Financial Conflict of Interest (FCOI) means a situation in which significant financial interests in a business, or other personal considerations provided by a business, may compromise, or have the appearance of compromising, an Investigator’s professional judgment in conducting or reporting research, the results of which could affect the aforementioned business, either directly or indirectly. An FCOI exists when the University, through its designated official(s), reasonably determines that an Investigator’s Significant Financial Interest (SFI) is related to a research project and could directly and significantly affect the design, conduct or reporting of the research.

With regard to any publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000; orWith regard to any non-publicly traded entity, an SFI exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s immediate family) holds any equity interest (e.g., stock, stock option, or other ownership interest); orIntellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.

An equity interest that when aggregated for the Investigator and the Investigator’s Immediate Family exceeded $10,000 over the last 12 months, and/or is expected to exceed $10,000 in value over the next 12 months as determined through reference to public prices or other reasonable measures of fair market value; orSalary, royalties or other payments not from the University for services (e.g., consulting fees or honoraria) that when aggregated for the Investigator and the Immediate Family over the last 12 months exceeded $10,000 or are expected to exceed $10,000 over the next 12 months.

Income from seminars, lectures, or teaching engagements sponsored by and service on advisory or review panels for a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education.

SFIs that are excluded are: income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

Investigators are now required to disclose the occurrence of any reimbursed travel or sponsored travel related to Institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration).You are NOT required to disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education. The Institution will determine if any travel requires further investigation, including determination or disclosure of the monetary value.

It is critical that the design, conduct, or reporting of any research or scholarly activity not be compromised. Business transactions and financial interests must be disclosed and reviewed by the Financial Conflict of Interest Committee to determine whether or not the researcher, University, or department, stands to benefit by significant financial gain. You can see the Policy in its entirety at http://policy.uconn.edu/?p=382.

When:

• A proposal submission (and annually thereafter)
• Any changes in SFI
• When research involves human subject research
• When a new investigator is added to an existing research project

You complete the forms located on the FCOI Forms page.

The federal and state regulations that govern objectivity in research require disclosure of financial interest including those of your spouse or domestic partner and dependent children.

The University is obligated by federal and state laws and regulations to identify, manage, reduce, and if possible, eliminate any potential conflict of interest.

When a proposal for research funding is made to a funding agency, federal (PHS & NSF) regulation require each person responsible for the planning, conduct, design or reporting of the project disclose any financial conflicts of interest. The University of Connecticut policy applies this standard to all externally funded research.

Yes. In any case in which HHS determines that an NIH-funded clinical research project’s purpose is evaluating the safety or effectiveness of a drug, medical device, or treatment, and that intervention has been designed, conducted, or reported by an investigator with a conflicting interest that was not managed or reported by the grantee organization as required by the regulation, then the grantee organization must require the investigator(s) involved to disclose financial conflict of interest in each public presentation of the results of the research, and by requesting an addendum to previously-published presentations.

A conflict of interest disclosure should be filled out and completed by the principal investigator and any other person (regardless of title or position) who is responsible for the design, conduct or reporting of research or educational activities. This may include faculty and research staff (research associates and assistants, postdoctoral fellows, graduate students, visiting scientists engaged in research conducted at the University) as well as consultants.

Any changes in the status of an existing conflict of interest disclosure should be disclosed to the Financial Conflict of Interest Committee immediately.

Each Investigator must complete training prior to engaging in research related to any PHS-funded grant or contract and at least every four years, and immediately under the designated circumstances:

• Institutional FCOI policies change in a manner that affects Investigator requirements
• An Investigator is new to an Institution
• An Institution finds an Investigator noncompliant with Institution’s FCOI policy or management plan.

Appeals of any decision of the Financial Conflict of Interest Committee concerning the existence of a conflict of interest or acceptability of a proposed management plan may be made in writing to the Vice President for Research.

Sanctions and penalties for those who knowingly and willfully disregard this policy, or refuse to comply with its terms, will be determined by the Vice President for Research in consultation with the Dean of the appropriate School with advice from the Investigator’s Department Head. Sanctions include, but are not restricted to:

• Letter of reprimand
• Notification to professional and/or scientific societies, funding agencies and/or professional journals
• Reassignment of duties
• Termination of grant support
• Adjustment of research space allocation
• Adjustment of salary
• Suspension
• Dismissal

FCOI information is available to the Vice President for Research, the Associate Vice President of Sponsored Program Services, and the Financial Conflict of Interest Coordinator. If your disclosure is referred to the Financial Conflict of Interest Committee, members of that Committee will also see your disclosure.

Institutions and contractors that receive funding from the National Institutes of Health (NIH) and the National Science Foundation (NSF) to conduct research are required to identify and manage Financial Conflicts of Interest for all NIH and NSF-supported investigators and to comply with the associated reporting requirements.NIH requires that the University must inform the relevant Institute of the existence of any Financial Interest that meets the sponsor definition of FCOI before spending any funds from an NIH award. Conflicts identified during the award period must be reported within 60 days of identifying them. These reports must indicate whether the FCOI has been managed, reduced, or eliminated.

• Administration on Aging (AoA)
• Administration for Children and Families (ACF)
• Administration for Children, Youth and Families (ACYF)
• Administration for Community Living (ACL)
• Agency for Healthcare Research & Quality (AHRQ)
• Agency for Toxic Substances & Disease Registry (ATSDR)
• Alliance for Lupus Research (ALR)
• American Cancer Society (ACS)
• American Heart Association (AHA)
• American Lung Association (ALA)
• Arthritis Foundation (AF)
• California Breast Cancer Research Program (CBCRP)
• California HIV/AIDS Research Program (CHRP)
• Centers for Disease Control & Prevention (CDC)
• Centers for Medicare and Medicaid Services (CMS)
• CurePSP
• Food and Drug Administration (FDA)
• Health Resources & Services Administration (HRSA)
• Indian Health Service (IHS)
• Juvenile Diabetes Research Foundation (JDRF)
• Lupus Foundation of America (LFA)
• National Institutes of Health (NIH)
• Office of Global Affairs (OGA)
• Office of the Assistant Secretary for Preparedness and Response (OASPR)
• Office of the Assistant Secretary for Health (OASH)
• Substance Abuse & Mental Health Services Administration (SAMHSA)
• Susan G. Komen for the Cure

Exception:

• PHS-funded SBIR Phase I and STTR Phase I awards

You may call the Financial Conflict of Interest Coordinator with any questions at (860) 486-8704, or email her at julie.padula@uconn.edu