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Financial Conflicts of Interest in Research Policy

Introduction

Policy Statement

Washington and Lee University ("W&L" or "the University") encourages its faculty and staff to participate in research activities and to do so with the highest ethical standards. While the potential for conflicts of interest is understandable, faculty and staff must prevent the introduction of bias into their research.

The purpose of this policy is to protect the credibility and integrity of the University's faculty and staff and to ensure public trust and confidence in the University's research and educational activities by identifying, understanding, and responding to conflicts of interest. This policy is based on the National Science Foundation's Investigator Financial Disclosure Policy, which became effective October 1, 1995. It is not intended to comply with the federal regulations issued by the Department of Health and Human Services entitled Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Serve Funding is Sought (42 CFR Part 50, Subpart F, and 45 CFR Part 94), which became effective August 24, 2012 ("the PHS regulations"), and, therefore, does not apply to Investigators involved with research funded, or proposed for funding, by the Public Health Service ("PHS") or any other sponsor that has adopted the PHS regulations.

Applicability

This policy applies to all Investigators (as defined in this policy), other than those Investigators involved with research funded, or proposed for funding, by PHS or any other sponsor that has adopted the PHS regulations. Investigators involved with research funded, or proposed for funding, by PHS or any other sponsor that has adopted the PHS regulations are subject to the University's Public Health Service Financial Conflicts of Interest Policy. All employees are also subject to the Conflict of Interest Policy as stated in the University's employee handbook.

Definitions

Conflicts Administrator means the individuals within the University who have been designated to solicit and review disclosures from Investigators of Significant Financial Interests related to the Investigator's institutional responsibilities. For the purposes of this policy, the Conflicts Administrator shall be the Associate Director for Strategic Initiatives and the Associate Treasurer and Controller, acting together, or his, her, or their designee(s).

Investigator means the principal investigator, co-principal investigators, and any other person at the University who is responsible for the design, conduct, or reporting of research, educational, or service activities funded, or proposed for funding, by a sponsor.¹

Significant Financial Interest means anything of monetary value, including, but not limited to, salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options or other ownership interests), and intellectual property rights (e.g., patents, copyrights and royalties from such rights). The term does not include:

i. Salary, royalties or other remuneration from the University;

ii. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;

iii. Income from service on advisory committees or review panels for public or nonprofit entities;

iv. An equity interest that, when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: (a) does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value; and (b) does not represent more than a 5% ownership interest in any single entity; or

v. Salary, royalties or other payments that, when aggregated for the Investigator and the Investigator's spouse and dependent children, are not expected to exceed $10,000 during the next twelve months.

Policy

I. Conflicts of Interest

A potential conflict of interest occurs when there is a divergence between an individual's private interests and his or her professional obligations to the University such that an independent observer might reasonably question whether the individual's professional actions or decisions are made by considerations of personal gain, financial or otherwise. An actual conflict of interest depends on the situation and not on the character or actions of the individual. For the purposes of this policy, a conflict of interest exists when the University, through the procedures described in this policy, reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of sponsored projects.

II. Investigator Disclosure

Each Investigator is required to disclose the following Significant Financial Interests:

A. Any Significant Financial Interest of the Investigator that would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by a sponsor; or

B. Any Significant Financial Interest of the Investigator in an entity whose financial interest would reasonably appear to be affected by the research or educational activities funded, or proposed for funding, by a sponsor.

Regardless of the above minimum requirements, any faculty or staff member, in his or her own best interest, may choose to disclose any other financial or related interest that could present an actual or potential conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potentially embarrassing or harmful allegations of misconduct.

Prior to the submission of a proposal for funding, each Investigator shall complete a Significant Financial Interest Disclosure Form ("disclosure form") and attach all required supporting documentation, if any. An Investigator must submit a disclosure form prior to the time a proposal is submitted even if he or she does not have any Significant Financial Interests. Supporting documentation that identifies the business enterprise or entity involved and the nature and amount of the interest should be submitted in a sealed envelope marked confidential and accompany the disclosure form. All financial disclosures must be updated by Investigators during the period of the award, either on an annual basis or as new reportable Significant Financial Interests arise or are acquired.

All disclosure forms and supporting documentation are to be submitted to the Conflicts Administrator. Additional information may be requested by the Conflicts Administrator and shall be furnished upon request. The Conflicts Administrator is responsible for the receipt, processing, review, and retention of all disclosure forms.

III. Review of Financial Conflicts of Interest

The Conflicts Administrator shall review all financial disclosures to determine whether a conflict of interest exists. If the Conflicts Administrator determines that there is potential for a conflict of interest covered by this policy, then the Conflicts Administrator shall determine what conditions or restrictions, if any, should be imposed by the University to manage actual or potential conflicts of interest arising from the disclosed Significant Financial Interests. Such conditions or restrictions include, but are not limited to, the following:

A. Public disclosure of Significant Financial Interests;

B. Monitoring of research by independent reviewers;

C. Modification of the research plan;

D. Disqualification from participation in all or a portion of the research;

E. Divestiture of the Significant Financial Interest; or

F. Severance of the relationships that create actual or potential conflicts of interest.

The Conflicts Administrator may require that a plan for reducing or eliminating conflicts of interest be incorporated into a Memorandum of Understanding between the University and the Investigator.

The Conflicts Administrator shall notify the Provost² of the conditions or restrictions to be imposed. If the Provost determines that imposing the above referenced conditions or restrictions would be ineffective or inequitable, or that the potential negative impacts that may arise from a Significant Financial Interest are outweighed by interests of scientific progress, technology transfer, or the public health and welfare, then the Provost may recommend that, to the extent permitted by the applicable federal regulations, the research go forward without imposing such conditions or restrictions. In these cases, the Provost shall make the final decision regarding resolution of any actual or potential conflicts of interest.

The Conflicts Administrator shall review all initial and updated disclosures of Significant Conflicts of Interest in accordance with this policy.

IV. Managing Conflicts of Interest

Actual or potential conflicts of interest shall be satisfactorily managed, reduced, or eliminated in accordance with this policy. Additionally, all required reports regarding the conflict of interest shall be submitted to the sponsor prior to expenditure of any funds under an award in accordance with the applicable federal regulations.

V. Violations of Conflict of Interest Policy

Whenever an Investigator has violated this policy or the terms of any resolution plan required by the Conflicts Administrator (including failure to file or knowingly filing incomplete, erroneous, or misleading disclosure forms) the Conflicts Administrator shall notify the Provost who may impose sanctions or institute disciplinary proceedings against the violating Investigator. If the violation results in a collateral proceeding under the University's policies, then the Provost may defer his or her decision on sanctions until such other proceeding is completed.

In addition, the University shall comply with all applicable federal regulations regarding the notification of the sponsor in the event an Investigator has failed to comply with this policy. The sponsor may take its own action as it deems appropriate, including the suspension of funding for the Investigator until the matter is resolved.

VI. Record Maintenance

Records of Investigator financial disclosures and of actions taken to manage actual or potential conflicts of interest shall be retained by the Conflicts Administrator until three years after the later of the termination or completion of the award to which they relate, or the resolution of any government action involving those records.

VII. Collaborative Projects/Sub-agreements

Collaborators, sub-recipients, and subcontractors from other organizations must either comply with this policy or provide a certification that their organizations are in compliance with applicable federal policies regarding Investigator Significant Financial Interest disclosure and that their portion of the project is in compliance with their institutional policies.