The first issue that requires investigation is whether the approved IACUC protocol actually states that 30–50% mortality is expected for new staff; simply having additional animals approved to account for 'experimental failures' does not in itself indicate that this high mortality is expected. The Guide states that “the institution should provide appropriate education and training to members of research teams...to ensure that they have the necessary knowledge and expertise for the specific animal procedures proposed...before beginning animal work”1. This could certainly be interpreted to mean that the IC-injection skills of the new staff must reach an acceptable success rate before survival procedures can be performed. In this case, the IACUC inspectors noted that the animals injected by the more experienced lab personnel were “doing fine.” Given this, it would seem unreasonable to accept the 50% mortality rate simply due to inexperience, unless the lab has provided specific data and references confirming that this is consistent with other labs/protocols using the same procedure. If such references or justification for such high mortality rates does not exist in the protocol, then noncompliance is indeed present.
In this circumstance, where training of lab staff is performed by senior lab members rather than an IACUC/animal resources trainer, the institution is not relieved of their responsibility to ensure “continuing IACUC oversight of animal activities (as) required by Federal laws, regulations and policies”1. An SOP describing the training protocol should be created with detailed information on the training process, including a description of the progression from dead animals to survival animals must be described, along with an explanation of how the proficiency of the trainee is assessed at each time point during training. This could involve using dye for dead animal and non-survival injections, followed by necropsy/histological examination to assess the location and depth of the injection. Ultimately, the IACUC and/or veterinary staff should oversee final assessment of proficiency to perform survival surgeries.
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