Individual Conflicts of Interest and Standards Governing Relationships with Business Entities

This policy, which applies to all University faculty and staff, provides the framework to effectively identify and manage conflicts of interest, and establishes standards that enable faculty and staff to collaborate with business entities while ensuring that students, faculty, and staff of the University, as well as the general public have confidence in the integrity and objectivity of the University’s research and discovery, teaching and learning, and outreach and public service activities.

Faculty and staff are encouraged to engage in relationships with business entities to further the University’s mission while acknowledging that inherent in these relationships is the risk that professional judgment may be improperly influenced by the existence of such relationships. Faculty and staff are held to a shared ethical standard of ensuring that their relationships with business entities are transparent, grounded in objectivity, and do not improperly influence their professional judgment, exercise of University responsibilities, or performance of University-related activities.

Some relationships with business entities require greater vigilance than others. For example, when a relationship with a business entity could influence decisions made in the provision of clinical health care or conduct of research involving human participants, ensuring the safety of patients and research participants is paramount.

Campuses, colleges, departments, and administrative units may adopt standards that are more, but not less, restrictive than those set forth in this policy.

Section I. Reporting, Review & Management Of Relationships With Business Entities

Report of External Professional Activities (REPA). All paid faculty, Professional and Academic Administrative employees (P&A), and other individuals designated by a senior leader or their designate, or the Conflict of Interest (COI) Program staff [“covered individuals”], must comply with the following requirements to report financial interests and business interests they or their family members hold that relate to the covered individual's University expertise and responsibilities:

• Annual reporting. Covered individuals must complete an annual Report of External Professional Activities (REPA), even if they have no reportable external activities, financial interests, or business interests.
• Change in circumstances reporting. In addition to the annual reporting requirement, covered individuals must file a REPA within 30 days of:
  • acquiring a significant financial interest or acquiring a business interest that relates to their University expertise and responsibilities;
  • assuming a new University responsibility that relates to an existing business or significant financial interest; or
  • for Public Health Service (PHS) and Department of Energy funded investigators, travel that is related to one’s University responsibilities valued in excess of $5000 paid for or reimbursed by a business entity.
    • Travel paid for or reimbursed by a governmental agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education does not need to be reported.
    • The covered individual must disclose the purpose of the trip, the identity of the sponsor/organizer, the destination, and the duration.

Supervisors or designees within the covered individual’s department, administrative unit, college, or campus are responsible for reviewing the REPA. Conflict of Interest (COI) Program staff review REPAs that reflect a significant financial or business interest, and refer potential conflict of interest matters to a Conflict Review Panel (CRP). A CRP determines whether a conflict of interest exists and, if so, whether the conflict can be managed under the terms of a conflict management plan. 

When a conflict management plan is established, the Conflict of Interest Program will conduct a compliance review 90 days after the plan is executed, and then annually until the conflict no longer exists and the management plan is retired by Conflict of Interest Program Staff. Compliance review results are reported to the CRP.

Institutional Review Board (IRB) Applications. Investigators, and individuals who enroll or consent participants, must disclose relevant financial interests and business interests when completing IRB applications for human participant studies.

Educational Requirements

Covered individuals must complete the University’s conflict of interest course when filing the REPA for the first time, and every four years thereafter.

In addition, investigators engaged in PHS or Department of Energy (DOE)-funded research, to include sub-recipient investigators, must complete the University’s conflict of interest course prior to engaging in research related to any PHS or DOE-funded grant, and must take the course immediately when:

• there is a revision to this conflict of interest policy or procedures in any manner that affects the requirements imposed on investigators;
• an Investigator is new to the University; or
• the investigator is found to be out of compliance with this policy or a conflict management plan.

Disclosing Business And Significant Financial Interests

All employees must disclose relevant business and significant financial interests in certain circumstances, whether or not required under the terms of a conflict management plan. For specific disclosure requirements, see Appendix: Required Disclosures.

Disclosing Conflict of Interest Information Associated With PHS or Department of Energy-Funded Research

The Conflict of Interest Program will provide the following information in a written response within five business days of a request involving a financial conflict of interest related to a PHS or DOE-funded research project:

• the investigator’s name, title, and role on the research;
• the name of the business entity in which the significant financial interest is held;
• the nature of the significant financial interest; and
• the approximate value of the significant financial interest in dollar ranges or a statement that the value cannot be readily determined.

For at least three years from the date on which the information was most recently updated, information concerning the significant financial interests of an investigator will remain available in order to respond to written requests for this information.

Section II. Standards Governing Relationships With Business Entities

1. Employees are prohibited from engaging in the following activities with business entities (see Appendix: Prohibited Activities with Business Entities for more details.)
   • Having a financial or personal beneficial interest in a University contract or purchase order in which the employee has direct or indirect influence (see Minnesota Statute, Section 15.43)
   • Receiving personal gain from the use of instructional materials without proper administrative approval
   • Ghostwriting
   • Endorsing a product or service related to one’s University responsibilities and expertise
   • Accepting payment for the selection, use or promotion of products or services for University purposes
   • Accepting payment for the referral of students to prospective employers
   • Accepting payment for the recruitment of patients for clinical research studies
   • Accepting payment for participating in surveys intended to promote, market or sell a drug or medical device directly to the practitioner
   • Using or disclosing nonpublic research information in violation of insider trading laws
   • Making professional referrals to a business entity in which they have a business or financial interest.

2. Receiving Personal Remuneration from a Company While Participating in a Human Participant Study Sponsored by that Company

   Investigators who participate in an open human participant research study requiring IRB approval and oversight that is sponsored by a company, or involves the development or evaluation of a company’s product, device, or other technology, may provide consulting or speaking services (“services”) for the company during the period of the research study if all of the following conditions are met:

   • Any payments made in exchange for the services are directed to the University under the terms of a University External Sales Agreement.
   • The funds are not used to support the salary of the investigator.
   • The arrangement is preapproved by a Conflict Review Panel.

   For purposes of this provision, a human participant research study is open from the time the study is approved by the IRB until participant enrollment is closed and the primary outcome from the study has been published.

   Investigators may receive study-related expenses as approved in the University budget for the study, including salary support and travel expenses.

   An investigator may request that the Conflict Review Panel approve an exception to this provision (Section II.B) in order to receive personal remuneration or equity from the company while participating in the study. Compelling circumstances must be present to warrant approval of the exception.  

3. Gifts

   A gift is any gratuity, favor, discount, entertainment, hospitality, loan, forbearance, services, training, transportation, lodging, meals, or other item that constitutes a personal benefit to the recipient. It does not include an award given for merit, excellence in a certain field of expertise, or a particular accomplishment. It also does not include a gift made to the University or its Foundation for University purposes.

   1. Gift acceptance standards
      1. Employees involved in clinical healthcare
         • May not accept gifts from any health care related business entity (e.g., pharmaceutical, biotechnology, medical device, or medical diagnostics) irrespective of the nature or value of the gift. This includes items of nominal value such as coffee mugs, pens, free services, or items with the name or logo of a business entity, with the exception of:
           • modestly priced meals or other items (e.g., tote bags or door prizes) offered to all attendees at a widely-attended educational event or professional conference;
           • modest refreshments, such as coffee, donuts, and soft drinks; or
           • meals approved in advance by the employee’s chancellor, dean or administrative unit head after determining that the meal is being offered in a context that supports the education, research, or outreach missions of the University. The value of the meal should be consistent with the standards set forth in Administrative Policy: Traveling on University Business.
      2. Employees involved in purchasing, or who directly or indirectly influence a University purchasing decision or contract
         • Minnesota statute prohibits employees in direct contact with suppliers or potential suppliers to the University from accepting gifts exceeding the standards for “nominal gift” set forth in Administrative Policy: Purchasing Goods and Services. This includes those employees who may directly or indirectly influence a purchasing decision or contract by establishing specifications, testing purchased products, evaluating contracted services, or otherwise.
      3. University Officials
         • University Officials are specified in and subject to the provisions of Board of Regents Policy:  University Officials Gifts Received and Given by Regents and University Officials.
      4. All other employees
         • Employees not otherwise specified in this section must exercise good judgment and should decline a gift that would compromise, or have the appearance of compromising, the employee’s decision making in University matters. Examples of allowable gifts include:
           • modestly priced meals or other items (e.g., tote bags or door prizes) offered to all attendees at a widely-attended educational event or professional conference;
           • modest refreshments, such as coffee, donuts, and soft drinks;
           • meals approved in advance by the employee’s chancellor, dean or administrative unit head after determining that the meal is being offered in a context that supports the education, research, or outreach missions of the University. The value of the meal should be consistent with the standards set forth in Administrative Policies: Business Expenses (for local meals) or Traveling on University Business (for meals while in travel status); or
           • items provided to employees pursuant to a University contract approved by the Office of General Counsel.
   2. Disposition of Prohibited Gifts. If an employee has received a gift that cannot be accepted, the employee may:
      1. return the gift;
      2. pay its market value;
      3. transfer the gift to charity; or
      4. share a perishable gift (e.g. a fruit basket or flowers) with the office if it is not practical to return the gift.
4. Consulting with Business Entities

   1. Written Agreement. Employees who plan to provide compensated consulting services for one year or longer relating to their University expertise and responsibilities should enter into a signed, written agreement with the business entity prior to providing the consulting services. The written agreement should:

      • state the timeframe covered by the agreement;
      • describe the services and any deliverables to be provided by the employee;
      • state the amount of compensation and expenses to be paid; and
      • make clear that the employee is acting solely in their individual capacity and not on behalf of the University.

      Compensation should fall within fair market value parameters for the services provided.

      Payment of travel, food, and lodging expenses should be consistent with the standards set forth in Administrative Policy: Traveling on University Business.

   2. Additional Compliance Obligations
      1. Unless an exception is approved by a Conflict Review Panel, employees may not receive personal remuneration or equity from a company while serving as an investigator on an open human participant study requiring IRB approval and oversight that is sponsored by that company, or involves the development or evaluation of that company’s product, device, or other technology.
      2. Employees must also comply with the requirements of Board of Regents Policy:  Outside Consulting and Other Commitments, Administrative Policy: Outside Consulting and Other Commitments, and related administrative procedures.
5. Attending or Participating in Events Sponsored by Business Entities
   1. Education and Training Events (non-accredited).
      1. Employees may attend on-site and off-site education and training events sponsored by business entities
      2. Chancellors, deans, and administrative unit heads will determine whether it is appropriate for the University or for the sponsoring business entity to cover such expenses or whether the covered individual must pay for them, taking into consideration the educational value of the event and whether the commercial interests of the company served by the participation of the covered individual outweigh the educational benefit to be derived by the covered individual from attendance at the event. Factors to consider include the frequency of the same or similar sponsored training, the venue, and the substance of the agenda.
      3. Employees may not accept compensation (e.g., an honorarium or consulting fees) simply for attending an education or training event sponsored by a business entity, listening to an audio presentation, or reviewing web based training developed by a business entity unless the activity is conducted in the context of a written consulting agreement which meets the requirements of Section II.D of this policy or the activity has been approved in advance by the employee’s chancellor, dean, or administrative unit head.
      4. An on-site educational or training event sponsored by a business entity that does not qualify as a “continuing education event” must receive prior approval from a chancellor, dean or administrative unit head, and must meet these criteria:
         • the funding is in the form of a grant to the unit;
         • the grant is unrestricted as to content and format of the activities for which it will be used; and
         • the University co-sponsor retains ultimate control with respect to the final selection of speakers, the order of presentations, and their content.

   2. Business Funding for Continuing Education Events (accredited). Business entities may fund on-site continuing education events if the following criteria are met:

      1. the funding is in the form of a grant to the unit;
      2. the grant is unrestricted as to content and format of the activities for which it will be used;
      3. the University co-sponsor retains ultimate control with respect to the final selection of speakers, the order of presentations, and their content; and
      4. the event meets applicable continuing education requirements.

      Chancellors, deans, and administrative unit heads may develop guidance to govern these circumstances.

   3. Presentations at Events Sponsored by Business Entities. Employees may give presentations in their individual capacities at events sponsored by business entities where the subject matter of the event relates to the individual’s University expertise and responsibilities if:
      1. the information presented is evidence-based;
      2. the employee represents that the lecture materials fairly reflect their independent views and not solely the views of the business entity; and
      3. the following information is disclosed to the audience:
         1. the employee’s business or financial relationship with the business entity, if any; and
         2. a representation that the employee is speaking and acting solely in their individual capacity and not on behalf of the University.
6. Using Products Developed and Provided by Business Entities

   1. Educational Materials. In connection with their University responsibilities, employees may use educational materials developed or provided by business entities, but may not disseminate to students or require students to use educational materials that advertise or otherwise promote a product or service of the business. This provision does not prohibit the use of scientific articles published in peer reviewed journals even if some sections of the journal contain advertising.

      When using educational materials developed by a business entity that do not reflect the name of the business entity that developed them, employees must disclose the name of the business entity, if known.

   2. Samples and Demonstration Items. Units must centrally receive, document and disseminate free or discounted samples and demonstration items provided by a business entity. If such items are offered to an employee, they must refer the individual offering the items to a central location as designated by the particular campus, college or administrative unit.

      This requirement does not apply to (a) textbooks, software and related educational items that are provided in limited quantity to University employees to review for potential course adoption, or (b) laboratory supplies, reagents or pharmaceutical products and medical devices, provided in limited quantity for evaluation purposes.

      In the clinical health care context, for demonstration and educational purposes, employees are permitted to use a product or information found in a product branded with the name of a particular business entity with a patient for whom the product has been prescribed.

      Chancellors, deans, and administrative unit heads may exempt certain arrangements from the requirements of this provision if they determine that the free sample or demonstration item would not influence any action an employee may take that could benefit the commercial interests of the business entity offering the free or discounted item.

7. Presence of Business Entity Representatives on Campus.
   1. Health Sciences. Representatives of business entities are not permitted in:
      1. Health Sciences college or school research, clinical or teaching areas unless invited by faculty or staff;
      2. Clinical areas in colleges and departments outside the Health Science college or school areas unless invited by faculty or staff.
   2. Other campuses, colleges, and administrative units. Chancellors, deans, and administrative unit heads are responsible for ensuring that the presence of representatives of business entities on campus supports the educational, research, and outreach missions of the University.
8. Business Entity Sponsorship of Fellowships and Scholarships. Chancellors, deans, and administrative unit heads may accept the sponsorship of fellowships and scholarships by business entities under the following conditions:
   1. the sponsorship must be in the form of a gift given to the University of Minnesota Foundation, or in the form of a grant given to the University through the Office of Sponsored Projects Administration;
   2. the gift or grant must be made without any expectation of reciprocity;
   3. the funds must be used to support educational programs and activities for students, residents, or fellows; and
   4. the business entity is not permitted to select the recipient of a scholarship or fellowship.

9. Sponsored Research Involving Sub-Grantees, Contractors, or Collaborators

   When individuals outside the University participate as a sub-grantee, contractor, or collaborator in sponsored research, the University, at least to the extent required by the research sponsor, will take reasonable steps to ensure that sub-grantees, contractors, or collaborators are adequately informed of their obligation to comply with all applicable conflict of interest reporting, review, and disclosure requirements as required by federal and state law, as well as all conflict of interest policies of research sponsors. This requirement is satisfied if the University's contract or other agreement with the sub-grantee, contractor, or collaborator includes a provision setting forth these obligations.

   For PHS or Department of Energy-sponsored research, the University will specify in the written agreement whether the University's or the sub-recipient's conflict of interest policy applies, and will specify time frames for the sub-recipient to act to enable the University to meet its reporting obligations to the PHS or Department of Energy. Where the agreement specifies that the University's conflict of interest policy applies, only those provisions relating to reporting of financial interests, conflict of interest determinations and management, and conflict of interest training, are applicable.

Non-Compliance

Non-compliance with the provisions of this policy includes, but is not limited to, failing to timely disclose a significant financial or business interest, failing to complete educational requirements, intentionally filing an incomplete, erroneous, or misleading report of external activities, failing to provide additional information as required by the REPA approving authority, or failing to follow an approved plan for managing, reducing or eliminating a conflict of interest.

Non-compliance with this policy may result in disciplinary action, up to and including termination of employment, as well as ineligibility of employees to submit grant applications, seek approval from the Human Research Protection Program, or supervise graduate students.

Failure to timely disclose a significant financial interest may result in a retrospective review to determine whether any PHS or Department of Energy-funded research or portion of the research conducted during the period of noncompliance was biased. For PHS research, the retrospective review, reporting, and submission of a mitigation report if bias is found, will be conducted in accordance with PHS procedures established in 42 CFR 50.605(a)(3). For DOE research, the retrospective review, reporting, and submission of a mitigation report if bias is found, will be conducted in accordance with Section V.a.1 of the DOE interim conflict of interest policy. See Administrative Procedure: Retrospective Reviews and Mitigation Plans.