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NIH to tighten rules on conflicts

New regulations would increase oversight of payments to researchers.

Recent scandals have raised concerns about biomedical researchers.

After a wave of financial scandals over the past few years involving biomedical researchers, the US National Institutes of Health (NIH) proposed far-reaching changes today that would lead to much tighter oversight of agency-funded extramural investigators and their institutions.

In the first proposed overhaul of financial reporting regulations since 1995, the agency is moving to counter a growing public perception that biomedical researchers are being compromised by increasingly numerous and lucrative consulting relationships with drug and device companies.

"This will be a substantial change in the way in which NIH seeks to oversee potential conflicts of interest," Francis Collins, the NIH director, said during a press teleconference today. "The public trust in what we do is just essential. And we cannot afford to take any chances with the integrity of the research process."

Senator Charles Grassley, the Iowa Republican whose investigations have exposed several researchers who failed to report lucrative company income related to their publicly funded work, called the new proposal "an important step in the right direction".

"Enforcement of current requirements has been lax, and the federal agency has failed to send a message to grantees that accountability in this area matters," Grassley said in a statement (see Money in Biomedicine: The Senator's Sleuth). He spearheaded legislation, enacted this year, that will require companies to publicly report payments to physicians of any kind above $10, starting in 2013. The new NIH rules would cover all researchers, whether or not they are physicians, who receive funding from the agency.

The proposed rules state that a "significant financial interest", or SFI, exists when the combined value of an investigator's equity holdings in, and payments from, a publicly traded company exceed $5,000 in any given year. Under current rules, the reporting threshold is set at $10,000.

Any amount of equity in a privately held company would be considered an SFI under the new rules.

Wider reach for reporting requirements

Principal investigators and other key personnel on any NIH-funded project would be required to annually report a large range of SFIs to their institutions, embracing anything that could touch on their "institutional responsibilities" broadly construed, and not only those that could conceivably pertain to specific NIH-funded research projects. Under current NIH rules, investigators are required to report to their institutions only the SFIs that they themselves deem relevant to their NIH research.

Institutions would be required to assess investigators' SFIs to identify those that are true financial conflicts of interest (FCOIs). They would then report these to NIH, in far greater detail than is now the case. For instance, institutions would have to alert the agency to the size of any FCOI. They would also have to draw up and implement a management plan for every conflict, and report its details to NIH. At present, institutions must simply report the fact that they have managed, reduced or eliminated a conflict, without going into details.

The proposed changes "will allow NIH to determine whether the institution has made the proper decisions," said Sally Rockey, NIH's acting deputy director for extramural research. "It will give us a much broader look at the nature of the decision that they made."

In addition, institutions will have to develop publicly accessible websites on which the financial conflicts of their NIH-funded investigators are to be posted. The websites would report the worth of any given financial interest in ranges, the lowest being less than $20,000 and the highest over $250,000.

Failures to enforce the new rules could be punished by NIH with a range of actions; the agency could impose special award conditions, withhold funding until a problem is resolved or terminate an award altogether.

One key group welcomed the proposal. "This is a significant milestone. It says volumes about NIH's commitment to maintaining the public trust," says Ann Bonham, the Chief Scientific Officer at the Association of American Medical Colleges (AAMC) in Washington DC. The AAMC had recommended a $5,000 reporting threshold in comments it submitted to NIH last summer.

Some groups had urged a lower threshold. The Federation of American Societies for Experimental Biology last year suggested that any payment or equity interest worth over $200 should be considered significant. And some institutions have adopted similar reporting rules for their faculty independent of NIH.

Rockey said that, although NIH is still open to argument on lowering the $5,000 threshold, "we were extraordinarily concerned about the administrative costs" that would be associated with requiring disclosures at a far lower amount. "We determined that those would probably outweigh the intended benefit of the regulations," she said.

The proposed changes will be formally published in the Federal Register on 21 May and will then be open for public comment for 60 days. Collins said that NIH would issue a final rule "later this year".


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NIH’s proposed changes in conflict of interest reporting requirements for extramural researchers

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Wadman, M. NIH to tighten rules on conflicts. Nature (2010).

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