In response to the issues posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) provides the following clarifications:
This scenario describes the unanticipated deaths of control animals during a procedure that was conducted in the long-running study. The deaths were reported to the IACUC by the conscientious PI. The scenario asks, “How should the IACUC handle the situation?”
In addition to reviewing the report to the IACUC from the PI, the IACUC must further investigate the unexpected deaths to meet its oversight responsibilities under the PHS Policy, the Guide and the Animal Welfare Act and Regulations (AWAR)1,2,3. The investigation requires a thorough analysis by the IACUC, in cooperation with the research team, to discern any changes that may have caused the deaths. In this particular study, items to review include: 1) homeostasis of the animals (e.g., fluctuations in room temperature, fluid, or thermal support for the animal), 2) suitability of the animals for the study (e.g., animal conditioning, age, and weight), 3) fidelity to the IACUC-approved procedure (e.g., comparison of the protocol to the procedures and specific anesthesia actually used), and 4) condition of equipment (e.g., examination of maintenance records on all anesthesia and support equipment in use). Although the research team conducted their own investigation of both the equipment and animals, the IACUC may consider expanded consultation with veterinary pathologists, an independent diagnostic evaluation of the anesthesia machine by a certified technician, and a call to the rabbit supplier about any changes in health or genetics of the colony. To encourage continued engagement of the research team, a reasonable approach is to allow the research to continue with enhanced monitoring of the next procedure by the veterinarian and, if available, an anesthesia specialist.
If a cause is established, the IACUC may request amendments to the protocol to incorporate appropriate changes. Additional training may be necessary to improve responses to anesthetic complications and to engage rapid veterinary assistance. The IACUC may also find that the protocol needs to address an expected level of mortality.
If all procedures were performed according to the protocol and the deaths are due to individual rabbits' sensitivity to anesthesia, the incident is not reportable. If some aspect of the procedure was not done in accordance with the protocol or, for example, there was equipment failure, or inadequate thermal control or fluid support, then the IACUC must report to OLAW4. If the IACUC is unsure as to whether an incident is reportable, contacting OLAW by phone is the recommended approach.
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).
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals 8th edn. 43–44 (National Academies Press, Washington, DC, 2011).
United States Department of Agriculture. Animal Welfare Act and Animal Welfare Regulations (2013).
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 (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, 30 (2018). https://doi.org/10.1038/laban.1412
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DOI: https://doi.org/10.1038/laban.1412