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Research Conflict of Interest Procedures: Difference between revisions
Research Conflict of Interest Procedures (view source)
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[[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[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]] | [[International Research Policy]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | [[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[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]] | [[International Research Policy]] | [[Health Care Vendor Interactions]] | [[Credit Hour Definition]] | ||
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<big>Research Conflict of Interest Procedures - DRAFT</big> | <big>Research Conflict of Interest Procedures - DRAFT 7/26/18</big> | ||
== Introduction == | == Introduction == | ||
Potential research conflicts of interest arise in a variety of circumstances in the academic medical center setting. '''Examples''' include but are not limited to the following: | Potential research conflicts of interest arise in a variety of circumstances in the academic medical center setting. '''Examples''' include but are not limited to the following: | ||
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# Salary, royalties, or a commitment for future royalties or other remuneration received outside of the University of Nebraska system, Nebraska Medicine or University Dental Associates (UDA); | # Salary, royalties, or a commitment for future royalties or other remuneration received outside of the University of Nebraska system, Nebraska Medicine or University Dental Associates (UDA); | ||
# Other income or payments for services (e.g. consulting fees, | # Other income or payments for services (e.g. consulting fees, permitted speaking engagements or honoraria) except for | ||
## income from seminars, lectures or teaching engagements sponsored by public or nonprofit entities; and | |||
## income from service on advisory committees or review panels for public or nonprofit entities; | |||
# Intellectual property rights (e.g. patents, copyrights and royalties from such rights); | # Intellectual property rights (e.g. patents, copyrights and royalties from such rights); | ||
#Equity interests (e.g. stocks, stock options or other ownership interests, both direct and indirect, i.e. trusts, etc.) that when aggregated for the Covered Person and the Covered Person’s spouse, parent, spouse of parent, and dependent children, exceeds $500 in value as determined through reference to public prices or other reasonable measures of fair market value, or represents more than five percent (5%) ownership interest in a single entity. Financial interests in mutual funds or retirement accounts where investment decisions are not under your direct control are excluded. | #Equity interests (e.g. stocks, stock options or other ownership interests, both direct and indirect, i.e. trusts, etc.) that when aggregated for the Covered Person and the Covered Person’s spouse, parent, spouse of parent, and dependent children, exceeds $500 in value as determined through reference to public prices or other reasonable measures of fair market value, or represents more than five percent (5%) ownership interest in a single entity. Financial interests in mutual funds or retirement accounts where investment decisions are not under your direct control are excluded. | ||
'''Institutional Conflict of Interest” (“Institutional COI”)''' may occur when the University or a Covered Person in a senior administrative position has a financial interest in a commercial entity that itself has an interest in a university research project, including potential conflicts with equity/ownership interests or royalty arrangements. An example of a potential Institutional COI is a proposed research project funded in whole or in part by an entity in which UNMC, an affiliated corporation, or other entity created to promote and facilitate technology transfer at UNMC (i.e., UNeMed), owns an equity interest or a future right to own an equity interest, the fair market value of which is greater than $500 or represents more than five percent (5%) ownership interest. <br /> | '''Institutional Conflict of Interest” (“Institutional COI”)''' may occur when the University or a Covered Person in a senior administrative position has a financial interest in a commercial entity that itself has an interest in a university research project, including potential conflicts with equity/ownership interests or royalty arrangements. An '''example''' of a potential Institutional COI is a proposed research project funded in whole or in part by an entity in which UNMC, an affiliated corporation, or other entity created to promote and facilitate technology transfer at UNMC (i.e., UNeMed), owns an equity interest or a future right to own an equity interest, the fair market value of which is greater than $500 or represents more than five percent (5%) ownership interest. <br /> | ||
The following example would not normally be considered an Institutional COI: an equity, royalty or other interest held in a University of Nebraska endowment or similar account, which is segregated from the decision making processes of research activities. For example, a stock interest held in an account managed by a University of Nebraska Office of Business and Finance would not trigger a reporting requirement. | The following '''example''' would not normally be considered an Institutional COI: an equity, royalty or other interest held in a University of Nebraska endowment or similar account, which is segregated from the decision making processes of research activities. For example, a stock interest held in an account managed by a University of Nebraska Office of Business and Finance would not trigger a reporting requirement. | ||
== Conflict of Interest Officer/Conflict of Interest Committee == | == <sup>Conflict of Interest Officer/</sup>Conflict of Interest Committee == | ||
The | <small>The Vice Chancellor for Academic Affairs shall appoint a Conflict of Interest Officer (“COI Officer”) who shall be responsible for and is authorized to oversee and monitor implementation and compliance with these Procedures. The COI Officer shall also be responsible to provide guidance and interpretation to Covered Persons seeking to comply with these Procedures, and to carry out the duties associated with reporting conflicts of interest. | ||
</small> | |||
The | The Vice Chancellor for Academic Affairs shall appoint a Conflict of Interest Committee (“COI Committee”) comprised of faculty, research staff, academic administrators, business operations personnel, at least one member of the Institutional Review Board (“IRB”) and at least one community member to fulfill the duties outlined in these Procedures. The COI Committee shall be a standing committee that operates in accordance with the guidelines set forth in UNMC Policy No. 8010, [[Conflict of Interest]], and shall be chaired by a senior faculty member appointed by the Chancellor. | ||
== Reporting Potential Conflicts == | == Reporting Potential Conflicts == | ||
===Conflicts of Interest=== | ===Conflicts of Interest=== | ||
# '''Initial disclosure.''' All faculty members, directors, administrators and department heads (or equivalents) shall complete | # '''Initial disclosure.''' All faculty members, directors, administrators and department heads (or equivalents) shall complete an [https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire] within 30 days of initial appointment/hire. The unit Personnel Action Form (PAF) Coordinators are responsible for ensuring forms are completed in a timely manner. | ||
# '''New potential conflicts.''' Covered Persons who propose to engage in an activity that would create a situation defined as a COI shall complete | # '''New potential conflicts.''' Covered Persons who propose to engage in an activity that would create a situation defined as a COI shall complete an [https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire] and submit it to the COI Officer. | ||
# '''Grant Applications and Sponsored Programs Agreements.''' Covered Persons who are principal investigators on grant applications or who submit a sponsored program agreement shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration as a part of the application process. All other Responsible Persons (individuals who are responsible for the conduct, design, or reporting of the research, whether or not salaries are requested) shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration at the time the grant is awarded. Sponsored Programs Administration shall report the existence of a COI and the management plan to federal grant administering agencies when required by federal regulation or the terms of the research grant. | # '''Grant Applications and Sponsored Programs Agreements.''' Covered Persons who are principal investigators on grant applications or who submit a sponsored program agreement shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration as a part of the application process. All other Responsible Persons (individuals who are responsible for the conduct, design, or reporting of the research, whether or not salaries are requested) shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration at the time the grant is awarded. Sponsored Programs Administration shall report the existence of a COI and the management plan to federal grant administering agencies when required by federal regulation or the terms of the research grant. | ||
# '''IRB Applications.''' Covered Persons listed in Section I of the IRB application shall submit a conflict of interest disclosure form as a part of the application process to the Office of Regulatory Affairs pursuant to UNMC Human Research Protection Program Policy 1.22. | # '''IRB Applications.''' Covered Persons listed in Section I of the IRB application shall submit a conflict of interest disclosure form as a part of the application process to the Office of Regulatory Affairs pursuant to UNMC Human Research Protection Program Policy 1.22. | ||