From John Russell, InsideIndianaBusiness.com, March 15, 2023
The 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. IU officials did not immediately respond to IBJ for comment.
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.