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August 23, 2011 -- New conflict of interest rules issued today by the U.S. Department of Health and Human Services and the National Institutes of Health provide a new framework to help researchers involved in federally sponsored medical research identify, manage, and ultimately avoid financial conflicts. The new rules are the first update since 1995 and seek to enhance the objectivity and integrity of the research process.
“The medical research conducted and funded by the federal government has long been the gold standard of scientific investigation,” said HHS Secretary Kathleen Sebelius. “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.”
Among the major changes to the regulations are the definition of significant financial interest (SFI), the extent of investigator disclosure, the information reported to the Public Health Service (PHS) awarding component, the information made accessible to the public, and investigator training. According to the HHS announcement, the revised regulations:
“These new rules will require more robust reporting of researchers’ potential conflicts of interest, both from the investigators and from our universities. Additionally, the rules require that our institutions make this information public, thus increasing the transparency of these potential conflicts,” said Jennifer Poulakidas, vice president for congressional and governmental affairs at APLU. “We strongly share the federal government’s goal of ensuring public trust in the research conducted at our universities. Along with other academic associations, cautioned HHS and NIH not to make these regulations unproductively onerous for faculty and universities and appreciate that some of our suggestions were adopted."
Universities remain largely responsible for ensuring that the integrity of the scientific research is not diminished by institutional ties to corporate partners. The final rules do not require universities to post online the specific financial conflicts involving campus scientists. Instead, universities are required only to respond to individual requests for such information.
Additional details about the major changes to the regulations can be found at: (http://grants.nih.gov/grants/FCOI_Final_Rule_inspection_Desk.pdf)
“The NIH is committed to safeguarding the public’s trust in federally supported research that is conducted with the highest scientific and ethical standards,” said NIH Director Dr. Francis S. Collins. “Strengthening key provisions of the regulations with added transparency will send a clear message that NIH is committed to promoting objectivity in the research it funds.”
The regulations will be implemented no later than 365 calendar days after publication of the final rule in the Federal Register. The final rule amends the PHS regulations ``Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought’’ (42 C.F.R. Part 50, Subpart F) and ``Responsible Prospective Contractors’’ (45 C.F.R. Part 94).
Additional information is available at:
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