Doc. T96-039, Passed by the Board of Trustees on April 2, 1997 Under most circumstances, conflicts of interest involving individuals associated with the University are addressed by Chapter 268A of the Massachusetts General Laws, which governs the conduct of public officials and employees. However, pursuant to Massachusetts General Laws Ch. 75 §14A, in the area of intellectual property and technology transfer…, I. Definitions, As used in this Policy, the following words shall have the following meanings:, Chair, – The Chairperson of the Conflicts Committee, as described in detail below., Clinical Research, – Research involving human subjects., Company, – Any corporation, partnership, association, or other legal entity, excluding entities controlled by the United States government, the Commonwealth of Massachusetts, and the University. A Company shall include all affiliates and other associated entities., Conflict of Interest, – (i) An actual or potential conflict between the personal interests of a Covered Individual and the interests of the University or the public or (ii) the reasonable appearance of such a conflict to the public. The University recognizes that the mere existence of a conflict of interest is not improper, but could lead to apparent or actual improper behavior. This Policy seeks to manage conflicts…, Conflicts Committee, – A five-campus committee that reviews and manages conflicts of interest, as further described in Article III., Covered Individual, – Any individual associated with the University, including without limitation faculty, staff, and students, but excluding members of the CVIP and Vice Chancellors for Research. Anyone who is not a Covered Individual remains subject to the more restrictive provisions of Mass. Gen. Laws Ch. 268A., CVIP, – The University Office of Commercial Ventures and Intellectual Property., Director, – The Executive Director of the CVIP., Equity, – All ownership interests in a Company and all rights to obtain ownership interests in a Company, including without limitation common or preferred stock, warrants, options, and partnership units, and also including compensation arrangements based on equity performance (e.g., phantom stock). "Equity" does not include ownership interests that are held through publicly-traded mutual funds., Financial Interest, – A Significant Financial Interest or Substantial Financial Interest, both as defined below., Non-Equity Compensation, – All compensation other than Equity that is provided by a Company or contractually promised by a Company, including without limitation salary, gifts, royalties, consulting fees, honoraria, goods, services, and travel expenses. "Non-Equity Compensation" does not include compensation that is provided by the University pursuant to (i) its Intellectual Property Policy or by another educational or…, Significant Financial Interest, – Has either of the following meanings., Clinical Research, – In relation to Clinical Research that is performed or directed by a Covered Individual, "Significant Financial Interest" means (i) any Equity in a Company that is directly owned by, or is under the control of, a Covered Individual or a member of his or her immediate family or (ii) Non-Equity Compensation from a Company in an aggregate amount greater than $1,000 within the prior twelve-month…, Non-Clinical Research, – In relation to research other than Clinical Research that is performed or directed by a Covered Individual, "Significant Financial Interest" means either (i) Equity that represents more than one percent (1%) of the total equity in a Company or has a total current value of more than $10,000 that is directly owned by, or is under the control of, such Covered Individual or a member of his or her…, Substantial Financial Interest, – Has either of the following meanings, Clinical Research, – In relation to Clinical Research that is performed or directed by a Covered Individual, "Substantial Financial Interest" has the same meaning as "Significant Financial Interest.", Non-Clinical Research, – In relation to research other than Clinical Research that is performed or directed by a Covered Individual, "Substantial Interest" means either (i) Equity that represents more than five percent (5%) of the total equity in a Company or has a total current value of more than $100,000 that is directly owned by, or is under the control of, such Covered Individual or a member of his or her immediate…, Vice Chancellor for Research, – The Vice Chancellor for Research at each campus, or where no such position exists, the Provost (or their designees)., II. Administration of Policy, Philosophy and Authority of Conflicts Committee, – The University assumes that its faculty and staff act with the highest level of personal responsibility, integrity and commitment to the University. Nevertheless, complex situations can arise involving Conflicts of Interest that require specialized knowledge and a multi-disciplinary, problem-solving approach. Therefore, the Committee will have the authority on behalf of the University to review…, The Conflicts Committee, – This Policy will be administered by a thirteen-member, University-wide Committee consisting of one member of the faculty at each campus appointed under procedures established by the campus; the Vice Chancellor for Research or his or her designee at each campus; the President or his or her designee; and two non-voting members who the President may appoint from outside the University. The…, III. Policy, Disclosure of Financial Interests, All Covered Individuals must disclose a Significant or Substantial Financial Interest to the Vice Chancellor for Research or his or her designee in situations in which the Financial Interest may present a Conflict of Interest involving the use of students, technology transfer activities or the outcome of research that is performed or directed by that Covered Individual with significant use of…, Company-Sponsored Research Proposals, – If a Covered Individual intends to perform or direct Company-sponsored research at the University, and if the Covered Individual has a Financial Interest in that Company, or has received a Financial Interest from that Company, then the Financial Interest should be disclosed to the Vice Chancellor for Research and allowed in accordance with this Policy before the Covered Individual submits to…, Company-Sponsored Research, – If a Covered Individual performs or directs Company-sponsored research at the University, and if the Covered Individual intends to receive or actually receives a Financial Interest in that Company or from that Company at any time (i) during the conduct of the research or (ii) within one year after cessation of the research, then the Financial Interest must be disclosed to the Vice Chancellor…, Government and Non-Profit Institution Grant Applications, – In general, if a Covered Individual intends to submit an application for research funding from a U.S. Government agency or a non-profit institution, then the Covered Individual must comply with any disclosure and approval procedures required by the agency or institution in connection with such application. For example, in order to comply with Public Health Service and National Science…, Government and Non-Profit Institution-Funded Research, – If a Covered Individual performs or directs research that is funded directly or indirectly by a U.S. Government agency or a non-profit institution, the Covered Individual must comply with any disclosure and approval procedures required by the agency or institution in connection with such funding. For example, in order to comply with Public Health Service and National Science Foundation…, Licensing to Certain Companies, – If a Company intends to obtain a license to University-owned intellectual property, directly or indirectly, and if the Covered Individual who developed, discovered, or created that intellectual property or who is involved in negotiating the license (i) becomes aware of such intention and (ii) has a Financial Interest in that Company, the Financial Interest must be immediately disclosed to the…, Involvement of Students, – Although involvement of students in the outside professional activities of faculty under certain circumstances may enrich the students' educational experience, such activities have the potential to create a Conflict of Interest when the faculty member has a role in supervising the student's research, classes, or graduate teaching work. Therefore, involvement of a student in the outside…, Changes to a Financial Interest, – All Covered Individuals must disclose significant changes in previously disclosed Financial Interests. A Financial Interest that becomes a Substantial Interest is always considered a significant change., Management of Conflicts, Covered Individuals are generally prohibited from having a Conflict of Interest that is disclosable under Section IV.A. unless the University has reviewed and allowed both the activity and the Financial Interest. There are two different procedures for review and allowance of these Conflicts of Interest, as set forth below. If a Conflict of Interest involves a Substantial Financial Interest, it…, Expedited Review and Allowance of Conflicts, – If a Conflict of Interest does not involve a Substantial Financial Interest, then the Conflict of Interest will ordinarily receive expedited review and allowance. Under this expedited procedure, the Vice Chancellor for Research member of the Committee will review the disclosures submitted by Covered Individuals at his or her campus and either grant preliminary allowance or recommend review by…, Full Review and Allowance of Conflicts, – If a Conflict of Interest involves a Substantial Financial Interest, the Vice Chancellor for Research member of the Committee will forward the disclosure to the Chair for inclusion on a Committee meeting agenda. The Chair will also include on the meeting agenda any other disclosures that have been selected by the Vice Chancellor for Research as appropriate for full review. The Conflicts…, Interim Measures, – The Conflicts Committee or its Chair, in consultation with the Vice Chancellor for Research of the campus, may impose any measures that it finds necessary or desirable to preserve the existing situation until a formal review is completed. Such measures may allow a Conflict of Interest to exist, with or without conditions, while a formal review is pending., Review of Conflicts, – The Conflicts Committee will formally review all conflicts disclosures that (i) involve a Substantial Financial Interest, (ii) are recommended for full review by the Vice Chancellor for Research, or (iii) are selected by the Chair from the list of other disclosures for expedited review. In the case of a Conflict of Interest involving a Substantial Financial Interest, the Conflicts Committee…, Disposition of Conflicts, – After completing the formal review, the Conflicts Committee may decide upon one or more of the following dispositions: Postpone consideration of the matter pending further information or investigation. Allow a Conflict of Interest because the circumstances require no action. Allow a Conflict of Interest with conditions, such as: public disclosure of the Financial Interest in publications…, IV. Public Statements, A number of problems my be posed when statements are made by scientists about research before the research has been publicized in scholarly journals or symposia, when the scientist has a Financial Interest in a Company that stands to benefit from the research. In order to avoid any such occurrences at the University, all Covered Individuals who perform or direct research for a Company in which…, V. Appeals, A Covered Individual may appeal an initial decision of the Committee by requesting a rehearing of the matter. The rehearing shall occur at the next regularly scheduled meeting of the Conflicts Committee. At the rehearing, the Covered Individual may personally appear before the Committee and shall have the right to be accompanied by counsel or a union representative. The Committee shall establish…, VI. Periodic Review of Policy, At least every three years following adoption of this Policy, the Conflicts Committee will conduct an evaluation of this Policy and, if necessary formulate amendments for consideration by the President of the University.
Type: Book page
Doc. T96-039, Passed by the Board of Trustees on June 5, 1996 Under most circumstances, conflicts of interest involving individuals associated with the University are addressed by Chapter 268A of the Massachusetts General Laws, which governs the conduct of public officials and employees. However, pursuant to Massachusetts General Laws Ch. 75 §14A, in the area of intellectual property and technology transfer…, I. Definitions, As used in this Policy, the following words shall have the following meanings:, Chair, – The Chairperson of the Conflicts Committee, as described in detail below., Clinical Research, – Research involving human subjects., Company, – Any corporation, partnership, association, or other legal entity, excluding entities controlled by the United States government, the Commonwealth of Massachusetts, and the University. A Company shall include all affiliates and other associated entities., Conflict of Interest, – (i) An actual or potential conflict between the personal interests of a Covered Individual and the interests of the University or the public or (ii) the reasonable appearance of such a conflict to the public., Conflicts Committee, – Shall have the meaning set forth in Article III., Covered Individual, – Any individual associated with the University, including without limitation faculty, staff, and students., CVIP, – The University Office of Commercial Ventures and Intellectual Property., Director, – The Executive Director of the CVIP., Equity, – All ownership interests in a Company and all rights to obtain ownership interests in a Company, including without limitation common or preferred stock, warrants, options, and partnership units, and also including compensation arrangements based on equity performance (e.g., phantom stock). "Equity" does not include ownership interests that are held through publicly traded mutual funds., Non-Equity Compensation, – All compensation other than Equity that is provided by a Company or contractually promised by a Company, including without limitation salary, gifts, royalties, consulting fees, honoraria, goods, services, and travel expenses. "Non-Equity Compensation" does not include compensation that is provided by the University pursuant to (i) its Intellectual Property Policy or by another educational or…, Financial Interest, – With respect to any Company, (i) any Equity in such Company that is directly owned by, or is under the control of, a Covered Individual or a member of his or her immediate family and (ii) Non-Equity Compensation from such Company in an aggregate amount greater than $1,000 within the prior twelve-month period that is directly or indirectly received by or contractually promised to a Covered…, Substantial Interest, – Has either of the following meanings., Clinical Research, – In relation to Clinical Research that is performed or directed by a Covered Individual, "Substantial Interest" has the same meaning as "Financial Interest.", Non-Clinical Research, – In relation to research other than Clinical Research that is performed or directed by a Covered Individual, "Substantial Interest" means either (i) Equity that represents more than five percent (5%) of the total equity in a Company or has a total current value of more than $100,000 that is directly owned by, or is under the control of, such Covered Individual or a member of his or her immediate…, Threshold Amount, – An amount of compensation that the Conflicts Committee has determined to be substantial, which amount will be established annually by the Conflicts Committee., Vice Chancellor for Research, – The Vice Chancellor for Research at each campus, or where no such position exists, the Provost (or their designees)., II. Administration of Policy, Philosophy and Authority of Conflicts Committee, The University assumes that its faculty and staff act with the highest level of personal responsibility, integrity and commitment to the University. Nevertheless, complex situations can arise involving Conflicts of Interest that require specialized knowledge and a multi-disciplinary, problem-solving approach. Therefore, the Committee will have the authority on behalf of the University to review…, The Conflicts Committee, This Policy will be administered by a thirteen-member, University-wide Committee consisting of one member of the faculty at each campus appointed under procedures established by the campus; the Vice Chancellor for Research or his or her designee at each campus; the President or his or her designee; and two non-voting members appointed by the President from outside the University. The President…, III. Policy, Disclosure of Financial Interests, All Covered Individuals must disclose a Financial Interest to the Vice Chancellor for Research or his or her designee in situations in which the Financial Interest may present a Conflict of Interest involving the use of students, technology transfer activities or the outcome of research that is performed or directed by that Covered Individual with significant use of University funds, facilities…, Company-Sponsored Research Proposals, – If a Covered Individual intends to perform or direct Company-sponsored research at the University, and if the Covered Individual has a Financial Interest in that Company, or has received a Financial Interest from that Company, then the Financial Interest should be disclosed to the Vice Chancellor for Research and approved in accordance with this Policy before the Covered Individual submits to…, Company-Sponsored Research, – If a Covered Individual performs or directs Company-sponsored research at the University, and if the Covered Individual intends to receive or actually receives a Financial Interest in that Company or from that Company at any time (i) during the conduct of the research or (ii) within one year after cessation of the research, then the Financial Interest must be disclosed to the Vice Chancellor…, Government and Non-Profit Institution Grant Applications, – In general, if a Covered Individual intends to submit an application for research funding from a U.S. Government agency or a non-profit institution, then the Covered Individual must comply with any disclosure and approval procedures required by the agency or institution in connection with such application. For example, in order to comply with Public Health Service and National Science…, Government and Non-Profit Institution-Funded Research, – If a Covered Individual performs or directs research that is funded directly or indirectly by a U.S. Government agency or a non-profit institution, the Covered Individual must comply with any disclosure and approval procedures required by the agency or institution in connection with such funding. For example, in order to comply with Public Health Service and National Science Foundation…, Licensing to Certain Companies, – If a Company intends to obtain a license to University-owned intellectual property, directly or indirectly, and if the Covered Individual who developed, discovered, or created that intellectual property or who is involved in negotiating the license (i) becomes aware of such intention and (ii) has a Financial Interest in that Company, the Financial Interest must be immediately disclosed to the…, Involvement of Students, – Although involvement of students in the outside professional activities of faculty under certain circumstances may enrich the students' educational experience, such activities have the potential to create a Conflict of Interest when the faculty member has a role in supervising the student's research, classes, or graduate teaching work. Therefore, involvement of a student in the outside…, Changes to a Financial Interest, – All Covered Individuals must disclose significant changes in previously disclosed Financial Interests. A Financial Interest that becomes a Substantial Interest is always considered a significant change., Management of Conflicts, Covered Individuals are generally prohibited from having a Conflict of Interest involving a Financial Interest, unless the University has reviewed and approved both the activity and the Financial Interest that give rise to the Conflict. There are two different procedures for review and approval of these Conflicts of Interest, as set forth below. If a Conflict of Interest involves a Substantial…, Expedited Review and Approval of Conflicts, – If a Conflict of Interest does not involve a Substantial Interest, then the Conflict of Interest will ordinarily receive expedited review and approval. Under this expedited procedure, the Vice Chancellor for Research member of the Committee will review the disclosures submitted by Covered Individuals at his or her campus and either grant preliminary approval or recommend review by the full…, Full Review and Approval of Conflicts, – If a Conflict of Interest involves a Substantial Interest, the Vice Chancellor for Research member of the Committee will forward the disclosure to the Chair for inclusion on a Committee meeting agenda. The Chair will also include on the meeting agenda any other disclosures that have been selected by the Vice Chancellor for Research as appropriate for full review. The Conflicts Committee will…, Interim Measures, – The Conflicts Committee or its Chair, in consultation with the Vice Chancellor for Research of the campus, may impose any measures that it finds necessary or desirable to preserve the existing situation until a formal review is completed. Such measures may allow a Conflict of Interest to exist, with or without conditions, while a formal review is pending., Review of Conflicts, – The Conflicts Committee will formally review all conflicts disclosures that (i) involve a Substantial Interest, (ii) are recommended for full review by the Vice Chancellor for Research, or (iii) are selected by the Chair from the list of other disclosures for expedited review. In the case of a Conflict of Interest involving a Substantial Interest, the Conflicts Committee will ordinarily permit…, Disposition of Conflicts, – After completing the formal review, the Conflicts Committee may decide upon one or more of the following dispositions: Postpone consideration of the matter pending further information or investigation; Approve a Conflict of Interest because the circumstances require no action; Approve a Conflict of Interest with conditions, such as: Public disclosure of the Financial Interest in publications…, IV. Public Statements, A number of problems my be posed when statements are made by scientists about research before the research has been publicized in scholarly journals or symposia, when the scientist has a Financial Interest in a Company that stands to benefit from the research. In order to avoid any such occurrences at the University, all Covered Individuals who perform or direct research for a Company in which…, V. Appeals, A Covered Individual may appeal an initial decision of the Committee by requesting a rehearing of the matter. At the rehearing, the Covered Individual may personally appear before the Committee and shall have the right to be accompanied by counsel or a union representative. The Committee shall establish written procedures for the conduct of re-hearings. A Covered Individual may appeal an initial…, VI. Periodic Review of Policy, At least every three years following adoption of this Policy, the Conflicts Committee will conduct an evaluation of this Policy and, if necessary, formulate amendments for consideration by the President of the University.
Type: Book page
Doc. T96-039, Passed by the Board of Trustees on April 11, 1996 Under most circumstances, conflicts of interest involving individuals associated with the University are addressed by Chapter 268A of the Massachusetts General Laws, which governs the conduct of public officials and employees. However, pursuant to Massachusetts General Laws Ch. 75 §14A, in the area of intellectual property and technology transfer…, I. Definitions, As used in this Policy, the following words shall have the following meanings:, Chair, – The Chairperson of the Conflicts Committee, as described in detail below., Clinical Research, – Research involving human subjects., Company, – Any corporation, partnership, association, or other legal entity, excluding entities controlled by the United States government, the Commonwealth of Massachusetts, and the University. A Company shall include all affiliates and other associated entities., Conflict of Interest, – (i) An actual or potential conflict between the personal interests of a Covered Individual and the interests of the University or the public or (ii) the reasonable appearance of such a conflict to the public., Conflicts Committee, – Shall have the meaning set forth in Article III., Covered Individual, – Any individual associated with the University, including without limitation faculty, staff, and students., CVIP, – The University Office of Commercial Ventures and Intellectual Property., Director, – The Executive Director of the CVIP., Equity, – All ownership interests in a Company and all rights to obtain ownership interests in a Company, including without limitation common or preferred stock, warrants, options, and partnership units, and also including compensation arrangements based on equity performance (e.g., phantom stock). "Equity" does not include ownership interests that are held through publicly traded mutual funds., Non-Equity Compensation, – All compensation other than Equity that is provided by a Company or contractually promised by a Company, including without limitation salary, gifts, royalties, consulting fees, honoraria, goods, services, and travel expenses. "Non-Equity Compensation" does not include compensation that is provided by the University pursuant to (i) its Intellectual Property Policy or by another educational or…, Financial Interest, – With respect to any Company, (i) any Equity in such Company that is directly owned by, or is under the control of, a Covered Individual or a member of his or her immediate family and (ii) Non-Equity Compensation from such Company in an aggregate amount greater than $1,000 within the prior twelve-month period that is directly or indirectly received by or contractually promised to a Covered…, Substantial Interest, – Has either of the following meanings., Clinical Research, – In relation to Clinical Research that is performed or directed by a Covered Individual, "Substantial Interest" has the same meaning as "Financial Interest.", Non-Clinical Research, – In relation to research other than Clinical Research that is performed or directed by a Covered Individual, "Substantial Interest" means either (i) Equity that represents more than five percent (5%) of the total equity in a Company or has a total current value of more than $100,000 that is directly owned by, or is under the control of, such Covered Individual or a member of his or her immediate…, Threshold Amount, – An amount of compensation that the Conflicts Committee has determined to be substantial, which amount will be established annually by the Conflicts Committee., Vice Chancellor for Research, – The Vice Chancellor for Research at each campus, or where no such position exists, the Provost (or their designees)., II. Administration of Policy, Philosophy and Authority of Conflicts Committee, The University assumes that its faculty and staff act with the highest level of personal responsibility, integrity and commitment to the University. Nevertheless, complex situations can arise involving Conflicts of Interest that require specialized knowledge and a multi-disciplinary, problem-solving approach. Therefore, the Committee will have the authority on behalf of the University to review…, The Conflicts Committee, This Policy will be administered by a thirteen-member, University-wide Committee consisting of one member of the faculty at each campus appointed by the Chancellor; the Vice Chancellor for Research or his or her designee at each campus; the President or his or her designee; and two non-voting members appointed by the President from outside the University. The President shall annually select the…, III. Policy, Disclosure of Financial Interests, All Covered Individuals must disclose a Financial Interest to the Vice Chancellor for Research or his or her designee in situations in which the Financial Interest may present a Conflict of Interest involving the use of students, technology transfer activities or the outcome of research that is performed or directed by that Covered Individual with significant use of University funds, facilities…, Company-Sponsored Research Proposals, – If a Covered Individual intends to perform or direct Company-sponsored research at the University, and if the Covered Individual has a Financial Interest in that Company, or has received a Financial Interest from that Company, then the Financial Interest should be disclosed to the Vice Chancellor for Research and approved in accordance with this Policy before the Covered Individual submits to…, Company-Sponsored Research, – If a Covered Individual performs or directs Company-sponsored research at the University, and if the Covered Individual intends to receive or actually receives a Financial Interest in that Company or from that Company at any time (i) during the conduct of the research or (ii) within one year after cessation of the research, then the Financial Interest must be disclosed to the Vice Chancellor…, Government and Non-Profit Institution Grant Applications, – In general, if a Covered Individual intends to submit an application for research funding from a U.S. Government agency or a non-profit institution, then the Covered Individual must comply with any disclosure and approval procedures required by the agency or institution in connection with such application. For example, in order to comply with Public Health Service and National Science…, Government and Non-Profit Institution-Funded Research, – If a Covered Individual performs or directs research that is funded directly or indirectly by a U.S. Government agency or a non-profit institution, the Covered Individual must comply with any disclosure and approval procedures required by the agency or institution in connection with such funding. For example, in order to comply with Public Health Service and National Science Foundation…, Licensing to Certain Companies –, If a Company intends to obtain a license to University-owned intellectual property, directly or indirectly, and if the Covered Individual who developed, discovered, or created that intellectual property or who is involved in negotiating the license (i) becomes aware of such intention and (ii) has a Financial Interest in that Company, the Financial Interest must be immediately disclosed to the…, Involvement of Students, – Although involvement of students in the outside professional activities of faculty under certain circumstances may enrich the students' educational experience, such activities have the potential to create a Conflict of Interest when the faculty member has a role in supervising the student's research, classes, or graduate teaching work. Therefore, involvement of a student in the outside…, Changes to a Financial Interest, – All Covered Individuals must disclose significant changes in previously disclosed Financial Interests. A Financial Interest that becomes a Substantial Interest is always considered a significant change., Management of Conflicts, Covered Individuals are generally prohibited from having a Conflict of Interest involving a Financial Interest, unless the University has reviewed and approved both the activity and the Financial Interest that give rise to the Conflict. There are two different procedures for review and approval of these Conflicts of Interest, as set forth below. If a Conflict of Interest involves a Substantial…, Expedited Review and Approval of Conflicts, – If a Conflict of Interest does not involve a Substantial Interest, then the Conflict of Interest will ordinarily receive expedited review and approval. Under this expedited procedure, the Vice Chancellor for Research member of the Committee will review the disclosures submitted by Covered Individuals at his or her campus and either grant preliminary approval or recommend review by the full…, Full Review and Approval of Conflicts, – If a Conflict of Interest involves a Substantial Interest, the Vice Chancellor for Research member of the Committee will forward the disclosure to the Chair for inclusion on a Committee meeting agenda. The Chair will also include on the meeting agenda any other disclosures that have been selected by the Vice Chancellor for Research as appropriate for full review. The Conflicts Committee will…, Interim Measures, – The Conflicts Committee or its Chair, in consultation with the Vice Chancellor for Research of the campus, may impose any measures that it finds necessary or desirable to preserve the existing situation until a formal review is completed. Such measures may allow a Conflict of Interest to exist, with or without conditions, while a formal review is pending., Review of Conflicts, – The Conflicts Committee will formally review all conflicts disclosures that (i) involve a Substantial Interest, (ii) are recommended for full review by the Vice Chancellor for Research, or (iii) are selected by the Chair from the list of other disclosures for expedited review. In the case of a Conflict of Interest involving a Substantial Interest, the Conflicts Committee will ordinarily permit…, Disposition of Conflicts, – After completing the formal review, the Conflicts Committee may decide upon one or more of the following dispositions: postpone consideration of the matter pending further information or investigation; approve a Conflict of Interest because the circumstances require no action; approve a Conflict of Interest with conditions, such as public disclosure of the Financial Interest in publications…, IV. Public Statements, A number of problems may be posed when statements are made by scientists about research before the research has been publicized in scholarly journals or symposia, when the scientist has a Financial Interest in a Company that stands to benefit from the research. In order to avoid any such occurrences at the University, all Covered Individuals who perform or direct research for a Company in which…, V. Appeals, A Covered Individual may appeal an initial decision of the Committee by requesting a review of the decision by the President or his or her designee. At the President's discretion, such appeal may be a review of the documentary record of the decision or may include a meeting with the Covered Individual and member(s) of the Committee. The decision of the President shall be final., VI. Periodic Review Of Policy, At least every three years following adoption of this Policy, the Conflicts Committee will conduct an evaluation of this Policy and, if necessary formulate amendments for consideration by the President of the University.
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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…
Type: Book page
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
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.
Type: Basic page
Type: Basic page
Type: Basic page
