citation_inspection: 24236

An IACUC approved pilot protocol involving rabbits did not contain an adequate rationale for the appropriateness of the species or the numbers of animals to be used for that activity. The protocol stated that 8 rabbits would be used but there was no rationale provided for why these were the numbers needed to make the procedures valid. An explanation is needed to justify these numbers, including factors such as how the numbers were generated, and why the numbers are necessary and / or statistically significant. The rationale for the appropriateness of the species and the number of animals to be used in a study is an important component of protocols that utilize animals. The rationale approved by the IACUC should provide assurance that the appropriate species and number of animals is being used to obtain the information the activity is designed to provide. In addition to assuring that the minimum number of animals is used to obtain the desired information, the rationale should also ensure that enough animals are used to make the activity worthwhile. It is the responsibility of the IACUC to ensure that proposals to conduct activities in ongoing activities involving animals contain rationales that explain the appropriateness of the number of animals to be used in those activities. To be corrected on all future protocols.