In this situation, we feel that the protocol can be approved with the understanding that the surgical training would occur as proposed and the Sturkie lab would not do unsupervised surgery until the AV signed off on the training. Although the Guide for the Care and Use of Laboratory Animals (the Guide)1 states, “The IACUC, together with the AV, is responsible for determining that personnel performing surgical procedures are appropriately qualified and trained in procedures,” it does not specifically state that this must be done prior to protocol approval. If the protocol is approved, then the Sturkie lab can start working on other non-surgical aspects of the protocol. Meanwhile, the IACUC and the AV can work with the Sturkie lab to achieve the required proficiency in cardiac artery ligation.

As Sturkie wrote in his protocol, the AV could oversee the training of his lab by the Fitzgibbons lab members, who are proficient in the technique they will be using. The mice that had been euthanized for another purpose could be used to train the Sturkie lab in the cardiac artery ligation procedure. Once the AV was confident in their skill level, members of the Sturkie lab could then move on to the next step (which Sturkie outlined as non-survival surgery) and then finally to survival surgery. If the AV was uncomfortable with anyone's proficiency, he could prohibit that person from advancing to the next level.

With careful post-approval monitoring, the group could proceed with the study. The Sturkie lab should regularly report the results of their surgeries and perform necropsies on mice that did not survive. Knowledge gained from the necropsies will help them refine their techniques and increase survival rates. Periodically, the AV could observe their surgeries and help them fine-tune their technique and increase their survival rate.

We feel this protocol should be approved but that Sturkie must follow the steps outlined in the protocol for completing the required training, with the AV monitoring the progress to ensure proficiency in the technique. This will allow the research to proceed while the regulations governing animal welfare and personnel training are observed.

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