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Conflict of Interest: Difference between revisions
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Policy No.: '''8010'''<br /> | Policy No.: '''8010'''<br /> | ||
Effective Date: ''' | Effective Date: '''09/04/07'''<br /> | ||
Revised Date: '''07/ | Revised Date: '''07/26/18'''<br /> | ||
Reviewed Date: ''' | Reviewed Date: '''07/26/18''' | ||
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<big>'''Conflict of Interest Policy'''</big> | <big>'''Conflict of Interest Policy'''</big> | ||
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#"Financial Disclosure by Clinical Investigators" Food & Drug Administration regulations at 21 CFR Part 54 | #"Financial Disclosure by Clinical Investigators" Food & Drug Administration regulations at 21 CFR Part 54 | ||
#Nebraska Conflict of Interest Statute at Neb. Rev. Stat. §49-1493 et. seq. | #Nebraska Conflict of Interest Statute at Neb. Rev. Stat. §49-1493 et. seq. | ||
#Bylaws of the Board of Regents of the University of Nebraska Sections 3.10, 3. | #Bylaws of the Board of Regents of the University of Nebraska Sections 3.10, 3.4.5 and 3.8 | ||
#Board of Regents Conflict of Interest Policy, RP-3.2.8 | #Board of Regents Conflict of Interest Policy, RP-3.2.8 | ||
#Board of Regents Patent & Technology Policy, RP-4.4.2 | #Board of Regents Patent & Technology Policy, RP-4.4.2 | ||
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#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 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 | #'''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. | ||
#'''Report FCOI to PHS'''. When the COI committee has implemented a COI management plan for PHS-funded research, update the PHS e-Commons with the FCOI report provided by the COI committee. Provide initial, annual and revised FCOI reports, if applicable for both UNMC and its subrecipients. Revised FCOI reports shall be submitted within 60 days of identification for new Investigators added to a grant, or newly identified FCOIs for existing investigators. The FCOI report shall contain the following elements: | #'''Report FCOI to PHS'''. When the COI committee has implemented a COI management plan for PHS-funded research, update the PHS e-Commons with the FCOI report provided by the COI committee. Provide initial, annual and revised FCOI reports, if applicable for both UNMC and its subrecipients. Revised FCOI reports shall be submitted within 60 days of identification for new Investigators added to a grant, or newly identified FCOIs for existing investigators. The FCOI report shall contain the following elements: | ||
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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 electronic system may be accessed 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 electronic system may be accessed at: https://unmc.coi-smart.com. Individuals shall disclose all financial interests related to their University of Nebraska (institutional) responsibilities. | ||
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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*[[Research Conflict of Interest Procedures]] | *[[Research Conflict of Interest Procedures]] | ||
*UNMC Policy No. 1049, [[Outside Employment]] | *UNMC Policy No. 1049, [[Outside Employment]] | ||
*[https://net.unmc.edu/rss/ Application for | *[https://net.unmc.edu/rss/ 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/hipaa/policies/6045-exhibit-a-statement-of-understanding.pdf Statement of Understanding] Training Information document | |||
This page maintained by [mailto:dpanowic@unmc.edu dkp]. | This page maintained by [mailto:dpanowic@unmc.edu dkp]. | ||