Doc. T96-039 | Policy on Conflict of Interest Relating to Intellectual Property and Commercial Ventures, Addendum, As amended on April 6, 2012 , I. Introduction, The National Institutes of Health (and other PHS agency) funding represents the largest source of funding of research activities of the University of Massachusetts. The PHS financial conflict of interest regulations have unique financial conflict of interest reporting and conflict management requirements. This policy is for the purpose of ensuring compliance with these important regulations (…, II. Mandatory Training, The VCR shall be responsible for ensuring that each Investigator is informed about (i) this FCOI Policy, (ii) the Investigator’s responsibilities regarding disclosure of Significant Financial Interests relating to the Investigator’s Institutional Responsibilities, and (iii) the FCOI Regulations. The VCR, through the designated institutional official(s), shall require each Investigator to complete…, III. Disclosure Procedures, Each VCR shall develop and administer an efficient and effective method for soliciting and reviewing timely disclosures from Investigators planning to participate in PHS- funded research, which may be through means of a written disclosure statement and/or electronic questionnaire (“PHS Disclosure Form”). The PHS Disclosure Form shall provide that the Investigator will submit the PHS Disclosure…, Publicly Traded-Entities, – With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not…, Privately Held Entities, – With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or domestic partner and dependent children) holds any equity interest (e.g., stock, stock option, or other ownership…, Intellectual Property, – Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests., Travel Reimbursements, – Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities in the twelve months preceding the disclosure; provided, however, that this disclosure requirement does…, IV. Management of Financial Conflicts of Interests, Each VCR shall designate an institutional official(s) to solicit and review PHS Disclosure Forms from each Investigator planning to participate in, or participating in, PHS-funded research. The designated institutional official(s) must review all PHS Disclosure Forms and determine whether an Investigator’s Significant Financial Interest is related to PHS- funded research and, if so related,…, greater than, $10,000 in value (measured by aggregating the various categories of interests reported) shall be submitted to the next monthly meeting of the Conflicts Committee for its consideration for expedited review or full review (depending the level of financial interest involved) in accordance with Article III.B of the Conflicts Policy. The Conflicts Committee will decide upon one of the following…, V. Reporting Financial Conflicts of Interests to PHS, Prior to expending any funds under an PHS funded grant, cooperative agreement or contract, the University, through the respective office of the VCR, must report to the applicable PHS funding agency the existence of any FCOI (as defined in IV above) and assure that the University has implemented a management plan in accordance with the FCOI Regulations and the Conflicts Policy (as discussed in IV…, VI. Subrecipient Compliance and Reporting, All proposed subrecipients under a PHS-funded research of the University shall have a financial conflicts of interest policy that conforms to the requirements of the FCOI Regulations. With respect to these subgrantees, subcontractors, and collaborators, the VCR must require these entities to enter into a written agreement and make a certification to the University at the time of award that its…, VII. Remedies, If an Investigator fails to comply with this FCOI Policy or a management plan and the non-compliance appears to have biased the design, conduct or reporting of the PHS- funded research, the University, through the respective office of the VCR, as required under the FCOI Regulations, shall promptly notify the agency of the corrective action taken or to be taken. In every respect, the VCR shall…, VIII. Enforcement and Sanctions, All persons subject to the Conflicts Policy and this FCOI Policy are expected to comply with it fully and promptly. Whenever an Investigator has violated the Conflicts Policy or this FCOI Policy, for example by a failure to disclose a Significant Financial Interest, the VCR or the Conflicts Committee may refer the matter to the appropriate University official or committee for disciplinary action…, IX. Records, The University, through the applicable VCR, is required pursuant to the FCOI Regulations to maintain all PHS Disclosure Forms and all related records of actions taken by the University with respect to disclosures of financial interests for a period of three years from the date of submission of the final expenditures report to the PHS or, where applicable, from other dates specified in 45 CFR 74.…
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Doc. T96-039 | Policy on Conflict of Interest Relating to Intellectual Property and Commercial Ventures, Addendum, As amended on August 1, 2012 , I. Introduction, The National Institutes of Health and other U.S. Public Health Service (PHS) agency funding represents the largest source of funding of research activities of the University of Massachusetts Medical School. To address the increasing complexities of the financial interests held by biomedical and behavioral researchers and the resulting interactions among government, research institutions, and the…, II. Mandatory Training, The VPR shall be responsible for ensuring that each Investigator is informed about (i) this FCOI Policy, (ii) the Investigator’s responsibilities regarding disclosure of Significant Financial Interests relating to the Investigator’s Institutional Responsibilities, and (iii) the FCOI Regulations. The VPR, through the designated institutional official(s), shall require each Investigator to complete…, III. Disclosure Procedures, The VPR shall develop and administer an efficient and effective method for soliciting and reviewing timely disclosures from Investigators planning to participate in extramurally funded activities, which may be through means of a written disclosure statement and/or electronic questionnaire (“Disclosure Form”). The Disclosure Form shall provide that the Investigator will submit the Disclosure Form…, Publicly Traded-Entities, – With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, “remuneration” includes salary and any payment for services not…, Privately Held Entities, – With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or domestic partner and dependent children) holds any equity interest (e.g., stock, stock option, or other ownership…, Intellectual Property –, Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests., Travel Reimbursements, – Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their Institutional Responsibilities in the twelve months preceding the disclosure; provided, however, that this disclosure requirement does…, IV. Management of Financial Conflicts of Interests, The VPR shall designate an institutional official(s) to solicit and review Disclosure Forms from each Investigator planning to participate in, or participating in, extramural funded activities. The designated institutional official(s) must review all Disclosure Forms and determine whether an Investigator’s Significant Financial Interest is related to any extramural funded project and, if so…, V. Reporting Financial Conflicts of Interests to PHS, Prior to expending any funds under a PHS funded grant, cooperative agreement or contract, the University of Massachusetts Medical School, through the Office of the VPR, must report to the applicable PHS funding agency the existence of any FCOI (as defined in IV above) and assure that the University of Massachusetts Medical School has implemented a management plan in accordance with this FCOI…, VI. Subrecipient Compliance and Reporting, All proposed subrecipients under a PHS-funded research project of the University of Massachusetts Medical School shall have a financial conflicts of interest policy that conforms to the requirements of the FCOI Regulations. With respect to these subgrantees, subcontractors, and collaborators, the VPR must require these entities to enter into a written agreement and make a certification to the…, VII. Remedies, If an Investigator fails to comply with this FCOI Policy or a management plan and the non-compliance appears to have biased the design, conduct or reporting of the PHS-funded research, the University of Massachusetts Medical School, through the Office of the VPR, as required under the FCOI Regulations, shall promptly notify the agency of the corrective action taken or to be taken. In every…, VIII. Enforcement and Sanctions, All persons subject to this FCOI Policy are expected to comply with it fully and promptly. Whenever an Investigator has violated this FCOI Policy, for example, by a failure to disclose a Significant Financial Interest, the VPR or the Conflicts Committee may refer the matter to the appropriate University official or committee for disciplinary action or other appropriate action. Violations of this…, IX. Records, The University of Massachusetts Medical School, through the Office of the VPR, is required pursuant to the FCOI Regulations to maintain all Disclosure Forms and all related records of actions taken by the University of Massachusetts Medical School with respect to disclosures of financial interests for a period of three years from the date of submission of the final expenditures report to the PHS…
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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.
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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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In this course, you will learn about various aspects of creating accessible Word documents, including how to structure a document to ensure it's accessible, how to provide accessible images and graphs, and content best practices.
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