University of Maryland Policy on Institutional Conflicts of Interest

The University of Maryland Policy on Institutional Conflicts of Interest (“this Policy”) governs Institutional Conflicts of Interest (ICOIs) at the University of Maryland (“the University”) and applies to University Officials. This Policy does not govern situations in which individuals who are not University Officials (i.e., faculty, staff, and students) might realize financial gain from the conduct of research or performance of other responsibilities at the University; the University's Conflict of Interest (COI) Committee, using existing policies and procedures, adequately identifies such situations and independently manages their associated risks to scientific objectivity and proper treatment of human and animal subjects, in accordance with the University of Maryland Policy on Conflict of Interest and Conflict of Commitment (II-3.10(A)(“COI/COC Policy”)) and the Disclosure and Conflict Management Guidelines.

1. “Conflict(s) of Interest (COI)” means situations in which University Employees are in a position to gain, or appear to gain, financial advantages or personal benefits stemming from their roles within the University. Such benefits can occur due to outside professional activities, external Relationships, Significant Financial Interests, or as a result of their research, administrative, or educational actions or decisions made while working at the University.
2. “COI Administrator” means the individual appointed by the University’s Vice President for Research to support the implementation of this Policy and to oversee the work of the Disclosure Office and COI Committee.
3. “COI Committee” means the advisory committee appointed by the President of the University in accordance with this Policy and the Disclosure and Conflict Management Guidelines and based on the authority granted by the Maryland State Ethics Commission (SEC) regarding conflicts associated with research or development.
4. “Disclosure(s)” means information that is required to be provided on all outside professional activities, external Relationships, and/or Significant Financial Interests.
5. “Gift” means any gratuity, favor, discount, entertainment, hospitality, loan, forbearance, software, license, special access, equipment, equipment time, samples, research data, or other item having monetary value. A Gift also includes services as well as Gifts of training, transportation, local or foreign travel, lodging, meals, and research hours, whether provided in-kind, by purchase of a ticket, payment in advance, or reimbursement after the expense has occurred. A Gift by definition is given without expectation of anything in return.
6. “Institutional Conflict of Interest (ICOI)” means situations in which the financial interests of the institution, or of a University Official acting within his or her authority on behalf of the institution, might affect, or appear to affect, the objectivity of institutional processes for the selection, design, conduct, reporting, review, or oversight of the University enterprise. For the purposes of evaluating ICOI, activities related to research, teaching, and outreach, and the administration of those functions, singly and collectively, represent the University enterprise.
7. “Management Plan” means a written plan provided by the University that describes how a conflict or potential conflict will be managed.
8. “Relationship(s)” means any interest, activity, service, employment, Gift, or other benefit or association with an individual or entity not part of the state government that would be prohibited by Maryland Public Ethics Law if not reported on a Disclosure and approved according to this Policy, the COI/COC Policy, the Disclosure and Conflict Management Guidelines, and any other relevant University System of Maryland and/or University policy.
9. “Significant Financial Interest” means anything of monetary value. For purposes of managing ICOIs, a Significant Financial Interest exists when there are one or more of the following of the University or a University Official (and those of the University Official's spouse and dependent children) that reasonably appear to be related to the University or University Official's institutional responsibilities: (1) interests in publicly-traded business entities; (2) interests in non­publicly-traded business entities; (3) intellectual property rights and interests upon receipt of income related to such rights and interests; and (4) compensated and uncompensated positions outside of the University that involve fiduciary responsibility to a non-University entity.
10. “University Official” means any individual(s) at the University who, because of their respective positions with the University, can affect or can reasonably appear to affect University processes for the design, conduct, reporting, review, or oversight of research and who have the authority to commit significant University resources. University Officials include but are not limited to: the President of the University, Assistant President, Vice Presidents, Associate and Assistant Vice Presidents, the Senior Vice President and Provost, Associate Provosts, Deans, Associate Deans, Department Chairs, Center and Institute Directors, and the Athletic Director, including those holding these positions in an interim capacity, as well as others who have discretionary authority to allocate resources related to the University enterprise as identified by any of the officials named previously. University Officials 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.

It is critical to the mission and reputation of the University to ensure that all financial, research, and educational activities are carried out with maximum objectivity. Because of numerous and complex relationships with public and private entities, the University must be aware of any Relationships involving Significant Financial Interest that may compromise or appear to compromise its integrity in research, teaching, outreach, or other activities. The University shall establish and maintain an oversight process to manage, reduce, or eliminate ICOIs.

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. ICOIs may arise when:

1. 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;
2. The University licenses an invention to a business entity and holds royalty and/or equity interests in the entity where such interests may be affected by ongoing University research or other University activities sponsored by that business entity;
3. A University vendor donates a Gift to the University;
4. The University holds investments in a business entity that has a financial or business relationship with the University;
5. The University provides or receives goods or services, including sponsored research awards, from a business entity in which the University has a financial, (including equity,) interest;
6. 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
7. The University has a business or Significant Financial Interest in a business entity whose commercial interests may be affected by human subjects research conducted at the University.

1. The ICOI Committee will review potential ICOI Disclosures and make a recommendation to the President on any actions that may be required to mitigate ICOI risks.
2. ICOI Committee Composition
   1. Voting Members:
      1. The COI Committee Chair, or designee;
      2. An external member from the scientific community without a University affiliation;
      3. The Institutional Review Board (IRB) Committee Chair, or designee;
      4. The Office of Research Administration (ORA) Director, or designee;
      5. Two (2) tenured faculty members from the University;
      6. An official from another local university; and
      7. The Vice President and Chief Administrative Officer, or designee.
   2. Ex-Officio/Non-voting Members include the following representatives or designees:
      1. The COI Administrator;
      2. A representative of the Office of General Counsel;
      3. The UM Ventures Director, or designee;
      4. The MTech Director, or designee; and
      5. Subject matter experts, on an as-needed basis.
3. Identifying Potential Institutional Conflicts of Interest
   1. Disclosures
      The Office of the President provides a list of University Officials identified as having discretionary authority to allocate resources related to the University enterprise. University Officials identified for ICOI Disclosure are required to update their Disclosure once per year and during the year as emerging circumstances warrant (i.e., a new consulting agreement; an appointment to a Board of a company, etc.).
   2. University Officials do not need to report the following:
      1. Compensation from the University, investment or savings income, retirement or insurance benefits, or spousal maintenance;
      2. Investments in retirement savings plans;
      3. Real estate which serves as the University Official’s primary home; or
      4. Credit card debt, personal household effects, vehicle leases or loans secured by vehicles, or mortgages/security agreements on a primary residence.
   3. Annual Reviews
      The ICOI Committee is responsible for reviewing the University's equity holdings, policies, and procedures at least annually and determining whether they adequately address the identification, Disclosure, and management of ICOIs. If the ICOI Committee determines that changes are required, it will make appropriate recommendations to the Vice President for Research who will then consult with the President.
      
      At least semi-annually the ICOI Committee will review information from the following entities in order to identify financial relationships the University has with business entities that could compromise the integrity of University research, teaching, outreach, and other mission-related activities:
      1. UM Ventures. Information regarding (1) payments made by business entities in excess of $100,000 to the University in the prior fiscal year, to include the amounts paid to departments and faculty under the University’s revenue sharing principles set forth in the University of Maryland Intellectual Property Policy (IV-3.20[A]), and (2) the name of business entities (University start-ups) in which the University holds an equity interest.
      2. ORA. Information regarding research sponsored by business entities during the prior fiscal year.
      3. University Officials. ICOI Disclosures from University Officials.
      4. University Relations. A list of business entities that donated Gifts of $50,000 or more in the prior fiscal year and the University departments and administrative units that were the recipients of those Gifts.
4. The ICOI Committee reviews this information against the profile of University research and technology programs to determine whether potential ICOIs exist in any areas, and notifies the heads of those areas affected regarding the potential conflict.
   1. Notification of License, Option, or Equity Arrangements
      UM Ventures notifies the ICOI Committee when it executes a license or option agreement with, or takes equity in, a business entity whose commercial interests may be affected by research conducted at the University.
5. Reviewing Potential Institutional Conflicts of Interest
   1. The ICOI Committee reviews each Disclosure for the potential to appear to affect any of the following: objectivity, independence, and integrity of research; safety of human and animal subjects; objectivity, independence, and integrity of teaching; objectivity and independence of outreach activities; appropriate use and allocation of University resources; and objectivity and independence in business and contracting decisions.
   2. The ICOI Committee provides a report to the Vice President for Research, who will review the report and recommendations of the ICOI Committee and forward them to the President to determine a course of action.
      1. In instances where the President has an ICOI, they must recuse themself and defer to the Chancellor of the University System of Maryland who will review, create, and approve a Management Plan in consultation with the Vice President for Research.
      2. In instances where the Vice President for Research has a potential ICOI, they must recuse themself from the review process. In such cases, the Office of the President will review the report and recommendations of the ICOI Committee and forward them to the President to determine the course of action.
6. Managing Institutional Conflicts of Interest
   1. The ICOI Committee will recommend a course of action to manage actual or perceived ICOIs, a Management Plan, which may consist of one or more of the following:
      1. No action required;
      2. Disclosure of the financial interest to affected persons in circumstances related to their University responsibilities;
      3. Oversight of decision-making or participation in an activity by an independent third party;
      4. Elimination of the financial interest or reduction to a level recommended by the ICOI Committee;
      5. Recusal from decision-making or participation in an activity that would directly or indirectly involve the person's financial interest; and
      6. Other measures as determined by the President.
7. Managing Institutional Conflicts of Interest Involving Equity
   1. When the University obtains an equity interest in a business entity, particularly a faculty start-up, both individual and institutional COIs may arise.
      1. University investments in start-up companies are subject to case-by-case approval by the Senior Vice President and Provost, based on recommendations from the Vice President for Research, UM Ventures, ORA, the Office of General Counsel, and other relevant units.
      2. When assessing an equity opportunity, the University will review the business entity's business plan and proposed structure, list of actual or anticipated investors, and any capitalization documents.
      3. University Officials cannot be the primary negotiator when negotiating agreements, including licensing and sponsored research agreements, with the University on behalf of a business entity. The University Official must either engage their own counsel or depend on the business entity's personnel to negotiate agreements.
      4. The University shall manage all subsequent relationships with a business entity in which the University has accepted equity at arm’s length and in a fair manner pursuant to relevant University policies and guidelines. For example, University inventions should be made available for licensing to appropriate companies and should not automatically be made exclusively available to business entities in which the University has taken equity. At the same time, holding equity in a business entity should not preclude that entity from licensing any invention when that entity is best able to develop and/or commercialize the invention.
      5. The University may accept sponsored research awards from a business entity in which the University holds equity, subject to the requirements of the University's COI/COC Policy.
8. Oversight of Management Plans
   The ICOI Committee verifies compliance with the Management Plan at least annually and modifies the plan to address any issues that arise.