NIH to tighten rules on conflicts

Published online 20 May 2010 | Nature | doi:10.1038/news.2010.257

New regulations would increase oversight of payments to researchers.

Meredith Wadman

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.

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