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<br /> | <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]]<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: '''07/09/24'''<br /><br /> | ||
<br /><br /> | |||
<big>'''Conflict of Interest Policy'''</big> | <big>'''Conflict of Interest Policy'''</big> | ||
== Basis for Policy == | == Basis for Policy == | ||
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#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://nebraska.edu/-/media/unca/docs/offices-and-policies/policies/executive-memorandum/disclosure-of-conflicts-of-interest-and-conflicts-of-commitment.pdf Executive Memorandum No. 36, Disclosure of Conflicts of Interest and Conflicts of Commitment] | |||
== Policy == | == Policy == | ||
Potential conflicts of interest arise in a variety of circumstances in the academic health sciences center environment when an individual's private financial interests either conflict with or create the appearance of conflicting with UNMC's public interests. This policy applies to potential conflict of interest arising in any UNMC activity, including but not limited to research, teaching, patient care, outreach to underserved populations and the associated business activities in support of them. Covered Persons shall disclose all financial interests related to their University of Nebraska responsibilities so that an analysis of potential conflict of interest may be conducted. When a conflict of interest is identified, the conflict will either be managed or eliminated to reduce the appearance of bias and maintain responsible stewardship of public resources. This policy shall be publicly posted in the UNMC [[Policies and Procedures]] manual on the UNMC internet site. | Potential conflicts of interest arise in a variety of circumstances in the academic health sciences center environment when an individual's private financial interests either conflict with or create the appearance of conflicting with UNMC's public interests. This policy applies to potential conflict of interest arising in any UNMC activity, including but not limited to research, teaching, patient care, outreach to underserved populations and the associated business activities in support of them. Covered Persons shall disclose all financial interests related to their University of Nebraska responsibilities so that an analysis of potential conflict of interest may be conducted. When a conflict of interest is identified, the conflict will either be managed or eliminated to reduce the appearance of bias and maintain responsible stewardship of public resources. This policy shall be publicly posted in the UNMC [[Policies and Procedures]] manual on the UNMC internet site. | ||
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#Sponsored research investigators who participate in sponsored research; and non-sponsored research investigators participating in human subjects or animal subjects research. | #Sponsored research investigators who participate in sponsored research; and non-sponsored research investigators participating in human subjects or animal subjects research. | ||
'''Investigator''' under PHS regulations shall mean the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research which may include graduate students, post-docs, residents, collaborators or consultants. | '''Investigator''' under PHS regulations shall mean the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research which may include graduate students, post-docs, residents, collaborators or consultants. | ||
'''Conflict of Interest (COI)''' under Regents Policy 3.2.8 shall mean situations when a Covered Person's direct or indirect personal financial interest, (whether or not the value is readily ascertainable) may compromise, or have the appearance of compromising, the Covered Person's professional judgment or behavior in carrying out | '''Conflict of Interest (COI)''' under Regents Policy 3.2.8 shall mean situations when a Covered Person's direct or indirect personal financial interest, (whether or not the value is readily ascertainable) may compromise, or have the appearance of compromising, the Covered Person's professional judgment or behavior in carrying out their obligations to the University of Nebraska. This includes indirect personal financial interests of a Covered Person that may be obtained through third parties such as a Covered Person's immediate family, business relationships, fiduciary relationships, or investments.<br /> | ||
'''De minimus''' means any remuneration received as payment for services and/or equity interests of $499 or less is not required to be disclosed. Any remuneration received for services and/or equity interests of $500 or greater is required to be disclosed. <br /> | |||
'''Equity''' includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. <br /> | '''Equity''' includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. <br /> | ||
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'''Senior/Key Personnel''' means the Project Director (PD)/Principal Investigator (PI) and any other person identified as senior/key personnel in the UNMC grant application, progress report, or any other report submitted to the PHS by UNMC. <br /> | '''Senior/Key Personnel''' means the Project Director (PD)/Principal Investigator (PI) and any other person identified as senior/key personnel in the UNMC grant application, progress report, or any other report submitted to the PHS by UNMC. <br /> | ||
'''Significant Financial Interest''' means a financial interest of the Investigator or | '''Significant Financial Interest''' means a financial interest of the Investigator or their Immediate Family Member that reasonably appears to be related to the Investigator's Institutional Responsibilities, and: | ||
#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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#'''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 | #'''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: | ||
#Provide oversight over the UNMC COI program, advise the COI officer, and provide guidance on UNMC COI policy matters. | #Provide oversight over the UNMC COI program, advise the COI officer, and provide guidance on UNMC COI policy matters. | ||
#Review Significant Financial Interests. Review Disclosures of Financial Interest in the amount of $5,000 and above for research Investigators and determine if these Significant Financial Interests are related to the research, and, if so related, whether the Significant Financial Interest constitutes a Financial Conflict of Interest. A Significant Financial Interest is a Financial Conflict of Interest if it could directly and significantly affect the design, conduct , or reporting of research, including PHS-funded research. | #Review Significant Financial Interests. Review Disclosures of Financial Interest in the amount of $5,000 and above for research Investigators and determine if these Significant Financial Interests are related to the research, and, if so related, whether the Significant Financial Interest constitutes a Financial Conflict of Interest. A Significant Financial Interest is a Financial Conflict of Interest if it could directly and significantly affect the design, conduct, or reporting of research, including PHS-funded research. | ||
#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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The Vice Chancellor for Business, Finance and Business Development 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 /> | The Vice Chancellor for Business, Finance and Business Development 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 | 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 they have a real or apparent conflict of interest. Such a conflict of interest would arise when the employee, officer, or agent, any member of their immediate family, their 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 1.22. The IRB shall review and approve proposed COI management plans as described in HRPP Policy 1.22. | 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. | ||
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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 == | ||
===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 /> | ||
{| class="wikitable" border="1" | {| class="wikitable" border="1" | ||
|- | |||
| Associate VC, Academic Affairs | |||
| Compliance Officer | |||
|- | |||
| College of Allied Health Professions | |||
| Sponsored Programs Administration | |||
|- | |- | ||
| College of Medicine | | College of Medicine | ||
| | | Associate General Counsel | ||
|- | |- | ||
| College of Dentistry | | College of Dentistry | ||
| | | Business and Finance | ||
|- | |- | ||
| College of Pharmacy | | College of Pharmacy | ||
| | | Vice Chancellor for Research | ||
|- | |- | ||
| College of Nursing | | College of Nursing | ||
| | | Research Compliance (Institutional Review Board) | ||
|- | |- | ||
| College of Public Health | | College of Public Health | ||
| | | Continuing Education | ||
|- | |- | ||
| Eppley Cancer | | Eppley Cancer Center | ||
| | | Community Member | ||
|- | |- | ||
|} | |} | ||
===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 | #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 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/ | *UNMC [https://www.unmc.edu/academicaffairs/_documents/compliance/Statement_of_Understanding.pdf Statement of Understanding] Training Information document | ||
*[https://nebraska.edu/-/media/unca/docs/offices-and-policies/policies/executive-memorandum/disclosure-of-conflicts-of-interest-and-conflicts-of-commitment.pdf Executive Memorandum No. 36, Disclosure of Conflicts of Interest and Conflicts of Commitment] | |||
This page maintained by [mailto:dpanowic@unmc.edu dkp]. | This page maintained by [mailto:dpanowic@unmc.edu dkp]. |