Great Eastern University’s (GEU’s) IACUC was presented with an allegation of non-compliance. The post-approval monitor, Mr. Cooper, identified that Dr. Guaio’s lab staff were not adhering to the humane endpoints approved in his IACUC protocol. Dr. Guaio’s IACUC protocol indicated that mice with tumors exceeding two centimeters of growth would be humanely euthanized. Cooper found over five cages containing Peromyscus (deer mice) with tumors exceeding these approved endpoints. Consequently, Dr. Guaio and his junior post-doc, Dr. Yin, were both required to attend the IACUC meeting to explain the protocol deviation. Guaio and Yin admitted no wrongdoing since the protocol deviation occurred only after consultation with the attending veterinarian, Dr. Tracy Thompson. They explained that their research included the use of novel therapeutics that reduce cancer growth. Yin said that even though the tumors exceeded the defined endpoints, they needed at least one extra week to administer the therapeutics and collect sufficient data for analysis. Although the protocol defined endpoints were exceeded, Yin indicated that based on his discussion with Dr. Thompson, the deer mice could be maintained for at least another week. Thompson examined the animals and granted the extension provided that monitoring was increased to twice a day and palliative care was provided (i.e., moving food to the cage floor, providing diet gel). Thompson attended the meeting and informed the IACUC that she felt the animals could continue in the study. She indicated that allowing the animals to continue in the study for a few extra days was much better that wasting the animals by mandating euthanasia just to satisfy the defined humane endpoints. If Guaio could get data out of these animals, then protocols could be amended to align the humane endpoints with what the animals are experiencing. GEU’s IACUC agreed with Thompson’s logic that precious animal resources should be preserved, but the committee indicated measures should be taken to ensure future processes would adhere with the regulatory expectations. The committee members were certain that deviating from an approved protocol was non-compliance, but struggled with the need to preserve animal resources. Can a veterinarian, PI, IACUC Administrator, or anyone else unilaterally permit animals to exceed the IACUC approved humane endpoints for the purpose of research activities and without IACUC approval?
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