In response to the issues raised in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) offer the following clarification and guidance:
The requirement for submission of an annual report of research facilities, finalized in 1971 (ref. 1), was enacted in order to collect information necessary for USDA to fulfill its responsibilities under the Animal Welfare Act—that is, to show that research facilities were following professionally acceptable standards governing care, treatment and use of animals. Research facilities are required to report the number of animals used in experiments without pain or distress; the number of animals used in experiments involving pain or distress for which pain-relieving drugs were used; and the number of animals used in experiments involving pain or distress for which pain-relieving drugs were not used. Routine procedures (e.g., injections, tattooing, blood sampling) involving some necessary pain and distress need not be reported because the pain and discomfort involved in such procedures are of a transient nature2.
In July 2000, USDA published a request for comments, recognizing that the current system does not include a means to report certain situations, such as the one described in this scenario, where animals experience pain or distress for a reason other than that the use of anesthetic, analgesic or tranquilizing drugs would have adversely affected the procedures, results, experiments, surgery or tests3.
Guidance on how to report this type of situation may be found in the Research Facility Inspection Guide4, on page 14.1.3. An animal that experiences an unexpectedly high level of pain due to the research procedures during a study, where the pain is recognized and appropriately treated, may be reported in Column D. Of greater concern is the training issue regarding timely reporting to the attending veterinarian of problems concerning animal health and well-being; as mentioned by the respondents, this needs to be resolved. Failure to monitor animals post-procedurally to ensure well-being and to promptly notify the veterinarian that animals were experiencing postoperative pain constitutes a serious departure from provisions of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals5. In PHS-supported animal studies, the PHS Policy (IV.F.3.a.) requires institutions to report such incidents and to provide a plan and schedule to prevent their recurrence5.
References
US Department of Agriculture. Animal and Plant Health Service. 9 CFR Part 2: Animal Welfare Regulations; Final Rule. Federal Register 36, 24917–24928 (1971).
US Department of Agriculture. Animal and Plant Health Service. 9 CFR Part 2: Animal Welfare Regulations; Final Rule. Federal Register 42, 31022–31029 (1977).
US Department of Agriculture. Animal and Plant Health Service. 9 CFR Part 2: Animal Welfare Regulations; Request for Comments. Federal Register 65, 42304–42305 (2000).
US Department of Agriculture. Animal Care Resource Guide: Research Facility Inspection Guide (US Department of Agriculture, Washington, DC, 2001). <http://www.aphis.usda.gov/animal_welfare/rig.shtml>
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).
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Brown, P., Gipson, C. Response to Protocol Review Scenario: A word from OLAW and USDA. Lab Anim 38, 347 (2009). https://doi.org/10.1038/laban1109-347
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DOI: https://doi.org/10.1038/laban1109-347
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