Conflict of Interest

The Division of Research Integrity and Compliance (DRIC) is responsible for managing all Conflicts of Interest (individual and institutional) that are related to research. USU’s Policy 307 states that a Conflict of Interest (COI) exists when a University employee owes a professional obligation to the University, which is or can be compromised by the pursuit of outside interests. USU does not take the view that a Conflict of Interest is inherently bad for the University. If an employee does have COI, the DRIC works with them to create an effective Management Plan.


Types of Research COIs

  • Financial conflict – A researcher stands to gain financially from the research, particularly if the research has a certain outcome.
  • Examples:
    • A researcher owns stock in a company that is sponsoring her/his research project, to be conducted at the University.
    • A researcher serves as the evaluator on a project for which she/he receives federal funding, which is contingent upon the project’s success.
  • Conflict of commitment – An employee has committed more than 100% effort to a range of projects.
    • Examples:
      • A faculty member uses University resources, including office or laboratory space, in support of her/his personal consulting work.
      • A faculty member dedicates more than the permitted four days per month working as a member of an advisory board.
  • Conflict of allegiance – An employee’s personal interests may create a bias in his/her discharge of University duties.
    • Examples:
      • A faculty member receives research funds/equipment/supplies from a source outside the United States and these funds do not go through the Sponsored Programs Office.
      • A faculty member has a joint appointment at another institution inside and/or outside the United States.
Exemptions that are NOT defined as significant financial interests:

  1. Salary, royalties, grant support or other compensation from USU;
  2. Income from seminars, lectures, or teaching engagements or service on advisory committees or review panels for public or non-profit entities;
  3. Royalty income from intellectual property rights arising out of USU employment that are assigned to organizations created to manage such rights on behalf of USU;
  4. Income from investment vehicles, such as mutual funds or retirement accounts, as long as the individual does not directly control the investment decisions made in these vehicles.
  5. If an equity interest that, when aggregated meets both the follow tests: (a) is less than the regulatory limit ($5,000 for PHS agencies, $10,000 for all other agencies) in value as determined through reference to public prices or other reasonable measures of fair market value, or (b) is less than five percent ownership interest in any single entity; and intellectual property rights (e.g., patents, copyrights or royalties from such rights).

Definitions

  • Conflict of Interest – A conflict of interest exists when a University employee owes a professional obligation to the University, which is or can be comprised by the pursuit of outside interests.
  • Immediate family – For the purposes of this policy means spouse/domestic partner and/or dependent children.
  • Institutional Conflict of Interest (ICOI) – A conflict of interest exists whenever the financial interests or holdings of the institution or the personal financial interests or holding of institutional leaders (those with direct authority over the allocation of institutional resources), might affect or reasonably appear to affect the design, conduct, reporting, review, or oversight of human subjects research.
  • Management Plan – A document that details how an employee will mitigate a Conflict of Interest. Disclosures submitted via Kuali serve also serve as a Management Plan.
  • Significant Financial Interest (SFI) – Any financial interest that is held by the individual, their spouse/domestic partner or dependent children, that is reasonably perceived to be related to the individual’s USU responsibilities, received from the entity in the twelve months preceding disclosure, when aggregated, exceed $5,000 for PHS agencies or $10,000 for all other agencies, and where one of the following are true:
    1. Interests in publicly traded entities.
    2. Compensation (salaries, consulting fees, honoraria, paid authorship, etc.) and the value of any equity interest (stock, stock option, or other ownership interest) in the entity.
    3. Interests in non-publicly traded entities:
    4. Compensation (salaries, consulting fees, honoraria, paid authorship, travel, etc.); or
    5. Any equity interest (e.g. stock, stock option or other ownership interest).
    6. Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests.

Employee Responsibilities

Every USU employee involved in research is required to complete a COI disclosure via Kuali.

A new disclosure is required:

  • When an employee is first hired at USU
  • Within 5 days of a change to the employee’s Significant Financial Interest(s)
  • Every time the employee submits a new proposal through the Sponsored Programs Office

AND

  • Within 365 days of the most recent disclosure submission

**Please note that failure to comply with COI policies may subject offenders to potential sanctions, ranging from verbal warning to termination of employment.


DRIC Responsibilities

The DRIC is responsible for collecting, tracking, and maintaining all records associated with Conflicts of Interest related to research at USU. The DRIC reviews every COI disclosure, determines if a COI or ICOI exists, and makes the final approval decision for all Management Plans. The DRIC provides education to faculty, students, and staff and assists other USU offices and committees (including the IRB, SPO, and IACUC) with questions concerning research COIs.

Kuali Instructions

Creating a COI Disclosure Instructions

  • Go to https://usu.kuali.co/res.
  • Click “Launch Kuali”.
  • At the bottom left side of the page, click the small squares icon.
  • Select “Conflict of Interest”.
  • Click green box “+ Create Annual Disclosure”.
  • Complete your COI Disclosure.

*Please note that Internet Explorer no longer supports Kuali.


Updating a COI Disclosure Instructions

COI disclosures must be updated within 30 days of a change in a Significant Financial Interest, every time a new proposal is submitted through the Sponsored Programs Office.

  • Go to https://usu.kuali.co/res.
  • Click “Launch Kuali”.
  • At the bottom left side of the page, click the small squares icon.
  • Select “Conflict of Interest”.
  • Click green box “+ Update Annual Disclosure”.
  • Complete your COI Disclosure.

*Please note that Internet Explorer no longer supports Kuali.


Assigned Review of a COI Disclosure Instructions

  • Go to https://usu.kuali.co/res.
  • Click “Launch Kuali”.
  • At top of screen, click “COI”.
  • On the left-hand side, click “Review Disclosures”.
  • Click on the name of the person under “Submitted By” to see the disclosure.
  • Review the listed financial entities and selected management options. Keep in mind how those responses pertain to any Project Declarations (ie Institutional Proposals).
  • As you look through the disclosure, you can click the “+ Comment” buttons to add comments. Please be sure to enable the option to make your comment visible to the reporter (PI) at the bottom of the page.
  • On the right-hand side you can click “Review Comments” to see your own comments and comments left by other reviewers.
  • Once you have completed your review, on the right-hand side you will be able to either click “Approve” or “Send Back to Revise” (if you made comments).
  • Note, the review process will continue until either the management plan is approved or the project proposal is rejected due to an unmanageable conflict of interest.

*Please note that Internet Explorer no longer supports Kuali.

 

Training

All USU researchers with a managed Conflict of Interest must complete online training via CITI. The training expires after 5 years. The following instructions explain how to register for the COI course.

For new CITI users:

  • Go to the CITI website.
  • Click “Register” in the upper right corner of the page.
  • Select “Utah State University” as your organizational affiliation.
  • Continue to step 7 on the CITI website.
  • Select “Conflict of Interest (COI)”  and go to the next page.
  • Click “Finalize Registration.”

For users already registered in CITI:

  1. Go to the CITI website and log in.
  2. Under “Main Menu/My Courses“ scroll down to the bottom.
  3. Under “My Learner Tools for Utah State University”, click "Add a Course".
  4. Select “Conflicts of Interest” and click "Next".
  5. Select “Yes, enroll me in the Conflicts of Interest Course” and click “Next”.
  6. You should now be enrolled.
  7. The DRIC will be notified when you pass all required course modules.

Institutional Conflict of Interest (ICOI)

The DRIC is responsible for reviewing all disclosures to determine if the interest represents an Institutional Conflict of Interest (ICOI) relating to human subjects research. ICOI is defined as a situation in which a financial interest of the university (e.g., investments held by the university in a company) or a Covered Official has the potential to bias, or appear to bias, research conducted by its employees or students.

For example, when USU licenses technology or other intellectual property, it may receive equity in a company as a result of that license and/or royalty or other fee as compensation for the use of that intellectual property. An ICOI is created if a researcher conducts human subjects research utilizing a drug, device, biologic, or other item on which USU owns intellectual property, has licensed the intellectual property, or receives royalties or other fees related to the USU intellectual property.

If the DRIC finds a potential ICOI from information provided by the Sponsored Programs Office, the finding will be forwarded to the Institutional Conflict of Interest Committee (ICOIC) for further review. The ICOIC must approve all institutional conflict involving research with human participants. After its review and action, the ICOIC shall forward to the IRB any approved plan or recommendation. Copies of this document shall also be provided to the department head and dean of the affected unit(s). The IRB shall have final authority to accept and have the management plan implemented, to alter the management plan, or to deny the management plan and reject the study. Additionally, the DRIC reports all ICOIs that involve human subjects research and related management plans to the Vice President for Research, as the Institutional Official, via an annual report.

Related Policies

USU Policies & Procedures

Utah State Policies

Federal Policies