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Conflict of Interest: Difference between revisions
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Policy No.: '''8010'''<br /> | Policy No.: '''8010'''<br /> | ||
Effective Date: '''09/04/07'''<br /> | Effective Date: '''09/04/07'''<br /> | ||
Revised Date: ''' | Revised Date: '''08/26/21 '''<br /> | ||
Reviewed Date: ''' | Reviewed Date: '''08/26/21''' | ||
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<big>'''Conflict of Interest Policy'''</big> | <big>'''Conflict of Interest Policy'''</big> | ||
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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 /> | '''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 /> | ||
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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; | ||
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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 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: | ||
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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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'''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 | '''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 Vice Chancellor of Academic Affairs or their designee. The Chancellor or their designee shall appoint a faculty chair of the COI Committee. The Vice Chancellor of Academic Affairs or their designee shall select the community member. The Chancellor or their designee can appoint additional voting and non-voting members. <br /> | ||
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'''Quorum.''' A quorum is required for meetings to be conducted. More than half of the membership present will constitute a quorum.<br /> | '''Quorum.''' A quorum is required for meetings to be conducted. More than half of the membership present will constitute a quorum.<br /> | ||
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'''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.<br /> | '''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.<br /> | ||
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'''COIC Member Conflicts.''' If a COIC member has a conflict of interest with a specific matter being discussed, the member shall declare that | '''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.<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 /> | ||
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