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NIH still bedevilled by conflicts of interest issue - November 20, 2009

nih og rep nov 09.bmpPosted for Meredith Wadman

The National Institutes of Health (NIH) is once again under fire for lax oversight of conflicts of interest among the extramural researchers it supports.

A November 18 report by the Inspector General of the Department of Health and Human Services, the NIH’s parent agency, recommends that the agency significantly tighten its policing of conflicts. NIH is the world’s largest biomedical research funder, and it channels 80% of its $31 billion budget to extramural grants.

The inspector general reached his conclusions by examining the financial conflict documentation from 41 extramural institutions for the government’s 2006 fiscal year. Current regulations require grantee institutions to “reduce, manage or eliminate” conflicts reported by their researchers that could reasonably be affected by their NIH-funded work.

The inspector found that, among the documentation for 184 conflicts involving 165 researchers, only six researchers’ conflicts were eliminated by their universities. The lion’s share, totalling 136, were “managed”. Grantee institutions “rarely” reduce or eliminate conflicts, the report concluded.

Among the report’s recommendations: that universities collect financial interest data in specific dollar amounts and not in ranges such as “$10,000-$50,000”. It also recommends that NIH require researchers to report to their institutions all their financial interests and not just those that they judge could reasonably be affected by their NIH-supported research.

“Full and complete disclosure ensures that the determination of whether a significant financial interest relates to the research rests with the grantee institution and not with the researcher,” the report argues.

Specific dollar amounts would certainly shed more light on the equity holdings of researchers. These were found by the inspector to be the most common financial interest, with 111 of the researchers reporting equity holdings, and six of these holding more than $100,000.

NIH is in the process of rewriting its conflict of interest reporting requirements; it is expected to issue new regulations by year’s end (see: Researcher payment reporting under scrutiny).

The report follows a similar briefing from the inspector general in January 2008 (see: NIH in the dark over conflicts of interest). Investigations by Senator Charles Grassley have pointed out several cases of underreporting of six-figure amounts by NIH-funded researchers (see: Money in biomedicine: The senator's sleuth).

Sally Rockey, acting deputy director of the office of extramural research at NIH, said in a statement that, "NIH has demonstrated its commitment to oversight activities and continues to make them an agency priority." She added that the inspector's recommendations "will be considered by the NIH along with public comments ... as it formulates a new regulation that will facilitate effective compliance."

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