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 a change from the 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. 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. ASH submitted comments concerning these specific issues and the Society is pleased the final rule incorporated its recommended changes.
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."
The final rule represents 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, the agency has never terminated a grant for non-compliance.
The issue of corporate payments to medical researchers has received significant attention and concern of policy makers 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 Senator Charles E. Grassley (R-IA) requires drug and medical device makers to disclose all payments made to physicians and researchers starting next year.
For more information about the final conflict of interest rules, please visit the NIH website.
For information about ASH's conflict of interest policy, please visit the Society’s website.
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