In response to the questions posed 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 guidance:

Though well intentioned, Great Eastern University's IACUC has incorrectly assumed that only a protocol is acceptable to OLAW to meet the oversight requirement described in the OLAW Frequently Asked Question (FAQ)1. The FAQ cited does not preclude the use of a standard operating procedure (SOP). Concerning animals used as sentinels, breeding stock, etc., the FAQ states “...the IACUC should review protocols and SOPs that involve animals for such purposes”1. The use of a sentinel protocol, a research protocol or an SOP is an institutional decision. It may be based on whether there is ongoing sentinel activity covering many different studies with the species. If only one study requires the species, then including the sentinel activity on the research protocol is an option with the principal investigator's concurrence. A third option is to describe the sentinel activity in an SOP reviewed and approved by the IACUC. Including research animals in the SOP should again have the investigator's concurrence. OLAW and USDA suggest that an institution inform investigators that their study animals may be used in this manner and provide a mechanism for them to decline participation with scientific justification.

The Animal Welfare Act Regulations (AWARs) §2.31 (d)(1) outlines the duties of the IACUC in regards to the review and approval of proposed and ongoing activities involving animals2. Under §2.31(e) of the AWARs, a proposal to make a significant change to an ongoing activity must contain the following information: (i) the identification of the species and the numbers of animals used; (ii) a rationale for involving animals and for the appropriateness and numbers of animals used; (iii) a complete description of the proposed use of the animals; (iv) a description of the methods used to assure that pain and distress will be limited to that which is unavoidable, along with the provisions for anesthetics, analgesics and tranquilizing agents where appropriate; and (v) a description of euthanasia methods2.

In light of the AWARs, an amendment to the current sentinel monitoring protocol to incorporate the use of study animals or an amendment to the research protocol to reflect the sentinel use would be acceptable. Facilities may utilize an SOP instead of an IACUC-approved protocol for the sentinel monitoring program. Although the AWARs do not specifically address SOPs, USDA acknowledges their role in animal care and use programs and therefore deems the use of an SOP acceptable in this instance.

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