US govt tightens financial conflict of interest rules for medical researchers

The US Department of Health and Human Services this week issued an updated Final Rule on conflict of interest, providing a framework for identifying, managing and ultimately avoiding investigators’ financial conflicts of interest. Staff from the National Institutes of Health worked with others in HHS to revise the 1995 regulations to update and enhance the objectivity and integrity of the research process, where federally-funded researchers may also receive payments or shares for pharmaceutical and medical device manufacturers.

“The medical research conducted and funded by the federal government has long been the gold standard of scientific investigation,” said HHS Secretary Kathleen Sebelius, adding: “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.”

Major changes to the regulations include 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. For example, the revised regulations: