UT's treatment of lab research animals under review
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UT's treatment of lab research animals under review

From Alexandra Mester, ToledoBlade.com, May 16, 2021

Days after announcing it had filed a federal complaint against the University of Toledo regarding a lab animal’s dehydration death, an animal-rights organization is asking for an accreditation to be revoked following its discovery that three research projects were suspended for noncompliance.

Michael Budkie, co-founder and executive director of Milford-based Stop Animal Exploitation Now, sent a letter to the Association for Assessment and Accreditation of Laboratory Animal Care International last week. Public records the group obtained show three research programs were suspended: one each in 2019, 2020, and 2021.

“Suspending protocols is relatively rare, and it’s seen as kind of a last resort,” Mr. Budkie told The Blade on Friday. “To see a comparatively small research facility with three suspended protocols in three years would put them in very bad company.”

Frank Calzonetti, UT’s vice president for research, said the problems were caught and self-reported by UT’s established processes governing research involving animal subjects.

“When something is out of compliance, we take it very seriously,” he said Friday. “We are monitoring ourselves very carefully. We are very much committed to research.”

The most recent record, dated in March, is a letter Mr. Calzonetti wrote to the National Institutes of Health Office of Laboratory Animal Welfare. It states a lab in February failed to euthanize an unspecified number of mice “when they reached humane endpoints” and also did not provide supplemental food or fluid “per the protocol’s instructions.” Mice were also euthanized in an unapproved laboratory.

The incidents combined led UT’s Institutional Animal Care and Use Committee to suspend the project, which the letter states is not receiving NIH funding, on March 17. Corrective measures outlined in the letter include a management plan, submission of daily logs, and personnel retraining.

“We have not permitted that research to continue,” Mr. Calzonetti said. “That faculty member no longer has animals. At this point, there is no more research under way in that lab.”

Mr. Calzonetti said separate incidents reported in 2019 and 2020 to the NIH occurred in the same lab.

“There were some challenges in that lab,” he said. “We insisted upon having better management and oversight of that lab to move forward before we would allow any more research to be conducted. We worked with the department chair who provided support [to hire] a laboratory manager to assist that faculty member.”

In September, 2019, UT informed the NIH when it learned that animal numbers in a breeding protocol were not reported by the lab as required. The letter states it was identified as the second serious noncompliance issue in six months related to breeding. The federally funded project was suspended until a new staffer or UT’s Department of Laboratory Animal Resources was hired to oversee breeding management.

A second letter in July, 2020 to the NIH regarding the same lab, Mr. Calzonetti said, detailed that nine mice in a federally funded research protocol died of post-operative infections in a two-month period. The university traced the issue to “the use of contaminated, diluted Meloxicam that had been stored by the laboratory at room temperature for an extended period of time.”

“This same laboratory failed to monitor mice post-operatively on three separate occasions in June and falsified post-operative records,” the letter states, adding that a student involved was subsequently working with UT’s Office of Research Integrity.

The project was suspended, and corrective measures included a management plan and the hiring of a lab manager. A response letter from the NIH acknowledged the communication and instructed the university to “inform the NIH funding component about the suspension and ensure that the grant is not charged for any unauthorized animal activities.”

Mr. Budkie said the collection of issues call into question not only what may be happening in other UT laboratories, but also the validity of the research findings.

“What becomes apparent is a long-term pattern, multiyear pattern, of failure to comply with the very minimal federal standards that are connected to the use of animals in experimentation,” Mr. Budkie said. “If they can’t even follow their own protocol, why should we believe they can even do science?”

Mr. Calzonetti said UT conducts about $12 million to $13 million in federally funded research involving animals each year, and estimated about 175 individual protocols were under way in 2020. He said the majority of the projects are related to human medicine, but a few are related to animal diseases.

Mr. Budkie noted increasing use of new technologies, such as 3-D bioprinting and organ chips that use human cells and microchips to simulate the structures and functions of living organs and can be connected to each other.

“Using animals is old technology,” he said.

UT is working to include more non-animal research as it becomes more available and more successful, Mr. Calzonetti said. The university now has connections with national laboratories to use supercomputers to perform virtual simulations and computational research.

But animal subjects still provide other benefits that have not yet been replaced by other technology, such as viewing disease progression over time.

“Animal research is very important for disease research,” he said. “There’s no real substitute for the animal models.”

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