HHS Issues New Rules on Financial Conflicts of Interest

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August 29, 2011

The Department of Health and Human Services (HHS) published new rules on August 25th on reporting financial conflicts of interest (FCOIs) by those engaged in research. The rules require institutions that receive Public Health Service (PHS) funding, including funding from the National Institutes of Health (NIH), to comply by August 24, 2012.

The most notable revision of rules originally promulgated in 1995 lowers the monetary threshold at which significant financial interests (SFIs) require disclosure from $10,000 to $5,000. The rules also require investigators to disclose to their institutions all of their SFIs related to their institutional responsibilities. The 1995 rules defined "investigator'' as the Principal Investigator and any other person who is responsible for the design, conduct, or reporting of research (or, in the case of PHS contracts, a research project) funded by PHS, or proposed for such funding.

Institutions will have to report information on FCOIs and how they are being managed. FCOI dollar amounts can be reported as a range, rather than a specific dollar amount. Permissible ranges, as stated in the rules, are $0-4,999; $5,000-9,999; and $10,000-19,999. Increments of $20,000 may be used for amounts between $20,000 and $100,000, and $50,000 increments for those above $100,000.

Additionally, the new rules require institutions to make certain information concerning financial conflicts of interest involving key personnel public either via website or, in the case of a requestor, by a written response within five business days.