IU med school shuts down research project that used expired supplies on pigs

Indiana University School of Medicine has terminated a research project involving surgery on live pigs after officials discovered the laboratory workers were using expired surgical supplies.

IU notified federal officials in January that the lead researcher has since retired and other members of the laboratory responsible for the work are no longer employed by the university.

“Accordingly, it is not expected that this work will be restarted,” Fred Cate, IU’s vice president for research, wrote Jan. 20 to officials at the National Institutes of Health and the U.S. Department of Agriculture.

It was unclear exactly what the medical school was researching under the project or how many pigs were involved overall.

In a brief statement to IBJ, IU spokeswoman Katie Duffey said: “Indiana University School of Medicine is committed to promoting the welfare of animals used in research, and has processes in place to assure their welfare. This issue was reported to the federal agencies as required, and the school and university worked together and took appropriate action to address the concerns raised.”

Under federal law, medical materials administered to live animals during so-called “survival procedures”—where the animals are supposed to survive the procedures—must be used within their expiration date.

In this case, however, IU lab workers were using expired stents, or wire mesh tubes that keep blood vessels open, during seven surgeries on pigs in July and August of 2022, IU told federal officials.

Cate wrote that the research group had “a pattern of non-compliance” and had been warned several times against using expired materials. The lead researcher—also known as the principal investigator or PI—was not named in the letter.

“The PIs have been repeatedly notified during semiannual inspections that use of expired equipment is prohibited and that they are required to have clearly labeled supplies as expired and that these items are not to be used for survival surgeries,” he wrote in a Sept. 29 letter.

Laboratories that receive funding from the federal government are required to report violations of animal welfare to the federal government.

IBJ obtained the letters from an Ohio-based group called Stop Animal Exploitation Now, which routinely sends open-records requests on animal welfare issues to government offices.

“We believe the general public has a right to know about what goes on in laboratories because in most instances, these projects are funded with tax dollars, said Michael Budkie, the group’s executive director.

He called for IU to issue a public apology and to reorganize its animal-care unit so that its researchers will not be able to repeat a pattern of non-compliance with animal welfare laws.

IU said its Institutional Animal Care and Use Committee has determined that it will repay any grant funds related to the use of expired materials, and that any data from the project cannot be used for any purpose.

It was unclear how many survival surgeries IU researchers conduct on pigs or other animals each year.

“The incident appeared to be a ‘significant departure from accepted practices of the relevant research community’ and was required to be reported to the university’s research integrity officer,” Cate wrote.

In a Feb. 7 response, the Office of Laboratory Animal Welfare at the National Institutes of Health in Bethesda, Maryland, wrote that it considered the matter closed.

“We find no cause for further action by this office at this time,” it wrote to Cate.