ICOI Disclosure Review Process

Institutional Conflict of Interest Committee
Original Effective Date: July 1, 2009
Last Revised: May 17, 2024

Introduction

The Washington University Policy on Institutional Conflict of Interest states “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.” This procedure outlines the process that the ICOIC uses to evaluate those interests for institutional conflicts of interest (ICOI). 

Disclosure Review

All covered Institutional Officials (IO)s are required to submit their personal financial interests, at a minimum, annually via the External Professional Activities disclosure (EPA). Additionally the ICOIC, ICOIC Chair (which includes ICOIC Vice-Chair), and COI program office within the Office of Research Ethics and Compliance (ORIE) may review disclosures of personal financial interests in relation to a specific pending project or agreement. The review process is completed in parallel with the CIRC disclosure review process.

Once submitted, these disclosures are prepared by the COI program staff for review by the ICOIC/ICOIC Chair as follows:

Administrative Review

All disclosures (including any EPA that lists at least one disclosed interest) go through an initial administrative review that is completed by the COI program office/staff.

  1. Administrative Review Process
    • Determines which (if any) financial interests of the IO or University meet the ICOIC’s thresholds for review.
    • Obtains clarifying information as needed to facilitate review.
  2. Administrative Approval Process
    • COI program staff may conclude the disclosure review process under delegated authority by the ICOIC (Policy on Institutional Conflict of Interest) when:
      • None of the reported financial interests meet ICOIC review thresholds
      • The individual has no research activities AND the individual’s direct reports are not serving as PI of any research
      • The financial interests of the IO and University and applicable research activities were previously reviewed by the ICOIC/ICOIC Chair. Defined as having no new material financial interests or new projects reported and no significant changes to previously reported interests
        • This includes reissuing management plans for conflicts already identified and managed by the ICOIC/ICOIC Chair.
    • All other disclosures are elevated to either Expedited Review or Chair Review as described below:

Expedited Review

Expedited Reviews occur when the financial interests and research activities do not appear related but cannot be Administratively processed.

  • Expedited reviews require 2 or more reviewers, one of whom must not have performed an administrative review of the same Financial Interest.
  • Expedited reviewers are Senior Research Compliance Specialists or higher.
  • Expedited reviewers only determine ‘no relatedness’ or elevate the disclosures for further review
  • The Expedited reviewers do not determine if a conflict exists.
  1. Expedited Review Process
    • Determines if material financial interests of the IO or University are potentially related to current or pending research activities.
    • Evaluates disclosure reviews for potential expedited review.
      • Examples include service, licensing agreements, and any others as deemed appropriate by the ICOIC.
    • Obtains clarifying information as needed to assess risks.
  2. Expedited Approval Process
    • Expedited reviewers may complete the disclosure review process under delegated authority by the ICOIC when the entities in which an IO or the University has a material financial interest:
      • Are NOT sponsoring or supporting his/her research or research within the IO’s area of supervision.
      • Have NO owned or licensed IP utilized or evaluated in the research
      • Do NOT appear to be engaged in activities directly related to the research
      • Do NOT appear to benefit directly from the outcomes of the research.
    • Additionally Expedited reviewers may:
      • Determine no relatedness for agreements with fixed financial terms such that any research activities or outcomes cannot influence the value. (i.e. no percentages of sales or milestone payments)
      • Lift holds on agreements to enable the continuation of negotiations or execution between WashU and an entity when:
        • The agreement does not relate to any human subjects research, and
        • The execution of the agreement would not potentially create an unmanageable situation, and
        • Formal approval is obtained by the ICOIC/ICOIC Chair as soon as possible.
    • All other disclosures are elevated to Chair or Committee Review as described below:

Chair Review

The ICOIC Chair is responsible for reviewing disclosures when potential relatedness is identified by the COI program staff or when the COI program staff is unable to assess potential relatedness.

The ICOIC Vice-Chair completes reviews when the ICOIC Chair is otherwise unavailable or as directed by the ICOIC Chair.

  1. Chair Review Process
    • Reviews new financial interests and projects when potential relatedness was identified by the COI program staff in order to:
      • Determine if the IO or University’s financial interest and research activity are related, and if yes;
      • Determine if a financial conflict of interest exists
    • Reviews currently managed financial conflicts of interest when the management plan needs to be revised or altered, including any changes that result in discontinuation of management.
    • Provides guidance and feedback to the COI program staff on additional information needed to complete a review.
    • May solicit expertise from non-ICOIC members, including inviting to meetings as non-voting participants, if deemed essential to appropriately complete a review.
    • Regularly reviews a subset of expedited review cases for verification of adherence to the ICOIC procedures.
  2. Chair Approval Process
    • For disclosure reviews determined unrelated or not having a ICOI, the review process is concluded.
    • Determine the appropriate management strategies needed to mitigate identified ICOIs effectively in accordance with ICOI Risk Matrix Process or elevate the case to Committee review.
    • The ICOIC Chair will typically refer higher risk/complex matters to the full committee for review, such as:
      • Cases involving human subjects research that require moderate management or higher and cannot be managed effectively through minimal management strategies alone such as disclosure and appointing a Safe Haven for the PI).
      • Cases involving non-human subjects research in which the PI is a junior faculty member under a conflicted IO and the ICOI cannot be managed effectively through minimal management strategies alone.
      • Cases involving multiple projects, multiple conflicted IO’s, or where the research will be conducted in multiple schools with differing levels of involvement or supervision such that in the aggregate are considered complex. Such cases often require joint review with the Conflict of Interest Review Committee to address individual FCOI in addition to IO and University ICOI
      • Any case identified by the Chair as warranting Committee review
    • The ICOIC Chair may elect to not elevate a complex case to the committee if the CIRC, in addressing individual FCOI, implements strategies that reduce or eliminate an ICOI such that any remaining ICOI risk can be addressed through minimal management strategies.
      • For example, the CIRC determines a study involving a conflicted IO must have a non-conflicted PI that does not report to the conflicted IO and further limits the IO’s role to technical advisor. This effectively addresses the FCOI and eliminates any potential ICOI due to the IO’s authority over the PI. The ICOIC Chair may require disclosure of the IO’s financial interests, however no further management is necessary and the case does not need to be elevated to the ICOIC.
    • An elevated review would primarily be to the full committee although the ICOIC Chair may opt to convene a sub-committee to accommodate schedules or agenda limitations of the full committee.

Full Committee Review

The Committee is responsible for reviewing disclosures elevated by the ICOIC Chair. The Committee has a standing monthly meeting. 

  1. Committee Review Process
    • For disclosure reviews:
      • The ICOIC Chair, an ICOIC member or COI staff will meet with the faculty/staff member prior to the Committee meeting to obtain necessary information.
        • The individual(s) has the opportunity to attend the sub/full committee meeting to obtain or provide information.
        • For cases involving WashU financial interests, the PI(s) of the related study(ies) or other individuals with the appropriate knowledge and expertise may be invited to attend.
      • If a determination cannot be made at the time of the meeting, the Committee may delegate the final determination to one or more members as deemed appropriate.
    • Complete noncompliance reviews.
    • Review faculty appeals as needed and allowed for under the ICOI Policy.
    • May solicit expertise from non-ICOIC members, including inviting to meetings as non-voting participants, if deemed essential to appropriately complete a review.
    • Regularly review summaries of new management implemented by the ICOIC Chair (typically at each monthly meeting), to include at a minimum:
      • Involving human subjects Research,
      • New projects added to existing management when management was initially established by the Committee,
      • Other cases as deemed appropriate.
  2. Committee Approval Process
    • For disclosure reviews determined unrelated or not having an ICOI, the review process is concluded.
    • Determine the appropriate management strategies needed to mitigate identified ICOIs effectively for both new reviews and appeals in accordance with the ICOI Risk Matrix.
    • Develop recommendations for corrective actions pertaining to noncompliance reviews.

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:
      • 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.