A submitted protocol must include all animal work to be done under that protocol; this includes work in a renewal protocol being conducted using animals remaining from an expiring protocol. It is the responsibility of the IACUC to develop mechanisms by which a PI can transfer animals from an expiring protocol to a renewal protocol that covers the activities involving those animals. The simplest way to do that is to provide a place in the protocol application for the PI to list animals that need to be transferred from an expiring protocol and to explain what, if any, procedures were done with those animals under the previous protocol and what procedures or studies will be done under the renewal protocol. The transferred animals should be counted and added to the number of new animals requested by the PI in the renewal protocol to calculate the total number of animals approved. Timing can complicate the transfer process. For example, on the day the renewal protocol is submitted to the IACUC office, the PI may have 30 rats remaining on the expiring protocol. But at the time of final approval of the renewal protocol, 10 rats may have reached the study endpoint, leaving only 20 rats; yet the new protocol was approved for 30 transferred rats. This difference does not constitute a problem, however, as regulatory language (Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy)1 and the Animal Welfare Act and Regulations2) on IACUC approval of animal numbers always uses the term 'approximate', giving both the IACUC and the PI the necessary leeway to plan animal studies in a dynamic environment.

While it is the IACUC's responsibility to ensure that animal activities are not done in the absence of an approved protocol3, it is the PI's responsibility to determine the disposition of animals remaining on an expiring protocol. If the animals will not be used under the renewal protocol, the PI may choose to terminate them and collect research data or may consider offering them for sale or transfer to other PIs who may be able to use them. The latter activity would require oversight from the animal resource department or the IACUC to ensure appropriate accounting of animal use.

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