In response to the issues posed in this scenario, the National Institutes of Health-Office of Laboratory Animal Welfare (NIH-OLAW) and the U.S. Department of Agriculture-Animal and Plant Health Inspection Service (USDA-APHIS) provides the following clarifications:
In this scenario, a surgeon skilled with cardiac procedures in humans, dogs, and swine is approved by the Institutional Animal Care and Use Committee (IACUC) to conduct similar procedures in mice. Without confirming his competency with the species, high mortality results. The IACUC must decide a course of action to remedy the issue and prevent further occurrences.
NIH-OLAW response
The first step to determine the cause of the mortalities is for the IACUC to thoroughly investigate how the surgeries were conducted. Complications resulting from the length of the surgeries and technique of the inexperienced surgeon may have contributed to the deaths, i.e., hypothermia, tissue dehydration, blood loss. Additionally, reviewing necropsy results and the anesthetic regimen may provide insight into the cause.
A further step toward correction is for the IACUC to modify the protocol form to ensure that a researcher’s experience with procedures are specific to the species proposed. The U.S. Government Principles1, Health Research Extension Act of 19852 and the PHS Policy3 refer to appropriately trained personnel and required instruction and training by the institution4. The Guide requires institutions to ensure that research staff members performing experimental manipulation, including anesthesia and surgery, are qualified to accomplish such procedures humanely and in a scientifically acceptable fashion4.
The IACUC should require hands-on surgical training for the surgeon and monitor their competency. The IACUC should focus additional training for all researchers that emphasizes institutional expectations to minimize pain, distress, and (in this case) unnecessary mortality. Training should also emphasize that when procedures do not go as expected the veterinary staff should be contacted promptly. Continuing IACUC oversight of animal activities through effective post approval monitoring is critical2,5.
USDA-APHIS response
The Animal Welfare Act (AWA) excludes from the definition of animal, mice of the genus Mus that were bred for use in research6. As a result, the AWA regulations cannot be applied to the mice in this scenario. In light of this, the USDA defers to OLAW or any agency with the appropriate regulatory authority, in accordance with the requirement under the AWA to consult and cooperate with other Federal agencies concerned about the welfare of animals in research7.
References
Office of Laboratory Animal Welfare, National Institutes of Health. Public Health Service Policy on Humane Care and Use of Laboratory Animals. (US Department of Health and Human Services, Bethesda, Maryland, USA, 2015. https://olaw.nih.gov/policies-laws/phs-policy.htm
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals. 8th Ed. pg. 15. (National Academies Press, Washington, DC, 2011).
Office of Science and Technology Policy, US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training. (Federal Register, May 20, 1985, Vol. 50, No. 97). https://olaw.nih.gov/policies-laws/gov-principles.htm
Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Institutional Responsibilities, Question No. G.1. (US Department of Health and Human Services, Bethesda, MD, USA, revised 2017). [online]. https://olaw.nih.gov/guidance/faqs#677
Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions. Institutional Responsibilities, Question No. G.6. (US Department of Health and Human Services, Bethesda, MD, USA, revised 2017). [online]. https://olaw.nih.gov/guidance/faqs#instresp_6
7 U.S.C. Section 2132(g)
7 U.S.C. Section 2145(a)
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Brown, P., Goldentyer, B. A Word from OLAW and APHIS. Lab Anim 48, 318 (2019). https://doi.org/10.1038/s41684-019-0422-7
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DOI: https://doi.org/10.1038/s41684-019-0422-7
