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Conflict of Interest: Difference between revisions
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[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[Disclosing Foreign Support and International Activities]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]]<br /> | [[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[Disclosing Foreign Support and International Activities]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Whistleblower]] | [[Electronic Digital Signatures and Records]]<br /> | ||
<br /> | <br /> | ||
Policy No.: '''8010'''<br /> | Policy No.: '''8010'''<br /> | ||
Effective Date: '''09/04/07'''<br /> | Effective Date: '''09/04/07'''<br /> | ||
Revised Date: ''' | Revised Date: '''06/27/23 '''<br /> | ||
Reviewed Date: ''' | Reviewed Date: '''06/27/23''' | ||
<br /><br /> | <br /><br /> | ||
<big>'''Conflict of Interest Policy'''</big> | <big>'''Conflict of Interest Policy'''</big> | ||
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#If with a publicly traded entity, 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 the disclosure, when aggregated, exceeds $5,000; | #If with a publicly traded entity, 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 the disclosure, when aggregated, exceeds $5,000; | ||
#If with a non-publicly traded entity, the value of any remuneration received exceeds $5,000 or when a research Investigator or Immediate Family holds any equity interest; | #If with a non-publicly traded entity, the value of any remuneration received exceeds $5,000 or when a research Investigator or Immediate Family holds any equity interest; | ||
#Intellectual property rights and interests upon receipt of income related to such rights and interests, excluding income paid by the University of Nebraska | #Intellectual property rights and interests upon receipt of income related to such rights and interests, excluding income paid by the University of Nebraska; | ||
#For PHS-funded research investigators, includes reimbursed or sponsored travel, excluding 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 affiliated with an Institution of higher education. | #For PHS-funded research investigators, includes reimbursed or sponsored travel, excluding 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 affiliated with an Institution of higher education. | ||
==Conflict of Interest Management Roles and Responsibilities == | ==Conflict of Interest Management Roles and Responsibilities == | ||
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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 Vice Chancellor for Business, Finance and Business Development (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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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. | 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 == | ||
===Conflict of Interest Committee (COIC) Governance=== | |||
'''COI Committee Composition.''' The COI Committee shall have at least 16 members representing the following areas: <br /> | '''COI Committee Composition.''' The COI Committee shall have at least 16 members representing the following areas: <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 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. | |||
===Quorum=== | |||
A quorum is required for meetings to be conducted. More than half of the membership present will constitute a quorum. | |||
===Voting=== | |||
All committee members are eligible to vote. No regular motion shall pass unless a majority of the COI Committee members present vote in favor of the motion. | |||
===COIC Member Conflicts=== | |||
If a COIC member has a conflict of interest with a specific matter being discussed, the member shall declare that they have a potential conflict and shall not vote on the matter. Such conflicts may arise when: | |||
#the member is participating in the research under review; | #the member is participating in the research under review; | ||
#the member has a financial relationship with a research sponsor under review; or | #the member has a financial relationship with a research sponsor under review; or | ||
#the member has a personal relationship or conflict with the individual under review that could potentially cause the member to be perceived as less than objective in their review. | #the member has a personal relationship or conflict with the individual under review that could potentially cause the member to be perceived as less than objective in their review. | ||
'''Committee Review by Telephone/Electronically'''. While face-to-face and/or Zoom meetings will normally be held, committee review of potential conflicts may be conducted by telephone or electronically at the discretion of the COI Committee chair. | '''Committee Review by Telephone/Electronically'''. While face-to-face and/or Zoom meetings will normally be held, committee review of potential conflicts may be conducted by telephone or electronically at the discretion of the COI Committee chair. | ||
===Meeting Minutes=== | |||
The Associate Director Campus Compliance or their designee shall prepare meeting minutes and present them for approval at the next scheduled COI Committee meeting. | |||
== Additional Information == | == Additional Information == | ||
*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer] | *Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer] | ||
*Contact the [mailto: | *Contact the [mailto:annebarnes@unmc.edu Vice Chancellor for Business, Finance and Business Development] | ||
*[[Conflict_of_Interest_Procedures|Conflict of Interest Procedures]] | *Business [[Conflict_of_Interest_Procedures|Conflict of Interest Procedures]] | ||
*[[Research Conflict of Interest Procedures]] | *[[Research Conflict of Interest Procedures]] | ||
*UNMC Policy No. 1049, [[Outside Employment]] | *UNMC Policy No. 1049, [[Outside Employment]] | ||
*UNMC Policy No. 8015, [[Health Care Vendor Interactions]] | *UNMC Policy No. 8015, [[Health Care Vendor Interactions]] | ||
*[https:// | *[https://unmc.coi-smart.com Application for Authorization to Engage in Outside Professional Activity] | ||
*[https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire] | *[https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire] | ||
*UNMC [https://www.unmc.edu/academicaffairs/_documents/compliance/Statement_of_Understanding.pdf Statement of Understanding] Training Information document | *UNMC [https://www.unmc.edu/academicaffairs/_documents/compliance/Statement_of_Understanding.pdf Statement of Understanding] Training Information document | ||