Printed on: 12/11/2018. Please go to http://policy.umn.edu for the most current version of the Policy or related document.

ADMINISTRATIVE POLICY

Institutional Conflict of Interest

Responsible University Officer(s):

University President

Policy Owner(s):

Chief Compliance Officer

Policy contact(s):

Jon Guden

Date Revised:

Jan 4, 2018

Effective Date:

May 31, 2006

POLICY STATEMENT

The University strives to ensure that its research, teaching, outreach and other activities are not compromised or perceived as biased by financial and business considerations.

Institutional conflicts of interest may arise when:

a University official with a business or significant financial interest in a business entity is in a position to take action on behalf of the University that may benefit or be perceived to benefit the business entity;
the University licenses an invention to a business entity and holds royalty or equity interests in the entity that may be affected by ongoing University research or other University activities;
a University vendor donates a gift to the University;
the University holds investments in a business entity that has a financial or business relationship with the University;
the University enters into a commercial transaction that compromises or appears to compromise the University’s research, teaching, or outreach mission activities, or its institutional reputation; or
the University has a business or significant financial interest in a business entity whose commercial interests may be affected by human participants research conducted at the University.

Financial Disclosure for University Officials (FDUO): University officials and other designated individuals must disclose their significant economic interests and affiliations, and those of their immediate family members (spouse, domestic partner, or dependent) upon their appointment and then annually thereafter, and identify how those interests may relate to their institutional responsibilities.
Annual Reviews
: The Conflict of Interest (COI) Program will review reports of University royalty earnings, gifts, purchases, and industry sponsored research projects to evaluate whether any institutional conflicts may arise from these interests. The COI Program will refer potential institutional conflicts of interest to the Institutional Conflict Review Panel for review and action.
Mission Related Commercial Transactions: The General Counsel will assess whether there is potential for an institutional conflict of interest prior to entering into substantive discussions or making an oral or written commitment regarding a commercial transaction that has a value greater than $2M, appears to have a significant impact on the University's mission or raises unusual questions of public interest or public policy.
Human Participants Research Involving More than Minimal Risk: When a unit within the University proposes to evaluate an invention in which the University has a financial interest under the terms of a University licensing agreement, and the evaluation is determined by the Institutional Review Board to involve "more than minimal" risk to human participants, the COI Program staff and Executive Panel will gather information for consideration by the full Institutional Conflict Review Panel. In assessing and managing potential institutional conflicts of interest involving human participant research, the Institutional Conflict Review Panel (ICRP) presumes that the research should not be conducted at the University unless there are compelling circumstances that justify proceeding with the research here despite the institutional conflict. (See Administrative Procedure: Reviewing and Managing Institutional Conflicts of Interest: II. Special Situations)

REASON FOR POLICY

To implement Board of Regents Policy: Institutional Conflict of Interest. This policy and procedure establish a process to manage, reduce, or eliminate institutional conflicts of interest. It is critical to the mission and reputation of the University to maintain the public's trust by ensuring that the University’s research, teaching, outreach, and other activities are not compromised or perceived as biased by financial and business considerations. In addition, because of its numerous and complex relationships with public and private entities, the University must be aware of any relationships involving financial gain that may compromise or appear to compromise its integrity.

PROCEDURES

FORMS/INSTRUCTIONS

APPENDICES

FREQUENTLY ASKED QUESTIONS

CONTACTS

Subject	Contact	Phone	Email
Primary Contact(s)	Jon Guden	612-626-4727	jguden@umn.edu
Policy and Procedure	Jon Guden	612-626-4727	jguden@umn.edu
Financial Disclosure for University Officials (FDUO) Questions	Jon Guden	612-626-4727	jguden@umn.edu

DEFINITIONS

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.
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.
Financial Disclosure for University Officials (FDUO): The financial disclosure statement completed by University Officials and other designated individuals.
Institutional Conflict of Interest: A situation in which the research, teaching, or outreach mission activities, or its institutional reputation may be compromised or appear to be compromised because of an external financial or business relationship held at the institutional level that may bring financial gain to the institution, any of its units, or the individuals covered by this policy.
Institutional Conflict Review Executive Panel: A subset of the Institutional Conflict Review Panel consisting of the chair, representatives from the Office of Institutional Compliance, and a representative from the Office of the General Counsel.
Institutional Conflict Review Panel: A Panel established by the president or delegate to evaluate potential institutional conflict of interest situations and develop conflict management plans. The panel consists of voting and nonvoting (ex-officio) members. Voting members may include faculty, professional academic and administrative staff, and community members. Nonvoting members may include representatives from the Office of Institutional Compliance, Office for Technology Commercialization, Sponsored Projects Administration, Human Research Protection Program, Office of Research Compliance, and the Office of the General Counsel.
Institutional Review Board (IRB): A component of the University’s Human Research Protection Program, the IRB consists of multiple biomedical panels and social behavioral panels comprised of faculty, students, and staff representing all University campuses, Fairview, and Gillette Children’s Specialty Hospital.
University Official: See Board of Regents Policy: Institutional Conflict of Interest

RESPONSIBILITIES

Board of Regents: Review and act on management plans involving institutional conflicts of interest as required by Board of Regents Policy: Institutional Conflict of Interest.
Conflict of Interest Program: Review disclosures, gather information and prepare agendas to assist the Institutional Conflict Review Panel with its responsibilities. Prepare conflict management plans and conduct management plan monitoring.
General Counsel: Advise the President or delegate on proposed conflict management plans before they are presented to the Regents for review and action. Take actions as appropriate under the procedure for mission related commercial transactions.
Institutional Conflict Review Executive Panel: Reviews matters presented by COI Program staff to determine whether to refer to the full panel for review. Can make “no conflict of interest” determinations.
Institutional Conflict Review Panel: Evaluate potential institutional conflict of interest situations. Develop and review institutional conflict management plans to ensure that the plans appropriately consider and address the issues. Forward management plans that meet the criteria for Regents approval to President or delegate and General Counsel for review and recommendation to Regents. Review information relating to implementation of conflict management plans.
Institutional Review Board (IRB): Reviews research projects involving human participants, working with investigators to ensure adequate protection and informed, uncoerced consent.
Office of Investments and Banking: Consult with Institutional Conflict Review Panel before voting on behalf of the University on an issue involving a company in which the University holds equity.
Office for Technology Commercialization: Provide information to the Conflict of Interest Program and to the Institutional Conflict Review Panel as requested. Coordinate with the Conflict of Interest Program when preparing license agreements that envision clinical trials at the University.
Other Individuals designated to file a FDUO: Complete a FDUO upon appointment and thereafter annually. These individuals are identified in Appendix: Other Individuals required to file a Financial Disclosure for University Officials.
President (or delegate): After consulting with the General Counsel, recommend approval, amendment or denial of management plans requiring Regents approval.
Purchasing Services: Provide information to the Conflict of Interest Program and to the Institutional Conflict Review Panel as requested.
Sponsored Projects Administration: Provide information to the Conflict of Interest Program and to the Institutional Conflict Review Committee as requested.
University Officials: Complete a FDUO upon appointment and thereafter annually.
University of Minnesota Foundation: Provide information to the Conflict of Interest Program and to the Institutional Conflict Review Panel as requested.

RELATED INFORMATION

Policies:

Board of Regents Policy: Code of Ethics for Members of the Board of Regents
Board of Regents Policy: Institutional Conflict of Interest
Board of Regents Policy: Individual Conflict of Interest
Administrative Policy: Individual Conflicts of Interest and Standards Governing Relationships with Business Entities
Minnesota State Law - Statute 15.43, Acceptance of Advantage by State Employee

Resources:

Council on Governmental Relations (COGR), Approaches to Developing an Institutional Conflict of Interest Policy (2002)
HHS/PHS Office of Human Research Protections (OHRP), Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (May 2004)

HISTORY

Amended:

January 2018 - Major Revision, Comprehensive Review:

Reduces the number of University Officials who are required to file a FDUO annually.
Provides a new appendix covering the list of other individuals required to file a financial disclosure, adds new definitions for Business Entity and Business Interests, and other general clean-up for the policy and procedure.

Amended:

May 2013 - Major Revision, Comprehensive Review:

Aligns the definition of an institutional conflict with the definition in Board of Regents Policy: Institutional Conflicts of Interest.
Combines six prior procedures into one and reduces the frequency of reporting by central units.
Incorporates two new standards of conflict review. The first addresses research in which the University holds a financial interest and involves more than minimal risk to human subjects. The second applies to certain mission-related commercial transactions.
Updates responsibilities and definitions to align with new and revised procedures.
Title changed to Institutional Conflict of Interest.

Effective:

June 2006

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