Response to Protocol Review Scenario: US regulations are the minimum

The newest edition of the Guide for the Care and Use of Laboratory Animals does not provide numeric standards for reptiles and amphibians but states that “[i]nstitutions, investigators, and IACUC members should evaluate the appropriate needs of each species...and continue to review ongoing research in these areas”¹. For Great Eastern, changes to amphibian and reptile space requirements are within the purview of the IACUC.

The IACUC has a responsibility to determine that animal housing “will be appropriate for the species and contribute to their health and comfort [and] will 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”². Roth may indeed fit this role, but there is an inherent conflict of interest in his ability to make decisions about animal housing, because such decisions have financial implications for his work (i.e., total per diem costs). Cost savings alone cannot be used to justify Roth's actions. The PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy) allows Great Eastern's Attending Veterinarian (AV) to serve this role, provided that he or she has sufficient knowledge and experience with the species². The handling of potential conflicts of interest is discussed in the US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training³. Principle IX defines who can make decisions on aspects of animal care, including animal housing; decisions regarding exceptions “...should not rest with the investigators directly concerned but should be made... by an appropriate review group such as an institutional animal care and use committee”³. If Great Eastern is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International, then it would be expected to follow these Principles, even with species not covered under the Animal Welfare Act and Regulations⁴ and projects not receiving NIH funding.

To begin to heal the rift with Roth, the IACUC should explain that the newly adopted European requirements are a starting point. The overarching goal is to achieve the performance standards of improved health and welfare of the species. Roth is free to request an exemption to this policy, but the onus is on him, and not the IACUC or AV, to provide scientific justification for the exception and to show that his space allowance does not negatively impact animal health and welfare.

Roth contends that the IACUC and AV have no authority to impose policy that differs from that set forth in US regulations. But one of the paramount reasons for the existence of an IACUC is to review the animal care program with consideration of general community interests in the care and use of animals¹. The US regulations are the minimum requirements. The IACUC is free to promulgate more stringent policies that reflect local ethics and mores. It might be helpful to all animal users, not just Roth, for the IACUC to explain in a user forum how policies are promulgated at Great Eastern. Allowing a user comment period for policies that might be considered controversial might help to move the Great Eastern research community toward better transparency and consensus building.

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