HHS issued an updated final rule (PDF) aimed at “providing a framework for identifying, managing and ultimately avoiding” financial conflicts of interest among scientists conducting government-funded research.
HHS issues updated final rule on research, conflicts of interest
“The medical research conducted and funded by the federal government has long been the gold standard of scientific investigation,” HHS Secretary Kathleen Sebelius said in a news release. “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.”
The rule applies to any institution applying for or receiving an HHS public health service grant and it goes into effect Aug. 24, 2012.
The rule finalizes proposed changes made last year. And, according to the release, it includes “major changes” to regulations concerning disclosure, public reporting and researcher training. A summary on the National Institutes of Health website lists new changes such as lowering the threshold for disclosure of payment for services or equity interests to $5,000 from $10,000; requiring travel expense reimbursement disclosure; and requiring the name of the entity with which the researcher has a financial conflict of interest, the nature the conflict—such as equity, consulting fees or honoraria—and the value of the interest.
In the rule, it's noted that the purpose of the original 1995 regulations was to protect against the design, conduct or reporting of any HHS-funded research being biased by researchers' financial conflicts of interest.
It is also stated that “The growing complexity of biomedical and behavioral research; the increased interaction among government, research institutions and the private sector in attaining common public health goals while meeting public expectations for research integrity; as well as increased public scrutiny, all have raised questions as to whether a more rigorous approach to investigator disclosure, institutional management of financial conflicts, and federal oversight is required.”
The rule was received positively by the Association of American Medical Colleges.
“Today's final rule from the NIH is an important step forward on the path to strengthening the integrity of biomedical research through enhanced requirements for disclosure and transparency,” Dr. Darrell Kirch, AAMC president and CEO, said in a news release.
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