Financial Conflicts of Interest in Externally Sponsored Research

Policy number: 10.7

Policy section: Research

Revised Date: January 2, 2019

1. Definitions

Definitions of capitalized terms are set forth in Appendix A.

2. Policy Statement

It is the policy of the University to ensure that research is conducted in accordance with applicable standards of federal, state, and local government agencies and other external sponsors. Persons subject to this policy must comply with those standards, to the extent applicable, and with any additional requirements imposed by this policy or other applicable University Policies and obligations. Nothing in this policy shall be read to preclude the University from taking actions to comply with federal, state, and local laws and regulations and to protect the integrity of University research and the University’s reputation.

3. Purpose

  1. To address potential risks that financial conflicts of interest in research entail, the University has developed this policy for the purpose of establishing clear guidelines and principles for disclosure, review, and elimination or management of potential, actual, and apparent conflicts of interest in order to help the University maintain the highest level of integrity in its research endeavors.
  2. Excellence and integrity in research are integral parts of the University’s mission. In support of these important goals, the University encourages and supports innovative and effective scholarship, research, and teaching in all fields. In recent years, corporations and other organizations have played an important role in research at universities as industry partners. Productive and positive interaction between University personnel and industry can benefit research and advance the University’s mission to translate discoveries for the public good. Personal financial interests, however, may give rise to conflicts of interest, which, unless appropriately addressed, may in fact or appearance compromise the objectivity of, and public trust in, University research.

4. Scope of this Policy

  1. This policy applies to faculty, staff, and other members of the University, regardless of title, who are responsible for:
    1. the design, conduct, or reporting of research at the University under grants or contracts funded by a federal, state, or local government agency or other external Sponsor;
    2. the oversight of such research;
    3. negotiation of research agreements; or
    4. externally funded educational activities. Such people are referred to in this policy as “Responsible Parties.” Each Responsible Party must make the disclosures required under this policy with respect to himself or herself and with respect to his or her spouse (or domestic partner), dependent children, and household members.
  2. Responsible Parties engaged in government-sponsored and other externally-sponsored research must comply with all requirements imposed by the laws and regulations governing those sponsors, and must consult with the Office of Research and Graduate Studies for guidance. A disclosure form to be used as required under this policy may be obtained from the Office of Research and Graduate Studies.

5. Conflict of Interest and Significant Financial Interests Defined

For purposes of this policy, a conflict of interest exists when the University reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of research. The term “Significant Financial Interest” is defined to include:

  1. A financial interest consisting of one or more of the following interests of the Responsible Party and an Immediate Family Member of the Responsible Party that reasonably appears to be related to the Responsible Party’s University responsibilities:
    1. With regard to any publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve-month period immediately prior to or immediately following the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000, or the equity interest in the entity represents more than five percent (5%) ownership. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
    2. With regard to any non-publicly traded entity, a Significant Financial Interest exists if the value of any remuneration received from the entity in the twelve-month period prior to or immediately following the disclosure, when aggregated, exceeds $5,000, or the Responsible Party (or the Responsible Party’s spouse (or domestic partner), dependent children or household member) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
    3. Intellectual property rights (e.g., patents, copyrights), royalties from such rights, and agreements to share in royalties related to such rights.
  2. The term Significant Financial Interest does not include the following types of financial interests: (i) salary, royalties, or other remuneration paid by the University to the Responsible Party (including intellectual property rights assigned to the University and agreements to share in royalties related to such rights) if the Responsible Party currently is employed or otherwise appointed by the University; (ii) income from investment vehicles, such as mutual funds and retirement accounts, as long as the Responsible Party does not directly control the investment decisions made in these vehicles; (iii) income from seminars, lectures, or teaching engagements sponsored by federal, state or local government agencies or non-profit entities; or (iv) income from service on advisory committees or review panels for a federal, state or local government agency or non-profit entity.
  3. A Responsible Party’s University responsibilities include professional responsibilities on behalf of the University, including, but not limited to research, research consultation, teaching and other professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards.

6. Committee on Conflicts of Interest in Research

A Committee on Conflict of Interest in Research (“CCIR”), chaired by the Assistant Vice President for Research Integrity and Operations and consisting of the University Controller, the Director of Internal Audit, and 4 faculty members appointed by the Associate Vice President for Research, is charged with the review of potential conflicts of interest and the other powers and responsibilities prescribed to it in this policy.

7. Disclosure

  1. Initial Disclosure. Responsible Parties have principal responsibility for avoiding conflicts of interest. Responsible Parties are required to make full, written disclosure of their Significant Financial Interests and other requested information to the Assistant Vice President for Research Integrity and Operations (or other University employee designated by the Associate Vice President for Research). Disclosures should provide sufficient detail to permit an accurate and objective evaluation and must be completed for each externally funded research project in accordance with established procedure. Responsible parties may obtain a disclosure form from the Office of Research Administration. Responsible Parties engaged in government-funded research may be subject to additional disclosure obligations and must consult with the Office of Research and Graduate Studies to identify and address those additional obligations.
  2. Updated Disclosures. Disclosures must be updated annually during the period of the award. Such updated disclosures shall include Significant Financial Interests not previously disclosed and updates to previously reported Significant Financial Interests. Updates should be submitted according to the same procedure as initial disclosures, described herein. Each Responsible Party is also responsible for submitting updated disclosures within the time frames and in accordance with the standards specified by sponsor rules and regulations.
  3. Disclosure by Additional University Personnel. Individuals who have responsibility for oversight of research or for negotiation of research agreements must submit disclosure forms reporting any financial interests in the manner set forth herein. Such disclosure forms shall be submitted annually to the Office of Research and Graduate Studies and updated as specified herein.

8. Review of Disclosures

  1. The Office of Research and Graduate Studies will review each disclosure form and other pertinent submitted information and shall determine whether a potential conflict of interest exists within five (5) working days of receipt. If a potential conflict of interest exists, the matter will be referred to the CCIR. The CCIR will, within ten (10) working days of receiving a referral of potential conflict of interest (or within such longer period as may be approved by the Assistant Vice President for Research Integrity and Operations), assess whether an apparent or actual conflict of interest exists and, if so, will make a recommendation indicating by what means the conflict should be avoided or managed. The CCIR and the Assistant Vice President for Research Integrity and Operations may obtain additional information from the individual involved and may consult with others who may have pertinent information.
  2. If the matter involves federally funded research, the review will proceed in accordance with applicable federal regulations.

9. Management of Actual or Apparent Conflicts of Interest

  1. After reviewing the recommendation of the CCIR and such additional information as he or she deems necessary, if the Assistant Vice President for Research Integrity and Operations determines that an actual or apparent conflict of interest exists, the Assistant Vice President for Research Integrity and Operations will determine whether to permit the activity, and if so under what conditions it is permitted. If the Assistant Vice President for Research Integrity and Operations permits the activity, the Assistant Vice President for Research Integrity and Operations, with the advice of the CCIR, may develop and implement a management plan that identifies actions that have been or will be taken to manage the conflict of interest, such as elimination or reduction of an external interest, modification of the individual’s participation in a research activity, monitoring of the research activity, or other means.
  2. Determination of the existence of a conflict of interest and the means identified for eliminating or managing the conflict will be communicated in writing to the affected individual and other appropriate personnel. When applicable, the appropriate manager responsible for grant and contract administration will also be notified of pertinent facts needed for grant administration and regulatory compliance.
  3. The Assistant Vice President for Research Integrity and Operations and the CCIR may monitor Responsible Party compliance with any management plan implemented pursuant to this Section on an ongoing basis until completion of the sponsored research project.

10. Appeal of CCIR Determinations

If the Responsible Party is dissatisfied with the determination as to the existence of a conflict of interest or an associated management plan, the Responsible Party may, within ten (10) calendar days of such determination or implementation of the management plan, appeal to the Associate Vice President for Research. After such review, the Associate Vice President for Research will make a decision after consultation with the President of the Faculty Senate, which shall be final. During the pendency of any appeal, the Responsible Party is required to comply with any management plan developed and implemented by the Assistant Vice President for Research Integrity and Operations

11. Report to Sponsors

The University will make reports to appropriate government agencies and other external sponsors to the extent required by, and in accordance with, its funding agreement with the sponsor and applicable law and regulation.

12. Record Retention

Financial disclosures, records of actions taken by the University with respect to each conflicting interest, and other records of actions under this policy will be maintained by the Office of Research Administration for a period of no less than three (3) years from the end of the project period, or for such longer period as required by external sponsor rules and regulations. Such records related to any litigation, claim, or audit will be retained until all litigation, claim, or audit findings involving the records have been resolved and any final action taken. In the event of an action by the external sponsor, records generated under this policy will be maintained by the Office of Research and Graduate Studies until such time as the action by the external sponsor is resolved. Upon authorized request of a sponsoring agency, disclosure documents and related records pertaining to the specific sponsored project will be made available to appropriate officials.

13. Research Misconduct

All persons subject to this policy are expected to comply fully and promptly with applicable requirements. Failure to make required disclosures, deliberate filing of incomplete, erroneous, or misleading disclosure forms, failure to comply with prescribed management plans, and other violations of this policy may constitute research misconduct as defined by University Policy 10.6, Standards for Addressing Research Misconduct, and will be referred to the Associate Vice President for Research for evaluation under that policy.

14. Related Policies and Documents

  • University Policy 1.3, Conflict of Interest
  • University Policy 10.1, Sponsored Research and Activities
  • University Policy 10.6, Standards for Addressing Research Misconduct
  • Research Handbook

Appendix A: Definitions

“Immediate Family Member” means, with respect to any person, the spouse, domestic partner, parent, stepparent, child, stepchild, sibling, stepsibling, grandparent, step-grandparent, grandchild, step-grandchild, father-in-law, mother-in-law, daughter-in-law, son-in-law, aunt, uncle, niece, or nephew of such person and any person who resides in the same household with such person. (See University Policy 1.3, Conflict of Interest.)

“Responsible Parties” means faculty, staff, and other members of the University, regardless of title, who are responsible for the design, conduct, oversight, or reporting of research at the University under grants or contracts funded by a federal, state, or local government agency or other external sponsor, or negotiation of research agreements or externally funded educational activities.

“University Policies” means, for the purposes of this policy, all University Policies included in the University Policy Manual and all other procedures, guidelines, and requirements of the Office of Research and Graduate Studies and the Office of Grant and Contract Accounting included in the Research Handbook, and the procedures, guidelines and requirements of all University colleges, schools, departments, centers, institutes, and divisions.

Revised: January 2, 2019

Adopted: August 21, 2012