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Response to Protocol Review Scenario: Oops!... I did it again

Lab Animal volume 46, pages 365–366 (2017)Cite this article

While there is not a regulatory limit to the number of procedures in an IACUC protocol, the Great Eastern IACUC should ensure that they understand how procedures are interrelated and what procedures are performed on an individual animal. White is not that innocent in regards to compliance with her protocol. Even if it was a mistake in oversight, she clearly did not indicate that animals would undergo multiple major survival surgeries. While the IACUC could have clarified this issue during its review, it is ultimately White's responsibility to ensure that the protocol accurately describes what will be performed on each animal. In addition, her stated justification for performing multiple major survival surgical procedures is inadequate according to the Guide1 and the Animal Welfare Regulations and Policies2,3, as all of these require a scientific justification or clinical necessity. They also specify that the surgeries must be essential components of a single research project or protocol. Although the surgeries are on the same protocol, they are not interdependent. At this point, there is no justification in the protocol and when questioned as to why this was necessary, White only stated she was trying to save time and money. If she would like to do this in the future, she will need to provide a scientific justification to the IACUC, which includes how the two procedures are interrelated. The only other option for White would be for the Institutional Official to appeal to the USDA Animal Care Regional Director who will forward it to the Animal Care Deputy Administrator for consideration of a special circumstance. This appeal would need to include several pieces of information: a scientific justification that does not include cost, the procedures proposed, and assurance that the IACUC has approved this exemption2,3.

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References

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

  2. United States Department of Agriculture. Animal Welfare Act and Animal Welfare Regulations (2013).

  3. United States Department of Agriculture. Animal Care Policy Manual (2016).

  4. National Institutes of Health, Office of Laboratory Animal Welfare. Guidance on Prompt Reporting to OLAW Under the PHS Policy on Humane Care and Use of Laboratory Animals. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-034.html

  5. National Institutes of Health, Office of Laboratory Animal Welfare. MOU Among USDA/FDA/NIH. https://grants.nih.gov/grants/olaw/references/finalmou.htm

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  1. Office of Laboratory Animal Resources, University of Colorado Denver, Aurora, CO

    Jori K Leszczynski, Derek Fong, Christopher Manuel & Michelle Wallace

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  1. Jori K Leszczynski
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  2. Derek Fong
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  3. Christopher Manuel
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  4. Michelle Wallace
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Leszczynski, J., Fong, D., Manuel, C. et al. Response to Protocol Review Scenario: Oops!... I did it again. Lab Anim 46, 365–366 (2017). https://doi.org/10.1038/laban.1351

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