The National Institutes of Health has finalized rules to reduce financial conflicts of interests among federally funded researchers who also receive payments or stock from drug and medical device companies.
The rules, which will affect more than 40,000 researchers, come after a string of high profile cases in which federally funded researchers failed to disclose millions of dollars from companies with a financial interest in the outcome of their work.
Researchers who receive more than $5,000 in income from drug or device companies must disclose the payments. Universities or other institutions employing the researchers must collect the data and provide for public access to it.
But in an about-face from proposed rules announced last year, institutions will not be forced to disclose conflict-of-interest information online. Instead, they may maintain the data offline and provide it only when requested.
This change reduces the administrative burden of the proposed public disclosure rule for institutions employing federally funded researchers, said Sally Rockey, the NIH’s deputy director for extramural research.
Universities also will be required to develop plans to manage the financial conflicts of individual researchers, but the plans do not have to be made public.
Praising the “vast majority of researchers” as ethical and sensitive to conflicts of interest, NIH Director Francis S. Collins called the new rules “an insurance plan against potential trouble downstream.”
Collins added that the rules will ensure that government-funded researchers can continue working with private companies.
“We depend critically on those [relationships] for advances in biomedical research, but we do want to make sure . . . that the highest standards of transparency and integrity are maintained,” Collins said Tuesday during a teleconference.
Tuesday’s announcement completes the first updating of the conflict-of-interest rules since 1995. As before, violations may be punished by suspension or termination of research funding.
While the NIH has temporarily suspended research grants after investigators failed to disclose outside income, Rockey said the agency has never terminated a grant for non-compliance.
In 2008, a research psychiatrist at Emory University, Charles Nemeroff, failed to disclose $1.2 million in payments from GlaxoSmithKline and other drug companies.
Watchdog groups immediately attacked the new rules.
“They’re playing hide the ball on this,” said Paul Thacker, an investigator with the nonprofit Project on Government Oversight. He said all conflict-of-interest information should be published online. “The take-home message is that these are half steps. [NIH] could have taken steps that ensured the trust of American taxpayers who are funding this research, but they chose not to take those steps.”
A spokesman for PhRMA said the drug industry lobbying group is reviewing the new rules.
The issue of corporate payments to medical researchers has exploded in recent years. In an influential 2009 report, the Institute of Medicine said such conflicts “threaten the integrity of scientific investigations.”
Several states have laws requiring public disclosure of physician and researcher income from drug and device companies.
On the federal level, a “sunshine” provision in the health-care reform act of 2009 pushed by Sen. Charles E. Grassley (R-Iowa) requires drug and medical device makers to disclose all payments made to physicians and researchers starting next year.