IACUC 101 Presented at EB 02

“IACUC 101” Presented at EB 02
IACUC Program to be Offered at EB 2004

·     Summary of the symposium
·        Links to handouts
·     Register for "IACUC 101 for Scientists at EB 2004"

Summary of the symposium

Some sixty scientists participated in a four-hour symposium at Experimental Biology 2002 on the workings of the Institutional Animal Care and Use Committee (IACUC).

“Everything You Ever Wanted to Know About the IACUC But Were Afraid to Ask” was organized by the American Physiological Society’s Animal Care and Experimentation Committee with support from the NIH Office of Laboratory Animal Welfare (OLAW). The session was co-sponsored by the American Society for Pharmacology and Experimental Therapeutics (ASPET), American Society for Nutritional Sciences (ASNS), American Association of Immunologists (AAI), American Association of Anatomists (AAA), and the Federation of American Societies for Experimental Biology (FASEB).

A similar program entitled “IACUC 101 for Scientists” is planned for the Experimental Biology 2003 in San Diego. That symposium will take place on Friday, April 11, 2003, from 1-5 pm. Further information and a registration form will be included in the EB 2003 Call for Papers.

APS Animal Care and Experimentation Committee Chairman John Stallone moderated “Everything You Ever Wanted to Know About the IACUC,” which was adapted from the popular “IACUC 101” series. The program offered an overview of the IACUC process plus opportunities to pose questions to representatives from NIH's Office of Laboratory Animal Welfare (OLAW) USDA’s Animal and Plant Health Inspection Service (APHIS)-Animal Care and the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) International.

Monte Matthews, the Director of the Office of Veterinary Services and Animal Care at the University of Oregon, described the evolution of the U.S. laboratory animal welfare system and the role played by the IACUC. The post-World War II origins of animal welfare oversight date to the post-World War II period when the U.S. began to increase its investment in biomedical research. In 1950, five Chicago-area veterinarians at research facilities began meeting to discuss ways to enhance science by improving the care provided to laboratory animals. By 1953 this group was publishing proceedings of its discussions and decided to become incorporated as the Animal Care Panel (ACP).

In 1952, the National Academy of Sciences established the Institute of Laboratory Animal Resources (ILAR) . Both ILAR and the ACP were addressing animal welfare issues 15 years before the first federal oversight law was approved. The ACP appointed an Animal Facilities Certification Committee that developed into the independent accrediting body now known as AAALAC. In 1963, the ACP sought NIH funding to develop a Guide for Laboratory Animal Facilities and Care, which evolved into the Guide for the Care and Use of Laboratory Animals (Guide). The Guide is now periodically updated by ILAR and published by the National Research Council. The Animal Care Panel itself continued to grow and in 1967 was reconstituted as the American Association for Laboratory Animal Care (AALAS).

Matthews explained that the 1966 Laboratory Animal Welfare Act (later known as the Animal Welfare Act) was the first federal law mandating animal care standards. It was passed in the wake of public outcry after Life magazine published an article, “Concentration Camps for Dogs,” describing the conditions in which dealers kept animals that were to be sold to research. The 1966 law set standards for areas where dogs and cats intended for research were housed. It also required facilities to maintain records on the dogs and cats they purchased.

The Animal Welfare Act was amended in 1970, 1976, 1985, and 1990, gradually expanding the number of animal species covered and the breadth of welfare requirements. The 1970 amendments changed the name of the law and extended USDA regulation beyond cats and dogs to include non-human primates, rabbits, guinea pigs, and hamsters. The 1970 amendments also granted the USDA discretion to regulate other species of warm-blooded vertebrates used in research. (One area of continuing controversy has been whether this provision permitted or required the USDA to regulate laboratory rats and mice, as well as birds. That controversy has been resolved for now with the approval of the 2002 farm aid bill, which amends the AWA specifically to exclude these species.)

The 1985 AWA amendments made sweeping changes to the regulations, requiring facilities that use covered species to designate an institutional official and to establish an IACUC to conduct program oversight and review all proposed research, educational, or testing activities.

Matthews also recounted the history of the parallel system of oversight for the care and use of laboratory animals that developed within the Public Health Service (PHS). The PHS is part of the Department of Health and Human Services and serves as the parent organization to such agencies as the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC). In 1971, the NIH formalized a policy requiring humane treatment of animals based upon the requirements of the Guide. This policy was formally adopted by the PHS as a whole in 1973 and was subsequently revised in 1979. In 1985, Congress adopted legislation reauthorizing NIH programs known as the Health Research Extension Act. This legislation included a provision making the PHS Policy on Humane Care and Use of Laboratory Animals part of the framework of laws governing the NIH and required henceforth that all PHS-funded research involving vertebrate animal species be conducted according to the PHS Policy. The elements of the PHS Policy largely paralleled the AWA in requiring the appointment of an institutional official and the establishment of an IACUC, although the composition and mandates of the IACUC differed somewhat from that specified by the AWA.

The year 1985 was a watershed for animal welfare oversight because it was also the year that the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training were adopted. These nine principles apply to all federally funded activities involving animals.

Symposium speaker Molly Greene of the University of Texas Health Science Center at San Antonio discussed the function and responsibilities of the IACUC. Greene has been with UTHSCSA since 1986 and currently serves as the Director of the Department of Academic Support. Her talk described key components of effective animal care and use programs. She emphasized that an effective program complies with federal, state and local laws and regulations; can assure the public of quality animal care; minimizes the burden on research teams; and facilitates scientific research.

Greene detailed the responsibilities of the various “team members,” including the Institutional Official, IACUC members, IACUC staff, attending veterinarian, and researchers, staff, and students. Greene said that the membership of an IACUC should represent the research and teaching strengths of the institution.

Greene noted that the ultimate purpose of IACUC review is to protect the continued use of animals in research. Sometimes, however, issues arise between investigators and the IACUC, and it is important to handle them in ways to minimize conflict. For example, Greene recommended that when the IACUC asks an investigator to modify a protocol prior to its approval, it should cite the pertinent section of regulation or policy in its comments to the investigator.

Greene provided a handout on Protocol Review Process Requirements listing the responsibilities of the IACUC under the AWA and the PHS Policy and identifying the sections of regulation or policy containing the various requirements. She recommended that the IACUC take responsibility for compliance issues so that the veterinarian and animal care staff can focus on animal care and facilitating research. She also referred participants to the statement on Adequate Veterinary Care on the website of the American College of Laboratory Animal Medicine which describes the responsibilities of the laboratory animal veterinarian.

In his talk, Stallone reviewed the basics of protocol review requirements as required under the AWA, PHS Policy, and U.S. Government Principles. He provided a series of issues to be addressed, IACUC approval criteria and questions that should be answered to the IACUC’s satisfaction before a protocol is approved. He provided two handouts developed by Greene to assist IACUCs. The first was a side-by-side comparison of the respective Protocol Review Content Requirements of the AWA regulations, PHS Policy, the Guide, and the U.S. Government Principles. The second was a model Protocol Review Checklist Greene designed to help IACUCs make certain that the protocol has addressed all relevant issues satisfactorily.

The question-and-answer sessions between talks covered a wide range of topics. One questioner wanted to know how to determine when significant and unexpected animal loss has occurred that should be reported to OLAW or USDA. OLAW Director Nelson Garnett, DVM explained that although it is difficult to give detailed guidance, it is generally expected that institutions with PHS Assurances will report cases where an approved activity has to be suspended or when there has been an instance of serious non-compliance with the PHS Policy or a deviation from the NRC Guide that result in the preventable deaths of animals.

Training requirements were also discussed. Garnett noted that training should be oriented toward the activities an individual engages in. The requirement for training specifies that training must be available but does not prescribe its frequency or intensity. Richard Van Sluyters, OD, PhD, a Professor of Optometry and IACUC Chair from the University of California, Berkeley, who was representing AAALAC, noted that investigators at his institution are asked to take a training refresher course at least every five years. This requirement is typically fulfilled through periodic seminars given to each department by the attending veterinarian. Jodie Kulpa, DVM, of the APHIS Animal Care staff at USDA recommended that training should be offered in a variety of lectures, workshops, hands-on clinics and on-line courses tailored to areas where researchers want and need further information. The website www.iacuc.org was recommended as a resource because it provides a list of training programs and model policies. The Medical Research Service of the Department of Veterans Affairs has also made available free web-based animal research training resources for investigators and IACUC members.

The panel was asked whether there are ethical standards in place for research involving animal exercise. At the moment, the only standard regarding exercise is the AWA requirement that dogs be provided with opportunities to exercise. AAALAC’s Van Sluyters indicated that it is important for scientists involved in specific types of research to provide written guidelines that IACUCs can use when reviewing protocols. Garnett said that OLAW is interested in supporting the development of such guidelines, as is the National Academy of Sciences, possibly in the form of an ILAR committee report similar to the Guide.

Another question that provoked a lively interchange involved protocols for animal models that cause pain and distress. The questioner was concerned about instances in which the attending veterinarian has decided to euthanize an animal without notifying the investigator so the data were lost and the animal’s life was wasted. Andrea Barnes, DVM, of the APHIS Animal Care staff commented that the issue may be one of specifying a humane end point for the experiment, and pilot studies may be needed to refine or define that end point. Barnes pointed out that the animal study proposal serves as a contract between the principal investigator and the animal care staff so it is important to indicate what are the end points for each group of animals and to spell out whether the investigator is to be notified before animals are euthanized. Van Sluyters noted that veterinarians have an obligation to euthanize animals that are suffering so provisions should also be made about how to proceed if the lab personnel are unavailable. Greene underscored the need for the IACUC to ensure that these procedures have been established before animal use begins.