Last week, academic researcher Dong- Pyou Han was sentenced to four years and nine months in federal prison for falsifying HIV research data. Han also was required to repay $7.2 million in grant funding to the National Institutes of Health (NIH). This sentence is considered extreme given historical precedents for academic research misconduct.
The trial of the Korean-born Han’s odyssey began in 2008 when he worked on an HIV vaccine research team led by Michael Cho, a professor at that time employed at Case Western Reserve University in Cleveland. Working with vaccine GP41 injected rabbits revealed signs of antibodies in the blood. That finding suggested the vaccine had prompted an immune response against the HIV in rabbits, enabling him to submit grant requests that led NIH officials to state they were “flabbergasted” by the results, according to the federal complaint.
No one knew—not even Cho—that Han accidentally contaminated the rabbit blood with human antibodies. Instead of admitting the mistake, Han continued to contaminate future samples. For the unsuspecting Cho, the tainted vaccine results were considered a breakthrough in the effort to find a viable vaccine for the virus.
Barely a year later, Cho was recruited by Iowa State University and brought Han and other members of his research team with him to the Ames campus to continue working on the vaccine and its surprising results. It also led to additional NIH grant funds and efforts by other researchers to validate the study findings.
Promoted to lab manager, Han had direct access to the samples and, according to the complaint, helped supply Cho with data for his grant applications. Court documents revealed that Han apparently was spiking the rabbit blood for many years. In early 2013, Harvard University researchers began raising questions and concerns after trying and failing to validate Cho’s research results. Harvard researchers eventually uncovered human antibodies in the rabbit blood samples.
Cho immediately informed Iowa State University about the problem and the federal government launched an investigation with his help, ultimately determining that his longtime assistant was behind the fraud. Confronted with the findings, Han resigned, admitted his guilt and accepted responsibility for the fraudulent results. Han’s misdeeds led Iowa State to pay back nearly $500,000 in grant money and the government cancelled an additional $1.4 million slated for the research team.
Han’s fraud, which over the years enabled Cho’s team to receive approximately $19 million in NIH grant money, prompted James Bradac, who oversees AIDS grants at the NIH, to call it “the worst case of research fraud he’s seen in more than two decades at the agency.”
In December 2013, Han initially was punished for his actions, receiving a three year ban on federal funding by the Office of Research Integrity (ORI), which is part of the U.S. Department of Health and Human Services—the maximum penalty it generally imposes on junior investigators.
Han’s trial has been a lightning rod for Senator Charles E. Grassley, Republican of Iowa, who has a history of investigating misconduct in the biomedical sciences. Grassley told the ORI in a Feb. 10, 2014 letter, that Han’s punishment “seems like a very light penalty for a doctor who purposely tampered with a research trial and directly caused millions of taxpayer dollars to be wasted on fraudulent studies.”
The senator’s outrage led to extensive media coverage last summer, prompting the federal prosecutor in Des Moines, Iowa, to press charges against Han. This led to the case before a grand jury.
In February, Han pled guilty to two felony charges of making false statements. Earlier this month at his sentencing, Han briefly spoke: “I deeply regret any and all misconduct. I meant no harm to anyone.”
U.S. District Court judge James Gritzner sentenced the 58-year old researcher. Gritzner commented that “the court cannot get beyond the breach of the sacred trust in this kind of research. …The seriousness of this offense is just stunning.” He added that Han was an otherwise good man who “made a terribly tragic decision over and over again” who probably would not commit more crimes if granted probation instead of prison.
The harsh sentence is being discussed throughout the research enterprise. It has raised questions about the uneven nature of penalties for scientific misconduct, how alleged research fraud is handled in the U.S. and how the loss of taxpayer-funded research funds can be recovered.
For Cami Gearhart, Quorum Review CEO, the fraud case goes to the heart of an IRB’s major concern: a betrayal of public trust. “I applaud efforts by regulators and law enforcement to take steps to reinforce the integrity of our system,” said Gearhart, who declined to discuss Han’s prison sentence.
Also applauding the prosecution of Han is national bioethics expert Arthur Caplan, who told the Des Moines Register that while prison sentences for academic fraud are exceedingly rare, he expects the outcome to fuel discussion on how to prevent such dishonesty in the future.
“I think the message will rip through the research community that the ante has been upped,” said Caplan.
Email comments to Ronald at firstname.lastname@example.org. Follow @RonRCW
This article was reprinted from Volume 19, Issue 27, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »