Policies, Procedures and Guidelines

CIRC Disclosure Review Process

Created 01.15.2020

Introduction

The WUSTL Research Conflicts of Interest Policy states “The Conflicts of Interest Review Committee(s) (CIRC) is the designated official(s) responsible for evaluating financial disclosures.” This procedure outlines the process that the CIRC uses to evaluate the disclosures for financial conflicts of interest (FCOI). 

Disclosure Review

All covered individuals are required to submit their personal financial interests, at a minimum, annually via the Financial Disclosure Statement (FDS).  Additionally the CIRC, CIRC Chair (which includes CIRC Vice-Chair), and COI program office may review disclosures of personal financial interests in relation to a specific pending project or agreement.  Once submitted, these disclosures are prepared by the COI program staff for review by the CIRC/CIRC Chair as follows:   

Administrative Review

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

  1. Admin Review Process:
    1. Determines which (if any) financial interests meet the CIRC’s thresholds for review..
    2. Obtains clarifying information as needed to facilitate review.
  1. Admin Approval Process:
    1. COI program staff may conclude the disclosure review process under delegated authority by the CIRC (Individual (Research) Conflicts of Interest Policy) when:
      1. None of the reported financial interests meet CIRC review thresholds
      2. The individual has no research activities
      3. The individual’s personal financial interests and research activities were previously reviewed by the CIRC/CIRC 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 CIRC/CIRC Chair.
    2. 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 activites 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:
    1. Determines if material financial interests are potentially related to current or pending research activities.
    2. Evaluates disclosure reviews for potential expedited review.
      1. Examples include service, licensing, evaluation/option, material transfer agreements, and any others as deemed appropriate by the CIRC.
    3. Obtains clarifying information as needed to assess risks.
  2. Expedited Approval Process:
    1. Expedited reviewers may complete the disclosure review process under delegated authority by the CIRC when the entities in which an individual has a material personal financial interest:
      1. Are NOT sponsoring or supporting his/her research
      2. Have NO owned or licensed IP utilized or evaluated in the research
      3. Do NOT appear to be engaged in activities directly related to the research
      4. Do NOT appear to benefit directly from the outcomes of the research
    2. Additionally Expedited reviewers may:
      1. 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)
      2. Lift holds on agreements to enable the continuation of negotiations or execution between WU and an entity when:
        1. The agreement does not relate to any human subjects research, and
        2. The execution of the agreement would not potentially create an unmanageable situation, and
        3. Formal approval is obtained by the CIRC/CIRC Chair as soon as possible.
    3. All other disclosures are elevated to Chair or Committee Review as described below:

Chair Review

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

  1. Chair Review Process:
    1. Reviews new financial interests and projects when potential relatedness was identified by the COI program staff in order to:
      1. Determine if the personal financial interest and research activity are related, and if yes;
      2. Determine if a financial conflict of interest exists
    2. 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.
    3. Provides guidance and feedback to the COI program staff on additional information needed to complete a review.
    4. May solicit expertise from non-CIRC members, including inviting to meetings as non-voting participants, if deemed essential to appropriately complete a review.
    5. Regularly reviews a subset of expedited review cases for verification of adherence to the CIRC procedures.
  1. Chair Approval Process:
    1. For disclosure reviews determined unrelated or not having a FCOI, the review process is concluded.
    2. Determine the appropriate management strategies needed to mitigate identified FCOIs effectively in accordance with Determining and Managing Research FCOIs Procedures or elevate the case to Committee review.
    3. The CIRC Chair will typically refer higher risk/complex matters to a sub/full committee for review, such as:
      1. Cases involving investigators intending to serve as PI or co-investigator of research sponsored or supported by an entity he or she co-founded or holds non-public equity, including:
        • Previously unmanaged entities (new entities or first SBIR/STTR/SRA)
        • Initial Fastrack and Direct to Phase II SBIR/STTR
          • Subsequent Fastrack and Phase II applications should also be elevated to the committee if the science or scope of the project significantly differs than previously reviewed applications (i.e. transitioning to human subjects research or exploring new indications for the IP)
        • Cases involving multiple projects with differing funding sources such that in the aggregate are considerd complex (i.e. Phase I SBIR/STTRs in combination with other federal sponsored research such as NIH or DOD that also evaluates the licensed IP).
      2. Complex FCOIs involving human subjects research such as:
        • Compelling circumstances exist to warrant the conflicted individual to have a more significant role than as technical advisor or performing clinical standard of care practices.
      3. Any case identified by the Chair as warranting Committee review
    4. An elevated review would primarily be to the full committee although the CIRC Chair may opt to convene a sub-committee to accommodate schedules or agenda limitations of the full committee.
      1. Only in instances when time constraints would create a direct risk to funding of a project should the review be delayed until a sub/full committee meeting is convened;
        • The CIRC Chair may initiate management strategies to address any FCOI (based on Committee determinations from prior cases)
        • The Committee will review the case at the next scheduled meeting and confirm the management plan established by the Chair.

Sub/Full Committee Review

The Committee is responsible for reviewing disclosures elevated by the CIRC Chair.  The Committee has a standing monthly meeting, with sub-committees held on an ad hoc basis.

  1. Committee Review Process:
    1. For disclosure reviews:
      1. The CIRC Chair, a CIRC member or COI staff will meet with the faculty/staff member prior to the Committee meeting to obtain necessary information.
        1. The individual(s) has the opportunity to attend the sub/full committee meeting to obtain or provide information.
      2. 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.
    2. Complete noncompliance and retrospective reviews as outlined in the Noncompliance Assessment Process and Potential Sanctions.
    3. Review faculty appeals as needed.
    4. May solicit expertise from non-CIRC members, including inviting to meetings as non-voting participants, if deemed essential to appropriately complete a review.
    5. Regularly review summaries of new management implemented by the CIRC Chair (typically at each monthly meeting), to include at a minimum:
      1. Involving human subjects Research,
      2. New projects added to existing management when management was initially established by the Committee,
      3. Other cases as deemed appropriate.
  1. Committee Approval Process:
    1. For disclosure reviews determined unrelated or not having a FCOI, the review process is concluded.
    2. Determine the appropriate management strategies needed to mitigate identified FCOIs effectively for both new reviews and appeals in accordance with Determining and Managing Research FCOIs Procedures.
    3. Develop recommendations for the VCR pertaining to noncompliance and retrospective reviews.

Definitions

Conflicts of Interest Review Committee (CIRC): The CIRC is a standing faculty committee, designated with the responsibility to provide an independent peer-reviewed assessment of personal financial interests reported by covered individuals. There is a Danforth Campus Committee and a School of Medicine Committee.

Financial Interest: Anything of monetary value, whether or not the value is readily ascertainable. For purposes of this Policy, a financial interest is “material” when it exceeds the applicable threshold for review.

Financial Conflict of Interest (FCOI): A financial conflict of interest exists when it is reasonably determined that a personal financial interest could directly and significantly affect the design, conduct, or reporting of research.

Human Subjects Research: Any research or activity which requires review by an Institutional Review Board.

Manage: taking action(s) to address a FCOI, to ensure, that the design, conduct, and reporting of research will be free from bias.

Potential Relatedness:  Circumstances in which the research activities of an investigator appear to overlap with his/her personal financial interests and may constitute a financial conflict of interest.  Examples include:

  • Investigator is involved with a project sponsored by a company with which they have a financial interest
  • Investigator is involved with a project evaluating a drug or device of a company with which they have a financial interest
  • Investigator is involved with a project evaluating IP for which there is an agreement entitling them to royalties
  • The investigator is involved in a project whose outcomes could directly benefit the entity

Research Activities: Any research, including clinical research, materials evaluations, or general research projects that may be unfunded or performed under an agreement or grant with an entity in which the entity provides full or partial funding of the project.