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Conflict of Interest: Difference between revisions
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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 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 (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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##Other information as needed. | ##Other information as needed. | ||
#'''Conduct retrospective review.''' If UNMC identifies a significant financial interest that was not disclosed by a research Investigator in a timely manner, or was not reviewed by UNMC, the COI officer shall, within sixty (60) days: review the significant financial interest and determine whether it is related to PHS-funded research. The COI committee shall determine whether a financial conflict of interest exists, and, if so, implement an interim COI management plan. Within 120 days, the COI committee shall complete a documented retrospective review of the research Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research conducted during the period of non-compliance was biased in the design, conduct or reporting of such research. The documented review shall contain all of the elements required by the PHS regulations. | #'''Conduct retrospective review.''' If UNMC identifies a significant financial interest that was not disclosed by a research Investigator in a timely manner, or was not reviewed by UNMC, the COI officer shall, within sixty (60) days: review the significant financial interest and determine whether it is related to PHS-funded research. The COI committee shall determine whether a financial conflict of interest exists, and, if so, implement an interim COI management plan. Within 120 days, the COI committee shall complete a documented retrospective review of the research Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research conducted during the period of non-compliance was biased in the design, conduct or reporting of such research. The documented review shall contain all of the elements required by the PHS regulations. | ||
#'''Reporting Bias & Mitigation Report.''' If bias is found with the design, conduct or reporting of PHS-funded research, the COI Officer shall notify the PHS awarding component promptly and submit a Mitigation Report containing the retrospective review information and a description of the impact of the bias on the research project and UNMC's plan of | #'''Reporting Bias & Mitigation Report.''' If bias is found with the design, conduct or reporting of PHS-funded research, the COI Officer shall notify the PHS awarding component promptly and submit a Mitigation Report containing the retrospective review information and a description of the impact of the bias on the research project and UNMC's plan of action taken to eliminate or mitigate the effect of the bias. | ||
#If the research is clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, the COI committee shall require the Investigator to disclose the FCOI in each public presentation of the results of the research, and request an addendum to previously published presentations, in addition to any applicable disclosure listed below in Disclosure of Financial Interest. | #If the research is clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, the COI committee shall require the Investigator to disclose the FCOI in each public presentation of the results of the research, and request an addendum to previously published presentations, in addition to any applicable disclosure listed below in Disclosure of Financial Interest. | ||
#'''Public Disclosure.''' Disclose Financial Conflicts of Interest (FCOI) of senior/key personnel involved in Public Health Service funded research only as determined by the COI Committee in response to public requests within five (5) business days of the request as required by PHS regulations. These requests shall be coordinated with the University of Nebraska Records Management Officer. | #'''Public Disclosure.''' Disclose Financial Conflicts of Interest (FCOI) of senior/key personnel involved in Public Health Service funded research only as determined by the COI Committee in response to public requests within five (5) business days of the request as required by PHS regulations. These requests shall be coordinated with the University of Nebraska Records Management Officer. | ||
#'''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 | #'''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. | |||
#'''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. | ||
#'''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 | #'''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 his/her 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 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 his/her decision within thirty (30) days of receipt. The VCAA's decision is final. | ||
===COI Committee.=== | ===COI Committee.=== | ||
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===Sponsored Programs Administration=== | ===Sponsored Programs Administration=== | ||
Sponsored Programs Administration shall: | Sponsored Programs Administration shall: | ||
#Notify all research Investigators submitting sponsored grant/contract proposals to review their Annual Disclosure of Financial Interest form and update the information as needed | #Notify all research Investigators submitting sponsored grant/contract proposals to review their Annual Disclosure of Financial Interest form and update the information as needed. | ||
#Coordinate with the COI Officer when Investigators disclose significant financial interests related to the sponsored project to determine if a COI management plan is required. | #Coordinate with the COI Officer when Investigators disclose significant financial interests related to the sponsored project to determine if a COI management plan is required. | ||
'''Subrecipients.''' Include provisions in PHS-funded subrecipient agreements that: | '''Subrecipients.''' Include provisions in PHS-funded subrecipient agreements that: | ||
#the subrecipient certifies that its FCOI policy complies with PHS regulations or | #the subrecipient certifies that its FCOI policy complies with PHS regulations or that the subrecipient will follow the UNMC COI policy; and | ||
#the subrecipient shall report identified FCOIs for its Investigators in a timely manner so UNMC can report identified FCOIs to the PHS in the time frames in '''Report FCOI to PHS''' and '''Conduct retrospective review''' above. | #the subrecipient shall report identified FCOIs for its Investigators in a timely manner so UNMC can report identified FCOIs to the PHS in the time frames in '''Report FCOI to PHS''' and '''Conduct retrospective review''' above. | ||
=== | ===Assistant Vice Chancellor, Business and Finance=== | ||
The | The Assistant Vice Chancellor for Business and Finance shall manage business conflict of interest by reviewing all Annual Disclosure of Financial Interest questionnaires completed by Covered Persons with contract signature authority under Executive Memorandum 13 and 14; Covered Persons with purchasing authority; Covered Persons who identify family member(s) with a financial interest with the University of Nebraska; and any other potential business-related financial interest identified by the COI Officer through the annual COI disclosure process or by any other person at UNMC. Business COI management plans shall be created to minimize the appearance of bias in decision-making and ensure state and federal regulations and University of Nebraska business-related policies are followed. Business COI management plans shall be reported through the UNMC COI committee and reported on the Annual COI report to the Board of Regents Audit committee. <br /> | ||
No employee, officer, or agent may participate in the selection, award, or administration of a contract supported by a Federal award or non-federal entity if he or she has a real or apparent conflict of interest. Such a conflict of interest would arise when the employee, officer, or agent, any member of his or her immediate family, his or her partner, or an organization which employs or is about to employ any of the parties indicated herein, has a financial or other interest in or a tangible personal benefit from a firm considered for a contract. | |||
===Institutional Review Board (IRB)=== | ===Institutional Review Board (IRB)=== | ||
The IRB shall require all Covered Persons listed on the IRB application who have a financial interest to update their Annual Disclosure of Financial Interest form pursuant to UNMC HRPP Policy | The IRB shall require all Covered Persons listed on the IRB application who have a financial interest to update their Annual Disclosure of Financial Interest form pursuant to UNMC HRPP Policy 1.22. The IRB shall review and approve proposed COI management plans as described in HRPP Policy 1.22. | ||
===UNeMED=== | ===UNeMED=== | ||
The President of UNeMED or designee shall coordinate with the COI officer on UNeMED activities where it appears that a Covered Person's or UNMC's financial interest may be a potential individual or institutional conflict of interest, including intellectual property interests and equity interests involving technology transfer companies. | The President of UNeMED or designee shall coordinate with the COI officer on UNeMED activities where it appears that a Covered Person's or UNMC's financial interest may be a potential individual or institutional conflict of interest, including intellectual property interests and equity interests involving technology transfer companies. | ||
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== 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 /> | ||
'''COI Committee Composition.''' The COI Committee shall have at least 16 members representing the following areas: </ | |||
'''COI Committee Composition.''' The COI Committee shall have at least 16 members representing the following areas: <br /> | |||
{| class="wikitable" border="1" | {| class="wikitable" border="1" | ||
|- | |- | ||
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|- | |- | ||
| Eppley Cancer Institute | | Eppley Cancer Institute | ||
| Associate General Counsel | | Associate General Counsel | ||
|- | |- | ||
| Munroe Meyer Institute | | Munroe Meyer Institute | ||
| Center for Continuing Medical Education | | Center for Continuing Medical Education | ||
|- | |- | ||
| Vice Chancellor for Academic Affairs | | Senior Vice Chancellor for Academic Affairs | ||
| Community Member | | College of Allied Health Professions | ||
|- | |||
|Community Member | |||
| | |||
|} | |} | ||
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'''Committee Review by Telephone/Electronically'''. While face-to-face 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.<br /> | '''Committee Review by Telephone/Electronically'''. While face-to-face 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.<br /> | ||
<br /> | <br /> | ||
'''Meeting Minutes.''' The | '''Meeting Minutes.''' The Compliance Manager 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:wlawlor@unmc.edu Assistant 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] | ||