Financial Conflict of Interest in Research

The University of Vermont (the “University” or “UVM”) recognizes its obligation to establish standards that provide a reasonable expectation that the design, conduct, and reporting of research funded under extramural grants, contracts, cooperative agreements or other type of awards will be free from bias resulting from Investigator financial conflicts of interest.

As such, Investigators must disclose to the University whether or not they, their spouse, and/or their dependent children hold any domestic or foreign Significant Financial Interest (SFI) that reasonably relates to the Investigator’s institutional responsibilities.

UVM recognizes the importance of allowing Investigators to collaborate with outside entities. These collaborations stimulate UVM’s research programs and are vital when translating academic research into knowledge and discoveries that can have significant public benefit. However, some outside activities may have an appearance, or potential financial conflict of interest that may compromise the objectivity of the research being conducted. The challenge is to balance and manage these outside interests without compromising the integrity of the research.

As such, this policy has been established to ensure the University is properly identifying, reviewing, and mitigating domestic and foreign financial conflicts that may arise in our research activities. 

In addition, the policy is designed to meet the requirements set forth by both federal and non-federal funding agencies regulations.

By adhering to this policy, we can maintain transparency and integrity in our research efforts and continue to build trust with our stakeholders and funding partners.

This policy applies to all UVM and University of Vermont Health (UVM Health) Investigators 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 source of funding.

In accordance with the federal regulations, this policy does not apply to Phase I Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) programs; however, this policy does apply to Phase II SBIR/STTR programs.

Assigned Committee: means the Committee to which the Investigator’s disclosed Significant Financial Interest is assigned and reviewed. The Financial Conflict of Interest (FCOI) Committee reviews disclosures of  Significant Financial Interests  that do not involve  human subject research while the Clinical Research Conflict of Interest (CRCOI) Committee, reviews disclosures of  Significant Financial Interests  associated with research involving human subjects.

Clinical Research Conflict of Interest (CRCOI) Committee: means a committee including, at a minimum, three members with expertise in research involving human subjects. All members of the committee are appointed by the Vice President for Research or designee. From time to time, the Designated Institutional Official may include an additional ad hoc member to the committee.

Designated Institutional Official: means the individual the University has designated to solicit and review disclosures of Significant Financial Interests from each Investigator who is planning to participate in, or is currently participating in, externally funded research.

Financial Conflict of Interest (FCOI) Committee: means a committee including, at a minimum, three members representing a cross section of academic disciplines. All members of the committee are appointed by the Vice President for Research or designee. From time to time, the Designated Institutional Official may include an additional ad hoc member to the committee.

Financial Conflict of Interest (FCOI): means a Significant Financial Interest (SFI) that could directly and significantly affect the design, conduct, or reporting of research.

Institutional Responsibilities: means an Investigator’s professional responsibilities on behalf of the University, or, for Investigators with dual appointments, on behalf of the University and the University of Vermont Health (UVM Health). Examples of institutional responsibilities include activities such as research, research consultation, teaching, professional practice, institutional committee memberships, or service on panels such as institutional review boards or data and safety monitoring boards.

Investigator: means the Project Director (PD) or Principal Investigator (PI) and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research.

Related Entity: means an entity that an Investigator holds an SFI in.

Research: means a systematic investigation designed to develop or contribute to generalizable knowledge.

Senior/Key Personnel: means the Project Director/Principal Investigator (PD/PI) and any other person identified as senior/key personnel by the University in the grant application, progress report, or any other report submitted to a funding agency by the Institution.

Significant Financial Interest (SFI): means a domestic or foreign financial interest consisting of one or more of the following interests of the Investigator, the Investigator’s spouse and/or the Investigator’s dependent children that reasonably appears to berelated to the Investigator’s Institutional Responsibilities:

1. With regard to any publicly traded entity, a Significant Financial Interest 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.

   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), and 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;

2. With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or if the Investigator (and/or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest);or
3. Intellectual property rights and interests (e.g., patents, copyrights), and/or technology that has been disclosed to UVM Innovations.
4. For PHS funded research only:
   1. Disclose any domestic or foreign reimbursed or sponsored travel related to the Investigator’s institutional responsibilities, exceeding $5,000, and any travel reimbursements made directly to theInvestigator.
   2. Disclose any foreign or domestic sponsored travel, that is paid on behalf of the Investigator and not reimbursed directly to the Investigator, related to the Investigator’s institutional responsibilities, regardless of monetary value.
   3. The University is required to determine if Investigators reimbursed or sponsored travel constitutes an FCOI, therefore the University may request additional information as needed from the Investigator or others in order to make such a determination.
   4. This disclosure requirement does not apply to travel that is reimbursed or sponsored by the following:
      1. a federal, state, or local government agency located in the United States,
      2. a United States Institution of higher education,
      3. an academic teaching hospital,
      4. a medical center, or
      5. a research institute that is affiliated with a United States Institution of higher education.

The term Significant Financial Interest does not include the following types of financial interests:

1. Salary, royalties, or other remuneration paid by the University or UVM Health to the Investigator if the Investigator is currently employed or otherwise appointed by the University of UVM Health;
2. Income from investment vehicles, such as mutual funds and retirement accounts, if the Investigator does not directly control the investment decisions made in these vehicles;
3. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of higher education.
4. Income from service on advisory committees or review panels for a  federal, state, or local government agency located in the United States, a United States Institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with a United States Institution of higher education.

Investigators and sponsored project personnel as may be required by an award’s terms and conditions, shall disclose to the University using the electronic research compliance system, UVMClick, all domestic or foreign Significant Financial Interest, including the interests of the Investigator's spouse and dependent children. Where no SFI exists, a disclosure is still required.

Disclosures must be on file as follows:

1. No later than at time of a proposal submission for externally sponsored research;
2. At the time of submission of a research project involving human subjects to the Institutional Review Board (IRB);
3. At least annually thereafter during the period of research activity;
4. During the research within thirty (30) days of acquiring or discovering  a new significant financial interest; At the time of a new sponsored research grant, contract or other award being received and accepted through Sponsored Project Administration; 
5. At the time of a new externally or internally funded clinical research project is initiated through the Institutional Review Board; and
6. For research funded by the Public Health Service (PHS) only, Investigators must disclose, within thirty (30) days of any foreign or domestic travel, related to the Investigator’s institutional responsibilities, reimbursed directly to the Investigator or sponsored in accordance with the above Definitions section, under Significant Financial Interest, #4.

The Designated Institutional Official or designee will monitor UVMClick for receipt of disclosures and review all  Investigator disclosures with significant financial interests to determination if the SFI is reasonably related to the research and constitutes an FCOI. 

Reviews of an Investigator’s initial disclosure will occur prior to the expenditure of funds under a new award.

An Investigator's SFI is related to research when the Designated Institutional Official or their designee reasonably determines that the significant financial interest: 

• could be affected by the research; or 
• is in an entity whose financial interest could be affected by the research. 

The Institution may involve the Investigator in the Designated Institutional Official’s or their designee’s determination of whether a significant financial interest is related to the research.

Where the Designated Institutional Official or their designee, reasonably determines that a significant financial interest is related to the research, the disclosure is submitted to the Assigned Committee to determine if the significant financial interest is a financial conflict of interest.

A Financial Conflict of Interest exists when the Assigned Committee, agrees that the Investigator’s Significant Financial Interest could directly and significantly affect the design, conduct or reporting of the funded research.

Where the Assigned Committee determines a financial conflict of interest exists, a management plan will be developed and implemented that will specify the actions that have been, and will be taken to manage such financial conflict of interest.

The Designated Institutional Official is responsible for the development and administration of a management plan. All those named in the management plan are responsible for following and complying with the management plan. Specific procedures will depend in part on the requirements imposed by the Assigned Committee, and the external sponsor of the research, if any.  

Management Plan conditions may include, but are not limited to, any and all of the following actions:

1. Public disclosure of financial conflicts of interest (e.g., when presenting or publishing the research, to staff members working on the study, to the Institution’s IRB, IACUC, and Data Safety and Monitoring Board, etc., as applicable);
2. For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
3. Appointment of an independent monitor capable of taking measures to protect the design, conduct, and reporting of the research against bias resulting from the FCOI;
4. Modification of the research plan;
5. Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;
6. Reduction or elimination of the financial interest (e.g., sale of an equity interest); or
7. Severance of relationships that create financial conflicts.

In some cases, inventors or creators of intellectual property will not be allowed to serve as Principal Investigator, Co-Investigators, or study team personnel for research involving that intellectual property or if allowed, may not be allowed to conduct certain activities such as determining eligibility, data analysis or consenting and enrolling patients in the research.

Management Plans will include the following key elements:

1. The role and principal duties of the conflicted Investigator in the research project;
2. Conditions of the management plan;
3. How the management plan is designed to safeguard objectivity in the research project
4. Confirmation of the Investigator’s agreement to the management plan
5. How the management plan will be monitored to ensure Investigator compliance; and
6. Other information the University judges to be relevant.

The University is committed to reporting all FCOIs to funding agencies in accordance with funding agency guidelines. However, given agency guidelines change periodically the University shall review agency reporting requirements to ensure best available information is used to deliver complete and timely reports.

For example, the NIH requires reporting thru ERA Commons, FCOI Module, as follows;

New FCOI Report (Initial submission)

Include: Grant Number, Name of Investigator with FCOI , Entity Name with FCOI, Nature of FCOI, Value of financial Interest (in increments), Description of how FCOI relates to research, Key Elements of Management Plan.

Report Due: (1) Prior to expenditure of funds, and (2) Within 60 days of any subsequently identified FCOI.

Annual FCOI Report

Include: Status of FCOI (i.e., whether FCOI is still being managed or no longer exists) and Changes to Management Plan, if applicable.

Report Due: At the same time as when the Institution is required to submit annual progress report (2 months prior to the next budget period start date), multi-year progress report, or at time of a No Cost Extension to the award’s period of performance.

Notes: The annual FCOI report is submitted to NIH separately through the eRA Commons FCOI Module.  In addition, the annual FCOI report is not to be submitted as part of the annual progress report nor is it a grant closeout requirement.  

Revised FCOI Report

Include: If applicable, update a previously submitted FCOI report to describe actions that will be taken to manage FCOI going forward or make changes to originally submitted FCOI report.

Due Date: Following the completion of a retrospective review when there is noncompliance with the regulation, if needed.

Mitigation Report 

Include: Project Number, Project Title, Contact PI/PD, Name of Investigator with FCOI, Entity Name with FCOI, Reason for review, Detail Methodology, Findings and Conclusion.

Report Due: When bias is found as a result of a retrospective review.

Alleged non-compliance or violations of this policy should be reported to the Designated Institutional Official who will inform the appropriate Department Chair, Dean, the Director of Compliance Services, the Vice President of Research, and, if applicable, the officials of UVM Health. At their discretion, the appropriate Department Chair or Dean, or if applicable, UVM Health officials will determine the manner in which the alleged non-compliance or violation will be investigated. 

In the event that the investigation reveals there was a deliberate breach of the policy, including, but not limited to, (i) failure to file; (ii) knowingly filing incomplete, erroneous or misleading disclosure forms; or (iii) failure to comply with procedures prescribed in fulfillment of this policy, the Dean will consult with the Vice President for Research on the appropriate sanction, if any, to be imposed.

Possible sanctions include (i) formal admonition; (ii) letter to the Investigator's personnel file; (iii) suspension of privileges to apply for external funds or seek IRB approval or supervise students in a research capacity; (iv) non-renewal of appointment; or (v) dismissal.

When applicable, determination of discipline for represented employees will occur in accordance with provisions of the applicable collective bargaining agreement.

In any case in which the PHS determines that an PHS-funded project of clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment has been designed, conducted, or reported by an Investigator with a conflicting interest that was not  managed or reported by the University as required by the PHS regulation, the University requires the Investigator(s) involved to disclose the Financial Conflict of Interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

Whenever a Financial Conflict of Interest is not identified or managed in a timely manner, including:

• Failure by the University to disclose a Significant Financial Interest that is determined by the University to constitute a Financial Conflict of Interest;
• Failure by the University to review or manage such a Financial Conflict of Interest; or
• Failure by the Investigator to comply with a Financial Conflict of Interest management plan;

The University shall, within 120 days of the University determination of noncompliance, complete a “retrospective review” of the Investigator’s activities and funded research project to determine whether any funded research, or portion thereof, conducted during the time period of the noncompliance was biased in the design, conduct, or reporting of such research.

The Designated Institutional Official shall document the retrospective review which must include at least the following key elements: 

1. Project number;
2. Project title;
3. PD/PI or contact PD/PI if a multiple PD/PI model is used;
4. Name of the Investigator with the FCOI;
5. Name of the entity with which the Investigator has a financial conflict of interest
6. Reason(s) for the retrospective review;
7. Detailed methodology used for the retrospective review (e.g., methodology of the review process, composition of the review panel, documents reviewed, etc.);
8. Findings of the review; and
9. Conclusions of the review.

In all cases involving PHS funded research: if bias is found, the Designated Institutional Official must notify NIH promptly and submit a mitigation report. If the FCOI was previously reported to the NIH, the mitigation report is submitted as a “Revised FCOI Report.” The mitigation report must include, at a minimum, the key elements documented in the retrospective review above and a description of the impact of the bias on the research project and the University plan of action or actions taken to eliminate or mitigate the effect of the bias (i.e., impact on the research project, extent of harm done, including any qualitative and quantitative data to support any actual or future harm; analysis of whether the research project is salvageable). Thereafter, the University will submit FCOI reports annually. 

If the University is carrying out the funded research through a subrecipient, the University through Sponsored Project Administration will require subrecipients to certify they have active and enforced financial conflict of interest in research policy that complies with the prime federal or non federal agency requirements.  The subaward issued to a subrecipient shall include terms that indicate subrecipient Investigators must comply with the subrecipient's financial conflicts of interest policy and include subrecipient reporting requirements of all identified financial conflicts of interest to the University. Such reporting due dates shall be sufficient to enable the University to provide timely FCOI reports, as necessary, to the prime funding agency. Due date for the initial FCOI report shall be made before expenditure of funds authorized in this Subaward and within 45 days of any subsequently identified COI.

Pursuant to the PHS and other federal agency FCOI regulations, University will provide a written response to any requestor within five (5) business days of a request of information concerning any significant financial interest disclosed to the Institution that meets the following three (3) criteria:

1. The significant financial interest was disclosed and is still held by the senior/key personnel as defined by this policy ;
2. The Institution determines that the significant financial interest is related to the PHS-funded research; and
3. The Institution determines that the significant financial interest is a financial conflict of interest.

Pursuant to the regulations, the University will provide the following:

• the Investigator’s name;
• the Investigator’s title and role with respect to the research project;
• the name of the entity in which the significant financial interest is held;
• the nature of the significant financial interest; and

the approximate dollar value of the significant financial interest (dollar ranges are permissible: $0-$4,999; $5,000-$9,999; $10,000-$19,999; amounts between $20,000-$100,000 by increments of $20,000; amounts above $100,000 by increments of $50,000), or a statement that the interest is one whose value cannot be readily determined through reference to public prices or other reasonable measures of fair market value.

Requests for public accessibility should also follow UVM’s Records and Documents Request Policy.

The disclosure form and records of all actions related to disclosure will be maintained for three years following the submission of the final financial report for the related award(s) or other retention periods specified by law or regulation as applicable. For PHS awards, the applicable regulation is specified in 2 C.F.R. 200.334 

The University will keep all records of all Investigator disclosures of financial interests and the Institution’s review of, or response to, such disclosure (whether or not a disclosure resulted in the Institution’s determination of a Financial Conflict of Interest), and all actions under the Institution’s policy or retrospective review, if applicable.   

Management plans are also retained in the University records. 

Additional procedures related to the implementation of this policy can be found at the Research and Integrity website.

Training/education related to this policy is as follows:

• 42 CFR Part 50.604(a)
• NSF: Award and Administration Guide: Chapter IV-Grantee Standards

Questions concerning the daily operational interpretation of this policy should be directed to the following (in accordance with the policy elaboration and procedures):