The National Institutes of Health suspended seven Duke research grants in early 2018 in response to research misconduct allegations and patient safety concerns.
A March 2018 letter from the NIH cited a previous letter that Duke had sent the NIH in December 2017 in which the University revealed research misconduct allegations against investigators in the psychiatry department and "clinical research irregularities."
"Due to a lack of details concerning patient and welfare and safety and with no further communications from Duke, in a letter dated January 31, 2018, NIH asked Duke to respond to NIH's overarching concern for the welfare and safety of research participants as well as several pertinent questions concerning the reported research irregularities," the March 2018 letter states.
All seven grants have since been reinstated with no findings of research misconduct during an investigation in response to the "anonymous allegations," wrote Michael Schoenfeld, Duke's vice president for public affairs and government relations, in an email to The Chronicle.
This is the latest irregularity to come to light in a line of research misconduct allegations the University has weathered over the past 10 years. The NIH placed restrictions on Duke in March 2018, requiring researchers applying for grants to submit detailed budgets and seek NIH approval when carrying unused funds into the next budget period.
In March, Duke paid $112.5 million to the federal government to settle a lawsuit that alleged that Duke brought in $200 million in research grants due to doctored data.
Former lab analyst Joseph Thomas filed the lawsuit in 2015 under the False Claims Act and alleged that the University used the falsified data to collect the grant money. The lawsuit cited the work of Erin Potts-Kant, a researcher in the pulmonary, allergy and critical care department of Duke Health, who has had at least 16 papers retracted after her data was called into question.
Anil Potti, a former Duke cancer researcher, fabricated research on how a patient's genes predict and affect the ability to respond to cancer drugs and the chance of relapse, according to a 2015 report from the federal Office of Research Integrity. The report also found that Potti's data was then used as the basis for clinical trials.
Potti parted ways with the University in 2010 but currently practices medicine at the Cancer Center of North Dakota in Grand Forks, according to the center's website.
Schoenfeld highlighted the initiatives Duke has recently undertaken to improve research integrity, including the appointment of Geeta Swamy as associate vice provost and vice dean for scientific integrity, the creation of an advisory panel on research integrity and excellence, mandatory research conduct training and improvements in clinical research oversight through the Clinical Quality Management Program.
"NIH takes seriously its responsibility to function as stewards of public funds," the NIH Office of Extramural Research wrote in an email to The Chronicle. "We have outlined in detail our expectations of awardees of Federal grant funds. While we cannot discuss the details of the 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."
Moira Rynn, chair for the department of psychiatry and behavioral sciences at Duke, did not respond to a request for comment from The Chronicle.
Read the full March 2018 letter from the NIH to Duke here:
Editor's note: This story was updated Friday morning to include NIH's comment to The Chronicle.
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