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  • Protocol Review
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Response to Protocol Review Scenario: Making the IACUC squeal

Lab Animal volume 43, pages 194–195 (2014)Cite this article

It's clear in this scenario that Ballantine did not fully understand the Animal Welfare Act regulations1 (AWARs) or the Guide for the Care and Use of Laboratory Animals (the Guide)2 when it came to the role of the IACUC and its review and approval of animal care and use. The AWARs require IACUC approval for the care and use of animals in ongoing activities1. This includes review to ensure that procedures minimize discomfort, distress and pain and that procedures that cause more than momentary pain and distress be performed with appropriate analgesics or anesthetics1. In this case, appropriate IACUC review had occurred, but Ballantine failed to recognize the importance of following the procedures as outlined in the protocol, leading to a protocol deviation. Failure to follow the procedure approved by the IACUC is a protocol deviation regardless of whether the non-approved method can be supported by other documentation.

What is reportable to USDA? According to the AWARs, there are very few instances in which the USDA must be notified. To our knowledge this includes change in the name, address, management or control of business ownership; IACUC suspension of a protocol; failure to correct a significant deficiency as planned during program review; the annual report; and incidents resulting in injury to cetaceans or humans in interactive programs1. Protocol deviations described in this scenario, which are not pervasive in the program, do not represent a significant deficiency in the program that would require reporting to the USDA.

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References

  1. Animal Welfare Act Regulations. 9 CFR, Chapter 1, Subchapter A, Parts 1–3.

  2. Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. (National Academies Press, Washington, DC, 2011).

  3. Guide for the Care and Use of Agricultural Animals in Research and Teaching 3rd edn. (Federation of Animal Science Societies, Champaign, IL, 2010).

  4. United States Department of Agriculture, Animal and Plant Health Inspection Service. Animal Care Policy Manual. Policy #17: Regulation of Agricultural Animals. (USDA, Beltsville, MD, 2011). http://www.aphis.usda.gov/animal_welfare/downloads/policy/Policy%2017%20Final.pdf

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Authors and Affiliations

  1. Kendall is the Director of Laboratory Animal Resources and Tuttle and Curtis are residents in the Comparative Medicine Training Program at Colorado State University, Fort Collins, CO.,

    Lon V. Kendall,  Wendy Tuttle &  Ryan Curtis

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  1. Lon V. Kendall
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  2. Wendy Tuttle
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  3. Ryan Curtis
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Kendall, L., Tuttle, W. & Curtis, R. Response to Protocol Review Scenario: Making the IACUC squeal. Lab Anim 43, 194–195 (2014). https://doi.org/10.1038/laban.541

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