Animal use protocols must be reviewed by the IACUC at appropriate intervals in accord with the Animal Welfare Act and Regulations1, the PHS Policy2 (not less than once every three years), USDA1 (not less than annually), the US Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training3 and the Guide for the Care and Use of Laboratory Animals4.
Our animal use protocols include an identification of the species and approximate number of animals to be used; the rationale for involving animals and for the appropriateness of the species and numbers used; and a complete description of the proposed use of the animals.
Annual renewals and modifications can be monitored by the use of a standard form containing basic protocol information: status of the project, assurance that activities are being done in accordance with the approved protocol and proposed departures from the protocol in the upcoming year. The USDA regulations1 (9 CFR Part 2, Subpart C, 2.31(c)(7); 2.31(d)) and the PHS Policy2 (IV.C.1) require that proposed significant changes to the currently approved protocol be reviewed and approved by the IACUC prior to implementation.
Once IACUC approval of a protocol has expired, the PI may not carry on any ongoing experimental work. Any work that is to be continued must be included in the newly submitted protocol and approved by the IACUC before the work can resume. The new protocol can be reviewed either at a regularly scheduled IACUC meeting or, if available, by designated member review. Carrying out any animal activities in the absence of valid approval is a serious and reportable violation5.
Any animals remaining on a protocol at the expiration of the approval period must be disposed of unless they can be transferred to an IACUC-approved protocol or renewal. These animals must be of the appropriate species, strain, age, genotype or sex listed in the new protocol, and the number of animals transferred contributes to the total animal numbers approved by the IACUC. If the institution has an IACUC-approved 'holding' protocol in place, animals may be temporarily transferred pending committee review and approval of a new animal use protocol.
References
Animal Welfare Act and Regulations.
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).
Public Health Service. US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training. Policy No. 102.02. (US Department of Health and Human Services, Washington, DC, 2002).
Institute for Laboratory Animal Research. Guide for the Care and Use of Laboratory Animals (National Academies Press, Washington, DC, 1996).
Public Health Service. Policy on Humane Care and Use of Laboratory Animals – Frequently Asked Questions (US Department of Health and Human Services, Washington, DC, 2006; revised 2009). http://grants1.nih.gov/grants/olaw/faqs.htm.
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Amato, J., Kittleson, A., Peters, J. et al. Response to Protocol Review Scenario: No 'ongoing' work. Lab Anim 38, 318 (2009). https://doi.org/10.1038/laban1009-318b
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DOI: https://doi.org/10.1038/laban1009-318b
