HHS Issues New Rules on Financial Conflicts of Interest
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.
The NIH has created a FCOI resource page that includes a summary of the major changes to the rules.
Senior Policy Analyst
- Tuition Discount Rates Reach New Record Level in 2015-16
- ED Offers Supplemental Cash Management Guidance
- Federal Agencies Release Guidance on Civil Rights Protections for Transgender Students
- 2016 CAO and CBO Collaborations
August 1-2, 2016
- 2016 Planning and Budgeting Forum
September 19-20, 2016
- 2016 Managerial Analysis and Decision Support
November 17-18, 2016
- WEBCAST: The Clery Act: Strategic Planning to Mitigate Institutional Risk
Thursday, May 26, 2016 1:00PM ET
- ON-DEMAND: Title IX: Key Issues Surrounding Institutional Compliance
- ON-DEMAND: Containing Cost and Risk with Renewables – the Power Purchase Agreement Story
- ON-DEMAND: NACUBO Live! Higher Education Accounting Forum
- ON-DEMAND: Are Hedge Funds and Private Equity Right for You? An Analysis of Alternative Investments
- ON-DEMAND: Responsibility Center Management: Two Different Perspectives