Last week, the U.S. National Institutes of Health (NIH) imposed unusual new requirements on researchers based at Duke University in Durham, North Carolina, who receive federal funds. The changes are a response to concerns over how the institution handled recent cases involving research misconduct and grant management.
According to a Duke spokesperson, NIH now requires Duke researchers to obtain prior approval for any modifications to new and existing grants. And any Duke researcher submitting a so-called “modular application” for a grant worth less than $250,000 per year must include “detailed budgets” justifying the costs.
Duke faculty learned of the changes on 21 March, in a letter from university administrators. “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,” according to the letter.
“To my knowledge this is a fairly rare and extensive action taken by NIH, although within NIH’s authority,” says Torrey Young, a lawyer at Foley & Lardner LLP in Boston who has represented a number of institutions in matters involving research misconduct and grants accounting. “These additional administrative burdens potentially could delay funding and extensions, as well as significantly increase duties for Duke’s Office of Research Support. This may also lead to reputational harm to the institution, leading to difficulty recruiting researchers.”
Although the changes go into effect 1 April, the Duke spokesperson says the new guidelines won’t affect funding for current 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,” the spokesperson says. The university will also “be in close communication with the NIH to ensure that their concerns are fully and quickly addressed.”
In a statement, the NIH Office of Extramural Research said it could not discuss the details regarding its concerns about the university. NIH also said it has imposed similar requirements on other organizations in the past.
Duke has been hit by multiple high-profile misconduct cases in recent years. One such case involved Anil Potti, a once-rising star in cancer research who fabricated data, leading to 12 retractions, multiple lawsuits, and reprimands from the medical board. The university is also involved in an ongoing lawsuit filed by a whistleblower, which alleges that a pulmonary scientist, her supervisor, and the university included fraudulent data in federal documents associated with more dozens of grants worth hundreds of millions of dollars.
Lynne Klauer, a spokesperson for the U.S. Attorney’s Office for the Middle District of North Carolina in Durham—where the ongoing lawsuit against Duke is taking place—says both sides are still engaged in the discovery process, which may wrap up in early spring or summer. Klauer said she was unable to comment on any pending litigation, or how it might relate to the changes imposed on Duke by NIH.
The letter to faculty notes that Duke will submit a report to NIH about its current procedures and plans for improvement. It includes: “FACULTY AND STAFF SHOULD NOT CONTACT NIH DIRECTLY—these new directives are not subject to individual appeals and Duke must comply with these procedures.”