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"IACUC 101 for Scientists" Summary

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.

IACUC RESPONSIBILITIES: 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.

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