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Conflict of Interest

IUPUI COI Committee Procedures

(By Action of IUPUI Conflict of Interest Committee October 27 2008)

The purpose of the IUPUI Conflict of Interest Committee ("COI Committee") is to assist with implementation of the Indiana University Policy on Financial Conflicts of Interest in Research, adopted by the Board of Trustees September 15, 2000, and any amendments thereto (the "Policy"), and the IUPUI Procedures for the Regulation of Financial Conflicts of Interest, effective February, 19, 2008 (the "Procedures").

Any capitalized term not defined herein has been previously defined within the Policy or the Procedures.

I. Authority

  • The COI Committee is established pursuant to the Policy and Procedures, and is empowered to:
    • Oversee the uniform disclosure process for Covered Persons (and such other members of the university community as are deemed appropriate by the COI Committee) regarding financial conflicts of interest;
    • Review annual disclosure forms in which real or apparent financial conflicts of interest have been identified, and develop management plans or other means of managing, reducing, or eliminating real or apparent conflicts of interest;
    • Consult with appropriate administrative officials in the development of such plans;
    • Coordinate with the campus Institutional Review Board(s) to identify and address real or apparent financial conflicts of interest arising in human subjects research;
    • Review and approve school/unit conflict of interest guidelines;
    • Help conduct and support education of faculty, staff, and students on conflicts of interest issues; and
    • Collect aggregate data for the campus regarding financial conflicts of interest and provide that data to the Vice President for Research Administration for compliance oversight purposes.
  • In the performance of its duties under paragraph (A) above, the COI Committee may impose conditions or restrictions to manage, reduce, or eliminate a real or apparent conflict of interest. Such conditions or restrictions may include, but are not limited to:
    • Public disclosure of Significant Financial Interests;
    • Monitoring of research by independent reviewers;
    • Modification of the research plan;
    • Disqualification from participation in all or part of a project in which an actual or potential conflict of interest exists;
    • Divestiture of Significant Financial Interests; and
    • Severance of relationships that create actual or reasonably perceived conflicts of interest.
  • The COI Committee is authorized to collect sufficient information to allow it to identify the existence and extent of a real or apparent financial conflict of interest and the feasibility of options for managing, reducing, or eliminating such a conflict.

II. Chairpersons

  • The Vice President for Research Administration shall appoint Co-Chairpersons for the COI Committee.
  • The Co-Chairpersons shall be voting members of the COI Committee.
  • The Co-Chairpersons may appoint a COI Committee member as acting chairperson to function in their absence.

III. Meetings

  • Meetings. The Committee shall meet at least monthly throughout the academic year unless a meeting is cancelled by the Co-Chairpersons for good cause. Notice of time and place shall be given at least one week in advance. The Co-Chairpersons may call a special meeting upon three days written, electronic or telephonic notice.
  • Minutes. Minutes of each meeting shall be kept by the COI Manager or his or her designee. COI Committee members will be provided with the minutes of the last meeting in advance of the next meeting.
  • Quorum. A quorum, which shall consist of a simple majority, is necessary to conduct the business of the COI Committee. In the absence of a quorum, the voting members present at a meeting may review disclosures and recommend COI Committee action, which must be subsequently ratified by a majority of the COI Committee members prior to taking effect. COI Committee member ratification may take place via electronic mail once given the opportunity to review the meeting minutes. The action of a quorum of the voting COI Committee members via an electronic mail or telephonic vote on an agenda item shall constitute official COI Committee action on the proposed agenda item.
  • Expedited Review. When necessary, an expedited review of the COI Committee may be obtained by discussion of the issue among the COI Committee Co-Chairpersons, university counsel and the COI Manager. Any action taken upon an expedited review shall be presented to the COI Committee at the next scheduled meeting for ratification. A disclosure may qualify for expedited review by the COI Committee in the following situations:
    • A legitimate business need or other good cause to review the study prior to the COI Committee's regularly scheduled meeting date; and
    • The delay in review was not caused by any action of the Covered Person requesting expedited review.

IV. Conflict of Interest Review

  • Objectives. The COI Committee shall attempt to manage, reduce, or eliminate conflicts in an efficient and amenable manner.  The COI Committee shall seek consensus in its decisions; however, if this cannot be obtained, the appropriate course of action to be taken shall be determined by a simple majority of those attending the meeting.
  • Voting. Each COI Committee member, other than the two ex officio members referred to in Article IV(e), shall have one vote.  Voting shall proceed within the COI Committee, after an opportunity for full discussion and debate has been afforded.
  • Circumstances for Review. The COI Office shall provide conflict of interest disclosures to the COI Committee disclosures for review and action in the following circumstances:
    • The Interested Person's unit or the Conflict of Interest Office ("COI Office") believes the disclosure presents a real or apparent conflict of interest and that management, reduction, or elimination of the conflict is required; and/or
    • The Interested Person's unit or the COI Office seeks the COI Committee's guidance on whether or not a disclosure presents a real or apparent conflict of interest.
  • Review Criteria. The COI Committee will review disclosures presented for review based on the criteria and principles set out in the COI Committee Guidelines, as they are established from time to time by the COI Committee.
  • Notice. The COI Committee, via the COI Office, will provide written or electronic notice to the Covered Person whose real or apparent conflict is under review, of any preliminary determination by the COI Committee regarding (1) the existence of a real or apparent conflict of interest; and (2) appropriate steps for managing, reducing, or eliminating that conflict of interest, after the COI Committee's meeting.
    • The Covered Person may respond in writing (including electronic writing) to the COI Committee's preliminary determinations within a reasonable deadline as established by the COI Manager.  Alternatively, the Covered Person may request to meet with the COI Committee at its next regular meeting or at a special meeting to answer questions or address issues of the COI Committee.
  • Timeframe for Review. The COI Committee shall use its best efforts to reach a final determination as to any real or apparent conflict of interest referred to them within sixty calendar days of receipt of the referral of the issue from the COI Manager.
  • Noncompliance. Failure of an individual to cooperate with the COI Committee in an effort to delay or interfere with the COI Committee's resolution of a financial conflict of interest under its jurisdiction shall be reported to the Vice President for Research Administration for further action consistent with paragraph 7. of the Policy or such other applicable policies of the University as may exist from time to time.

V. Subcommittees and Administrative Review

  • Administrative Review. In certain cases, the COI Committee may designate the COI Manager to provide administrative review and approval of a limited category of disclosures. Administrative approvals of disclosures will be reported at the next scheduled COI Committee meeting.

VI. Participation of Non-members

  • Attendance. No person outside the COI Committee has a right to attend COI Committee meetings, nor shall persons outside the COI Committee be permitted to attend a meeting without the consent of the Co-Chairpersons.
  • Attendance by Invitation. The COI Committee may invite non-members to attend, or a Covered Person may request to attend, COI Committee meetings in order to provide the COI Committee with information that is relevant or necessary to its review and analysis.
  • Request for Invitation.  As specified in Article VI above, a Covered Person may request to meet with the COI Committee after he or she has received notice of the COI Committee's preliminary findings. The COI Committee may also request that a Covered Person attend a meeting of the COI Committee to discuss resolution of a conflict or other matter before the COI Committee.

VII. Records

  • Maintenance. The COI Manager shall see that proper records are maintained, specifically:
    • Minutes of each meeting with the names of those present, the issues and disclosure reports reviewed, a summary of the discussion of the issues, and any other COI Committee actions and discussion,
    • Copies of notification of COI Committee action and any other relevant data;
    • Annual disclosures and any updates thereto; and
    • Correspondence.

VIII. Extensions of Time

  • The COI Committee may, for good cause shown and by a simple majority vote, approve reasonable extensions of any deadlines in these procedures; however, no extension shall be inconsistent with the fulfillment of the University's obligations under applicable law.

IX. Reports

  • Internal Reporting. The COI Committee shall submit an annual report to the Vice President for Research Administration in November of each year. Such report shall contain data as to the numbers of conflicts reviewed and the nature of resolutions and data as to any trends. The report shall cover the previous academic year.
  • External Reporting. The COI Committee will assist and coordinate with the Vice President for Research Administration in assuring full compliance with all federal reporting requirements with respect to conflicts of interest.
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