The National Institutes of Health (NIH) in Bethesda, Maryland, is not doing an adequate job of overseeing conflicts of interest involving the researchers who receive its grants, according to a new report from federal investigators. The report says NIH should collect more details on how universities are managing conflicts, but NIH says that's not its job.
The report comes amid growing concerns about conflicts of interest in biomedical research, such as instances in which an investigator has a financial stake in a company whose drug he or she is testing. NIH has faced questions about similar types of conflicts involving its extramural grantees, who get 80% of the institute's $29 billion budget. For example, an investigator might have patents related to his or her NIH-funded research or own stock in a company that's a subcontractor on a grant. Federal rules require that such conflicts be "managed," for example, by disclosing them or adding a researcher without a conflict to the project. Although NIH leaves the actual managing to institutions, the institute is supposed to file reports on its policies and procedures.
That system isn't working very well, concludes the Inspector General (IG) of the Department of Health and Human Services (HHS) in a 30-page report released today. One problem is record-keeping: While NIH gave the IG office 438 reports for 2004 to 2006, NIH's 24 grantmaking institutes indicated they had more reports but didn't have time to dig them out of their files. HHS is also concerned because most of the reports contain no details about the conflicts. This leaves NIH grants officials unable to make sure conflicts are being adequately managed, the report says.
In a response included in the report, NIH agreed with two of the IG's recommendations: that it should monitor institutions' policies more closely, and that it should maintain a central NIH database of all conflict-of-interest reports. But it disagreed with a third recommendation that universities file more detailed reports. That would shift responsibility for managing of conflicts to NIH, the agency suggests. Keeping that role with institutions is "an appropriate framework," NIH wrote. NIH Deputy Director for Extramural Research Norka Ruiz Bravo says the agency has other ways to make sure institutions are handling conflicts properly, such as site visits.
The Association of American Medical Colleges (AAMC) agrees with NIH, calling the recommendation to require more details "unfeasible" in a statement. Not only would it require a "regiment of experts" at NIH to collect the information and look for problems, says AAMC senior vice president for biomedical and health sciences research David Korn, but institutional officials who know the investigators are better able to manage their conflicts. "It's not cookie-cutter stuff," Korn says. "There are always circumstances that need a custom-tailored response." If NIH follows the report's advice to amend the regulations, Korn says, "the universities would fight extremely hard to not let that happen."