Financial Conflict of Interest

Conflicts of interest may occur when outside financial interests bias, or have the appearance of biasing , the design, conduct, and reporting of research. The Public Health Service (PHS) released revised financial conflict of interest (FCOI) regulations (42 CFR 50) in 2011. Institutions are required to revise institutional FCOI policies to be in full compliance with all of the regulations by August 24, 2012.

Texas A&M University System Regulation 15.01.03 Financial Conflict of Interest in Research implements federal law and regulations adopted by the Public Health Service of the U.S. Department of Health and Human Services and the National Science Foundation to address when a Significant Financial Interest (SFI) reasonably appears to affect or bias the design, conduct or reporting of research. The Texas A&M University-Corpus Christi Rule to implement the System regulation has been drafted and is in the approval process, and the university will be compliant by the August 24, 2012 deadline.

TAMUS Regulation 15.01.03 applies to all research activities regardless of the funding source, as well as to research activities that do not have external funding. Investigators1 are required to:

  1. Complete the TrainTraq course Financial Conflicts of Interest in Research 2111716
  2. Complete the FCOI disclosure via Maestro. Please see Maestro submission instructions for guidance.
    • The Financial Disclosure Statement Identifies all Research or Research Activities2 in which the Investigator is engaged at the time the Financial Disclosure Statement is submitted; and
    • Discloses each Significant Financial Interest (SFI) held by the Investigator or a Covered Family Member3 that is reasonably related to the Investigator's Institutional Responsibilities4

Each Financial Disclosure Statement will be reviewed, and if an SFI is identified, Caroline Lutz, Research Compliance and Export Control Officer, will contact the Investigator to determine if a financial conflict of interest (FCOI) exists and develop a Management Plan specifying the steps to be taken to manage, reduce or eliminate the FCOI.

1 Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of Research or Research Activities.
2 Research or Research Activities means any systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge.  The term encompasses basic and applied research, scholarship (e.g., a published article, book, or book chapter) and product development (e.g., a diagnostic test or drug).  The term also includes educational activities funded by the National Science Foundation (NSF) or proposed for funding by NSF.
3 Covered Family Member includes an Investigator’s spouse, dependent child, stepchild or other dependent, for purposes of determining federal income tax liability during the period covered by the financial disclosure statement, and a related or non-related, unmarried adult who resides in the same household as the Investigator and with whom the Investigator is financially interdependent as evidenced, for example, by the maintenance of a joint bank account, mortgage, or investments.
4 Institutional Responsibilities means an Investigator’s professional responsibilities within the Investigator’s field of discipline on behalf of a system member, including teaching, research, research consultation, professional practice, committee memberships, and service on panels such as an Institutional Review Board (IRB).  This term includes consulting and other external employment approved under System Regulation 31.05.01 – Faculty Consulting, Outside Professional Employment and Conflicts of Interest.  However, this term does not include external employment approved under System Regulation 31.05.02 – External Employment.