In response to a number of issues posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) provides the following clarifications:
First, the PHS Policy IV.B.3.d., defines a significant deficiency as one that is a threat to the health and safety of animals.1 In the scenario, the exposed electrical wires, while a hazard to personnel, do not pose a risk to the animals and therefore are considered a minor deficiency for reporting in the semiannual report to the Institutional Official (IO). The facility management must be promptly contacted and the wiring problem corrected.
Second, as mentioned by reviewers, the change in the protocol involves the addition of a procedure, i.e. housing mice in the school's cold room. Veterinary verification and consultation (VVC) may not be used to add a new procedure that was not previously approved on the protocol.2 Existence of an SOP approved for other protocols does not justify the addition of a new procedure. In addition, exposing the mice to an environment outside of the recommended temperature range of the Guide, 68-79° F, is a change that has a negative impact on animal welfare and results in greater distress to the animals.2,3 Such a change must be reviewed and approved by full committee review (FCR) or designated member review (DMR).2
References
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986, revised 2015).
National Institutes of Health. Guidance on Significant Changes to Animal Activities. Notice NOT-OD-14-126 [online]. https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-126.html (National Institutes of Health, Washington, DC, 26 August 2014).
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. pp. 43–44 (National Academies Press, Washington, DC, 2011).
National Institutes of Health. Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals. Notice NOT-OD-05-034 [online]. http://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-034.html (National Institutes of Health, Washington, DC, 24 February 2005).
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Brown, P. Response to Protocol Review Scenario: A Word from OLAW. Lab Anim 47, 10 (2018). https://doi.org/10.1038/laban.1393
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DOI: https://doi.org/10.1038/laban.1393