Other parties within the University (beyond the Conflict of Interest Office) have responsibility for aspects of this process. 

1. Discuss with your supervisor to obtain approval in writing.

Applicable policies to consider include:

• Policy 5-204: Remunerative Consultation and Other Employment Activities (make sure your external financial relationships won’t disrupt your job at the University)

Excerpt: “All Employees of the University holding full-time positions shall give full services to the work of the university during scheduled work periods. Any non-University employment must not interfere with the discharge of the person's full-time service obligations to the university. It is expected that all full-time University Staff Members will treat the University as their prime employment activity.”

• University Rule 1-006E: Individual Financial Conflict of Interest in Transactions (you will need to recuse yourself from any transactions that the University has related to your financial relationships)

Excerpt: “The following types of activities present conflicts of interest in which an Employee who has a Substantial Interest in a Business Entity is not allowed to participate because such an activity would be a violation of law or is judged by the University to be a violation of its institutional values.

1. 1. 1. An Employee is not allowed to negotiate for the University or UURF or act as a University decision-maker or a UURF decision-maker regarding any Transaction with a Business Entity in which the Employee has (or will likely have) a Substantial Interest.
      2. An Employee is not allowed to disclose or use any of the University’s controlled, private, or protected business information (1) to further the Employee’s or another’s business interests or (2) to secure special privileges or exemptions for the Employee or others.
      3. Solicitation or receipt of a Gift by a University Employee, whether directly or indirectly through the institution, is not allowed, when (a) the purpose or effect of the Gift is likely to improperly influence the Employee in the discharge of the Employee’s University responsibilities; (b) the Gift is given to reward the Employee for official action taken; or (c) the Gift is given in close proximity to recent past, present, or future transactions between the University and the giver of the Gift.”

• Supplemental Rule 1-006: Health Sciences Industry Relations Policy (applicable if you are part of UU Health Sciences)
• Policy 8-001: Medical Practice Plan for the University of Utah School of Medicine Full-Time Faculty (applicable if you are a faculty member in the School of Medicine)
• Other departmental or University policies may also apply

2. Update your financial disclosure in BRR once the financial relationship is approved.

• If you are participating in research through the Institutional Review Board or Office of Sponsored Projects, the COI Office will automatically perform COI reviews on a case by case basis for each research project (see University Rule 1-006C: Individual Financial Conflict of Interest in Research) to determine whether there is a conflict of interest and what management might be necessary.
• If you are participating in scholarly or educational activities where your financial relationship may be a conflict of interest, please review University Rule 1-006D: Individual Financial Conflict of Interest in Scholarly or Educational Activity and contact the COI Office (coi@utah.edu) to discuss.
• If you are participating in other activities where your financial relationship may be a conflict of interest, contact the COI Office (coi@utah.edu) to discuss. Remember that you must recuse yourself from any transactions that the University has related to your financial relationships.
• Continue to update your financial disclosure at least annually and within 30 days of a change in your financial relationships.

COI correspondence is sent to the email address you submitted when you registered in the ERICA system. To update your email address, please log on to ERICA (https://erica.research.utah.edu). Then, click on your name in the top right corner to access My Profile settings. From here you may update your contact information.

To protect the researcher, the research team, the University, the science, the public, and human participants enrolled in research projects.

The following employees are required to submit a BRR Disclosure Form annually:

1. All faculty members, excluding emeritus faculty, visiting faculty, and non-health sciences adjunct faculty;

2. All staff employed at the manager level or above; and

3. All staff with purchasing authority or delegated purchasing authority, including account executives and their delegates, staff authorized to use an institutional credit card (e.g., Purchasing Card or PCard), and staff authorized to make purchases through UShop.

Each Investigator and each Employee is required to submit a BRR Disclosure Form and receive approval from the Individual Conflict of Interest Committee prior to engaging in the following activities:

1. Research;

2. Scholarly or Educational Activity; or

3. Transactions

Any Financial Relationship (yours or a Family Member's) reasonably related to your responsibilities to the University: 

• Any Compensation/Remuneration received from an external Business Entity 
• Any equity ownership interests (e.g. stock, partnership interest, member interest) in an industry business entity, excluding ownership in mutual funds and/or pension funds. 
• Any leadership position (e.g. officer, director, partner) in an industry business entity, even if unpaid. 
• Any intellectual property in which an Employee has, or reasonably foresees having, the right to receive Compensation as a result of licensing or other commercialization of Intellectual Property created by that Employee, including the right to receive shares of revenue, royalties, or share of royalty income under University Property.

Yes, the University Individual Conflict of Interest Policy requires disclosure of intellectual property rights and interests (e.g., patents, copyrights), when the patent application is filed or when the copyright is asserted or upon receipt of income related to such rights and interests, including royalty income from Intellectual Property owned by the University of Utah Research Foundation. 

Within the University, the information provided in your BRR Disclosure Form is confidential and is only used for the purposes of administering the policy by the Conflict of Interest Committee and other University offices with oversight responsibilities, as appropriate. Under certain circumstances, the University is required to make personal financial information publicly available to comply with federal and state law. 

No, many Financial Relationships do not create a conflict of interest. You are required to disclose all Financial Relationships that reasonably appear related to your professional responsibilities to the University, as defined by your department or job description. The Individual Conflict of Interest Committee is responsible for determining whether the financial relationship(s) creates a conflict of interest. 

Yes. The Conflict of Interest Committee only considers “Significant Financial Interests” when evaluating Research for conflicts of interest. Business Transactions are evaluated against "Substantial Interests", which have different thresholds based on the Utah Public Officials and Public Employees Ethics Act. 

• For publicly traded business entities, any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the business entity as of the date of disclosure, when aggregated for the individual and the individual’s family member, exceeds $5,000. 

• For non-publicly traded business entities, any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated for the individual and the individual’s family member, exceeds $5,000, or any equity interest. 
  
  
• Intellectual property rights and interests (e.g., patents, copyrights), when the patent application is filed or when the copyright is asserted or upon receipt of income related to such rights and interests, including royalty income from intellectual property owned by the University of Utah Research Foundation. 

The University uses a peer review process to determine if a conflict of interest exists. The Individual Conflict of Interest Committee, as designated in Policy 1-006, includes faculty and staff who are charged with reviewing Financial Relationships to identify conflicts of interest that need to be managed, reduced or eliminated. 

The Individual Conflict of Interest Committee will work with you to design a way to manage, reduce, or eliminate the conflict (a “management plan”).  The Committee tries to design a management plan that will allow you to continue your University work while ensuring that your personal Financial Relationships do not negatively affect, or bias, that work. If the Committee determines that management is not possible for your circumstances, you may be required to eliminate your conflict of interest by divesting your financial interest or modifying some aspects of the work you do for the University.

The Individual Conflict of Interest Committee routinely makes the its determinations and management plans available to: 

• the individual’s University superiors (Department Chair/supervisor) 
• the appropriate University offices, including but not limited to, the Office of the Vice President for Research, the Office of General Counsel, Internal Audit, Institutional Review Board, Office of Sponsored Projects, Technology Commercialization Office, Procurement and Supply Management, Graduate School
• other Employees whose responsibilities to the University are directly affected by the conflict of interest 

Depending on the specific circumstances, the management plan approved by the Committee may also require disclosure of the conflict to human subjects participating in research, to students or other subordinates at the University, and/or disclosure of the details about your financial relationships on the University’s publicly available Conflict of Interest website. 

Yes, Research involving human subjects must receive the highest level of protection from bias or appearance of bias created by an individual’s conflict of interest. The Committee is required to apply a “rebuttable presumption” standard, which is a presumption against the conduct of research with human subjects in any circumstance where the individual has a conflict of interest relating to the research. The Committee may approve conduct of the research by the individual only upon a finding of compelling circumstances and only when the Committee can craft an effective management plan to mitigate the conflict. Otherwise, the conflict must be eliminated or the research project shall not be conducted by the individual.  

• Early-stage research: In addition to the examples of compelling circumstances provided in the 2008 AAMC Report - Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research, experimentation to further develop an early stage discovery may similarly require the insights, knowledge, perseverance, laboratory resources, or special patient populations of the discoverer. The best interests of patients who could benefit from the discovery may justify further involvement of the discoverer as an investigator. If such circumstances are deemed compelling by the applicable conflicts of interest committee, the analysis should define the stages of the research and the specific activities for which there are compelling reasons for the conflicted discoverer/investigator’s involvement, and an approved management plan should be structured to restrict the investigator’s roles to those stages and activities. The management plan should include a clear discussion of the time line proposed for elimination of the conflicted investigator from research participation and the strategy to restrict the time of involvement of a conflicted investigator to a minimum. Approval and management of the conflict may differ between experiments designed to promote further development on the one hand and those designed to validate claims linked to the discovery on the other. Approval of such research when human subjects are involved should require particularly stringent analysis of the degree of risk to subjects and of the effectiveness of particular provisions of the conflict management plan to protect subjects and prevent the introduction of bias of the conflicted investigator.

• Low risk research: In considering the degree of risk to human subjects, as called for in the 2001 Report, an institution’s conflicts of interest committee may encounter human subjects studies in which careful assessment finds risk to human subjects to be sufficiently low, so that the disposition of any associated conflict by the committee may be similar or identical to the disposition that would be made by that institution in non-human subjects research.

Please visit the Office of Foreign Influence website.

Please contact Trent Foxley, Risk Manager for International Engagement and Compliance, at trent.foxley@hsc.utah.edu.