Institutional Conflict of Interest Policy

Original Effective Date: July 1, 2009
Last Revised: May 17, 2024

Contents

1. Introduction
2. Definitions
3. Administration of Institutional Conflicts of Interest Policy
4. Significant Financial Interests
5. Review and Management of Institutional Conflict of Interest
6. Implementation and Monitoring
7. Dispute Resolution
8. Non Compliance
9. Additional Guidance and Procedures

1. Introduction

An institutional conflict of interest (“ICOI”) may include situations in which the financial interests of an institution or an institutional official, acting within individual’s authority on behalf of the institution, may affect or appear to affect the research, education, clinical care or other activities of the institution. ICOI’s are of particular concern when financial interests create the potential for inappropriate influence over the institution’s research activities, where the integrity of the institution’s research and the welfare of human research participants may actually be, or reasonably appear to be, compromised or injured by the conflicting financial interest. This Policy is intended to protect against harm to human research participants and to protect the integrity of research performed at or under the auspices of Washington University (University).

The University, including its officials, must balance many competing interests. University-industry relationships are important to advancing scientific frontiers and essential to enabling the commercial development of academic discoveries for the benefit of the public. In addition, the University engages in relationships with a variety of companies that may lead to financial benefit for the University in many forms, including royalty payments, other payments and equity from licensing intellectual property, sponsored educational and research agreements, and major gifts. Such relationships with commercial entities are generally part of legitimate educational, research, and business activities, and predictably will lead in some cases to conflicts of interest. This Policy is not intended to prohibit or discourage such relationships, but, as much as possible, to manage them so they do not compromise, or reasonably appear to compromise, the integrity of the University’s primary missions, including the safety and integrity of its research mission. The protection of human research participants, and the protection of the integrity of the University and its research programs, must remain for the University its highest priority.

2. Definitions

  1. A covered Institutional Official (IO) includes:
    • the Chancellor, executive vice chancellors, provost, vice chancellor for operations and technology transfer, vice chancellor for research, deans, executive chair of the IRB, chairs of the conflict of interest review committees, chair of the institutional conflict of interest committee, and any other University official or volunteer so designated by the Chancellor; and
    • any roles/positions, as identified by the deans of the schools, having final decision making authority over both of the following, which will be evaluated on a regular basis by the Chancellor and School Deans:
      • Faculty appointments, salaries, and promotions. Examples include filling open faculty positions, terminating non-tenured faculty appointments, promoting faculty, granting leaves of absences, and approving salary increases; and,
      • Resource allocations necessary to support research activities. Examples include allocating research space (e.g., wet or dry lab space), designating shared research support personnel, facilitating access to shared research equipment, allocating departmental or unrestricted gift funds to support research activities.
  2. Institutional Conflict of Interest (ICOI): whenever the financial interests of the University or the personal financial interests of an Institutional Official either affect, or reasonably appear to affect, the design, conduct, reporting, review, or oversight of research.
  3. Research: a systematic investigation, study, or experiment designed to develop or contribute to generalizable knowledge. This includes basic, behavioral, and social sciences research and encompasses basic and applied research (e.g. a published article, book or book chapter) and product development research (e.g. diagnostic test or drug).
  4. Significant Financial Interest: a financial interest that exceeds the applicable threshold for a specific category of financial interest, as established by the ICOI Committee and approved by the Chancellor in consultation with the Provost, Executive Vice Chancellor for Medical Affairs, Vice Chancellor for Research, and the Office of the Vice Chancellor & General Counsel.

3. Administration of Institutional Conflicts of Interest Policy

  1. Authority:
    • The University is responsible for evaluating Significant Financial Interests of the University and Institutional Officials in relation to Research conducted under the auspices of the University. The Institutional Conflict of Interest Committee (ICOIC), a standing committee comprised of faculty and non-University members, is the designated body authorized by the University for evaluating and addressing those interests under this Policy.
    • The Office of Research Integrity & Ethics (ORIE) is the administrative unit under the Office of the Vice Chancellor for Research, designated with managing the administration of the University’s conflicts of interest programs and providing support to the ICOIC. ORIE shall identify and communicate activities needing review, as prescribed by this policy, corresponding procedures, and/or under delegated authority established by the ICOIC.
  2. Composition of the ICOI Committee
    • The ICOI Committee will ordinarily consist of six or more members appointed by the Chancellor, or designee, for staggered four-year terms. The ICOIC will be comprised of individuals with sufficient independence, expertise, and seniority. The ICOIC should include at least one member with no affiliation with the University; two senior faculty (representing both the Danforth and Medical School campuses); and the sitting chair of at least one of the Conflicts of Interest Review Committees. Emeriti faculty are eligible to serve. The Executive Director of Compliance and Audit, and Assistant Vice Chancellor for Research Integrity & Ethics serve as non-voting ex-officio members. A representative of the Office of the Vice Chancellor & General Counsel will attend meetings and serve as legal advisor to the ICOIC and ORIE.

      A quorum will consist of one more than half of the voting committee members, at least one of whom should be a member with no affiliation with the University.
  3. Responsibilities:
    • The ICOIC’s responsibilities include, but are not limited to:
      • Formulating standards and procedures to identify ICOIs and develop management plans;
      • Establishing compelling circumstance criteria and a risk matrix for evaluating ICOIs related to human subject Research, including any recommendations for updates for approval by the Chancellor in consultation with the Vice Chancellor for Research;
      • Convening as a committee to evaluate complex cases, as determined by the ICOIC;
      • Identifying and developing appropriate management of ICOIs;
      • Overseeing the development of education for covered individuals;
      • Developing guidelines and procedures for specific categories of ICOI that present minimal risk to the integrity of the Research and no risk for human research participants, and that can be handled administratively with pre-defined management plans and documentation. Such cases will be reviewed post-management by the ICOIC Chair to confirm adherence to the procedures.
      • Developing procedures describing the administrative tasks delegated to ORIE.
    • Members of the ICOIC shall recuse themselves from the ICOI review process when they:
      • Hold a material personal financial interest in any entity under review;
      • Are co-investigators in the Research under review or;
      • Are under the direct supervision of the Institutional Official under review.
    • The ORIE’s responsibilities include, but are not limited to:
      • Completing preliminary assessments of the financial interests to determine whether further review is required in accordance with ICOIC approved procedures;
      • Conducting reviews through authority delegated by the ICOIC in accordance with procedures established by the ICOIC;
      • Documenting the ICOIC meetings and outcomes;
      • Developing procedures and forms to obtain and review institutional financial disclosure information;
      • Monitoring compliance with ICOI management plans, evaluating potential non-compliance, initiating investigations, reporting non-compliance and the outcome of investigations to the appropriate University officials and overseeing implementation of corrective actions;
      • Developing and assisting in the delivery of education for covered individuals;
      • Carrying out delegated duties according ICOIC approved procedures; and
      • Keeping and maintaining records in a secure manner.

4. Significant Financial Interests

The ICOIC is responsible for evaluating activities and financial interests of the University in relation to Research conducted under the auspices of the University, and those of Institutional Officials in relation to Research occurring in the Institutional Official’s line of supervision and authority. The type of Research and financial interest determines if evaluation is warranted by the ICOIC according to procedures developed by the ICOIC.

The following financial and fiduciary interests of the University or Institutional Officials require disclosure and assessment for potential ICOI as provided in this Policy. The receipt or possession of such financial or fiduciary interests in an entity does not, standing alone, warrant formal review unless that interest meets or exceeds thresholds for being a Significant Financial Interest.

  1. Income from licensing agreements: The University is entitled to receive income from licensing agreements including milestone payments and/or royalties.
  2. Non-publicly traded equity: Any ownership or rights to non-public equity in an entity. For the University, this does not include equity managed by the WashU Investment Management Company (WUIMC).
  3. Publicly traded equity: Any ownership or rights to equity holdings in a public traded entity and, for the University, not managed by the WUIMC.
  4. Governance, Fiduciary, Officer, or Board of Director roles:
    • For the University: through technology licensing activities, investments, or other executed agreements, the University has obtained the right to appoint one or more officers or directors to the governing board of any company.
    • For Institutional Officials: any director, senior leadership, officer, or managerialrole with an entity, regardless of compensation.
  5. Remuneration for Institutional Officials: Compensation or income from external professional activities with an entity.
  6. Gifts from companies: Any restricted or unrestricted gift given to the University by an entity used for research purposes.

5. Review and Management of Institutional Conflict of Interest

The ICOI Committee shall evaluate the Significant Financial Interests of:

  1. The University in relation to human subject Research being conducted under the auspices of the University; and
  2. Institutional Officials in relation to all Research.

In discharging its responsibilities to assess and manage potential ICOIs, the ICOIC shall utilize a risk based model to ascertain the potential relatedness (i.e. the potential for Research or outcomes to influence the value of, or be influenced by, a financial interest) and impact on current or pending Research with the goal of preserving both the reality and appearance of professional integrity in the research enterprise at the University, and mitigating the risk to Research subjects.

Assessing Research

In assessing and managing potential ICOIs for Research involving human subjects, in accordance with the Institutional Conflict of Interest Risk Matrix for Human Subjects Research, the ICOIC will consider:

  1. The phase and design of the Research
  2. The nature of the science involved; and
  3. The nature of the financial interest.

The ICOIC will also take into consideration the following risk factors, including without limitation:

  1. How closely the financial interest is related to the Research;
  2. The degree to which the financial interest may be affected by the Research;
  3. The degree of risk that any overlapping and conflicting interests appear to pose to the integrity of the Research;
  4. The degree of influence the Institutional Official has over the Principal Investigator including professional development; and
  5. The degree to which the ICOI can be effectively managed.

The ICOIC uses the same approach described above when evaluating Significant Financial Interests of Institutional Officials in Research not involving human subjects.

As the risk to the integrity of the Research increases, the importance of demonstrating compelling circumstances increases. The ICOIC applies this risk matrix to determine whether sufficient compelling circumstances exists.

Compelling circumstances that may be considered include without limitation:

  1. The University is uniquely qualified, by virtue of distinctive resources (e.g. special facilities or equipment, unique patient population);
  2. The University investigators have unique experience and expertise essential to the safe or successful conduct of the Research;
  3. The Research provides unique access to a therapeutic option that would otherwise be unavailable to patients;
  4. The Research provides a therapeutic option for patients that have exhausted or have no existing conventional treatment options; and
  5. The involvement of participants is minimal with little to no safety concerns and no impact to clinical care such that the Research may be treated as non-human subject Research.

Establishing Management for ICOIs

If the ICOIC determines that the ICOI can be managed, the ICOIC will develop a management plan governing the ICOI, prescribing conditions and actions necessary to mitigate the risk and manage the ICOI. For Research involving human subjects, this includes that the criteria for compelling circumstances has been met.

In creating case-specific ICOI management plans, the ICOIC may include one or more of the following management strategies among any others it may deem appropriate:

  1. Disclosure of the ICOI to Research participants;
  2. For Institutional Officials, formal recusal of the conflicted official from the chain of authority over the Research and possibly also from authority over salary, promotion, and space allocation decisions affecting the investigator, as well as communication of the recusal arrangements to the official’s superior and colleagues;
  3. For Institutional Officials, designation of a “safe haven” (e.g., a non-conflicted senior individual) with whom the investigator can address ICOI-related concerns;
  4. Use of an external IRB;
  5. Independent oversight and/or external monitoring of the Research, particularly endpoint assessments;
  6. Use of an external Data Safety Monitoring Board (“DSMB”) or similar review board to evaluate the design, analytical protocols, and primary and secondary end-point assessments, and to provide ongoing evaluation of the Research for safety, performance issues and the reporting of results;
  7. Disclosure of the ICOI in public presentations and publications, and to all individuals, including (but not limited to) graduate students and other trainees, engaged in the design, conduct or reporting of the research;
  8. Disclosure of the ICOI to other centers in a multi-center trial; and
  9. Disclosure to the sponsors of the Research as required by the sponsor and all applicable regulations and laws.

If an ICOI cannot be managed, the Significant Financial Interest will need to be eliminated or reduced to a level no longer deemed significant. If the Institutional Official or University is unable or unwilling to reduce or eliminate the financial interest the Research cannot move forward.

The ICOIC will issue its written conclusions, including the rationale for the ICOI, any mitigating factors or compelling circumstances, and required management strategies to be implemented to address the ICOI to the Institutional Official or Principal Investigator of the impacted Research, copying the Dean or Officer overseeing the applicable Research or Institutional Official. An annual report of ICOIC determinations and management will be provided to the Chancellor and Chairman of the Audit Committee of the Board of Trustees.

6. Implementation and Monitoring

ICOI management plans are issued to the individual(s) responsible for implementing the management strategies who will be encouraged to maintain documentation illustrating compliance with the plan’s requirements. ICOI disclosures and management plans may be monitored by the ICOIC or its designee to assure compliance with this Policy.

7. Dispute Resolution

Appeals or disputes resulting from administrative or ICOIC Chair determinations shall be referred to the ICOIC.

Appeals from decisions of the ICOIC shall be referred for final resolution to a committee established by the Chancellor or representative appointed by the Chancellor.

Final authority for the management of ICOI rests in the Chancellor.

8. Non Compliance

Violations of the requirements of this Policy by a covered individual shall, if not resolved, be subject to review and, where appropriate, corrective action and/or disciplinary action.

9. Additional Guidance and Procedures

Significant Financial Interests

Institutional Conflict of Interest Matrix for Human Subjects Research

ICOI Disclosure Review Process