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. Under Federal law, UC Merced must be in compliance with all of the new requirements by August 24, 2012. Please consult the list of Federal and non-Federal sponsors that have adopted the new PHS regulations. The new regulations apply only to grants and cooperative agreements awarded on or after Aug 24th 2012, including noncompeting continuing awards.
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:
Who must disclose?
Any personnel on a PHS-funded project who are responsible for the design, conduct or reporting of the research. This would include senior and key personnel and all others who contribute to the scientific development or execution and reporting of a project in a substantive, measurable way whether or not they request or receive salary or compensation. The requirement for disclosure extends to the spouse, registered domestic partner and dependent child(ren) of such personnel.
When must disclosure be made?
Personnel must disclose any Significant Financial Interests related to their institutional responsibilities at the time a proposal is submitted for PHS funding, at least annually throughout the period of any resulting award, and within thirty (30) days of acquiring or discovering any new Significant Financial Interest.
What must be disclosed?
- Publicly traded equity owned or acquired in the previous 12 months in any publicly traded entity, the value of which exceeds $5,000. Mutual funds or retirement funds over which you do not control investment decisions are excluded.
- Any equity interest owned or acquired in the previous 12 months in any non-publicly traded entity, which exceeds $5,000. This includes any stock, stock option or other ownership interest. Any income or other payment for services received within the previous 12 months from any entity, which exceeded $5,000. Payments from the Regents, income from seminars, lectures or teaching engagements sponsored by a federal, state or local government, a U.S. institution of higher education, or a research institute, academic medical center or hospital affiliated with a U.S. institution of higher education are excluded.
- Any payments received within the past 12 months for any intellectual property rights and interests (e.g., patents or copyrights, assigned or licensed to a party other than the Regents), which exceed $5,000.
- Any travel reimbursement or payment by any entity within the past 12 months, regardless of value. Payments from federal, state or local governments, U.S. institutions of higher education, or a research institute, academic medical center or hospital affiliated with U.S. institution of higher education are excluded.
What else is required?
Mandatory Training: The FCOI regulations also include new requirements for mandatory and ongoing education and training. UCOP has sent an email to all researchers 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. You may access the training by going to UC Merced Learning Management System and searching for ”COIR” if the course is not already listed in your personal training menu. Please follow the instructions below:
- Log in to the UC Learning Center using your UC Merced Net ID.
- Search for keyword: COIR in the UC Learning Center search bar on the left of the screen.
- Select the Conflict of Interest class, click “Start." The online course will begin.
Regulations: 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.
Contact: For any other questions or concerns, please contact Deborah Motton, Assistant Vice Chancellor for Research & Economic Development, at email@example.com, 209-383-8655.