The Legal Basis
The PHS Policy
The PHS policy requires that investigators adhere to the US Government Principles. Principle III states, "Methods such as mathematical models, computer simulation, and in vitro biological systems should be considered". Principle IV states that "Proper use of animals, including the avoidance or minimization of discomfort, distress, and pain when consistent with sound scientific practices, is imperative" .While no guidance is provided regarding assurance of compliance is provided, the Policy declares the UAWC responsible for maintaining such compliance.
The Federal Animal Welfare Act (and USDA regulations)
“...the IACUC (UAWC) shall determine that the proposed activities or significant changes in ongoing activities meet the following requirements. .... (ii) The principal investigator has considered alternatives to procedures that cause more than momentary or slight pain or distress to the animals, and has provided a written narrative description of the methods and sources, e.g., the Animal Welfare Information Center, used to determine that alternatives were not available”.
Section 2.32(c)(5)(ii) also requires that the institution assure that personnel are trained in utilization of services providing information about alternatives.