Plan tightens regulations but waters down proposal to publicly disclose financial conflicts.
NIH director Francis Collins says tighter financial conflict rules will strengthen public trust.Elie Dolgin
After more than two years of deliberations, the US National Institutes of Health (NIH) today issued a financial conflict-of-interest policy that would create more substantial reporting requirements for federally funded investigators and their institutions.
But the policy also takes a step back from a proposed requirement that institutions post such conflicts on publicly accessible websites. Under the final rule, institutions can opt out of maintaining a public website if they make the information available upon request within five business days of receiving an inquiry.
The updated regulations are intended to tighten conflict-of-interest oversight and to preserve public trust in the face of growing relationships between academia and industry, NIH director Francis Collins said today in a press briefing. “We’re confident that the results will further add to the public sense of confidence in the scientific process and the results that come out of NIH-funded research,” he said.
The NIH has been under pressure to crack down on financial conflicts of interest since investigations spearheaded by Senator Charles Grassley (Republican, Iowa) uncovered researchers who had neglected to report millions of dollars of income from companies with a stake in their research.
In keeping with draft regulations proposed in May 2010, the final policy lowers the threshold at which an investigator’s financial interest must be declared from $10,000 to $5,000. Previous guidelines, set in 1995, required that institutions merely reported an investigator’s financial conflict of interest and whether it was being managed, decreased or eliminated. Now institutions must also provide some detail as to how they are dealing with the conflict. Those management plans, however, still do not have to be made public.
To boost transparency, the draft guidelines released last May also proposed a requirement that institutions post financial conflicts on a publicly accessible website. Earlier this month, Nature News reported that the NIH had dropped that requirement after coming under pressure from the White House Office of Management and Budget (see Conflict disclosure plan dropped). In January, President Barack Obama tasked that office with evaluating and minimizing the cost of new regulations. The NIH estimates that, overall, the new policy will cost 25% more than the 1995 regulations, and that the cost of implementing the public disclosure requirements across 2,000 institutions would be $350,000.
Without the website requirement, however, public trust could be damaged, argues Ned Feder, a staff scientist at the Project on Government Oversight in Washington DC. Requiring a request in order to retrieve the information is a “barrier”, he says. “It really is a shame.”
But the added flexibility will come as a relief to universities, says Carrie Wolinetz, associate vice president for federal relations at the Association of American Universities in Washington DC. Many universities expressed concern about the added financial burden of establishing and maintaining the websites, she says, and questioned whether it would benefit the public.
“It would just be information up on the website, without any sort of context or education about what the information really meant,” she says. “I think the flexibility in the new rule is a good middle ground.”
Meanwhile, Sheldon Krimsky, an ethicist at Tufts University in Boston, Massachusetts, is most concerned with how the regulations allow institutions to designate an official to determine whether an investigator’s financial interests pose a conflict. “That designated official may be thinking, ‘Well I know this person, and he’s not going to let money affect the outcome of his research’,” says Krimsky. “It’s setting the bar too high.”