Response to Protocol Review Scenario: A word from OLAW

In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) offers the following guidance:

The Office of Laboratory Animal Welfare (OLAW) recognizes the accurate, well-considered advice of the commenters and offers the following guidance, directed at the overarching context of the scenario.

IACUCs at PHS Assured institutions have the responsibility and authority to ensure that animal activities are conducted in compliance with the standards of the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy). The Policy (IV.C.1.) states, “...the IACUC shall conduct a review of those components related to the care and use of animals and determine that the proposed research projects are in accordance with this Policy”¹.

IACUCs must ensure the appropriate care and use of animals while supporting high quality science. They must institute appropriate measures to prevent, reduce, mitigate, and correct noncompliance (PHS Policy IV.F.3.a) while minimizing regulatory burden on the research team, veterinary staff, and the IACUC¹. IACUCs make these decisions by weighing the balance of risk and burden based on federal standards, institutional animal care and use policies, and requirements of the research.

IACUCs meet these competing demands in various ways. Examples include allowing PIs to reference SOPs in protocols, encouraging PIs to include flexibility in the initial protocol—such as with dose ranges, drug formularies and procedure frequency—and developing policies to permit use of veterinary verification and consultation (VVC) for significant changes to previously approved animal activities².

The Guide for the Care and Use of Laboratory Animals presents the following standard of what is necessary for the IACUC to assess proposed research: “a clear and concise sequential description of the procedures involving the use of animals”³. The IACUC is within its authority to require Waite to submit an amendment to protocol M33-16 that describes the proposed procedure, rather than referencing protocol M22-16. Description of the procedure will mitigate potential noncompliance, including inadequate IACUC review, deviation from the protocol due to subsequent significant amendment to M22-16, or differing expiration dates of the two protocols. In this scenario, the IACUC has wisely decided that the burden of cutting and pasting a procedure into a request for significant changes offsets the greater risk of potential noncompliance.

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