Doc. T96-039 | Policy on Conflict of Interest Relating to Intellectual Property and Commercial Ventures , , I. Need for a detailed policy on oversight of Conflicts of Interest (COI), The University of Massachusetts Medical School (UMMS) has as its stated mission “To advance the health and well-being of the people in the Commonwealth and the world through pioneering advances in education, research and healthcare delivery”. It has become increasing apparent that in order to fulfill this mission, UMMS must engage in a variety of complex relationships with outside entities,…, II. AAMC Policies and Guidelines, AAMC 2001 and 2002 Policies and Guidelines for the Oversight of Individual and Institutional Financial Interests in Human Subjects Research: Protecting Subjects, Preserving Trust, Promoting Progress (Parts 1 and 2) The Association of American Medical Colleges (AAMC) is comprised of the 137 accredited US medical schools, with participation of their associated teaching hospitals through the Council…, III. UMMS Procedures, In accordance with the standard of review established in the Guidelines (as informed by the AAMC reports) and in furtherance of the Conflicts Policy, UMMS has developed the following procedures to assist UMMS in the consideration of conflicts of interest cases involving Clinical Research., Institutional COI Official:, The Vice Chancellor or Vice Provost for Research (VPR) or his/her designee shall serve as the institutional COI official for UMMS, including all three schools within UMMS (the School of Medicine, the Graduate School of Nursing, and the Graduate School of Biomedical Sciences).The VPR shall be responsible for developing procedures, using available databases, to identify potential institutional…, UMMS Committee for Oversight of Clinical Research involving Individual COI:, This committee shall be constituted by the UMMS VPR or his/her designee, and will consist of 7 faculty members, 1 designated by the Graduate School of Nursing, 1 by the Graduate School of Basic Sciences, and 5 by the School of Medicine, the Associate Vice Chancellor for Management, and the Chief Compliance Officer of the UMass Memorial Medical Health Center., UMMS Committee for Oversight of Clinical Research involving Institutional COI:, This committee shall also be constituted by the VPR or his/her designee, and will consist of 5 members, 3 of whom shall be external to the University of Massachusetts, and the other 2 faculty from UMMS. If either of the faculty members on the Committee has a Pecuniary Interest in the matter, they would be replaced by an ad hoc member., Roles and Responsibilities:, It shall be the responsibility of the investigator to inform the VPR or his/her designee when he/she perceives that any individual or institutional conflicts exist, may exist, or may be perceived to exist. The investigator shall also inform the Institutional Review Board (IRB) at the time of submission of the protocol in question. It shall be the responsibility of the VPR, in accordance with the…
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