Financial conflicts of interest that could bias researchers funded by the U.S. National Institutes of Health (NIH) are rare, a report released last week found: About 3% of the 55,600 grants the agency awarded in 2018 involved at least one researcher reporting such a conflict. But some experts question whether the data are capturing all relevant conflicts.
The 25 September report by the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS), NIH’s parent agency, follows a 2008 OIG analysis that found NIH was not collecting adequate data on financial conflicts, such as payments from drug companies for consulting or royalties from patents. The report helped prompt HHS to tighten its reporting rules, which now require investigators to tell their institution about all conflicts related to their institutional duties. The institutions then tell NIH about those that could bias an NIH-funded research project and explain how the conflict will be managed.
A decade on, NIH’s improved tracking system allows a count for the first time. OIG found that in 2018, 202 of 2064 grantee institutions reported any financial conflicts of interests. A total of 1668 unique grants had at least one conflict. In total, 3978 separate “significant financial interests” were reported, because grants can have more than one investigator, and each investigator can have several types of conflicts.
About half of these significant financial interests involved researchers holding an equity stake in a company. One-fourth involved payment for services. Institutions said they could not readily report monetary values for about 45% of reported conflicts, mostly because they involved privately owned equities, the OIG report says. When institutions did tell NIH dollar values of significant financial interests posing conflicts, 85% were less than $100,000 (see graph).
The report urges NIH to correct inconsistencies with how officials at different NIH institutes scrutinize information on reported conflicts. NIH should also consider asking institutions specifically about researchers’ foreign conflicts of interest, amid rising concern that scientists with funding from China and other countries are threatening the integrity of U.S.-funded biomedical research.
Although the rate of 3% of grants with a conflict of interest might seem low, it “doesn’t sound unreasonable” because NIH only wants to be informed about conflicts that could bias a specific NIH-funded project, says Heather Pierce, a policy expert for the Association of American Medical Colleges in Washington, D.C. An investigator could have many other financial ties, such as those that show up in a federal database of payments that drug companies make to physicians, that have nothing to do with a specific NIH grant, she notes.
But the low number of reports surprises some experts on conflicts of interest in biomedicine. In surveys and other studies, about 25% or more of academic biomedical researchers have reported industry relationships, notes Sheldon Krimsky of Tufts University in Medford, Massachusetts. The OIG report “doesn’t tell us the whole story,” he says. And research integrity expert Lisa Bero of the University of Sydney in Australia says many researchers don’t understand the reporting rules—such as a prominent cancer researcher who lost his job because he thought many of his payments from drug companies did not need to be reported in his research papers. Bero suggests allowing investigators to determine which conflicts they believe are relevant to their work and should be reported to their institutions “is a real loophole” that could be minimizing the true scope of financial conflicts.