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POLICY
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ADMINISTRATIVE POLICY
Home : Administration & Operations : Compliance and Legal

Individual Conflicts of Interest

Effective Date: September 2005
Last Update: August 2012
Responsible University Officer:
  • University President
Policy Owner:
  • Director, Office of Institutional Compliance
Policy Contact:
CONSULTED WITH: University Senate

Printed on: . Please go to http://policy.umn.edu for the most current version of the Policy or related document.

POLICY STATEMENT

All covered individuals will be 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.

This policy covers: All faculty and P&A staff except those who are governed by the companion administrative policy: Individual Conflicts of Interest: Standards Governing Individuals Involved in Clinical Health Care; all other individuals with responsibility for the design, conduct, or reporting of University research; and all other individuals authorized to act on behalf of the University to fulfill its research and discovery, teaching and learning, and outreach and public service missions.

Covered individuals involved in one or more higher-risk activities (as defined below), and covered individuals involved in research sponsored by the Public Health Service (PHS) are held to more restrictive standards.  These standards are highlighted throughout this policy where applicable.

Covered individuals involved in higher risk activities include those who are:

  • involved in clinical health care (and governed by a separate policy as described above);
  • involved in human subjects research subject to review by the Institutional Review Board (IRB) where the IRB has determined that research conducted by the covered individual involves “more than minimal” risk to subjects;
  • involved in technology commercialization;
  • in a position to exert control over the content of University curriculum that could benefit the commercial interests of a business entity and, at the same time, create opportunity for or further an existing financial relationship between the covered individual and that business entity; or
  • in a position to take any other action on behalf of the University that could benefit the commercial interests of a business entity and, at the same time, create opportunity for or further an existing financial relationship between the covered individual and that business entity.

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

SECTION I. REPORTING & MANAGING RELATIONSHIPS WITH BUSINESS ENTITIES

  1. Annual Reporting. Annually, covered individuals, including those who are temporarily away from campus (e.g., leave, sabbatical), must complete a Report of External Professional Activities (REPA) to report significant financial interests and business interests, with respect to themselves and their family members, that are related to the covered individual's University expertise or responsibilities.

    Significant financial interests (SFI) include financial interests in a business entity consisting of one or more of the following :

    1. Remuneration. The amount of remuneration, in specified ranges, received from a business entity in the calendar year preceding the REPA reporting or anticipated during the calendar year following the REPA reporting that annually equals or exceeds $10,000.  Reporting is required when the annual amount received from a business entity meets the following thresholds:
      1. for individuals engaged in PHS-sponsored research, a value that exceeds $5,000 (when aggregated with equity interests);
      2. for all other covered individuals, a value that equals or exceeds $10,000.
    2. Equity Interests. The value of aggregated equity interests (e.g., stock, stock options, or other ownership interest) in a business entity, as determined through reference to public prices or other reasonable measures of fair market value as of the date of REPA reporting, that meets the following thresholds:
      1.  for individuals engaged in PHS-sponsored research, a value that exceeds $5,000 (when aggregated with remuneration) in a publicly traded business entity, or any equity interest in a non-publicly traded business entity;
      2. for all other covered individuals, a value that equals or exceeds $10,000, or an ownership interest of 5% or more (regardless of worth)
    3. Royalties Paid in Connection with Intellectual Property Rights. The value of any royalties paid in connection with intellectual property rights, e.g., patents and copyrights, and any agreements to share in royalties related to such rights when the annual aggregated dollar amount meets the following thresholds:
      1. for individuals engaged in PHS-sponsored research, a value that exceeds $5,000
      2. for all other covered individuals, a value that equals or exceeds $10,000.

    Business interests include holding any executive position in a business or membership on a board of a business entity, whether or not such activities are compensated.

    Travel-related information.  Individuals engaged in PHS sponsored research must report travel paid for or reimbursed by a business entity, unless the trip was 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.

  2. Reporting Not Required. Covered individuals are not required to report the following:
    1. Salaries, royalties, or other remuneration paid by the University to the covered individual.  Royalties are exempt to the extent the individual does not have any other relationship with the business entity paying the royalties that could result in a conflict of interest.
    2. Salaries, royalties, or other remuneration paid to adjunct faculty by their primary employer.
    3. Income from seminars, lectures, or teaching engagements sponsored by a federal, state, or local government agency, an institution of high education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.
    4. Income from service on advisory or review panels for a federal, state, or local government 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.
    5. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the covered individual does not directly control the investment decisions made in these vehicles.
    6. Income from non-profit entities organized solely for education, religious, philanthropic, or research purposes (with the exception of non-profit entities created by for-profit corporations)(this exclusion does not apply to covered individuals involved in PHS sponsored research).
    7. Income from services provided to professional organizations (this exclusion does not apply to covered individuals involved in PHS sponsored research).
  3. Periodic Reporting. In addition to the annual reporting requirements, all covered individuals must complete a new REPA within 30 days of a substantial change in a business or financial interest that relates to their University expertise or responsibilities, or a change in their University responsibilities that relates to an existing business or financial interest. A "substantial change" includes, but is not limited to, an increase in the value of an existing financial interest to a value that qualifies it as a significant financial interest or the acquisition of a new financial interest.

    Individuals involved in PHS sponsored research must also report travel paid for or reimbursed by a business entity within 30 days of the trip unless the trip was 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.

  4. Application of These Reporting Requirements to Adjunct Faculty. Adjunct faculty who are involved in one or more of the higher risk activities as part of their University-related responsibilities or who are responsible for the design, conduct, or reporting of research, whether compensated or uncompensated, are subject to these reporting requirements. However, even if an adjunct faculty member is not involved in any higher risk activity, a chancellor, dean, or administrative unit head, may, in the exercise of discretion, determine that the nature of an adjunct faculty member’s relationship with one or more business entities is such that it should be reported on a REPA.
  5. REPA Review. Covered individuals have responsibility for the accuracy and completeness of the information reported on the REPA. Chancellors, deans, and administrative unit heads are responsible for reviewing that information and following up with the covered individual if they have questions or if they have reason to believe that the information reported may not be accurate or complete. All potential conflict of interest matters will be reviewed and managed centrally.
  6. Conflict of Interest Determinations and Management
    1. Determinations. University conflict review committees are authorized to determine whether an individual conflict of interest exists. Before a determination is made that a conflict of interest exists, conflict review committees or their corresponding executive committees will confer with the covered individual. Conflict review committees will determine whether a conflict exists by considering the nature of the University activity, the nature of the financial interest or business interest, and how closely the interest is related to the covered individual's University expertise and responsibilities.
    2. Management. When a conflict review committee determines that an individual conflict of interest exists, it will determine whether the conflict must be eliminated or reduced or whether it can be effectively managed. A conflict management plan will be developed, in consultation with the covered individual and, in appropriate circumstances, with the covered individual's chancellor, dean, or administrative unit head. An interim management plan for individuals engaged in PHS-sponsored research may be created in order to comply with the timing requirements imposed by the PHS conflict of interest regulations. If an interim conflict management plan is created, a final plan will be issued after all the steps described above have been completed.

      Additional restrictions may be imposed and additional obligations required when the conflict involves human subjects research. Covered individuals must fully comply with all management elements set forth in their conflict management plan and must confirm their compliance in writing at least annually. When required by the terms of a conflict management plan, covered individuals must also provide documentation demonstrating compliance.

      Covered individuals may not engage in University activities in which there is an identified conflict of interest except in accordance with the terms of their conflict management plan.

  7. Conflict of Commitment Review. The Conflict of Interest Program will forward all REPAs reflecting income amounts exceeding $100,000 to the covered individual's unit head for a conflict of commitment review in accordance with Administrative Policy: Outside Consulting and Other Commitments and related procedures.

SECTION II. STANDARDS GOVERNING RELATIONSHIPS WITH BUSINESS ENTITIES

  1. Consulting with Business Entities
    1. Written Agreement. Covered individuals engaged in one or more higher risk activities who provide compensated consulting services relating to their University expertise or responsibilities must enter into a signed, written agreement with the business entity prior to providing the consulting service. The written agreement must state the need for the services, describe the services and any deliverables to be provided, state the compensation to be paid and the timeframe covered by the agreement, and make clear that the covered individual is acting solely in his or her individual capacity and is not speaking for or acting on behalf of the University.

      All other covered individuals are encouraged to enter into such agreements, but are not required to do so, unless directed by a chancellor, dean, or administrative unit head.

      A copy of any written agreement may be requested for review as part of a conflict of interest review or other oversight process.

    2. Fair Market Value. Professional fees paid for the consulting services provided should fall within reasonable parameters of the fair market value of the services provided. In addition to professional fees, covered individuals may also accept a business entity's payment of or reimbursement for reasonable and actual expenses incurred for travel, meals, and lodging.
    3. Travel Expenses. Payment for or reimbursement by the business entity for travel, food, and lodging should be consistent with the standards set forth in Administrative Policy: Traveling on University Business, unless a chancellor, dean, or administrative unit head approves a different standard.
    4. Documentation Required. Covered individuals engaged in one or more higher risk activities who enter into a consulting relationship with a business entity must maintain documentation reflecting (a) the remuneration received from and any travel expenses paid for or reimbursed by the business entity and (b) the services provided, including estimates of the time and effort committed to providing the services. This documentation must be retained for the duration of the consulting relationship plus two years and must be available on request.
    5. Additional Compliance Obligations. Covered individuals 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.
  2. Using Products Developed and Provided by Business Entities
    1. Educational Materials. In connection with their University responsibilities, covered individuals 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, covered individuals 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 a covered individual, he or she 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 covered individuals 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 limited circumstances, chancellors, deans, and administrative unit heads may exempt certain arrangements from the requirements of this provision, taking into consideration whether the receipt of the free sample or demonstration item could influence any action a covered individual may take that could benefit the commercial interests of the business entity offering the free or discounted item.

  3. Attending or Participating in Events Sponsored by Business Entities
    1. Education and Training Events (non-accredited). Covered individuals may attend on-site and off-site education and training events sponsored by business entities but may or may not be reimbursed for the expenses associated with attendance at such events. 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.

      Covered individuals may accept the payment or reimbursement for attendance at or participation in education and training events sponsored by business entities where the training is mandated by law.

    2. Business Funding for Continuing Education Events (accredited). Business funding for continuing education events held at the University must be in the form of a grant made to a central or collegiate administrative unit. Although the business entity may have input with respect to the content or format of activities for which the grant may be used, the University co-sponsor will retain ultimate control with respect to the content or format of activities.

      These educational events must meet applicable professional continuing education requirements. Chancellors, deans, and administrative unit heads may develop guidance to govern these circumstances.

      Covered individuals 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.A of this policy and the activity has been approved by the covered individual’s chancellor, dean, or administrative unit head.

    3. Sales and Marketing Events. Covered individuals may give presentations at sales or marketing events sponsored by business entities when the subject matter of the event relates to their University expertise or responsibilities, if the information presented is evidence-based, and the individual represents that the lecture materials fairly reflect their independent views and not solely the views of the business entity.

      In these circumstances, the following information must be disclosed by the covered individual to the audience: the covered individual's financial or business relationship with the business entity, if any; and a representation that the covered individual is speaking and acting solely in his or her individual capacity and not on behalf of the University.

  4. Presence of Business Entity Representatives on Campus

    Representatives of business entities are not permitted in any AHC research, clinical or teaching areas unless invited by faculty or staff, or the AHC has a contract for services in place with the business entity that permits access. Chancellors, deans, and administrative unit heads in other colleges and administrative units are responsible for creating local policies to ensure that the presence of representatives of business entities on campus supports the educational, research, and outreach missions of the University.

  5. Gifts, Meals, & Entertainment
    1. Gifts

      Covered individuals:

      • may accept gifts that do not exceed the nominal value of $25.00, except as described below, and may only accept gifts of greater value if they do so on behalf of the University or unless a chancellor, dean, or administrative unit head determines that the acceptance of gifts is appropriate in an international context;
      • may accept gifts provided by a business entity at widely-attended off-site educational events if acceptance is optional and the gift is offered to all attendees (e.g., tote bags and door prizes at conferences); and
      • may not accept gifts where the aggregate value of gifts from a single business entity exceeds $50 annually.

      The term "gift" does not include an award given for merit, excellence in a certain field of expertise, or a particular accomplishment.

      Covered individuals who have purchasing authority on behalf of the University must ensure that their acceptance of gifts meets the standards for "nominal gift" set forth in Administrative Policy: Purchasing Goods and Services.

      The President or delegatee may grant a categorical exception, in writing, where the recipients of the gifts are not in a position to take action on behalf of the University that could benefit the commercial interests of the business entity offering the gifts.

    2. Meals and Entertainment.

      Covered individuals engaged in one or more higher risk activities, unless authorized by a departmental approver in advance, may not accept meals, entertainment, or similar benefits from a business entity either on or off-site, with the exception of modest meals offered to all attendees at educational events.

      For all other covered individuals, chancellors, deans, and administrative unit heads may exempt certain activities from the restrictions imposed on covered individuals engaged in one or more higher risk activities, but must ensure that business entities that provide meals, food, entertainment, or similar benefits to covered individuals do so to support the education, research, and outreach missions of the University.

      The restrictions of this provision do not apply to events sponsored by business entities to benefit students (e.g., recruiting events).

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

    When individuals outside the University participate as a sub-grantee, contractor, or collaborator in sponsored research with covered individuals, 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-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. 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.

  7. Prohibited External Relationships or Activities

    Covered individuals may not:

    1. Accept Payment for Promotion of Products or Services. Covered individuals may not accept payment for promoting the products or services or other commercial interests of a business entity.

      This prohibition also applies to "switching arrangements" in which a covered individual is influenced by financial gain to change the selection and/or use of an item used in University activities from a competing product to the product of a particular business entity.

      This does not prevent a covered individual, with the approval of a chancellor, dean, or administrative unit head, from selecting a product that the covered individual developed for educational, research, or outreach purposes.

    2. Receive Personal Gain Resulting from the Use of Instructional Materials They Developed. Covered individuals may not personally profit from the assignment of materials, or the assignment of the venue for the purchase of materials, to students in classes, or any other instructional setting at the University without proper administrative approval by their department.
    3. Engage in Ghostwriting. Covered individuals may not have their names and University affiliation associated with a publication or other article that was created by a business entity where the covered individual had no meaningful authorship in the publication or article. Authorship must be restricted to those individuals who made a significant intellectual contribution to the work including: conception, design, and performance; analysis and interpretation; and manuscript preparation and critical editing for intellectual content.
    4. Make Endorsements. Covered individuals may not endorse a product or service developed or sold by a particular business unless a contract entered into by the University permits the endorsement. This provision applies to both written and oral endorsements when the product or service relates to the covered individual's University-related expertise or University responsibilities, whether or not the covered individual uses his or her University title in making the endorsement. This provision is not intended to restrict (1) classroom discussions and other educational activities that involve comparative analysis, or (2) the covered individual from providing an opinion based on scholarly activity and research.

SECTION III. DISCLOSING BUSINESS AND SIGNIFICANT FINANCIAL INTERESTS

  1. Whether or not required by the terms of a conflict management plan, covered individuals must make the following disclosures:
    1. To research sponsors. Covered individuals must disclose relevant business or significant financial interests to sponsors of research as required by the sponsor.
    2. To professional journals and other publications. When submitting a paper for publication, a covered individual must disclose to the editor any business or significant financial interest that may be affected by the publication. This provision also applies to release of information to news media.
    3. In the context of a public appearance. Covered individuals must disclose relevant business or significant financial interests when they make an appearance, either in person or by way of a written communication, before any public body, commission, group, or individual, to present facts or to give an opinion respecting any issue or matter up for consideration, discussion, or action.
  2. When required by the terms of a conflict management plan:
    Covered individuals must disclose relevant business or significant financial interests (e.g., to students, colleagues, and patients.)
  3. When responding to external requests for financial conflict of interest information associated with PHS-funded research:
    The University will provide the following information in a written response within five business days of the request:
    • the investigator’s name, title, and role on the research;
    • the name of the business entity in which the SFI is held;
    • the nature of the SFI; and
    • the approximate value of the SFI in dollar ranges or a statement that the value cannot be readily determined.
  4. Retaining Documentation of Disclosures Made. Covered individuals must retain documentation of the disclosures made for the period of time that the plan is in effect.

SECTION IV. EDUCATIONAL REQUIREMENTS

All covered individuals who are required to report business and financial interests on a REPA will be required to complete educational requirements on University policies and procedures on individual conflicts of interest and any applicable state and federal laws at least once every four years.

In addition, investigators engaged in Public Health Service (PHS)-funded research, to include sub-recipient investigators, must also complete a conflict of interest course within 30-days of any of these events:

  • the University revises this conflict of interest policy or procedures in any manner that affects the requirements of Investigators;
  • an Investigator is new to the University; or
  • the University finds that an Investigator is not in compliance with this policy or a conflict management plan.

SECTION V: COMPLIANCE

All covered individuals must comply with Board of Regents Policy: Individual Conflicts of Interest, this Administrative Policy and any other University policy or procedure related to conflicts of interest, and applicable federal and state law. Non-compliance may result in disciplinary action, up to and including termination of employment, as well as ineligibility of covered individuals to submit grant applications, seek approval from the Human Research Protection Program, or supervise graduate students.  For individuals engaged in PHS-sponsored research, failure to timely disclose a significant financial interest may result in a retrospective review to determine whether any PHS-funded research or portion of the research, conducted during the period of noncompliance, was biased.

SECTION VI. REVIEW

The policy owner is responsible for reviewing and updating this policy as appropriate on a regular basis.

REASON FOR POLICY

To implement Board of Regents Policy: Individual Conflicts of Interest and to comply with federal and state law. This policy is intended to ensure that covered individuals report and fully disclose financial and business interests that relate to their University expertise and responsibilities so that potential conflicts of interest can be reviewed and, where conflicts of interest are found to exist, eliminated, reduced, or effectively managed. To gain and maintain the public’s trust, the University must demonstrate that the work that is conducted here is free from improper influence and bias that might otherwise result from external interests and relationships.

PROCEDURES

FORMS/INSTRUCTIONS

APPENDICES

FREQUENTLY ASKED QUESTIONS

ADDITIONAL CONTACTS

Subject
Contact
Phone
Fax/Email
Primary Contact(s)
612-626-7852
Technical problems
EGMS helpline
612-624-1600
Policy questions
Policy helpline
612-626-1462

DEFINITIONS

Academic Employees
Appointment categories which include Faculty (regular, term and adjunct; probationary and tenure track; temporary and visiting) and Academic Professional and Administrative (P&A) Staff.
Accredited
An educational or training event that meets the requirements for continuing education credits established by a recognized continuing education organization or body.
Associated Entity
Any trust, organization, or enterprise over which the covered individual, alone or together with an immediate family member, exercises a controlling interest.
Business Entity
Any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint stock company, receivership, business or real estate trust, or any other nongovernmental legal entity organized for profit, nonprofit, or charitable purposes. With the exception of nonprofit entities created by for-profit entities, this definition does not include organizations and entities that are organized solely for educational, religious, philanthropic, or research purposes.
Business Interest
Holding any executive position (e.g. Chief Executive Officer, Chief Operating Officer, Chief Scientific or Technical Officer) in a business or membership on a board of a business entity, whether or not such activities are compensated. The term "board of directors" refers to the board of any business including boards of trustees, scientific advisory boards, medical advisory boards, and boards of professional societies.
Clinical Health Care
The provision of medical, nursing, or other health-related care to humans or animals for the treatment of disease or injury. In the context of animals, this definition includes those owned by the University and those brought to the University by their owners specifically for the purpose of health care.
Conflict of Interest (Individual)
A relationship between a covered individual's private business or financial interests, or those of the covered individual's family members, and the covered individual's expertise and responsibilities such that an independent observer might reasonably question whether the individual's objectivity in the performance of University responsibilities could be compromised by considerations of personal gain.
In the context of research, a financial conflict of interest means a significant financial interest that could directly and significantly affect the design, conduct, or reporting of the research.
Conflict Management Plan
A formal document approved by the applicable conflict review committee that directs the covered individual’s management of the conflict of interest.
Conflict Review Committee (CRC)
University committees responsible for determining whether a given situation involves a conflict of interest and, if it does, also determining whether the conflict must be eliminated or, alternatively, identifying mechanisms to effectively manage the conflict. Each committee will consist of both voting and nonvoting members. Voting members consist of faculty and professional academic and administrative staff and community members whose appointments to the committee have been approved by the University's Senior Vice Presidents. Nonvoting members may include representatives from the Office of Institutional Compliance, Office of Technology Commercialization, Sponsored Projects Administration, Human Research Protection Program, Office of Research Education and Oversight Programs, and Office of the General Counsel.
Covered Individual
Includes the following: (a) faculty and staff; (b) individuals with responsibility for the design, conduct , or reporting of University research; and (c) other individuals authorized to act on behalf of the University to fulfill its research and discovery, teaching and learning, and outreach and public service mission.
Departmental Approver
The immediate administrator; typically the department head, department chair, or department/division director.
Electronic Grants Management System (EGMS)
The electronic system used by covered individuals to complete the Report of External Professional Activities (REPA) (http://egms.umn.edu/REPA/).
Endorsement
A promotional statement made to further the commercial interests of a business entity.
Equity Interest
Any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
Fair Market Value
The rate of compensation paid under a consulting agreement to a covered individual that meets the following criteria:
  • reflects the expertise and credentials of the covered individual;
  • is comparable to the compensation paid to the covered individual's peers;
  • is reasonable in the context of the services provided; and
  • does not include an enhancement in exchange for an agreement to improperly:
    • make or induce others to make referrals to a business entity;
    • make or induce others to endorse the products or services of a business entity; or
    • improperly influence research results to benefit the interests of a business entity.
Family Member
The covered individual's spouse or domestic partner, dependent children, and any other family member whom the covered individual reasonably knows may benefit personally from actions taken by the covered individual on behalf of the University.
Financial Interest and Significant Financial Interest
  1. Financial Interest
    Anything of monetary value, including, but not limited to:
    • An interest in a business consisting of any stock, stock option, or similar equity interest (excluding any interest arising solely because the investment is in a pension, mutual fund, or other institutional investment fund over which the employee does not exercise control); or
    • The receipt of or the right or expectation to receive any income, such as a consulting fee, honoraria, salary, allowance, royalty, or any other form of compensation from a business entity.
  2. Significant Financial Interest

    For investigators conducting PHS-funded research, anything of monetary value where the value  exceeds:

    • $5,000 with respect to an aggregated annual remuneration received from a business entity;
    • $5,000 when aggregating remuneration received with the value of any equity interest held  in a publicly traded business entity;
    • any equity interest held in a non-publicly traded company; or
    • $5,000 with respect to royalty income received.

    For all other covered individuals, anything of monetary value where the value equals or exceeds:

    • $10,000 or  an ownership share of 5% (regardless of worth)  in a business entity as determined through reference to public prices or other reasonable measures of fair market value;
    • $10,000 with respect to an aggregated annual income of all types from a business entity; or
    • $10,000 with respect to the payment of or a commitment for future royalties from a business entity.
Higher Risk Activity
The higher-risk activities pertain to covered individuals who are:
  • Involved in clinical health care;
  • involved in human subjects research subject to review by the Institutional Review Board (IRB) where the IRB has determined that research conducted by the covered individual involves "more than minimal" risk to subjects;
  • involved in technology commercialization;
  • in a position to exert control over the content of University curriculum that could benefit the commercial interests of a business entity and, at the same time, create opportunity for or further an existing financial relationship between the covered individual and that business entity; or
  • in a position to take any other action on behalf of the University that could benefit the commercial interests of a business entity and, at the same time, create opportunity for or further an existing financial relationship between the covered individual and that business entity.
Institution of Higher Education
A public or nonprofit educational institution in the United States that is accredited or pre-accredited by a nationally recognized accrediting agency or association, and provides a post-secondary program of education for which the institution awards a bachelor's degree or provides not less than a 2-year program that is acceptable for full credit toward a bachelor's degree. See 20 U.S.C. 1001(A)
Investigator
For purposes of Public Health Service funded research, an investigator means the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the PHS, or proposed for such funding, which may include, for example, collaborators or consultants.
Non-accredited
See Accredited
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 approving authority, or failing to follow an approved plan for managing, reducing or eliminating a potential conflict.
Outside Associates
Researchers working for sub-grantees, contractors, or collaborators outside the University who participate in research for which the University has primary responsibility.
Outside Commitment
Outside consulting or other professional commitments, paid or unpaid, that are beyond the scope of the individual's University employment responsibilities.
Outside Consulting
An outside commitment that is paid professional service intended to further the interests of an outside party, regardless of whether such services are provided as an employee of the outside party, an independent contractor, a business owner, or as a director or manager.
Participate
To be part of a University activity in any capacity, including, but not limited to, serving as the principal investigator, co-investigator, research collaborator, or provider of direct services or patient care. The term also applies to teaching, engaging in outreach activities, and/or providing administrative services. The term does not apply to individuals who provide primarily technical or advisory support and have no direct access to the data or control over its collection or analysis. The term also does not apply to the study participants, unless they are in a position to influence the study's results or have privileged information as to the outcome.
Public Health Service Agencies
Federal funding source for research. See Appendix:  Public Health Service Agencies.
Remuneration
Includes salary and any payment of services not otherwise identified as salary (e.g., consulting fees, honoraria, and paid authorship).
Report of External Professional Activities (REPA)
The form in the Electronic Grants Management System (EGMS) used by covered individuals to report external professional activities at least annually.
Reporting Obligations
A requirement to report means that, at least annually, covered individuals must provide information regarding external financial and business relationships that relate to their University responsibilities using an established reporting process internal to the University. Covered individuals must also report substantial changes in financial or business interests within 30 days of the time that the change occurs. With respect to a financial interest, a "substantial change" includes, but is not limited to: (1), an increase in the value of an existing financial interest to a value that qualifies it as a significant financial interest; (2) a covered individual’s acquisition of a new significant financial interest (e.g., through purchase, marriage, or inheritance); (3) Assuming an executive or other fiduciary role with a business entity; or (4) a change in a covered individuals responsibilities that relates to an existing business or financial interest.
Sales and Marketing Event
An event sponsored by a business entity primarily for the purpose of promoting its commercial interests.
SFI
See Financial Interest
Sponsored Project
An externally funded activity that is governed by specific terms and conditions. Sponsored projects must be separately budgeted and accounted for subject to terms of the sponsoring organization. Sponsored projects may include grants, contracts (including fixed price agreements), and cooperative agreements for research, training, and other public service activities.
Substantial Change
Includes the following:
  • an increase in the value of an existing financial interest, or the acquisition of a new financial interest, that qualifies as a significant finance interest
  • the holding of any new paid or unpaid executive or board position in a business entity; this does not include positions with governmental entities or entities organized solely for educational, religious, philanthropic, or research purposes.
  • (for PHS sponsored researchers only) travel paid for or reimbursed by an entity unless the travel was 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.
  • a change in University responsibilities (e.g., a new research project) that relates to an existing business or significant financial interest.
Technology Commercialization
When the University either licenses technology developed by a University inventor to a third party or provides notice to the inventor that it is waiving or otherwise assigning to an inventor all or part of the University's rights, titles, or interests in or to a technology created by the inventor.
Travel Expenses
Include costs of transportation, lodging, meals and incidentals.
Unit Head
The department, unit or division head, as appropriate.
University Activities
Teaching, research, outreach, public service, and administrative activities. These activities also include clinical activities engaged in by faculty covered under private practice plans.

RESPONSIBILITIES

Collegiate Approver
The senior administrative officer for the college or administrative unit (typically a dean or vice president) or that officer's designee. Reviews REPA. Follows up with the covered individual if there are questions regarding the information reported. Approves REPA where the covered individual has no reportable interests. 
Conflict Review Committee (CRC)
Reviews REPAs and other related information to determine if a conflict of interest exists, and, if a conflict of interest exists, takes action to manage, reduce, or eliminate the conflict and defines the elements of a conflict management plan.
Covered Individual
Reports external professional activities at least annually and, where a conflict management plan has been issued to the individual by a CRC, complies with management mechanisms specified in the plan and, at least annually, confirms his or her compliance with the plan.
Department Approver
Reviews REPA forms completed by covered individuals in the approver's college, unit, or department. Addresses any identified discrepancies with the covered individual or the collegiate approver.
Executive Conflict Review Committee
A subgroup of a Conflict Review Committee that gathers information to evaluate conflict of interest risk, in appropriate situations determines whether a conflict of interest exists, and prepares potential conflict of interest matters for presentation to the appropriate CRC. Members include the chair of the associated CRC, representatives from the Office of Institutional Compliance, and a representative from the Office of the General Counsel.
Office of Institutional Compliance
Administers the conflict review and oversight process, convenes the CRCs, and directs the Conflict of Interest Program.
Unit Approver
Responsible for reviewing the REPA and following up with the covered individual if they have questions or if they have reason to believe that the information reported may not be accurate or complete.

RELATED INFORMATION

Board of Regents Policies:

Administrative Policies:

Other Related Information:

HISTORY

Amended:
August 2012 - The policy clarifies a) periodic reporting requirements and b) application of the conflict of interest policy to certain sub-recipients of PHS-sponsored research.
Amended:
October 2010 - The policy: a) expanded reporting requirements to reflect the change in the definition of family members, b) differentiates operationally the ethical standards that apply to those individuals whose University responsibilities involve higher risk activities; c) adds standards to govern relationships with business entities, e.g., the acceptance of gifts, the presence of business representatives on campus, and the use of products developed and provided by business entities; and d) incorporates a separate appendix covering those individuals involved in the provision of clinical health care. Title changed to Individual Conflicts of Interest.
Amended:
February 2010 - Updated Administrative Procedure: Evaluating and Managing Individual Conflict of Interest Disclosures with additional language about IRB involvement in evaluation and management of conflicts.
Amended:
October 2009 - Added Frequently Asked Questions.
Effective:
September 2005
Supercedes:
September 2005 - Administrative Policy: Purchasing Conflict of Interest, issued 1/1993, revised 9/2003. See Board of Regents Policy: Individual Business or Financial Conflict of Interest for more details on the history of this policy.

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Last modified on March 26, 2014