NIH Suspended Some Grants to Duke Amid Concern for Patient Safety

Ivan Oransky, MD

May 21, 2019

The US National Institutes of Health (NIH) last year suspended seven grants to Duke University in Durham, North Carolina, "to assure the welfare and safety of research participants," Medscape Medical News has learned.

The move came after a December 15, 2017, letter from Duke to NIH referring to "allegations of research misconduct against several investigators in the Duke Department of Psychiatry and...potential issues concerning clinical research irregularities such as not adhering to the research plan, inadequate reporting of adverse events to the [institutional review board] IRB and regulatory agency, and signing data forms without conducting assessments," according to a March 12, 2018, letter from the NIH to Duke that was recently obtained by Medscape Medical News.

"Due to lack of details concerning patient 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 NIH wrote.

The case is at least the third at Duke in the last decade that has drawn intense scrutiny from federal regulators. In 2015, after a prolonged investigation, the US Office of Research Integrity (ORI) found that Anil Potti, MD, once a cancer researcher at the university, "engaged in research misconduct" in work supported by federal grants. In March, the university settled a whistleblower lawsuit alleging misconduct in lung research for $112.5 million.

In 1999, federal regulators briefly shut down all clinical trials at Duke because of issues in its IRB process. Michael Carome, MD, director of the health research group at the nonprofit consumer advocacy organization Public Citizen, was with the Office for Protection from Research Risks (OPRR; now the Office of Human Research Protections) at the time, and told Medscape Medical News that what is described in the 2018 letter is "really reminiscent of circumstances that occurred in 1998 and 1999 regarding the Duke system for protecting human subjects."

In 1998, there had been a number of allegations that led the OPRR to conduct a site visit. "We looked at records related to dozens of research studies," Carome said. "We confirmed that there were serious noncompliance issues that had been going on for a number of years."

Duke's responses to a letter from OPRR outlining these issues "were inadequate," Carome said, and in May 1999 the agency suspended Duke's ability to conduct all clinical trials. At that point, Duke responded appropriately, Carome said, and trials were allowed to resume.

"You see that same pattern here," Carome said. "The NIH, in this letter, is describing circumstances in which Duke is not responding adequately. It's certainly a pattern of extended noncompliance, a history of noncompliance that has spanned multiple areas over multiple decades."

In the current case, the funding agency "suspended the seven NIH grant awards identified as impacted by these issues until Duke is able to assure the welfare and safety of research participants." The grants are no longer suspended, Duke told Medscape Medical News, and no patients were harmed as a result of the irregularities.

The March 12, 2018, letter also informed Duke that its grants would be subject to stricter oversight because of how the university had mishandled "several misconduct cases."

Retraction Watch had filed a public records request for the letter a year ago, but none of the federal agencies involved had yet produced it. The letter recently became available as part of court filings in the whistleblower case.

Duke "Expressed Confusion"

The NIH would not say which grants or investigators were involved in the allegations involving the psychiatry department, nor would Duke, whose spokesperson, Michael Schoenfeld, cited "ORI, NIH, and Duke policies that prohibit naming individuals and projects in cases where there are no findings of research misconduct." The investigation "of these anonymous allegations did not result in any finding of research misconduct," Schoenfeld said.

"NIH takes seriously its responsibility to function as stewards of public funds," the NIH Office of Extramural Research wrote in an email response to questions from Medscape Medical News. "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."

The NIH wrote in its March 2018 letter that it was "of particular relevance" that on a February 5, 2018, phone call, "Duke expressed confusion about how to manage NIH awards under these circumstances of misconduct allegations; acknowledged that Duke did not follow NIH protocol, including the requirement in the terms and conditions of NIH awards to notify NIH and seek approval for changes in senior/key personnel; and specifically asked for NIH's further guidance and assistance."

A February 14, 2018, letter from Duke "did not sufficiently address our concerns, including but not limited to: failure to note halts to study enrollment in NIH progress reports, enrollment of ineligible patients into clinical protocols, and ambiguity as to whether the IRB has been (as opposed to "will be") notified of protocol deviations," the NIH wrote.

"Over the past several years, Duke has implemented a number of education and oversight initiatives to address research integrity," Schoenfeld said. Those have included a "Clinical Quality Management Program (CQMP) for investigator-initiated studies that are not otherwise externally monitored," training in the responsible conduct of research, and the appointment of Geeta Swamy, MD, as associate vice provost and vice dean for scientific integrity.  

The university has also appointed a new advisory panel on research integrity and excellence that includes members from Stanford University, Caltech, and The Rockefeller University.

Ivan Oransky, MD, is Medscape vice president for editorial and cofounder of Retraction Watch.

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