Stakeholders Respond to NIH Request on Transparency in Research
Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) have recommended that researchers receiving NIH grants report outside income to increase transparency of federally funded biomedical research.
The senators sent a letter to the NIH last week, responding to its May 8 Federal Register notice of potential changes to its disclosure policy. The American Academy of Orthopaedic Surgeons (AAOS) and Emory University - whose former Department of Psychiatry and Behavioral Sciences chair Charles Nemeroff had come under Grassley's scrutiny for allegedly receiving drugmaker money for speaking engagements - also submitted comments (WDL, Jan. 5).
In addition to recommending that researchers report outside income to the nearest $1,000, the senators also suggest that universities complete a plan to manage researchers' potential conflicts of interest. The plan and researchers' outside income also should be made public on the NIH's website, the senators write.
Grassley and Kohl cite a number of instances in which universities have failed to manage their professors' financial conflicts of interest. "It is clear that this is a pervasive problem that requires an immediate change in NIH requirements for disclosure of potential conflicts of interest by their grantees," the lawmakers say in their letter.
"With almost $24 billion in extramural funds distributed by NIH each year, and in light of the additional $10 billion provided by the American Reinvestment and Recovery Act to fund research grants, it is imperative that NIH properly fulfills its mission to advance the public's welfare and makes responsible use of the funding provided," they add.
Emory's response to the NIH notice says it "believes that requiring Investigators to report to their Institution all Significant Financial Interests related to their Institutional obligations is outside the realm of federal regulation and should remain an Institutional decision."
An array of enforcement options already exist, including suspension of funding and stop work orders. "These and the other enforcement options available to funding agencies appear robust enough to not warrant expansion," the university writes.
AAOS agrees that current options, especially the stop work orders, are sufficient to ensure institutional compliance with financial disclosure requirements. The group adds that many institutions have financial conflict-of-interest training, but implementing an online system for such training could ensure appropriate training.
"Independent confirmation of institutional compliance should not be required. The additional expense of such a system could decrease the available research funding, and again, create a disincentive for legitimate investigators," the group adds.