COI News

PHS Funded Summary of Changes to FCOI Policy (PDF)

Message from the Douglas Magde (Chair - Independent Review Committee on Conflict of Interest) regarding new mandatory conflict of interest rules

Dear Colleagues:

The U.S. Department of Health and Human Services and the Public Health Service (PHS) have issued new financial conflict of interest (FCOI) disclosure regulations. These new FCOI regulations establish new standards and thresholds for financial disclosures that must be followed by institutions that apply for or receive research support from PHS agencies, including the National Institutes of Health (NIH). The new rules also apply to a handful of non-federal sponsors. I am writing to let you know about the new regulations and UC San Diego’s approach to implementing them. Under Federal law, UC San Diego must be in compliance with all of the new requirements by August 24, 2012.

New (and more stringent) mandatory financial disclosures: The new FCOI regulations differ in several significant ways from the existing rules, including reduced disclosure thresholds and more onerous review and reporting obligations. The PI and any other individual, who, regardless of title or position, has responsibility for the design, conduct, or reporting of PHS-funded research each must separately disclose certain financial interests that exceed the thresholds provided by PHS and that are related to any of their institutional responsibilities. The institution is then required to determine whether the disclosed financial interest could be affected by the research and, if so, whether the financial interest could directly and significantly affect the design, conduct, or reporting of the NIH-funded research. The Conflict of Interest Office is presently developing a “user-friendly” online disclosure form that complies with the regulations.

Mandatory Training: The FCOI regulations also include new requirements for mandatory and ongoing education and training. UCOP will be sending an email to all researchers in the next week or two regarding required conflict of interest in research training. A component of this training will satisfy the mandatory training under the new FCOI rules. All PHS investigators, as defined by the rule, must complete this training prior to beginning work on a PHS-funded project with a Notice of Award issue date after August 24th.

The 2011 revised regulations and recently updated FAQs prepared by the NIH can be accessed at the NIH Financial Conflict of Interest webpage. The UC Policy on Disclosure of Financial Interests & Management of Conflicts of Interest, Public Health Service Research Awards will be available on August 24, 2012. More information, including information about the on-line disclosure process and UC San Diego’s plan for implementing the regulations will be forthcoming. If you have any immediate questions, please contact Angela Fornataro McMahill, Director – Conflict of Interest Office at amcmahill@ucsd.edu or 858-534-6465.

As you know, funding from PHS supports a significant portion of UC San Diego’s extramural research portfolio. Thus, as you will agree, it is important to ensure our compliance with the new FCOI regulations and, in this regard, we anticipate heightened scrutiny from the federal government in evaluating our ongoing compliance. We realize that compliance with the new FCOI regulations will be a challenge for the campus, and we are working hard in making roll-out and ongoing compliance as convenient as possible.

Thank you for your cooperation.