According to the Animal Welfare Act and Regulations (AWARs) and the PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy)2, IACUCs are required to review and approve significant changes regarding the use of animals in ongoing activities described in an IACUC-approved animal study proposal. The NIH interprets significant changes to mean those that have the potential to substantially and directly affect the health and well-being of the experimental animals and must therefore be reviewed and approved by the IACUC. The PHS Policy and AWARs do not indicate that changing the strain of the mouse model is a significant change. But the IACUC may be concerned if the creation of this knockout mouse (which can be considered a transgenic strain by the NIH Office of Biotechnology Activities) requires ABSL-2, ABSL-3 or ABSL-4 containment.
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