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Covered individuals at the University of Minnesota must comply with Board of Regents Policy: Individual Business or Financial Conflict of Interest and all applicable federal and state laws related to conflict of interest. All paid University academic employees and individuals with research responsibilities must disclose potential conflicts of interest in accordance with Procedure 2.1.16.1, Disclosing Potential Individual Conflicts of Interest. Where a potential conflict is identified, the covered individual must follow an approved plan to manage, reduce or eliminate the conflict.

Unit heads and deans are responsible for reviewing conflict of interest disclosures in accordance with Administrative Procedure: Evaluating and Managing Individual Conflict of Interest Disclosures. Situations presenting a moderate to high potential for conflict shall be referred to one of two University Conflict Review Committees -- the Provost's Committee or the Academic Health Center (AHC) Committee as appropriate. Potential conflicts of interest that involve research with human subjects have additional restrictions and are reviewed with extra scrutiny because of the potential to compromise the welfare of the human subjects.

There are some situations, such as conflicts of interest in purchasing, where the activity is prohibited regardless of an employee's classification or the value of the employee's outside interest. Purchasing conflicts and other special situations are addressed in Administrative Procedure: Avoiding Conflicts of Interest in Special Situations.

Once proposed activities have been administratively reviewed with a plan of action completed and approved, University administration has the responsibility to vigorously defend the activity so long as the covered individual complies with the plan of action, the disclosure requirements, other University policies, and the law.

When covered individuals participate in sponsored research involving sub-grantees, contractors, or collaborators outside the University, the University, to the extent required by the sponsor, will take reasonable steps to ensure that investigators working for these outside entities comply with appropriate conflict of interest disclosure and review requirements. These steps may include requiring the investigators to comply with the University's policy or obtaining appropriate assurances from the outside entity that it complies with applicable federal regulations or sponsor policies on conflict of interest.

Individual conflicts of interest are governed by Board of Regents Policy: Individual Business or Financial Conflict of Interest and various regulations, including federal regulations on research objectivity and state law related to conflicts in purchasing. This policy enables covered individuals to comply with these requirements. In addition, the required reporting is designed to assist covered individuals in arranging external professional activities or relationships so as not to interfere with their primary duties to the University nor compromise the educational interests of University students with whom they work.

• Disclosing Potential Individual Conflicts of Interest
• Evaluating and Managing Individual Conflicts of Interest Disclosures
• Avoiding Conflicts of Interest in Special Situations

• Report of External Professional Activities (REPA)

Subject	Contact	Phone	Fax/Email
Primary Contact	Margaret Adson	612-626-1462	bexxx001@umn.edu
Technical problems	EGMS helpline	612-624-1600	repa@egms.umn.edu
Policy questions	Policy helpline	612-626-1462

Academic Employee

Any person holding a paid academic appointment at any percentage of time at the University, appointed in the Faculty (94xx) or Academic Professional or Administrative (93xx, 96xx, 97xx) employee groups.

Associated Entity

Any trust, organization, or enterprise over which the employee, alone or together with an immediate family member, exercises a controlling interest.

Business

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 or membership on a board regardless of compensation.

Collegiate Approver

The senior administrative officer for the college or administrative unit (typically a dean or vice president) or that officer's designee.

Conflict of Interest (Individual)

A situation that compromises a covered individual's professional judgment in carrying out University teaching, research, outreach, or public service activities because of an external relationship that directly or indirectly affects a business or significant financial interest of the covered individual, an immediate family member, or an associated entity.

Contribution

A donation of assets to the University or its foundations. Assets may be in the form of cash, securities, tangible personal property, partnership interests, or pledges for acceptable assets that are assigned to the University.

Conflict Review Committee (CRC)

One of two committees formed at the University responsible for advising the deans and other senior officials about potential individual conflicts of interests--designated the Provost's Conflict Review Committee and the Academic Health Center Conflict Review Committee. Each committee is appointed by senior officers and comprised of three-quarters voting faculty members from the colleges to be served and one quarter voting membership from faculty outside the colleges and representatives from outside the University. The CRC also includes nonvoting representatives from the Office of Regulatory Affairs, Office of Technology Commercialization, Sponsored Projects Administration, Research Subjects Protection Programs and Office of the General Counsel.

Covered Individual

All paid University faculty; academic professional and administrative employees; and other individuals with the responsibility for the design, performance, or reporting of University research.

Departmental Approver

The immediate administrator, typically the department head, department chair, or department/division director.

Electronic Grants Management System (EGMS)

Electronic Grants Management System (http://egms.umn.edu). The electronic system used by covered individuals to complete the Report of External Professional Activities.

Executive Position

Any position that includes responsibilities for a significant segment of the operation or management of a business.

Financial Interest (see also "Significant Financial Interest" below)

Anything of monetary value including, but not limited to:

1. an interest in a business consisting of any stock, stock option, or similar ownership interest in such business, but excluding any interest arising solely by reason of investment in such business by a mutual, pension, or other institutional investment fund over which the employee does not exercise control; or
2. receipt of, or the right or expectation to receive, any income in one or more of the following forms: a consulting fee, honoraria, salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty derived from the licensing of technology or other processes or products, rent, capital gain, or any other form of compensation.

Immediate Family

The covered individual's spouse or domestic partner and dependent children.

Participate

To be part of the 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 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.

Significant Financial Interest

Anything of monetary value where the value equals or exceeds:

• an aggregated equity interest in a business representing ownership of five percent (regardless of worth) or a value of $10,000, as determined through reference to public prices or other reasonable measures of fair market value;
• an aggregated annual income of all types from a business of $10,000 over the next 12 months; or
• a commitment for future royalties from a business beyond the next 12 months that are expected to be $10,000 in aggregated annual income.

Sponsored Project

"Sponsored project" means research, training, and instructional projects involving funds, materials, or other compensation from outside sources under agreements that contain any of the following: The agreement binds the University or an affiliated institution to a line of scholarly or scientific inquiry specified to a substantial level of detail; a line-item budget is involved; financial reports are required; the award is subject to external audit; unexpended funds must be returned to the sponsor at the conclusion of the project; or the agreement provides for the disposition of either tangible or intangible properties that may result from the activity.

Covered individual

Disclose activities. Comply with approved plan to resolve conflict.

Department Approver

Review disclosure form. Recommend course of action to collegiate approver.

Collegiate Approver

Review disclosure form and department approver's recommendation and determine course of action. Submit the disclosure for review by the Conflict Review Committee (CRC) if the situation presents a moderate to high potential for conflict. Determine course of action after receiving recommendation of the CRC.

Conflict Review Committee (CRC)

Review conflict of interest disclosures referred by collegiate approvers and advise the collegiate approver on appropriate plan to manage, reduce or eliminate the conflict.

Regulatory Affairs Officer (RAO)

Administer the conflict review and oversight process. Convene the CRC. Direct the Regulatory Affairs Office.

• Clarification of Reporting Requirements for Particular Appointment Situations

There is no FAQ for this policy.

Federal

• Federal Office of Management & Budget - Circular A-21
• Public Health Service regulations 42 CFR, part 50, subpart F
• Food and Drug Administration regulations at 21 CFR 54
• National Science Foundation Grantee Conflict of Interest Policies

State

• Minnesota State Statute § 15.43.

Board of Regents Policies:

• Individual Business or Financial Conflict of Interest
• Commercialization of Intellectual Property Rights
• Outside Consulting and Other Commitments

Senate Policies

• Educational Materials Conflict of Interest

Effective:

September 2005

Supercedes:

Purchasing Conflict of Interest policy. See the Board of Regents Policy: Individual Business or Financial Conflict of Interest for more details on the history of this policy.

To obtain a copy of a historical policy, e-mail the U Policy Librarian at policy@umn.edu or call 612-624-4372.