NIH criticized for lax oversight of grants

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The National Institutes of Health doles out billions to universities for research without ensuring grantees' compliance with federal financial conflict-of-interest regulations, a government report found. And the agency is hesitant to step up the oversight.

In fiscal year 2007, NIH appropriated $29.2 billion, 80% of which went to universities, medical schools and other research institutions across the country and around the world.

Yet, “Many Institutes' primary method of oversight is reliance on grantee institutions' assurances that financial conflict-of-interest regulations are followed,” asserts the report by the US Office of Inspector General.

It's common for researchers based at medical schools to consult for pharmaceutical and device manufacturers. These ties can present ethics challenges, especially if the consulting payment could be viewed as influencing a researcher's opinion.

OIG recommended that NIH, as an oversight body, should take a more active role in overseeing financial conflicts of interest among grantee institutions. That means collecting details of the nature and management of financial conflicts of interest. But that's not about to happen. In a response, NIH countered that collecting such details is the university's legal responsibility.

NIH overhauled its ethics policy in 2005, including a ban on outside consulting, but the rule applies only to agency employees (MM&M, October 2005).

As part of its inquiry, OIG asked the 24 Institutes with grant-making authority to turn over information on conflicts of interest among the institutions to which they awarded funds.

NIH provided only 438 reports for fiscal years 2004 through 2006. That's not an accurate count, OIG stated in the 30-page report. The problem stems from the fact that NIH lacks a central source for providing a total count of financial conflict-of-interest reports. OER, its Office of Extramural Research, does maintain a database of grants given to universities, but it's incomplete.

Furthermore, of the reports collected, at least 89% did not state the nature of the conflicts or how they would be managed. That's because regs do not explicitly require such details to be reported. Only 30 of the 438 reports included detailed financial conflict-of-interest descriptions, while 15 provided a detailed description of how conflicts would be managed, reduced or eliminated.

The FDA also has struggled to ensure public trust in its advisory committee members. Last year a CBS News analysis found that, since 2002 medical professionals had registered 189 conflicts of interest at 86 advisory committee meetings.

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