Response to Protocol Review Scenario: IACUC recommends, IO approves

The US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training state, “normally, the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied”¹. The Attending Veterinarian therefore has the authority to set the minimum housing requirements for any animals used by the institution for research, training or teaching. In practice, informed veterinary recommendations are typically supported by the IACUC.

According to OLAW, “institutions have discretion to subject animal activities to IACUC oversight regardless of the source of funding. This practice ensures uniform standards, appropriate oversight and accountability, and therefore is often in the best interest of the institution.”². In addition, the use of animals in scientific teaching falls under the category of research training and is therefore included in activities covered in the institution's Animal Welfare Assurance. The IACUC has the authority to require that all investigators meet the recommendations of the Guide for the Care and Use of Laboratory Animals³ in order to protect animal welfare and the research interests of the institution as a whole.

Although Roth proposes that his expertise supersedes the judgment of the veterinarians, Principle IX of the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training indicates that “the decisions should not rest with the investigators directly concerned but should be made, with due regard to Principle II, by an appropriate review group such as an institutional animal care and use committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.”¹. Because the standards of the Association for Assessment and Accreditation of Laboratory Animal Care International are the product of an appropriate review group for the species specifically included in the document, adaptation of these standards by the IACUC is a reasonable approach. This change to the animal care program should be agreed to in a timely manner by the Institutional Official (IO) before it is implemented. Roth's challenge to the veterinarians to provide proof of minimum space requirements is relevant in the context of research but not that of his current activities (teaching). The IACUC must investigate the concerns raised by the veterinarians by timely inspection to determine whether immediate suspension is indicated. It would also be appropriate to include in the investigation an outside expert opinion provided by a scientist independent of Roth but in the same field (and carrying out research in an institution with a current Animal Welfare Assurance), a curator of herpetology of a regionally recognized and accredited zoological collection or a veterinarian specializing in exotics.

Once space requirements have been recommended by the IACUC and approved by the IO, unambiguous compliance with these institutional standards must be documented by Roth via an animal use protocol amendment. Compliance must be confirmed by inspection of the animals and enclosures by a representative of the IACUC, preferably on a regular basis over an extended period. Continued housing of Roth's teaching animals under unsatisfactory conditions would trigger IACUC suspension of the protocol and formal reporting of the violation to the IO⁴. The animals would be transferred to appropriate housing and held by the institution until appropriate use or disposition was determined and carried out.

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