Some medical researchers at Duke University may face extra red tape as the federal agency that pays for their work tries to make sure the school's riding herd on their money.
The National Institutes of Health have told Duke officials they'll have to secure its permission ahead of time if they want to "carry forward" unspent money from a grant from one fiscal year to the next, or if they want to extend an unfinished project using any unspent grant money previously earmarked for it.
Professors learned of the decision Wednesday, via a memo co-signed by Provost Sally Kornbluth, Chancellor for Health Affairs Eugene Washington and two other senior administrators.
Kornbluth, Washington and their colleagues acknowledged the clampdown is "a result of [NIH] concerns about Duke's management of several research-misconduct cases" and other problems.
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They acknowledged that one of the cases involved Anil Potti, a disgraced former cancer researcher who in the late 2000s falsified data that went into journal articles and grant applications. He resigned in 2010.
It's possible that another concerns Erin Potts-Kant, the former lab technician that Duke has admitted in court fabricated data that went into 29 medical research reports early this decade.
The significance of the NIH move is that the federal agency, which funds tens of millions of dollars worth of research at Duke each year, seems worried about "more than just individual bad actors," said Torrey Young, a Boston-based lawyer who's worked on research-misconduct cases.
"It’s a call for making sure the entire process is being overseen by the university, which is the ultimate recipient of the grant funds," Young said. "Historically, a lot of research misconduct cases have focused on the individual investigator. This is drawing more attention to institutional processes."
Kornbluth and the other administrators said Duke will give the NIH a report by April 30 that explains "our current policies and procedures, planned improvements, and assessment of our internal controls."
That should "cover many of the improvements in research administration we have made over the past 10 years," which include better training and software, and the hiring of more grant-oversight staff, they said.
Duke's chief spokesman, Vice President for Public Affairs and Government Relations Michael Schoenfeld, said the added paperwork demands "will not impact funding for current research grants."
He added that Duke believes it's "already addressed many of the concerns" and "will continue to look for opportunities to improve our oversight."
The added NIH requirements take effect Sunday and also address a specific class that can supply a researcher up to $250,000. For those, Duke will have to turn in "detailed budgets" before the NIH hands out any money.
The true paperwork burden will likely fall on back-office functionaries the university and units like the School of Medicine employ to help professors with their grant applications, accounting and financial reporting. But the demands for up-front permission complicate otherwise-routine sorts of requests, Young said.
"Knowing that NIH is going to be looking closely at all of these might change the level of scrutiny [they receive on campus] before they let them go out the door," she said.
It's not particularly clear why the NIH is only acting on the matter now, given the age of the known misconduct cases. But "these cases very often take a long time," particularly when they involve litigation or a federal Office of Research Integrity investigation, Young said.
The Potts-Kant case is the focus of an ongoing federal whistle-blower lawsuit that alleges the former lab tech compromised research grants worth $112.8 million to Duke and a further $120.9 million to institutions like UNC-Chapel Hill and N.C. State University.
Potti, meanwhile, agreed to a settlement with the Office of Research Integrity that essential gave the feds a temporary right to veto his participation in research they're funding.
In both cases, critics alleged that Duke was at the very least slow to act on warnings of possible misconduct. The person behind the whistle-blower lawsuit, former lab analyst Joseph Thomas, contends the university actually tried to cover up the fraud that ensued from Potts-Kant's data fabrications or falsifications.