Research Integrity - Financial Conflict of Interest in Research

UVM's Financial Conflict of Interest (FCOI) in Research Policy has been designed to ensure compliance with federal regulations and implements a process to review and manage disclosed Significant Financial Interest (SFI) that have the potential to compromise the objectivity of the research being conducted.

The FCOI Policy requires Investigators to do the following;

1. Complete Disclosures. All UVM and UVM Health Investigators, thru the UVMClick - COI system must disclose whether or not they hold any Significant Interest (PDF).
2. Disclosures are made annually, updated as appropriate, and updated at time of a new sponsored project award or IRB submission award.
3. The UVMClick - COI system will automatically remind Investigators when to log in and complete their annual certification/disclosure.
4. The UVMClick is designed to use Investigator's @uvm email.
5. Complete FCOI Training. FCOI Training is required every 4 years. Navigate to CITI Program, our online source for FCOI Training. FCOI Training reminders will come directly from CITI.

Who

1. All UVM and UVM Health Investigators must disclose whether or not a Significant Financial Interest (PDF) is held by themselves, their spouses, or their dependent children related to their institutional responsibilities when funded research is proposed, annually thereafter, and make an updated disclosure when any new Significant Financial Interest arises.
2. “Investigator” is defined as the Principal Investigator (PI), Project Director (PD) or any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research regardless of the funding source of the research.

When

1. Annual certification/disclosures are required by all Investigators using the UVMClick - FCOI system.
2. UVMClick will automatically remind Investigators (using their @uvm email) when they must log in and complete their annual certification/disclosure.
3. The annual certification/disclosure satisfies the requirement that a disclosure is made at time of proposal submission.
4. If an annual certification/disclosure is not present at the time of proposal submission, SPA will trigger an event that directs the Investigator to log in and complete disclosure.

What

• All Investigators must submit an annual disclosure, even when the Investigator has nothing to disclose.
• The Investigator must disclose any financial interest to the extent that it meets the definition of significant financial interest (PDF).
• It is not the responsibility of the Investigator to determine whether there is a conflict of interest which requires a management plan.
• Once the Investigator discloses a Significant Financial Interest, a research compliance officer works together with the Investigator to determine whether the Significant Financial Interest is related to the Investigator's research (DOC).
• If there is a relationship, a Financial Conflict of Interest committee reviews the case and determines whether there is a financial conflict of interest which requires a management plan. 

There are two committees:
 

1. The Financial Conflict of Interest Committee (generally for sponsored projects and non-human subject research)
2. The Clinical Research Conflict of Interest Committee (generally for human subject research, including UVM Health industry funded clinical trials)

A Financial Conflict of Interest means a significant financial interest that could directly and significantly, affect the design, conduct, or reporting of the research.

All disclosed SFI will be reviewed at time of IRB submission or at the time of a new award being processed by SPA unless other regulations require an earlier review.

1. At time of award acceptance for those disclosures that indicate a Significant Financial Interest (SFI), SPA will trigger a Research Certification update.
2. At time of IRB submission for those disclosures that indicate a Significant Financial Interest (SFI), RPO will trigger a Research Certification update.
3. All research certifications where an SFI exists will be reviewed by the UVM Research Compliance Assistant Director or the respective COI Committee to determine if the SFI is a Financial Conflict of Interest (FCOI).
4. Where an FCOI exists, award funds may not be released into PeopleSoft financials or the IRB approval will not be released until the FCOI is either eliminated or managed with a management plan.

Training completion dates.

1. UVM FCOI Policy requires Investigators to complete FCOI training every 4-years.
2. CITI is our online source for FCOI Training.
3. Login to CITI through the “Login Through My Institution” portal, selecting the University of Vermont.
4. FCOI Training reminders are delivered directly from CITI. (30, 7, and 1 day before training expiration and 1, 7, 30 days after expiration) That's 6 reminders!
5. Award funds may not be released into PeopleSoft financials until all Investigators are FCOI trained.

Please Note: You will not be able to complete your disclosure if your FCOI training has expired. Once you complete the FCOI training, it takes an overnight refresh, for your COI Training complete cert to link to UVMClick disclosure, once linked, you will be able to complete and submit your disclosure.

Already have a UVM-affiliated CITI account?

1. Always login to CITI through the “Log In Through My Institution” portal and select the University of Vermont.
2. To add the FCOI Training Course, select “View Courses”
3. Scroll to “Learner Tools for University of Vermont”
4. Select “Add a Course”
5. Select "Conflicts of Interest” and complete the course.

Create a UVM-affiliated CITI account:

Registration Instructions for those who do not have a UVM CITI Account.

1. Open your browser and go to CITI Program – Login.
2. Click on "Login" which is located at the top right of the CITI page.
3. Then, click "Login Through My Institution" to view registered organizations.
4. From the drop-down menu, click on "University of Vermont".
5. Sign in with your UVM Net ID and password.
6. You will be prompted to affiliate your CITI account with UVM.
7. If you have an existing CITI account, choose first option and follow the instructions to link your UVM account.
8. Otherwise, choose second option and select "Click here to create a new CITI Program Account."
9. If you do not receive these prompts, then proceed to step 5.
10. To add the FCOI Training Course, select “View Courses”
11. Scroll to “Learner Tools for University of Vermont”
12. Select “Add a Course”
13. Select "Conflicts of Interest” and complete the course.

Preferred Email: Please check to ensure the email registered with CITI is your FirstName.LastName@uvm.edu. If not, please update thru your account settings.

• National Science Foundation Research (PDF)
• Public Health Service Research (PDF)
• All Other Sponsored Research (PDF)

1. NIH Financial Conflict of Interest
2. NSF Financial Conflict of  Interest
3. NASA Financial Conflict of Interest (PDF)
4. Energy Financial Conflict of Interest (PDF)

The FCOI Policy is different from the Conflict of Interest and Conflict of Commitment Policy, which applies to all UVM employees, including staff, whether or not they are engaged in sponsored research.

Both FCOI and COI disclosures are made under the same disclosure form thru UVMClick - COI.

Managing Financial Conflicts of Interest in Human Subject Research (PDF)

This presentation will cover: 

• Defining Significant Financial Interest (SFI) within the scope of a research protocol

• Required FCOI training

• When to disclose SFIs to UVM

• How to disclose and update SFIs

• Managing conflicts