Duke University's Institutional Conflict of Interest Policy and Implementation, Study notes of Medicine

Download Duke University's Institutional Conflict of Interest Policy and Implementation and more Study notes Medicine in PDF only on Docsity! 1 | P a g e Revised: 8.15 Approved by ICOI: 8.15 Reviewed by EC of BOT: 11.6.15 Institutional Conflict of Interest in Research Implementation – Duke University 1. Introduction An institutional conflict of interest ("Institutional COI") describes a situation in which the financial interests of an institution or an institutional official, acting within his or her authority on behalf of the institution, may affect or appear to affect the research, education, clinical care, business transactions, or other activities of the institution. Institutional COIs are of significant concern when financial interests create the potential for inappropriate influence over the institution’s activities. This implementation document is based on the University’s Institutional Conflict of Interest Policy in order to protect against exposure from risks related to Institutional COIs as they may affect research performed at or under the auspices of the University. 2. Conflict of Interest Office The University will maintain one or more offices to manage day-to-day operations regarding conflict of interest. One office, selected by the President, will manage processes regarding institutional COI. This office will perform an administrative review of potential institutional COIs and will prepare a draft management plan in collaboration with the Institutional COI Committee Chair (or his/her designee). The office will also prepare summary reports for use by the Institutional COI Committee. Regular reports will be made no less than annually to the President and Board of Trustees. 3. Institutional Conflict of Interest Committee In order to review and manage Institutional COIs, a seven member committee will be established that includes at least two members who are not employed by Duke (“external members”), who should also not be members of the Board of Trustees. A member of the General Counsel’s Office will be a non-voting participant. The chairs of the Campus, Administrative, and School of Medicine Conflict of Interest Committees will be voting members. The other two members will be tenured faculty, one from the School of Medicine, one from the University but not the School of Medicine. The President of the University will designate the committee chair, who will be a voting member of the Committee. The committee chair is selected from the chairs of the Campus and School of Medicine Conflict of Interest Committees. Members (other than ex-officio) will serve renewable three year terms. Members may serve past their term until new members are appointed. The Committee will be advisory to the University Board of Trustees, which holds final authority regarding questions of Institutional COIs. The quorum for voting shall be: At least one external member and at least four 2 | P a g e Revised: 8.15 Approved by ICOI: 8.15 Reviewed by EC of BOT: 11.6.15 employee members OR two external members, and at least three employee members. Decisions of the Committee shall be by majority vote of members present. Appointments to the committee will be made by the University President or his/her designee, in consultation with the Executive Committee of the Academic Council (ECAC), and with approval of nominees by the Executive Committee of the Board of Trustees. The primary reporting line of authority for the Institutional COI Committee will be through the Executive Committee of the Board. A proxy vote will be allowed for voting members who cannot attend when requests are made ahead of time and the proxy designee has been approved by the committee chair. 4. Management of Reporting of Potential Institutional Conflicts of Interest There are two broad categories of Institutional COI in Research: Conflicts that affect the institution directly and those that relate to institutional officials who have oversight responsibilities. Ascertainment of Direct Institutional COIs: Gifts: All gifts to Duke University must be processed through one of the institutional development offices. When a gift of $10,000 or more comes from a sponsor of research, the Conflict of Interest Office should be notified by the development office. A list of all gifts will be produced by the development office and distributed to the COI Office on a regular basis. The list of research sponsors will be maintained by the COI Office, drawing from the SPS database. All donations over $100,000 should also be reported to the COI Office as early in the development phase as possible but no later than upon receipt. [Gift amounts are the results of totals for each calendar year.] Licensing agreements: Licensing agreements are executed by the Duke Office of Licensing and Ventures. OLV will provide a report at least quarterly of new and existing agreements (including equity holdings, royalty payments, other payments, and their stipulations) to the Conflict of Interest Office. Equity holdings: The University receives equity holdings from time to time as consideration in licensing agreements. In some cases, the results from a single study can significantly change the value of the equity. For this reason, the potential for an Institutional COI is often inherent in these situations. This potential COI is managed by a process in which researchers and administrators who oversee research are removed from any management or administrative decisions regarding equity. To manage and administer these equity holdings and manage potential institutional conflicts of interest regarding private equity secured through licensing agreements, DUMAC, Inc. (Duke’s investment management firm) will maintain a relationship with a third party custodian manager whereby the University is blinded to the holding or selling of the equity. Any communication with the management firm will be filtered through the Office of Internal Audit.