University of Connecticut University of UC Title Fallback Connecticut

FCOI FAQs

Investigator is defined as “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.”
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.

Each Investigator must disclose his/her known SFIs (including those of the Investigator’s Immediate Family) that reasonably appear to be related to the Investigator’s Institutional Responsibilities (including those that would reasonably appear to be affected by the research for which funding is sought or are in entities whose financial interests would reasonably be affected by the research).  In determining whether a financial interest has to be disclosed, the Investigator shall consult the definition of SFI within the University policy and, if in doubt, resolve in favor of disclosure.

  • 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; or
  • With 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); or
  • Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
  • Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities.

*For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value

Each Investigator must disclose his/her known SFIs (including those of the Investigator’s Immediate Family) that reasonably appear to be related to the Investigator’s Institutional Responsibilities (including those that would reasonably appear to be affected by the research for which funding is sought or are in entities whose financial interests would reasonably be affected by the research).  In determining whether a financial interest has to be disclosed, the Investigator shall consult the definition of SFI within the University policy and, if in doubt, resolve in favor of disclosure.

  • An equity interest that when aggregated for the Investigator and the Investigator’s Immediate Family exceeded $5,000 over the last 12 months, and/or is expected to exceed $5,000 in value over the next 12 months as determined through reference to public prices or other reasonable measures of fair market value; or when the Investigator (or the Investigator’s Immediate Family) holds  holds a 5% or greater equity interest (e.g., partnership, ownership, stock, stock option, or other ownership interest) in a single publicly traded entity or holds any equity interest in a non-publicly traded entity; or
  • Salary, 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 $5,000 or are expected to exceed $5,000 over the next 12 months.

Investigators governed by FDA regulations would also have a Significant Financial Interest if one or more of the following apply:

  • Compensation made to the investigator in which the value of compensation could be affected by the outcome of the study/research project.
  • A proprietary interest in the tested product, including but not limited to, a patent, trademark, copyright or licensing agreement.
  • Significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for one year following completion of the study.
Disclosure is not required for:
  • Income from seminars, lectures, or teaching engagements sponsored by (and service on advisory committees 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.
  • Salary, royalties, or other remuneration paid by the Institution to the Investigator if the Investigator is currently employed or otherwise appointed by the University, including intellectual property rights assigned to the University and agreements to share in royalties related to such rights.
Disclosure is not required for:
  • 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 required to disclose the occurrence of any reimbursed travel or sponsored travel that is related to Institutional responsibilities (including purpose of trip, sponsor/organizer, destination, and duration).
  • Investigators 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 research at the University not be compromised by the conflicting financial interests of an investigator. Investigators’ financial interests must be disclosed and reviewed by the Financial Conflict of Interest in Research Committee (FCOIRC). You can see the Policy in its entirety at http://policy.uconn.edu/?p=382.

A financial disclosure must be filed:

  • Once every 12 months
  • Within 30 days of acquiring or discovering a new financial interest
  • Within 30 days of any reimbursed or sponsored travel
Submit the SFI disclosure form electronically within the InfoEd External Interests module (www.infoed.uconn.edu).
The federal and state regulations that govern objectivity in research require disclosure of financial interests including those of your Immediate Family, which includes 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.
  • Proposal Submissions: 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.At the time of submission of a new proposal, an Investigator must have completed their online financial disclosure in the InfoEd External Interests Module. The University will not submit a proposal until such disclosure has been submitted.
  • Human Subject Research:  When research involves human subjects, the Investigator must disclose the presence of any related SFIs to the Institutional Review Board (IRB).  If an Investigator has an FCOI, but a management plan is not on file, the IRB will contact the VPR or their designee and hold approval of the protocol until the FCOIRC makes a determination.
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 financial disclosure should be submitted annually within the InfoEd External Interests module (www.infoed.uconn.edu) 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 in Research  Committee immediately by updating your financial disclosure form electronically with the InfoEd External Interests module (www.infoed.uconn.edu).  An updated disclosure must be completed and filed within thirty (30) days at any time when an Investigator acquires or discovers a new reportable SFI not disclosed in the last disclosure.
The training requirements as specified under federal regulations and UConn policy are complete once a faculty member, and any other investigator that conducts sponsored research, has submitted a financial disclosure form electronically within the InfoEd External Interests module (www.infoed.uconn.edu).
In situations where an Investigator disputes the decision of the FCOIRC, the Investigator may request to present the case to the FCOIRC in person. An Investigator who disagrees with the FCOIRC’s determination may appeal in writing to the Vice President for Research (VPR). An appeal may be made in regard to whether the professional judgment of the Investigator is likely to affect his or her conduct of research, but Investigators may not contest the terms and conditions of this.

The Provost is the senior administrator responsible for overseeing the implementation of this Policy. The Provost has delegated the disclosure/review/management process to the Vice President for Research or his/her designee (VPR). The VPR, in consultation with the Dean of the appropriate School and the Investigator(s) Department Head, will review all breaches of the policy, including:

  • 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
Information is available to the Vice President for Research, the Associate Vice President for Research Integrity and Regulatory Affairs, and the Committee Staff for the Financial Conflict of Interest in Research Committee (FCOIRC).  If your disclosure is referred to the FCOIRC, 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)
  • 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)
  • Food and Drug Administration (FDA)
  • Health Resources & Services Administration (HRSA)
  • Indian Health Service (IHS)
  • 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)
  • Office of Global Affairs (OGA)
  • National Institutes of Health (NIH)

Non-PHS agencies using the PHS FCOI Regulations

  1. Alliance for Lupus Research (ALR)
  2. Alpha-I Foundation
  3. American Asthma Foundation
  4. American Cancer Society (ACS)
  5. American Heart Association (AHA)
  6. American Lung Association (ALA)
  7. Arthritis Foundation (AF)
  8. CurePSP
  9. Juvenile Diabetes Research Foundation (JDRF)
  10. Lupus Foundation of America (LFA)
  11. Patient-Centered Outcomes Research Institute (PCORI)
  12. Susan G. Komen for the Cure

Exception:

  • PHS-funded SBIR Phase I and STTR Phase I awards
You may contact Kristen Tremblay, Committee Staff for the Financial Conflict of Interest in Research Committee, with any questions at (860) 679-3276 (or email at fcoi@uconn.edu).