NIH considers revisions in federal conflict-of-interest rules
■ Organizations say researchers should disclose all financial interests, whether related directly or indirectly to their research.
By Susan J. Landers — Posted July 22, 2009
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The National Institutes of Health is considering the first re-examination since 1995 of the Public Health Service conflict-of-interest regulations for researchers who seek federal funding.
As a first step, the NIH solicited public input on how to revise several areas of the rules. Comments were due July 7.
"Given that it's been 14 years since the regulations went into effect, this is an opportunity to step back and see whether these rules are working as well as we'd like them to work," said Susan Ehringhaus, senior director and regulatory counsel for the Assn. of American Medical Colleges. "The answer is, probably not."
The NIH Advance Notice of Proposed Rulemaking comes at a time of heightened public focus on conflicts in medicine, including failures by physicians to disclose ties with drug companies and the elimination of negative findings in research studies. In an April report, the Institute of Medicine called on academic medical centers, journals and professional societies to strengthen their conflict-of-interest policies.
The NIH asked six questions in its notice. They included: Should investigators disclose all financial interests regardless of dollar value? Should the definition of "significant financial interest" be revised? How should institutional compliance be defined? Institutional conflict of interest is not currently addressed by the regulations.
In a joint letter to the NIH, the AAMC and the Assn. of American Universities recommended that investigators be required to report to their universities all financial interests, whether related directly or indirectly to their research. The groups also recommended that the NIH lower the threshold for disclosing financial interests from $10,000 to $5,000.
In its comments, the Federation of American Societies for Experimental Biology recommended that the Public Health Service develop and make available to all researchers an electronic universal reporting form to ensure compliance with requirements while minimizing regulatory burden.
The NIH will review the comments and issue proposed regulations.