Doc. T96-039, | Policy on Conflict of Interest Relating to Intellectual Property and Commercial Ventures , I. Introduction, The missions of the of University of Massachusetts (UMass) and its five campuses include the important goal to advance the health and well-being of the people in the Commonwealth of Massachusetts, the nation, and the world through advances in education, research and knowledge. It has become increasing apparent that in order to fulfill its mission, UMass must engage in a variety of complex…, II. AAMC and AAU, Association of American Medical Colleges, (AAMC) and, Association of American Universities, (AAU) - “Protecting Subjects, Preserving Trust, Promoting Progress” (Parts 1 and 2), 2001 and 2002 and “Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research,” 2008 The AAMC comprises the 137 accredited US medical schools with participation by their associated teaching hospitals through the Council of Teaching…, III. Conflicts Reporting Process, Covered Individuals shall report to the Vice Chancellor for Research (VCR) when he/she perceives that any individual or institutional conflict of interest in Clinical Research exists, may exist, or may be perceived to exist. This is in addition to reporting all financial interests to the campus Institutional Review Board (IRB). Upon the VCR’s receipt of the disclosure of the Covered Individual,…, IV. Campus Review Procedures, Due to the unique complexities and health and safety concerns raised by Clinical Research and the myriad of campus constituencies and administrative bodies that participate in these decisions, including the campus IRB, the campuses may, but are not obliged, to develop additional procedures, beyond those set forth herein, for assisting the VCR in the consideration of these Clinical Research cases…, V. Relationship of UMass Policy to Faculty Physicians employed by UMass Memorial Health Center (UMMHC), Physicians and other providers employed by UMMHC who hold faculty or other positions (e.g., student, resident, fellow, or other health care provider) at the University of Massachusetts Medical School are Covered Individuals who are subject to the Conflicts Policy for all participation in Clinical Research within the UMMHC or elsewhere, including clinical or research sites operated by the…, Pecuniary Interest in Research (Defined), Pecuniary Interest in Research, include the following interests of the Covered Individual (and spouse/domestic partner and dependent children) that is reasonably related to the Covered Individual’s Institutional Responsibilities: With regards to, Publicly-Traded Entities, , any payment or value, including salary, consultant payments, honoraria, paid authorship, equity interest (stock, stock option or other ownership interest) during the prior twelve months. With regards to, Privately Held Entities, , any payment or value, including salary, consultant payments, honoraria, paid authorship, equity interest (stock, stock option or other ownership interest) during the prior twelve months. With regards to, Intellectual Property, , intellectual property rights and interests (patents, copyrights) upon receipt of income related to such rights and interests. With regards to, Travel Reimbursements, , any reimbursed or sponsored travel related to the Covered Individual’s Institutional Responsibilities during the prior twelve months (with the exception of travel that is reimbursed or sponsored by a Federal, state, or local government agency, an institution of higher education, an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of…, does not include, : salary, royalties, or other remuneration paid by the University to the Covered Individual if the Covered Individual is currently employed or otherwise appointed, including intellectual property rights assigned to the Institution and agreements to share royalties related to such rights; income from investment vehicles, such as mutual funds and retirement accounts; income from seminars, lectures…, “Institutional Responsibilities”, means the Covered Individual’s professional responsibilities on behalf of the University, including activities such as research, teaching, clinical or other professional practice, academic activities, scholarly events, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Type: Book page
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…
Type: Book page
