Research Integrity - Financial Conflict of Interest in Research

Financial Conflicts of Interest in Research (FCOI)

About

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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 submits a Disclosure and When Do I submit?

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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.

Do I need to submit a disclosure if I have nothing to disclose or if I feel like I have no conflict?

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Yes, all Investigators must make an annual disclosure, even when the Investigator has nothing to disclose.

It is not the responsibility of the Investigator to determine whether or not there is a significant financial interest (PDF) becomes a Financial Conflict of Interest (FCOI) that would require a Management Plan.

FCOI is determined by the one of our two committees:

  1. Financial Conflict of Interest Committee (for sponsored projects and non-human subject research)
  2. Clinical Research Conflict of Interest Committee (for for human subject research)

As a reminder:

  1. Significant Financial Interest (PDF) means a financial interest that could directly and significantly, affect the design, conduct, or reporting of externally funded research. Investigators using UVMClick – FCOI will either certify no SFI or disclose SFI.
  2. Financial Conflict of Interest (FCOI) means a Significant Financial Interest (SFI) that could directly and significantly, affect the design, conduct, or reporting of externally funded research.
  3. All disclosed SFI will be reviewed at time of IRB submission or at the time of a new award being processed by SPA.
  4. At that time the UVM Research Compliance Officer and the respective COI Committee will determine if the disclosed SFI is an FCOI.

Research Certifications At Time of Award Acceptance and IRB Submission?

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  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 Officer 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.

Required FCOI Training

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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.

FCOI Training Instructions

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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.

UVM FCOI Procedures By Sponsor (NSF, NIH, All Other)

Federal Sponsor COI Policies (NSF, NIH, NASA, Energy)

FCOI in Research Policy vs UVM Conflicts of Interest Policy vs Conflicts of Commitment Policy

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The FCOI Policy is different from the Conflicts of Interest and Conflicts 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.

Contact Research Integrity

Victoria Jones

Research Compliance Officer

Victoria.Jones.1@UVM.edu

Brian Prindle

Executive Director for Research Administration and Integrity

Brian.Prindle@UVM.edu