Duke to pay government $112.5M for using fake data to obtain research grants

Duke University officials announced Monday that the school will pay $112.5 million to the federal government to settle a lawsuit over falsified data on research projects that was used to obtain grants from the National Institutes of Health and other federal agencies.

Officials said the alleged misconduct occurred from 2006 to 2013, when Duke officials fired Erin Potts-Kant, the technician accused of fabricating the data, for embezzling grant funds from the university over the same period.

"We expect Duke researchers to adhere always to the highest standards of integrity, and virtually all of them do that with great dedication," Duke President Vincent Price said in a statement. "When individuals fail to uphold those standards, and those who are aware of possible wrongdoing fail to report it, as happened in this case, we must accept responsibility, acknowledge that our processes for identifying and preventing misconduct did not work, and take steps to improve."

The $112.5 million payment includes both reimbursement for grants received as a result of the falsified data and associated penalties.

Duke has taken the following steps to improve the quality and integrity of research conducted on campus:

• Appointed an Advisory Panel on Research Integrity and Excellence, chaired by Ann M. Arvin, professor of pediatrics and microbiology and former vice provost and dean of research at Stanford University, and including Edward M. Stolper, William E. Leonhard Professor of Geology and former provost of the California Institute of Technology, and Barry S. Coller, David Rockefeller Professor, physician in chief and vice president for medical affairs at Rockefeller University. The advisory panel will provide recommendations for improving the structure and function of research administration, with a focus on promoting research integrity, by June 30.
• Established a new, integrated leadership structure for research to provide clear and consistent policy guidance, oversight and accountability for all research at Duke University and Duke Health.
• Launched an initiative to promote values and a culture of excellence and accountability at Duke.
• Created an Executive Oversight Committee, chaired by Chancellor for Health Affairs A. Eugene Washington and including senior leadership and faculty, and a related Faculty Advisory Committee to oversee the ongoing implementation of Duke’s research excellence initiative.

Duke spent three years reviewing more than 50 potentially compromised research grants and Potts-Kant's experiments, which involved measuring the lung function of laboratory mice using highly specialized equipment. The research wasn't connected to any human subject or clinical research, officials said.

The school also retracted scientific publications that relied on the data.

This isn't Duke's first encounter with fraudulent research.

The federal government determined that Dr. Anil Potti, who resigned in 2010, exaggerated claims that he discovered a better way to treat cancer.

Duke halted work on his clinical trials after learning he also lied about his credentials, including claiming that he was a Rhodes Scholar. The university later retracted nine articles published on Potti's research after the falsified data came to light and Duke settled lawsuits brought by patients in the clinical trial and the estates of patients who had since died.

After the Potti case, Duke appointed Geeta Swamy as associate vice provost and vice dean for scientific integrity. Swamy leads the Office of Scientific Integrity, which includes the Advancing Scientific Integrity, Services and Training (ASIST) initiative, and oversees conflicts of interest, research misconduct, a new institutional research incident response team and the Clinical Quality Management Program.

The university in recent years also has required Responsible Conduct of Research training for all School of Medicine faculty and staff involved in research, as well as science and accountability plans for all School of Medicine units.

"Through these efforts, many of which have been underway for several years, we aim to promote and adhere to the highest standards of research excellence and integrity," Price said. "We continue to have great confidence in the high quality of Duke faculty and their research. This settlement, which results primarily from willful misconduct that took place in one laboratory, but which affected the work of many more researchers, should not diminish the life-changing and life-saving work that takes place at every day at Duke. Our difficulties in ferreting out and ending such misconduct remind us that important work remains to be done."