Procedures for disclosing, reviewing and managing conflicts of interest

The following procedures describe how UAM 2,050: Conflict of Interest Policy is implemented. It is intended to assist employees with submitting conflict of interest (COI) disclosures, understanding how disclosures are reviewed, and understanding how conflicts of interest are managed.

Applicability

UAM 2.050: Conflict of Interest Policy applies to all employees of the University of Nevada, Reno.

Colleges, schools, departments, and divisions within the University may have additional conflict of interest policies, procedures and/or requirements that address their specific needs.

Conflict of interest disclosures

Certain financial interests and relationships can result in situations that create a risk that an employee’s professional judgement or objectivity could be unduly influenced by external interests. Disclosure is central to the University's ability to identify these situations and take action to eliminate, reduce or manage associated risks.

A disclosure informs the University about circumstances that have the potential to cause a risk situation. It is not a reflection on the likelihood that the employee would actually allow an outside interest to influence their professional judgment or use their University position to gain an unwarranted advantage for an outside interest.

Who needs to submit a COI disclosure and when

All University employees must submit a conflict of interest disclosure if they have any of the significant financial interests and/or external relationships listed below (1) at the time of hire and (2) within thirty days of discovering or acquiring a new significant financial interest or external relationship.

Additionally, the following employees must submit a conflict of interest disclosure annually during the University’s conflict of interest disclosure campaign.

• Academic Faculty
• Administrative Faculty
• Classified Staff
• Medical Residents
• Postdoctoral Fellows

During the annual COI disclosure campaign, the aforementioned employees submit a COI disclosure to either identify potential conflict of interest situations or attest that they have none. Deans and directors are responsible for compliance with annual disclosure requirements for employees in their units.

Investigators submitting proposals to a Public Health Service agency or the National Science Foundation must have a current COI disclosure on record no later than at the time of proposal submission.

How to submit a COI disclosure

Conflict of interest disclosures are submitted online through InfoEd. All University employees who have a NetID can access InfoEd using their UNR NetID and password.

Once logged into InfoEd, click on External Interests on the left side of the page, then click on Update.

On the following page, click on “Create/Update COI Disclosure.”

A set of five screening questions will display, each requiring a “Yes” or “No” response. The first four questions ask about potential conflict of interest situations. The fifth question asks if the employee plans on participating in a compensated outside activity and reminds them of the requirement to submit a Compensated Outside Activities request prior to starting the activity.

If responses to all screening questions are “No,” the disclosure serves as an attestation that the employee has no potential conflict of interest situations to disclose. After saving the screening page, the employee certifies that their responses are accurate and then submits the disclosure. InfoEd sends the employee an email thanking them for submitting their disclosure, with a reminder to update the disclosure within 30 days of acquiring or discovering a new conflict of interest situation.

If a “Yes” response is entered for one or more of the four COI screening questions, InfoEd will then load follow-up pages to gather more information about the situation. Once the employee has responded to all follow-up questions, the disclosure can certified and submitted. The employee will receive an email letting them know that their disclosure is under review.

Note: if a person submitting a COI disclosure cannot access InfoEd, a paper version of the disclosure form can be submitted. An electronic copy of the form will be saved in InfoEd. Notify the Conflict of Interest Designation to receive a paper COI disclosure form.

How COI disclosures are reviewed

COI Designated Official

The University has designated an institutional official to solicit and review conflict of interest disclosures, provide information and training about conflicts of interest to the University community, and to facilitate compliance with conflict of interest policies and regulations.

Disclosures with one or more “Yes” responses to the four COI screening questions are reviewed by the COI Designated Official. In this review, the COI Designated Official determines whether a significant financial interest, external relationship, paid travel, or student impact situation constitutes a potential conflict of interest situation and if further review is required. The COI Designated Official may seek additional information before making this determination.

If it is determined that the employee does not have a conflict of interest situation, the employee will receive an email notifying them of the determination, with a reminder to update their disclosure within 30 days of acquiring or discovering a new significant financial interest, external relationship, paid travel or student impact situation.

If the COI Designated Official determines that a potential conflict of interest situation has been disclosed, the disclosure will reviewed by the COI Committee.

COI Committee review

Multiple factors are considered during the review of a COI disclosure, for example:

• The value of the financial interest – financial interests with higher values may be considered higher risk.
• The scope of the relationship with an external entity – longer and closer associations may increase risk.
• The extent of the employee’s ability to make decisions on behalf of the University regarding an outside entity.
• The extent of an employee’s ability to provide private information about the University to an outside entity.
• The seriousness of possible harm that could occur if the employee’s decisions or actions were unduly influenced by the external interest.

If the COI Committee determines that the employee does not have a conflict of interest situation, the employee will receive an email notifying them of the determination, with a reminder to update their disclosure within 30 days of acquiring or discovering a reportable significant financial interest, external relationship, paid travel, or situation that could negatively impact a student.

If the COI Committee determines that a conflict of interest situation exists, it then recommends actions to manage or eliminate the risk.

Conflict of interest management

If the COI Committee determines that the risks involved in a COI situation can be minimized to an acceptable level through management, the COI Designated Official works with the employee and others to implement a COI Management Plan, based on the COI Committee’s recommendations.

A COI Management Plan Administrator is assigned to implement the plan, monitor compliance, and submit status reports.

If students and/or other trainees are involved, a Student/Trainee Advocate will be assigned. The Student/Trainee Advocate is charged with meeting with students/trainees to review their rights as scholars and researchers and be a point of contact if the student/trainee has any concerns. The Management Plan Administrator may serve as the Student/Trainee Advocate, or another person may be assigned.

If there is a risk of bias in the design, conduct or reporting of research, an Independent Reviewer may be assigned and charged with scientific oversight. The Management Plan Administrator may serve as the Independent Reviewer, or another person may be assigned.

The Plan Administrator, Student/Trainee Advocate, Independent Reviewer, or anyone else with a COI Management Plan role must not have a financial or vested interest in the external entity and must not be subordinate to the employee or anyone else with a financial interest in the entity. 

The COI Management Plan must be approved and signed by the employee, the employee’s department chair or director, dean or vice president, the COI Designated Official, the Associate Vice President for Research Administration, the Vice President for Research and Innovation, everyone assigned an oversight role on the plan, and, in some situations, the President of the University. In some situations, a modified COI Management Plan that has fewer management elements may be implemented. In these situations, fewer signatories may be assigned.

Elements of a COI Management Plan

The elements in a COI Management Plan vary depending on the nature of the situation and can involve:

• Requirements to disclose the conflict of interest to faculty, staff, students and collaborators; on publications; and in presentations.
• Requirements about the use of University resources.
• Information about invention disclosures and intellectual property rights.
• Requirements regarding the involvement of students.
• Mechanisms to reduce, eliminate or manage the risk of bias in the design, conduct or reporting of research.
• Supervisory changes that may be required if more than one person in a department has the same conflict of interest.
• Requirements for the approval of contracts with and invoices from the external entity.
• Requirement for the employee to recuse themselves from University deliberations, decisions, and negotiations regarding the external entity.
• Conflict of Interest training requirements.
• Any other conditions necessary to reduce or eliminate the risk that the employee’s external interest could unduly influence their professional responsibilities to the University.

 A copy of the signed COI Management Plan is distributed to all parties involved and an electronic copy is saved in InfoEd.

Notifying sponsors about conflicts of interest

The University is committed to compliance with all sponsor requirements regarding the disclosure and management of conflicts of interest.  If a sponsor requires that Principal Investigators (PI) have a current COI disclosure on file at the time of proposal submission, Sponsored Projects will notify the PI of this requirement and will not submit a proposal until this requirement is met.

The Director of Sponsored Projects will notify sponsors about conflicts of interest that arise during the course of a project if the terms and conditions of the award include this requirement. The University will comply with the sponsor’s requirements for management or elimination of the conflict of interests.

Monitoring compliance with COI Management Plans

The COI Management Plan Administrator is responsible for monitoring compliance with the terms of the plan on a regular basis. The COI Management Plan Administrator must submit a status report to the COI Designated Official at least annually. An electronic copy of the status report will be saved in InfoEd.

The Student/Trainee Advocate must meet with all students/trainees involved with the conflict of interest situation to go over the “Student/Trainee Agreement and Guidelines for Participation in Faculty Enterprises” form. The form describes the conflict of interest situation, goes over students’/trainees' rights as scholars and researchers, and includes contact information for the Student/Trainee Advocate. The form should be signed by the student/trainee and the Student/Trainee Advocate and sent to the COI Designated Official. An electronic copy of the agreement will be saved in InfoEd.

The COI Management Plan Administrator and Student/Trainee Advocate should notify the COI Designated Official about any concerns related to the conflict of interest. If the concern cannot be resolved by the COI Designated Official, it will be addressed by the COI Committee or by an appropriate higher authority.

Renewing or revising COI Management Plans

COI Management Plans are typically valid for one year. Upon review of the COI Management Plan Status Report, the plan may be extended for an additional year at the discretion of the COI Designated Official. If conditions change or if there is evidence of non-compliance with the plan, the COI Committee will review the plan and may recommend revisions.

Terminating a COI Management Plan

COI Management Plans are terminated when the conflict of interest situation no longer exists or when the COI Committee determines that the risk is no longer manageable and must be eliminated.

Eliminating conflicts of interest

Under certain circumstances, the University may require elimination of the conflict of interest rather than management. For example, the conflict of interest situation may be one that is prohibited under institutional or other policies or the risk of harm outweighs the benefit of continuing the situation.

Possible actions to eliminate the conflict of interest include:

• Reducing a financial interest to a level that is not considered significant
• Divestment of the financial interest that is causing the conflict of interest
• Termination of the relationship that is causing the conflict of interest
• Changing supervisory structures
• Prohibiting transactions and/or relationships between the University and an external entity
• Modifying a researcher’s role on a project
• Terminating employment at the University

The decision to eliminate a conflict rather than managing it is made after careful deliberation by the COI Committee in conjunction with authorities such as the Provost, Vice President of Research and Innovation, and General Counsel.

Appealing a conflict of interest decision

Employees may appeal a conflict of interest determination through written notification to the Vice President for Research and Innovation for a research-related conflict of interest situation, or the Provost for a non-research related conflict of interest situation.

Employees may appeal to the President of the University concerning the decision of the Vice President for Research and Innovation or the Provost. The President's decision on this appeal is final.

A Vice President may appeal a determination that she/he has conflict of interests by notifying the President. The President's decision on the appeal is final.

An electronic copy of the final decision will be saved in InfoEd.

Reporting potential conflict of interest situations

Although the COI disclosure process is the primary method of identifying conflict of interest situations, the COI Designated Official reviews possible conflict of interest situations that are disclosed or discovered in other ways. Conflict of interest concerns may be brought to the attention of the COI Designated Official, or may be reported by submitting an Anonymous improper activity form.