NIH places new regulations on Duke research in wake of prior misconduct cases

The National Institutes of Health issued additional regulations for researchers at Duke after high-profile research misconduct cases have surfaced at the University in recent years.

The guidelines, which take effect April 1, will require Duke researchers applying for grants under $250,000 per year to submit a detailed budget of their proposed costs. Researchers must also receive prior NIH approval when extending grant budget periods and carrying over unused funds into the next budget period. The new regulations, however, will not affect current research grants.

“Duke has already addressed many of the concerns that prompted this change through enhanced internal controls, education and training and new information systems, and will continue to look for opportunities to improve our oversight,” wrote Michael Schoenfeld, vice president for public affairs and government relations, in an email to The Chronicle.

Duke faculty learned of the additional regulations in a memo sent by Provost Sally Kornbluth, Chancellor for Health Affairs A. Eugene Washington, Mary Klotman—dean of the School of Medicine—and Marion Broome, dean of the School of Nursing.

“Duke will also be providing a report to the NIH by April 30 detailing our current policies and procedures, planned improvements, and assessment of our internal controls,” wrote the four administrators, in a copy of the memo obtained by The Chronicle.

They cited the development of new data systems, the addition of new grant administrator positions and expanded training in research ethics as evidence of the University’s effort to combat research misconduct in its laboratories.

The memo also noted that there was a link between the NIH’s restrictions and past controversies Duke has weathered over falsified research and embezzlement of research funds.

“NIH reports that these new requirements are a result of its concerns about Duke’s management of several research misconduct cases and grant management issues that date back to 2010, some of which have been widely reported like the Anil Potti case,” the administrators wrote.

In an email to The Chronicle, the NIH Office of Extramural Research wrote that NIH "takes seriously its responsibility to function as stewards of public funds."

"While we cannot discuss the details of the ongoing issues with Duke University, we often enhance our degree of grant oversight when concerns arise about an awardee’s ability to effectively and properly manage NIH research funds," the office wrote. "We expect to work with Duke University officials to address and correct any concerns."

Potti, a former cancer researcher at Duke, had engaged in misconduct by fabricating research that was subsequently used as the basis for clinical trials, according to a 2015 report from the government Office of Research Integrity. 

Much of Potti's research, which focused on analyzing a patient’s genes to predict the effectiveness of cancer drugs, was shown to be falsified. For example, in one grant application, he stated that nine out of 33 patients in a trial responded beneficially to a cancer drug, yet there were only four people in the trial, and none of them responded to the drug. Nine of Potti’s papers have been retracted since the allegations of misconduct surfaced.

As a penalty, the ORI mandated that Potti be supervised for any NIH-funded research he conducted for the next five years. Potti, who resigned in 2010, currently practices medicine at the Cancer Center of North Dakota in Grand Forks, according to the center's website.

Duke became the focus of another inquiry into potential research misconduct after six papers authored by former professor of medicine William Foster and former clinical research coordinator Erin Potts-Kant were retracted in the period from 2013-2015. Joseph Thomas, who worked in the pulmonary division alongside Foster and Potts-Kant, sued Duke for mishandling the allegations of misconduct. The lawsuit stated that the results presented in the retracted papers led to over $80 million in funding for grants to Duke researchers and $120 million to Duke-unaffiliated research grants. 

Potts-Kant—who was also arrested for embezzling nearly $15,000 in funding—later admitted to altering some of the data presented in papers. Sixteen of her papers have been retracted since her arrest in 2013.

In April 2017, the University’s motion to dismiss the lawsuit alleging research misconduct was denied, and in June, Duke acknowledged that the fraudulent data could have “potentially affected grant applications.”

Several professors whom The Chronicle contacted did not respond to requests for comment or referred The Chronicle to Schoenfeld's office.

“Duke is committed to upholding the highest standards of integrity in all our work and will of course adhere to the new guidelines,” Schoenfeld wrote. “The University looks forward to working with its scientists and administrators to ensure responsible stewardship of these grants and we will be in close communication with the NIH to ensure that their concerns are fully and quickly addressed." 


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