III-1.11(C)

Policy on Identifying and Addressing Institutional Conflicts of Interest to Preserve Integrity of Research and Other Academic Activity

Academic Affairs   |   Approved December 21, 2023

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Responsible VP/AVP

Roger Ward, EdD, JD, MSL, MPA

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Revision History

Revised June 1, 2011

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Purpose

The purpose of this Policy is to set forth the standards and procedures for identification, review, and management of relationships which are deemed to constitute Institutional Conflicts of Interest (“ICOI”) (as defined in Section IV).

The scope of an ICOI review involves the financial interests of the University of Maryland, Baltimore (“University”) and of those senior leaders acting within their authority on behalf of the University in matters that could (or could reasonably be perceived to) negatively impact the objectivity or integrity of the University’s core missions of research, scholarship, or teaching.

Policy Statement

I. Principles:

1. University officers or employees (see Definitions), employees in the Office of Research and Development, including employees in the Office of Technology Transfer, and University development officers will identify and report to the COI Officer Significant Financial Interests and Significant Relationships relating to Academic Activity at the University. The COI Officer will determine whether or not the matters reported are subject to review and management of ICOI under this Policy and will monitor the development and implementation of management plans for interests and relationships that are subject to this Policy.
2. The Dean of a school proposing Academic Activity will determine whether or not the school supports the Academic Activity, with or without revisions or conditions to manage the ICOI¹, and and will identify a funding source if required, for implementing an ICOI management plan. If the Dean does not support the activity of fund the management plan, then no further action is taken and the Academic Activity is not approved.
3. The COI Advisory Committee will consider the possible effects of ICOI on Academic Activity and recommend an ICOI management plan. In this role, the COI Advisory Committee will defer to the IRB with respect to plans relating to Academic Activity involving human subjects research. The COI Advisory Committee may make recommendations in such cases, but ultimately the IRB will determine whether the ICOI can be managed in a manner that protects human subjects and what management plan is required for approved Academic Activity.
4. The President will determine whether or not to grant final approval for the Academic Activity, if it is supported by the Dean. For approved Academic Activity, the President shall establish in an ICOI management plan any conditions under which the Academic Activity must be conducted. If the Academic Activity involves human subjects research reviewed by the IRB, any requirements for ICOI management that are established by the IRB will be incorporated in the management plan.
5. An ICOI management plan may include any or all of the following requirements, or other provisions: public disclosure of approved Academic Activity and the related ICOI, including posting on the University’s Research Integrity Office web site; publication of related research results; separating decision-making authority regarding the Academic Activity from decision-making authority regarding any Significant Financial Interest(s) involved in ICOI; and disclosing any Significant Relationships and measures taken to prevent them affecting Academic Activity.
6. In situations involving ICOI arising from (1) a Significant Financial Interest arising from the relationship between a Sponsor and a specific officer or employee, or (2) a Significant Relationship between the University and individuals associated with the Sponsor, no proposals for Academic Activity at the University may be submitted to that Sponsor without prior approval of the proposed Academic Activity by a Dean or the President, as appropriate. Academic Activity may not begin without the approval of the President of an ICOI management plan and, for research involving human subjects, approval by the IRB.
7. Approved Academic Activity and the related Significant Financial Interests or Significant Relationships will be reviewed whenever a significant change in the Academic Activity, the Significant Financial Interest, or the Significant Relationship occurs or is anticipated, or when the Academic Activity is required to be reviewed for continuation or renewal. All such changes must be reported to the COI Officer for review. Unless stated otherwise in the original written determination of the President, the President will also determine whether or not to allow an approved ICOI to continue. The President may request the COI Advisory Committee to review and make recommendations on continuations.
8. Human subjects research may not be conducted without being reviewed and approved by the Institutional Review Board. The President may not approve human subjects research that the IRB does not allow. The IRB is not required to approve human subjects research that the President has approved.
9. Sponsors (e.g., the National Institutes of Health) may have requirements regarding the reporting and management of ICOI. In such cases, the requirements of the Sponsor shall be observed.
10. Where the Academic Activity or ICOI involves another USM institution, the COI Officer will coordinate the determinations of the University and the other USM institution.

II. Procedures:

1. The Human Research Protections Office and the Office of Research and Development will include appropriate questions to identify ICOI in forms used for routing and approval of proposals for Academic Activity. If ICOI is disclosed to the IRB or to ORD, the office receiving the disclosure will forward the information to the COI Officer for review under this Policy. Independent of disclosures through routing, the COI Officer will routinely gather information related to identification of persons and entities that having Significant Financial Interests or Significant Relationships as discussed abovel.

2. When potential ICOI has been identified by, or reported to, the COI Officer, the COI Officer will contact the Principal Investigator (for Research) or faculty or staff member primarily involved (for other Academic Activity), and other persons as appropriate, to discuss the potential ICOI and request all relevant information. The persons contacted by the COI Officer are “ICOI Contacts."
3. ICOI Contacts must provide relevant information to the COI Officer in a timely manner. This information must include details of the Significant Financial Interest or Significant Relationship, a description of all potentially related Academic Activity, and any proposed ICOI management plan, including identifying the funding source for any costs of an ICOI management plan. The COI Officer will determine if the Academic Activity is subject to this Policy and will review the information for completeness.

4. If the Academic Activity is subject to this Policy, the COI Officer will notify the Office of Research and Development (if Sponsored Academic Activity is involved), the IRB (if proposed academic activity involves human subjects), and the relevant Department Chair’s and Dean’s Offices, informing them of a pending submission for review of ICOI. The COI Officer will present the information to the relevant Department Chair(s) and Dean(s) for review, or, if the ICOI issues involve decision makers at that level, to the President or his designee for review. The Dean, if the reviewer, shall determine whether or not to support the Academic Activity, with or without revisions to manage the ICOI. If the Dean does not support the activity, then no further action is taken and the activity is not approved. If the Dean has a Significant Financial Interest or the Dean’s decisions might be affected by a Significant Relationship, the President or designee will make the determination after consulting the Dean. If the President does not approve the activity, then no further action is taken and the activity is not approved.

5. If the President has a Significant Financial Interest or the President’s decisions might be affected by a Significant Relationship, the President will consult the Chancellor, and ask the Chancellor to name a designee to make a determination after consulting the Dean. If the President or designee does not approve the activity, then no further action is taken and the activity is not approved.
6. If the Dean (or President or designee) supports the Academic Activity, the COI Officer will assemble and prepare relevant materials, including documentation of the Dean’s support, and present the matter to the COI Advisory Committee for consideration.
7. The COI Advisory Committee shall review the information reported by the COI Officer as well as the relevant Academic Activity proposal to determine whether to recommend 1) approving the Academic Activity as described in the proposal and the proposed ICOI management plan; or 2) modifications of the proposal or the management plan which would be necessary for the COI Advisory Committee to recommend approval of the ICOI; or 3) disapproval of the Academic Activity described in the proposal because no adequate ICOI management plan has been proposed or can be developed by the COI Advisory Committee.
8. The COI Advisory Committee’s recommendations will be forwarded by the COI Officer to the ICOI Contact, the Dean of the School in which the Academic Activity is being proposed, and the President.
9. The President shall determine whether or not to approve the proposed Academic Activity, with or without revisions and/or conditions in an ICOI management plan. The President may consult with the Dean, the COI Advisory Committee, the COI Officer, and the Provost, as well as University administrators and outside advisers, as necessary in order to determine the President’s decision concerning ICOI. The President’s determination shall be made in writing and shall be forwarded to the Dean of the School and Chair of the Department in which the Academic Activity is proposed to take place, the IRB (if research involving human subjects is involved), the ICOI Contact, and the COI Officer for implementation and monitoring and for posting on the University’s Research Integrity Office web site.
10. If the facts presented by an ICOI also require disclosure and/or exemption for an Individual COI under the Maryland Public Ethics Law, then the COI Officer will assist the individuals involved in the Academic Activity and those having the Significant Financial Interest in disclosing the COI and either requesting an exemption from the President, as provided in the Maryland Public Ethics Law and related policies and procedures of USM and the University, or requesting advice or an opinion from the State Ethics Commission. The COI Officer will coordinate concurrent review of the Individual COI(s) and the ICOI. The President will decide whether or not a proposed Academic Activity will be allowed to proceed concurrently with the Significant Financial Interest based on the circumstances of and recommendations concerning both the Individual COI(s) and the ICOI and will determine the ICOI management plan.
11. Any administrator or member of the COI Advisory Committee who would be involved in the proposed Academic Activity, or who has any personal financial interest in any entity that would be involved, shall recuse himself from participation in review of the ICOI issue.

Definitions

A. COI Officer: The University employee who is designated to administer this Policy.

B. COI Advisory Committee: The University committee which is constituted pursuant to the University Procedures Implementing Board of Regents Policy on Conflicts of Interest in Research or Development (III-1.11(A)).

C. Covered Senior Official Relationship: A relationship of a Senior Official with an external entity: (a) if the relationship is a “Significant External Relationship;” and (b) if that entity:

1. Is sponsoring or proposes to sponsor research, scholarship, or teaching at the University;
2. Receives greater than $100,000 from the University in revenue for purchases or other transactions over a 12-month period; and/or
3. Is licensing or proposes to license intellectual property from the University.

“Significant External Relationship” means any of the following which are also reasonably related to the Senior Official’s institutional responsibilities:

1. The Senior Official (or his/her immediate family member) has external engagements with an entity that provides greater than $25,000 to the Senior Official (or such family member) in income in a 12-month period; *
2. The Senior Official serves as a fiduciary or other senior management role in an entity (such as President, Chief Executive Officer, Chief Operating Officer, Treasurer, Chief Scientific Officer, Chief Medical Officer); or
3. The Senior Official (or his/her immediate family member) owns an ownership interest in the entity (if the entity is privately held, any ownership interest regardless of value, and if the entity is publicly held, an ownership interest valued greater than $25,000).

* Significant External Relationship does not include income from: (1) the University or University of Maryland Faculty Physicians, Inc., or its affiliates; (2) investment vehicles, such as mutual funds and retirement accounts, so long as the individual does not directly control the investment decisions made in these vehicles; or earned income from salary of an immediate family member unless the family member’s position involves a fiduciary duty to the non-University entity.

D. Covered University Transaction: Any of the following:

1. The University receives gift(s) in aggregate from a commercial entity in a 12-month period greater than $500,000 in total cumulative value, if that entity proposes to sponsor research, scholarship, or teaching at the University.
2. The University receives payments (or has the right to receive future payments) resulting from technology transfer licensing to a commercial entity, including royalty payments, milestone payments and other fees, if the licensed technology is tested or evaluated at the University:

   1. Using human subject research;

   2.  

      Using cells that are derived from or mimic human cells; and/or

   3.  

      Using tissues obtained from human subjects.

3. The University holds equity in a non-publicly traded company, if that entity proposes to sponsor research, scholarship, or teaching at the University.
4. The University holds equity in a publicly traded company (other than through an independent investment vehicle) valued at greater than $100,000, if that entity proposes to sponsor research, scholarship, or teaching at the University.

E. ICOI Management Plan: A written plan to ameliorate, manage, and mitigate the potential impact of an Institutional Conflict of Interest.

F. Institutional Conflict of Interest (“ICOI”): A Covered University Transaction or Covered Senior Official Relationship which could (or could reasonably be perceived to) negatively impact the objectivity or integrity of the University’s core missions of research, scholarship, or teaching.

G. Senior Official: The President, Provost, Deans, Department Chairs, Division Chiefs, Center Directors, and Vice Presidents (if they have responsibility for approval, conduct, funding, or oversight of research, scholarship, or teaching at the University).

Scope and Exceptions

This Policy applies to “Covered University Transactions” and “Covered Senior Official Relationships” (as such terms are defined in Section IV) that are determined to constitute Institutional Conflicts of Interest.

Compliance with this Policy only covers review of institutional interests and is separate from and in addition to review under state ethics laws, policies, and procedures concerning individual conflicts of interest and conflicts of commitment applicable to faculty and staff. Senior Officials identified in this Policy may have multiple disclosure obligations. Review of a Significant External Relationship under this Policy is not considered approval of outside professional activities / secondary employment addressed by other policies.

Roles and Responsibilities

Guiding Principles.

In the event of a Covered University Transaction or a Covered Senior Official Relationship, the following guiding principles will guide the decision-making process of the COI Officer and the COI Advisory Committee, and the formulation of Institutional ICOI Management Plans:

1. Gifts from commercial entities must not compromise (or appear to compromise) the integrity of University research, scholarship, or teaching.
2. The University’s potential to receive financial gain from intellectual property that it owns must not compromise (or appear to compromise) the evaluation or testing of that intellectual property by University personnel.
3. The University’s ownership interest in a commercial entity must not compromise (or appear to compromise) the testing or evaluation of the commercial entity’s products by University personnel.
4. Senior Officials must not use their official University positions or influence to gain further advancement for themselves, immediate family, or other personal and business associates, at the expense of the University.
5. Significant External Relationships must not compromise (or appear to compromise) the integrity of University research, scholarship, or teaching.
6. University personnel must comply with executed ICOI Management Plans.

Procedures.

Identifying Potential Institutional Conflicts of Interest.

1. Semi-Annual Reports. At least semi-annually, the following offices shall provide information to the COI Officer, in order to enable the COI Officer and the COI Advisory Committee to identify Covered University Transactions:
   • (i) Office of Technology Transfer: Information regarding transactions with commercial entities during the previous semi-annual period which satisfies the definition of Covered University Transactions.
   • (ii) Office of Sponsored Programs Administration: Information regarding research sponsored during the previous semi-annual period which satisfies the definition of Covered University Transactions.
   • (iii) Office of Clinical Trials and Corporate Contracts: Information regarding research sponsored during the previous semi-annual period which satisfies the definition of Covered University Transactions.
   • (iv) Office of Philanthropy: A list of commercial entities that donated gifts in aggregate of $500,000 or more in the previous semi-annual period, and the University departments and administrative units that were the recipients of those gifts.
2. Senior Official
   • (i) Senior Officials must complete and submit to the COI Officer an annual ICOI disclosure form, in which all Significant External Relationships must be reported.
   • (ii) Senior Officials must also submit to the COI Officer a copy of the annual Financial Disclosure Statement that they file with the Maryland State Ethics Commission.
   • (iii) Senior Officials must update their disclosures during the year as emerging circumstances warrant (e.g., a new consulting agreement; appointment to a Board of a commercial entity; etc.).

Reviewing Potential Institutional Conflicts of Interest.

1. The COI Officer will review each ICOI disclosure. If the disclosure sets forth a Covered Senior Official Relationship that in the judgment of the COI Officer constitutes an Institutional Conflict of Interest, then the COI Officer will make a recommendation to the COI Advisory Committee.
2. The COI Officer and the COI Advisory Committee will determine whether a Covered University Transaction or Covered Senior Official Relationship constitutes an Institutional Conflict of Interest. If so, the COI Officer and the COI Advisory Committee will recommend a course of action to manage the Institutional Conflict of Interest and formulate an ICOI Management Plan.
3. The COI Advisory Committee will provide a report with its recommendations and the ICOI Management Plan to the CoI Officer and the Provost. The Provost may either approve, modify, or reject them. If the Provost approves them, he/she will forward them to the President for his/her approval.
4. If the President has an Institutional Conflict of Interest, he/she must recuse himself/herself and defer to the Chancellor of the University System of Maryland, who will create and approve an ICOI Management Plan for the President in consultation with the Provost.
5. If the Provost has a potential Institutional Conflict of Interest, he/she must recuse himself/herself from the review process. In such cases, the President will review the report and recommendations of the COI Advisory Committee and determine the course of action.

ICOI Management Plans.

ICOI Management Plans may consist of one or more of the following:

1. Recusal of a Senior Official from the chain of authority over a transaction or project (including a research study) and from supervision of personnel conducting the activity, and appointment of a nonconflicted individual to assume this role.
2. For research studies, disclosure of the ICOI to all stakeholders (including all investigators conducting the study, the sponsor, and the public in presentations and publications).
3. For human subject studies, disclosure of the ICOI in consent forms and/or to applicable regulatory bodies, as well as to University and external IRB, external biostatisticians, external contract research organizations and/or an external Data Safety Monitoring Board (“DSMB”).
4. Reduction or elimination of transactions or other engagements with an external entity.
5. Recusal from decision-making or from participation in an activity that would directly or indirectly involve the person’s financial interest.
6. Declining gifts or funding for sponsored research projects or other activities.
7. Divestment of a financial interest.

Oversight of ICOI Management Plans.

The COI Officer and the COI Advisory Committee are responsible for verifying compliance with any ICOI Management Plans at least annually, and for modifying the plans to address any issues that arise.

Noncompliance.

Senior Officials are expected to provide complete and truthful information relating to their external engagements that may give rise to the involvement of the COI Advisory Committee or an ICOI Management Plan. Noncompliance with an executed ICOI Management Plan, failure to disclose, or the submission of erroneous, misleading, or incomplete information may be the subject of disciplinary procedures and sanctions. The COI Official or the COI Advisory Committee shall refer concerns relating to noncompliance, failure to disclose, or submission of inaccurate information to the President, Provost, or other appropriate University authority for review.