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Conflict of Interest: Difference between revisions
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The UNMC Conflict of Interest Officer shall be responsible for implementing the UNMC COI management program. The COI management program shall also include review and approval of the "Application for Authorization to Engage in Outside Professional Activity" forms as delegated by the Chancellor with associated management of conflict of commitment under Regents Policy 3.8. and UNMC Policy 1049, [[Outside Employment]]. The COI Officer shall: | The UNMC Conflict of Interest Officer shall be responsible for implementing the UNMC COI management program. The COI management program shall also include review and approval of the "Application for Authorization to Engage in Outside Professional Activity" forms as delegated by the Chancellor with associated management of conflict of commitment under Regents Policy 3.8. and UNMC Policy 1049, [[Outside Employment]]. The COI Officer shall: | ||
#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: | #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 Associate 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. | #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 Associate 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 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 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. | ||
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#'''Board of Regents Annual Report.''' Submit the annual Conflict of Interest and Outside Activities report to the University of Nebraska Director of Internal Audit and Advisory Services for review by the Board of Regents Audit Committee. | #'''Board of Regents Annual Report.''' Submit the annual Conflict of Interest and Outside Activities report to the University of Nebraska Director of Internal Audit and Advisory Services for review by the Board of Regents Audit Committee. | ||
===Covered Persons=== | ===Covered Persons=== | ||
#'''Annual Disclosure of Financial Interest.''' Individuals covered under this COI policy shall complete a UNMC Annual Disclosure of Financial Interest Questionnaire through the UNMC electronic e-Disclosure system annually. Covered Persons shall receive an e-mail notification from the Compliance Department to complete the form. The UNMC Disclosure of Financial Interest form contains all elements required under Board of Regents policy and federal regulations (including PHS regulations) and is incorporated into this policy by reference. The e-Disclosure system may be accessed through the Research Support System (RSS) website at: | #'''Annual Disclosure of Financial Interest.''' Individuals covered under this COI policy shall complete a UNMC Annual Disclosure of Financial Interest Questionnaire through the UNMC electronic e-Disclosure system annually. Covered Persons shall receive an e-mail notification from the Compliance Department to complete the form. The UNMC Disclosure of Financial Interest form contains all elements required under Board of Regents policy and federal regulations (including PHS regulations) and is incorporated into this policy by reference. The e-Disclosure system may be accessed through the Research Support System (RSS) website at: https://unmc.coi-smart.com . Individuals shall disclose all financial interests related to their University of Nebraska (institutional) responsibilities. | ||
#'''Research Investigators''' shall review and update their Annual Disclosure of Financial Interest when sponsored grants and contracts are submitted, including PHS-funded research. Investigators shall update their Annual Disclosure of Financial Interest form within thirty (30) days of discovering or acquiring a Significant Financial Interest and on an annual basis thereafter during the period of the award. | #'''Research Investigators''' shall review and update their Annual Disclosure of Financial Interest when sponsored grants and contracts are submitted, including PHS-funded research. Investigators shall update their Annual Disclosure of Financial Interest form within thirty (30) days of discovering or acquiring a Significant Financial Interest and on an annual basis thereafter during the period of the award. | ||
#'''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. | ||
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#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 Vice Chancellor 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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==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 of 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 Vice Chancellor of 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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'''Meeting Minutes.''' The COI Coordinator chair shall prepare meeting minutes and present them for approval at the next scheduled COI Committee meeting. | '''Meeting Minutes.''' The COI Coordinator chair shall prepare meeting minutes and present them for approval at the next scheduled COI Committee meeting. | ||
== Additional Information == | == Additional Information == | ||
Contact the [mailto:swrobel@unmc.edu Chief Compliance Officer] | *Contact the [mailto:swrobel@unmc.edu Chief Compliance Officer] | ||
Contact the [mailto:dthomas@unmc.edu Associate Vice Chancellor for Business and Finance] | *Contact the [mailto:dthomas@unmc.edu Associate Vice Chancellor for Business and Finance] | ||
[[Conflict_of_Interest_Procedures|Conflict of Interest Procedures]] | *[[Conflict_of_Interest_Procedures|Conflict of Interest Procedures]] | ||
[http://webmedia.unmc.edu/policy/8010-1.doc Appendix 1 - Disclosure of Potential Business Conflict of Interest] | *[http://webmedia.unmc.edu/policy/8010-1.doc Appendix 1 - Disclosure of Potential Business Conflict of Interest] | ||
[[Research Conflict of Interest Procedures]] | *[[Research Conflict of Interest Procedures]] | ||
[[Outside Employment]] | *UNMC Policy No. 1049, [[Outside Employment]] | ||
[http://www.unmc.edu/academicaffairs/docs/COI-SMART_Quick_Reference_Card_Aug_2012.pdf Application for Permission to Engage in Professional Activity Outside the University] | *[http://www.unmc.edu/academicaffairs/docs/COI-SMART_Quick_Reference_Card_Aug_2012.pdf Application for Permission to Engage in Professional Activity Outside the University] | ||
[http://webmedia.unmc.edu/policy/COIForm.doc Disclosure of Potential Conflict of Interest Form] | *[http://webmedia.unmc.edu/policy/COIForm.doc Disclosure of Potential Conflict of Interest Form] | ||
*[https://unmc.coi-smart.com https://unmc.coi-smart.com] | |||
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This page maintained by [mailto:dpanowic@unmc.edu dkp]. | This page maintained by [mailto:dpanowic@unmc.edu dkp]. | ||