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Conflict of Interest: Difference between revisions
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#Ensure UNMC policy meets Board of Regents policy and state and federal regulatory requirements; | #Ensure UNMC policy meets Board of Regents policy and state and federal regulatory requirements; | ||
#Implement annual disclosure requirements for Covered Persons and monitor to ensure compliance. The UNMC electronic Annual Disclosure of Financial Interest form is incorporated into this policy by reference. The Annual Disclosure of Interest and Application for Authorization to Engage in Outside Professional Activity forms are located at: https://unmc.coi-smart.com . | #Implement annual disclosure requirements for Covered Persons and monitor to ensure compliance. The UNMC electronic Annual Disclosure of Financial Interest form is incorporated into this policy by reference. The Annual Disclosure of Interest and Application for Authorization to Engage in Outside Professional Activity forms are located at: https://unmc.coi-smart.com . | ||
#Coordinate identified conflict of interest matters with Sponsored Programs Administration, UNeMED, the Institutional Review Board (IRB), the Institutional Animal Care and Use (IACUC) committee, the | #Coordinate identified conflict of interest matters with Sponsored Programs Administration, UNeMED, the Institutional Review Board (IRB), the Institutional Animal Care and Use (IACUC) committee, the Assistant Vice Chancellor, Business and Finance (for business COI), and the Continuing Medical and Nursing Education offices as relevant. Whenever a potential COI involving activities with another University of Nebraska campus or university affiliated entity is disclosed or identified, notify the other campus or university affiliated entity COI contact and collaboratively review and manage the potential COI. | ||
#'''COI Education.''' Provide COI education to Covered Persons at time of hire, and every four (4) years thereafter, and immediate re-education when there are policy changes or when investigators fail to comply with the COI policy. For investigators conducting Public Health Service (PHS) sponsored research, education shall be completed prior to the expenditure of any PHS funds. | #'''COI Education.''' Provide COI education to Covered Persons at time of hire, and every four (4) years thereafter, and immediate re-education when there are policy changes or when investigators fail to comply with the COI policy. For investigators conducting Public Health Service (PHS) sponsored research, education shall be completed prior to the expenditure of any PHS funds. | ||
#When Covered Persons have significant financial interests related to their institutional responsibilities, present information to the COI committee for potential COI management plan creation. | #When Covered Persons have significant financial interests related to their institutional responsibilities, present information to the COI committee for potential COI management plan creation. | ||
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#'''Education.''' Covered Persons shall complete education on Board of Regents COI policy, UNMC COI policy, and PHS COI regulations, and their disclosure responsibilities prior to initially completing the Annual UNMC Disclosure of Financial Interest, and every four (4) years thereafter. Covered Persons shall not spend any PHS research funds until education has been completed. | #'''Education.''' Covered Persons shall complete education on Board of Regents COI policy, UNMC COI policy, and PHS COI regulations, and their disclosure responsibilities prior to initially completing the Annual UNMC Disclosure of Financial Interest, and every four (4) years thereafter. Covered Persons shall not spend any PHS research funds until education has been completed. | ||
#'''Disclosure of Financial Interest.''' Covered Persons who are research Investigators shall disclose the nature of all financial interests related to their research (e.g. consulting advisory board, intellectual property) in all publications and presentations and to all UNMC personnel involved in the research project, including students. In human subjects research, Investigators shall disclose their financial interests related to the research in the informed consent, as required by UNMC HRPP Policy 1.22. | #'''Disclosure of Financial Interest.''' Covered Persons who are research Investigators shall disclose the nature of all financial interests related to their research (e.g. consulting advisory board, intellectual property) in all publications and presentations and to all UNMC personnel involved in the research project, including students. In human subjects research, Investigators shall disclose their financial interests related to the research in the informed consent, as required by UNMC HRPP Policy 1.22. | ||
#'''Appeal Rights.''' Covered Persons may appeal adverse decisions made under this policy to the Vice Chancellor for Academic Affairs. The appeal shall be in writing and contain a description of the adverse decision, justification for why the decision should be changed, and the change desired. The appeal request shall be submitted to the COI Officer. The VCAA shall respond in writing to the Covered Person with their decision within thirty (30) days of receipt. The VCAA's decision is final. | #'''Appeal Rights.''' Covered Persons may appeal adverse decisions made under this policy to the Senior Vice Chancellor for Academic Affairs. The appeal shall be in writing and contain a description of the adverse decision, justification for why the decision should be changed, and the change desired. The appeal request shall be submitted to the COI Officer. The VCAA shall respond in writing to the Covered Person with their decision within thirty (30) days of receipt. The VCAA's decision is final. | ||
===COI Committee=== | ===COI Committee=== | ||
The UNMC COI Committee composition and operating procedures are contained in Appendix A. The COI Officer shall be a member of the COI committee and shall provide administrative support for the committee. The COI committee shall: | The UNMC COI Committee composition and operating procedures are contained in Appendix A. The COI Officer shall be a member of the COI committee and shall provide administrative support for the committee. The COI committee shall: | ||
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#Create COI Management Plans for Financial Conflicts of Interest. | #Create COI Management Plans for Financial Conflicts of Interest. | ||
#Conduct retrospective reviews of newly identified Significant Financial Interests as described in Conduct Retrospective Review above. | #Conduct retrospective reviews of newly identified Significant Financial Interests as described in Conduct Retrospective Review above. | ||
#Review COI Policy violations and recommend sanctions, if appropriate, to the Vice Chancellor Academic Affairs and to the appropriate UNMC administrator responsible for supervision of the individual(s) violating the policy. | #Review COI Policy violations and recommend sanctions, if appropriate, to the Senior Vice Chancellor for Academic Affairs and to the appropriate UNMC administrator responsible for supervision of the individual(s) violating the policy. | ||
===Sponsored Programs Administration=== | ===Sponsored Programs Administration=== | ||
Sponsored Programs Administration shall: | Sponsored Programs Administration shall: | ||
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Upon request, the COI Officer shall make available to the public information concerning identified FCOIs held by Senior/Key personnel receiving PHS research funding as required by PHS regulations. Information shall be provided in writing within five (5) business days of the request. The COI officer shall coordinate these public requests with the University of Nebraska Records Management Officer. All other financial interest disclosure information and conflict of interest determinations shall remain confidential and may be withheld from the public as permitted under Neb. Rev. Stat. 84-712.05, "Records which may be withheld from the public; enumerated." | Upon request, the COI Officer shall make available to the public information concerning identified FCOIs held by Senior/Key personnel receiving PHS research funding as required by PHS regulations. Information shall be provided in writing within five (5) business days of the request. The COI officer shall coordinate these public requests with the University of Nebraska Records Management Officer. All other financial interest disclosure information and conflict of interest determinations shall remain confidential and may be withheld from the public as permitted under Neb. Rev. Stat. 84-712.05, "Records which may be withheld from the public; enumerated." | ||
==Sanctions == | ==Sanctions == | ||
Covered Persons who violate this policy may receive corrective action under UNMC Policy No. 1098, [[Corrective/Disciplinary Action|Corrective and Disciplinary Action Policy]]. The COI Committee may also recommend other corrective action such as additional training, or for serious violations, recommend that research funding be withheld or recommend other appropriate sanctions to maintain the integrity of the research. The Vice Chancellor | Covered Persons who violate this policy may receive corrective action under UNMC Policy No. 1098, [[Corrective/Disciplinary Action|Corrective and Disciplinary Action Policy]]. The COI Committee may also recommend other corrective action such as additional training, or for serious violations, recommend that research funding be withheld or recommend other appropriate sanctions to maintain the integrity of the research. The Senior Vice Chancellor for Academic Affairs shall review and approve all proposed sanctions. The sanctions shall be coordinated with the respective Dean, Director or Vice Chancellor for enforcement. | ||
== Policy 8010 Appendix A == | == Policy 8010 Appendix A == | ||
<big>Conflict of Interest Committee (COIC) Governance</big><br /> | <big>Conflict of Interest Committee (COIC) Governance</big><br /> | ||
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'''Membership Term.''' COI Committee members shall serve for a term of three years, which may be automatically renewed upon mutual agreement of the member and the Chancellor or their designee. New members shall be nominated by the department/unit and approved by the Vice Chancellor | '''Membership Term.''' COI Committee members shall serve for a term of three years, which may be automatically renewed upon mutual agreement of the member and the Chancellor or their designee. New members shall be nominated by the department/unit and approved by the Senior Vice Chancellor for Academic Affairs or their designee. The Chancellor or their designee shall appoint a faculty chair of the COI Committee. The Senior Vice Chancellor for Academic Affairs or their designee shall select the community member. The Chancellor or their designee can appoint additional voting and non-voting members. <br /> | ||
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'''Quorum.''' A quorum is required for meetings to be conducted. More than half of the membership present will constitute a quorum.<br /> | '''Quorum.''' A quorum is required for meetings to be conducted. More than half of the membership present will constitute a quorum.<br /> | ||