Compliance

Financial Conflict of Interest

University Corporation at Monterey Bay is in compliance with federal and state requirements which require principal investigators and other key personnel on certain sponsored projects to disclose financial interests.

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Financial Conflict of Interest Policy - Government Funding

The U.S. Department of Health and Human Services and the Public Health Service issued new financial conflict of interest disclosure regulations in 2012. These new FCOI regulations establish 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. These rules also apply to a handful of non-federal sponsors. In addition, the National Science Foundation has their own regulations and FCOI disclosure requirements. Please review the Financial Conflict of Interest Policy-Government funding linked above.

PHS Mandatory Financial Disclosure

The new FCOI regulations differ in several significant ways from the existing rules, including reduced disclosure thresholds and more onerous review and reporting obligations.

  • 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.

  • Personnel must disclose any Significant Financial Interests related to their Institutional Responsibilities at the time a proposal is submitted for PHS or NSF 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.

  • 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, copyrights, assigned or licensed to a party other than the Regents), which exceed $5,000.

    Travel reimbursement or payment by any entity within the past 12 months. 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 PHS FCOI regulations also include new requirements for mandatory and ongoing education and training certification. 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 certification prior to beginning work on a PHS-funded project with a Notice of Award issue date after August 24, 2012. To assist researchers with compliance, CSUMB subscribes to the Collaborative Institutional Training Initiative (CITI) on-line certification program. Any researcher affiliated with CSUMB may complete CITI Program training.