Earlier this week, the U.S. Department of Health and Human Services 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, according to an NIH press release. The rules follow a series of cases that involved a failure to disclose millions of dollars, The Washington Post reports.
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 new regulations lower the monetary threshold at which significant financial interests require disclosure, generally from $10,000 to $5,000.
A display copy of the conflict of interest final rule is available on the NIH website. The regulations will be implemented no later than 365 calendar days after the final rule is published in the Federal Register.