to follow the Guide, the Principles and the PHS policy requirements, before receiving PHS support for studies in which animals or animal facilities were used.
Institutions were required to include in their Assurance a list of committee members with their position titles and credentials. Committees were composed of at least five members including at least one veterinarian. The members had to be knowledgeable regarding the care and use of animals used in research.
The 1979 PHS policy continued to accept AAALAC accreditation as a means of demonstrating conformance with the Guide, but an alternative was annual review of the animal facilities and procedures by the institution's IACUC. Institutions were required to report to NIH (OPRR) any nonconformance with the Guide or problems encountered in implementing the PHS policy, and submit annual reports indicating progress toward full conformance. Review of individual proposals or projects by the IACUC was encouraged but not required.
The most recent revision, officially the PHS Policy on Humane Care and Use of Laboratory Animals, (referred to in this document as the PHS Policy), was promulgated in 1986 and reprinted in 1996 and 2000. It further defined and outlined requirements of an animal care and use program. This revised PHS Policy includes provisions of the Health Research Extension Act of 1985, enacted on November 20, 1985 as Public Law 99-158. The 1986 PHS Policy applies to both extramural and intramural PHS research and requires the Institutional Animal Care and Use Committee (IACUC) members to be appointed by the Chief Executive Officer of the institution. The IACUC must evaluate and prepare reports on

all of the institution's programs and facilities (including satellite facilities) for activities involving animals at least twice each year, and is required to review the care and use of animals in PHS-supported activities. The IACUC, through the Institutional Official (IO), is responsible for compliance with reporting requirements. Minority views filed by members of the IACUC must be included in reports filed under this PHS Policy. The PHS Policy also requires training or instruction for scientists, animal technicians and other personnel involved in animal care, treatment or use. This training or instruction must include information on the humane practice of animal care and use as well as training or instruction in research or testing methods that minimize the number of animals required to obtain valid results and minimize animal distress.

The Interagency Research Animal Committee, made up of representatives of federal agencies that use or require the use of experimental animals, promulgated the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training” in 1985 (see Appendix F). These Principles were subsequently incorporated into the 1986 PHS Policy, and remain in effect today as a model for federal agencies that develop specific agency policies for the use of animals.
With the promulgation of the 1986 version of the PHS Policy, OPRR (now OLAW) embarked upon an extensive national education program. The program began with the co-sponsorship of one- to two-day workshops in conjunction with Assured institutions at different geographical locations. Many of the early workshops focused on basic provisions set forth in the 1986 PHS Policy, such as protocol review and semiannual program evalu-ations. That cosponsorship of approximately four to five workshops a year continues today, although the topics are now generally more specialized, covering areas such as performance standards, field studies, and laboratory animal management and technology. Since 1995 OLAW has expanded its educational role to include development of a Web-based tutorial, an extensive Web site with sample documents to assist institutions in their implementation of the PHS Policy, co-sponsorship of ARENA’s IACUC 101 program, and this revised ARENA/OLAW Guidebook.
Special interest groups concerned about the acquisition and welfare of animals used in research continue to influence research animal care and use. These groups include local and national humane societies concerned about animal welfare and well-being, and antivivisectionist groups that are opposed to the use of animals in research. The activity of some animal rights groups escalated and became more vocal in the early 1980s. This activity peaked in a series of illegal break-ins and vandalism and was brought to the forefront of public opinion soon after two incidents involving alleged "animal cruelty" and "insensitivity" in two well-known research institutions. This climate raised public concern and visibility of animals in research and served as a catalyst for amendments and clarifications of guidelines and regulations providing for animal welfare.
New USDA regulations based on the 1985 amendment to the AWA became effective between October 1989 and August 1991. These regula-tions require each registered research institution to appoint an IACUC of not less than three members, including a veterinarian, which "serves as the agent of the research facility that assures that the facility is in full com-pliance with the Act." The regulations also require a member not affiliated with the institution representing community interests in the proper care and treatment of animals. These USDA Animal Welfare Regulations (AWRs) and the PHS Policy contain many common requirements.
The Scientists Center for Animal Welfare (SCAW) was instrumental in pro-viding early guidance to institutions on IACUC functions and organization through regional conferences and workshops, culminating in a special 1987 American Association for Laboratory Animal Science (AALAS) publication entitled, "Effective Animal Care and Use Committees". Since 1983, training and guidance of this type has also been provided through annual animal care and use conferences sponsored by Public Responsibility in Medicine and Research (PRIM&R) and the Applied Research Ethics National Association (ARENA), regional workshops supported by OLAW, and numerous similar activities. The first Institutional Animal Care and Use Committee Guidebook was written by a committee of experts under the auspices of ARENA and published by NIH in 1992. The present edition, published in 2002, is the first revision.
During the 1990s there was an evolution in the ways that IACUCs fulfilled their mandate. This was in part due to increased experience implementing the PHS Policy and AWRs, but may also be attributed to new reports, such as the 1996 Guide which emphasizes performance goals as opposed to engineering standards, and the 1997 ILAR report, Occupational Health and Safety in the Care and Use of Research Animals, that shifted the focus of occupational health programs to risk based systems. Other factors contributing to this evolution came from the research community, such as the development of transgenic animals and in vitro alternatives to the

production of monoclonal antibodies. The IACUC community has also gained a greater understanding of and appreciation for the role of nonaffiliated and nonscientific IACUC members. Humane endpoints in research and innovative ways to address environmental enrichment of primates are other areas that grew in sophistication during the 1990s. Training of IACUC members and animal users has received greater attention and the number of training programs and modules has increased significantly. Finally, OLAW, USDA and AAALAC International have all placed an increased focus on IACUC functions.

While originally borrowed from the human Institutional Review Board structure, the concept of IACUCs to review and ensure animal welfare is now common practice in the animal research community. The goal of each IACUC is to ensure the humane care and use of animals used in research, and compliance with guidelines and regulations, while maintaining flexi-bility to best meet the unique needs of the institution. Active participation by research scientists allows for the scientific needs of research investigators to be considered; participation by nonaffiliated members incorporates a public conscience; and the involvement of veterinarians ensures appropriate medical care and animal well-being. A program of continuing education is essential to ensure that animal care and use standards and ethical principles continue to be applied at the highest possible level.

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