NIH releases new conflict of interest rules for researchers

The National Institutes of Health finally released rules Wednesday aimed at reducing financial conflicts of interest among federally funded researchers.

Researchers now will be required to disclose income from drug and medical device companies that exceeds $5,000 -- a cap lowered from $10,000. Scientists also will have to complete training on their institution's financial conflict of interest policy, and institutions will have to report to the Public Health Service information on conflicts of interest and how they are being managed. Some information on conflicts held by senior personnel must be accessible to the public, and the new regulations must be implemented within a year.

The new rules affect more than 40,000 researchers at universities and other facilities throughout the country who collectively receive 83 percent of the $30 billion NIH budget.

"Our financial conflict of interest rules must keep up with the times if we are to maintain our leadership role in the global scientific community," Health and Human Services Secretary Kathleen Sebelius said in a statement.

The new regulations have disappointed those seeking greater transparency, however. In May 2010, NIH originally proposed rules that would require academics and researchers receiving government grants to publically disclose online all contributions that could be perceived as a financial conflict of interest. The proposed system would have required the information remain on a public website for five years

Now, after pressure from the Office of Management and Budget, that proposal has been scrapped in favor of the current rules. Instead of a website, those interested will have to contact the university and ask for information regarding researchers' financial conflicts of interest. Universities' conflict management system is not required to be public.

An article published earlier this month in Nature magazine reported that OMB was blocking the proposed website rule.

Sen. Chuck Grassley, R-Iowa, became involved, sending a letter to OMB Director Jack Lew in early August asking him to reconsider.

"I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama's call for more transparency in the government," Grassley said in the letter. "The public's business should be public. The consequences of a lack of transparency include doctors' possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers. Transparency is a backstop against such practices."

After NIH released the new regulations, Grassley voiced his disapproval.

"Making the method of disclosure optional hurts public access. An institution that doesn't want to disclose information readily will be able to opt for the written request, knowing that requiring a request in writing is a barrier," Grassley said in a press release. "This is a missed opportunity to inject transparency where it's really needed."

Several university associations, including the Association of Medical Colleges and the Association of American Universities, have argued that a higher level of transparency would increase costs with little benefit.

"There are serious and reasonable concerns among our members that the Web posting will be of little practical value to the public and, without context for the information, could lead to confusion rather than clarity regarding financial conflicts of interest and how they are managed," the organizations stated in a letter to NIH.

The Project on Government Oversight has been urging NIH and OMB to increase transparency, publishing letters and meeting with the administration to discuss the issue.

Ned Feder, staff scientist for POGO, in an interview with Government Executive acknowledged the downsides of increased labor and costs, but said the advantages of transparency outweighed the disadvantages.

"What form of public disclosure these days even approximates disclosure on the Internet?" he said. "Financial contributions do have an effect on judgment. The federal government should insist on transparency in the financial arrangements of researchers whose work it supports."

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