Who is considered an Investigator?
Investigator means the project director or Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research (regardless of sponsor or funding source), which may include, for example, collaborators or consultants.
What are considered my Institutional Responsibilities?
Institutional Responsibilities means an investigator’s professional responsibilities on behalf of the institution which may include research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
How do I know what Significant Financial Interests (SFIs) to disclose?
UConn Health FCOI in Research policy requires disclosure of SFIs with entities that are related to your institutional responsibilities and that meet a certain threshold. In addition, you must also disclose certain types of intellectual property and appointments to serve in a representative or professional capacity for an entity related to your institutional responsibilities.
As noted above, “institutional responsibilities” are your professional responsibilities on behalf of the University (e.g., research, teaching, etc.). An SFI is considered “related” to your institutional responsibilities if the financial interest is with an entity related to your field of expertise and/or your role as a University employee. Once you’ve established there is a possible “related interest,” the threshold for disclosure according to the policy is defined as follows:
- Significant Financial Interest (SFI) means a financial interest consisting of one or more of the following interests of the investigator (and those of the investigator’s spouse and dependent children) that reasonably appears to be related to the investigator’s institutional responsibilities:
- 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 represents more than 5% ownership in any single entity. 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;
- 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 spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);
- Intellectual property rights and interests (e.g., patents, licensing agreements, trademarks, or copyrights) upon receipt of income related to such rights and interests;
- For PHS-funded investigators, any reimbursed or sponsored travel related to their institutional responsibilities if the value when aggregated exceeds $5,000 from any single entity.
When do I need to submit or update a financial disclosure?
Investigators submit or update their financial disclosure:
- Annually (at the time of the annual disclosure, the investigator must disclose the current aggregated value of the SFIs received over the previous year);
- Within thirty (30) days of the acquisition or discovery of a new reportable SFI;
- PHS or PHS-standard researchers: within 30 days of reimbursed or sponsored travel in excess of $5,000 from a single entity possibly related to your institutional responsibilities.
What does not need to be disclosed?
You do not need to disclose the following:
- 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;
- Income from investment vehicles, such as mutual funds and retirement accounts, as long you do not directly control the investment decisions made in these vehicles;
- Income from seminars, lectures and teaching engagements sponsored by U.S. Federal, state or local government agencies; U.S. institutions of higher education or U.S. research institutes; U.S. academic teaching hospitals or U.S. medical centers that are affiliated with U.S. Institutions of higher education;
- Income from service on advisory committees or review panels for U.S. Federal, state or local government agencies; U.S. Institutions of higher education or U.S. research institutes; U.S. academic teaching hospitals or U.S. medical centers that are affiliated with U.S. Institutions of higher education;
- Travel expenses paid by the University or by a sponsored research award to the University ;
- Travel reimbursed or sponsored by a federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center or a research institute that is affiliated with an institution of higher education.
What is a Financial Conflict of Interest?
- Investigators are obligated to submit a financial disclosure and to disclose any financial interests as requested on the form. The University then determines whether a financial conflict of interest (FCOI) exists.
- An FCOI is a situation in which an investigator’s significant financial interest in an entity 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 entity, either directly or indirectly.
- In summary, FCOI means a significant financial interest (SFI) that could directly and significantly affect the design, conduct or reporting of research.
- An FCOI exists when the University, through its designated official(s), reasonably determines that an investigator's SFI is related to a research project and could directly and significantly affect the design, conduct or reporting of the research.
- The UConn Health Financial Conflict of Interest in Research Committee (FCOIRC) meets regularly to review financial disclosures, identify FCOIs in the conduct of research, and to assign appropriate management or mitigation plans for identified FCOIs.
- The UConn Health Policy #2006-01 (Individual Financial Conflicts of Interest in Research promotes objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research will be biased by any conflicting financial interest of an investigator.
Why do I need to submit a financial disclosure in the InfoEd Financial Interests [FCOI] system?
In order for the University to maintain public trust and support in carrying out its research mission, the University must demonstrate that it subjects itself to the highest standards of ethical behavior. Situations in which financial consideration may compromise, or have the appearance of compromising, an investigator’s professional judgement in the design, conduct, or reporting of research must be managed or mitigated when they occur.
The University’s policy on Financial Conflicts of Interest (FCOI) in Research promotes objectivity in research by establishing standards to ensure the design, conduct, or reporting of research will not be biased by any conflicting financial interest of an investigator.
While the University encourages investigators to engage in appropriate outside relationships, all investigators must, in accordance with University policy, disclose any significant financial interests (including those of a spouse and/or dependent child) that relate to the investigator’s institutional responsibilities and, if applicable, comply with financial conflict of interest management or mitigation plans.
Please note, three roles at UConn Health are subject to UConn Health policies requiring submission of a financial disclosure: research investigators, clinical practitioners, and certain identified Institutional Officials. Individuals who have more than one of these roles at UConn Health are only required to submit one disclosure in the UConn Health InfoEd Financial Interests [FCOI] system. The one disclosure will cover the applicable institutional policy for which the individual is required to submit a financial disclosure.
When was the FCOI policy changed?
The revised FCOI policy was effective on August 24, 2012 and corresponds with the 2011 Public Health Service (PHS) revised Financial Conflict of Interest (FCOI) regulations (42 CFR 50). These regulations apply to any institution receiving funds from a PHS entity.
The Policy applies to all investigators responsible for the design, conduct or reporting of research.
Who can I contact if I have additional questions?
Researchers, Institutional Officials (IOs), and Covered Officials (COs) responsible for research oversight may contact Gus Fernandez-Wolff in the Office of the Vice President for Research, Research Compliance Services at (860) 679-8125 or email@example.com or firstname.lastname@example.org
Clinical practitioners: Individuals who are not a Researcher or IO/CO and who receive the invitation to complete a financial disclosure have been identified by the Clinical Conflict of Interest Committee as required to submit a financial disclosure under the Individual Financial Conflicts of Interest in Clinical Health Care policy. If you have questions related to this policy, you may email the Clinical Conflict of Interest Committee at CCoI@uchc.edu.
For additional information, please also visit the NIHs FAQ regarding the implementation of the revised PHS FCOI regulations for grants and cooperative agreements.