Stop Animal Exploitation NOW!, a national watchdog organization for lab research on animals, sent a letter to the director of the National Institutes of Health on April 8, asking that the NIH revoke USC’s animal welfare assurance.

The assurance allows the University to receive federal funding for lab research on animals in exchange for complying with federal policies for humane animal research. If USC’s animal welfare assurance was revoked, the University would not receive federal funding for lab research on animals.

The letter cited several violations of animal welfare laws by USC researchers in recent years — including improper surgeries and unapproved euthanasia of mice — as well as retracted journal articles as evidence that the University’s animal research programs are not “adequately supervised” and therefore should not receive federal funding for research on animals.

The letter follows a separate complaint SAEN filed Oct. 30 against USC to the United States Department of Agriculture after a U.S. Department of Agriculture inspection determined that researchers violated multiple federal codes and euthanized three rabbits. SAEN previously filed a federal complaint against USC in 2021 and sued the University in 2019 for violations of animal welfare laws.

In a statement to the Daily Trojan, the University wrote that it would continue biomedical research while ensuring welfare for live animals. The University also wrote that USC researchers explore alternatives to live animal research through grants from the University.

“USC is highly committed to the ethical and humane treatment of animals in research and meets or exceeds all accrediting and regulatory standards, with researchers having to complete comprehensive training,” the statement read.

The NIH did not respond to requests for comment. 

In an interview with the Daily Trojan, Michael Budkie, the executive director of SAEN, said USC’s self-reports that it suspended research protocols or took other actions against research labs found to violate animal research policies showed that the University admitted to systemic issues in its scientific research.

“If you’re talking about a private individual that’s had three DUIs, at some point, you would expect their driver’s license to be revoked,” Budkie said. “How many failed USDA inspections and how many failed or suspended research protocols, let alone retracted journal articles, does it take for the animal welfare assurance to be revoked?”

Attached to the SAEN letter were copies of six additional reports dating to 2021, which were sent by the USC Office of Research and Innovation to the NIH Office of Laboratory Animal Welfare and were obtained through the Freedom of Information Act. 

The letters reported the USC Institutional Animal Care and Use Committee’s responses to each violation of research protocols for experiments involving animals, including suspending principal investigators and requiring training for lab staff. 

David Favre, a professor at Michigan State University College of Law as well as the editor in chief of the Animal Legal & Historical Center, said universities that are granted animal welfare assurances are required to have a committee that oversees animal experimentation. He said the letters from IACUC were evidence that it was doing its job, so the University would meet the requirement for receiving an animal welfare assurance.

Budkie said self-reports of animal welfare violations by USC, as well as by other universities, did not necessarily show that universities had animal welfare as their primary interest.

“If they actually had a real concern for the welfare of the animals and they instilled that in their staff, there would be nothing to report about,” Budkie said. “And secondly, they filed these reports because if they don’t, that is, in and of itself, another violation of regulations … so don’t think that this was any wonderful thing they did. They don’t have a choice.”

However, Favre said SAEN would need to provide information that was not already reported to NIH to prove that USC was not adequately supporting animal welfare in research.

Favre said it was unlikely that the NIH director would respond to the letter because of the high volume of letters he likely receives. Favre said there would be a higher likelihood of a response if the letter was instead sent to OLAW at NIH, which oversees animal welfare assurances and evaluates potential violations of live animal research policies. 

Budkie said SAEN did not send their letter to OLAW, in part because he said OLAW often did not take “meaningful actions” against universities in response to SAEN’s complaints in the past. Budkie said as of April 17, the NIH sent an email confirmation to SAEN that it had received the letter but had not substantively responded to the letter.

According to Budkie, SAEN’s goal is to eliminate live animal research. He said results from experiments that were conducted on animals could “never be accurately generalized” to humans, partially because of differences between species. He instead suggested alternatives to live animal research like organs-on-chips, which use live human cells to imitate the structure and function of organs.

“One of the things that a lot of people don’t understand is that … in addition to having requirements that make the experimentation less torturous for the animals,” Budkie said. “The regulations in the Animal Welfare Act also, if followed, standardize the experimentation.”

Favre said new technology, such as computer programs that can simulate the brain of a mouse, could potentially replace live animal research in the future, but it has not developed enough.

“There may indeed be occasions where animals have to be used in experiments, but I probably would have a much more narrow view about when that’s appropriate,” Favre said.

Budkie said the University should have ended research projects that violated federal policies on animal research or permanently terminated the involved principal investigators to ensure that researchers did not commit similar violations again. According to the reports attached to the SAEN letter, one principal investigator was removed because of repeat violations, while another was temporarily suspended.

“If USC did a good job of enforcing federal regulations, then none of these situations with these principal investigators would have progressed to the point where things were so bad that they needed to be suspended,” Budkie said.

Favre said there is a process for the NIH to revoke individual grants that violated live animal research policies, but that NIH “almost never” revokes the animal welfare assurance for an institution.

“There is no procedure in the law or in the policy statement [on using live animals for research] that makes provision[s] for doing such a thing,” Favre said.

Favre said USC had taken appropriate action by addressing the six previous incidents mentioned in the SAEN letter within the University.

“I think NIH would be fairly OK with what the outcomes were in these individual cases, that they would say, ‘Yes, you’ve matched the problem to the remedy that the IACUC put in place,’” he said.