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Conflict of Interest: Difference between revisions
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*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 == | ||
===COI Officer=== | |||
The UNMC Conflict of Interest Officer shall be responsible for implementing the UNMC COI management program. <br /> | |||
The COI management program shall also include review and approval of the "Application for Authorization to Engage in Outside Professional Activity" forms as delegated by the Chancellor with associated management of conflict of commitment under Regents Policy 3.8. and UNMC Policy 1049, [[Outside Employment]]. The COI Officer shall: | The COI management program shall also include review and approval of the "Application for Authorization to Engage in Outside Professional Activity" forms as delegated by the Chancellor with associated management of conflict of commitment under Regents Policy 3.8. and UNMC Policy 1049, [[Outside Employment]]. The COI Officer shall: | ||
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*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: | ||
:*The role | :*The role and principal duties of the conflicted Investigator in the research project; | ||
:*Conditions of the management plan; | :*Conditions of the management plan; | ||
:*How the management plan is designed to safeguard objectivity in the research project; | :*How the management plan is designed to safeguard objectivity in the research project; | ||
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*'''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=== | |||
*'''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 e-Disclosure system may be accessed through the Research Support System (RSS) website at: http://net.unmc.edu/rss/ . 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 3.01. | *'''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 3.01. | ||
*'''Appeal Rights.''' Covered Persons may appeal adverse decisions made under this policy to the Vice Chancellor for Academic Affairs. The appeal | *'''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. | ||
shall be in writing and contain a description of the adverse decision, justification for why the decision should be changed, and the change | ===COI Committee.=== | ||
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 | 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: | ||
within thirty (30) days of receipt. The VCAA's decision is final. | |||
The UNMC COI | |||
*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. | ||
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*Conduct retrospective reviews of newly identified Significant Financial Interests as described in Conduct Retrps[ectove Review above. | *Conduct retrospective reviews of newly identified Significant Financial Interests as described in Conduct Retrps[ectove 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 Vice Chancellor Academic Affairs and to the appropriate UNMC administrator responsible for supervision of the individual(s) violating the policy. | ||
===Sponsored Programs Administration=== | |||
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. Sponsored Programs Administration shall verify review has been completed for all applications. | *Notify all research Investigators submitting sponsored grant/contract proposals to review their Annual Disclosure of Financial Interest form and update the information as needed. Sponsored Programs Administration shall verify review has been completed for all applications. | ||
*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 in the alternative that the subrecipient will follow the UNMC COI policy; and | :*the subrecipient certifies that its FCOI policy complies with PHS regulations or in the alternative 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 | :*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 '''Repprt FCOI to PHS''' and '''Conduct retrospective review''' above. | ||
===Associate Vice Chancellor, Business and Finance=== | |||
The Associate Vice Chancellor of 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. | |||
===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 #3.12. The IRB shall review and approve proposed COI management plans as described in HRPP Policy #3.12. | |||
===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. | |||
===Continuing Education Offices=== | |||
UNMC is accredited by the Accreditation Council for Continuing Medical Education (ACCME). The Continuing Medical Education (CME) office shall review disclosures of financial interest for UNMC employees who are serving as course directors, faculty or peer reviewers for UNMC CME courses, as required by the ACCME Standards for Commercial Support. | |||
==Institutional Conflict of Interest Management == | ==Institutional Conflict of Interest Management == | ||
In order to avoid real or perceived favoritism in relationships with research sponsors, each/every potential Institutional COI shall be reported. Any Covered Person who has knowledge of potential Institutional COI shall report the information to the COI Officer. Potential Institutional COI may be identified through the Annual Disclosure of Financial Interest questionnaire for senior administrative personnel. The COI Officer shall convene a group of senior UNMC officials appointed by the Chancellor to review the disclosure and propose a management plan for Chancellor approval if appropriate. It is important to note that PHS COI regulations do not cover institutional conflict of interest. | In order to avoid real or perceived favoritism in relationships with research sponsors, each/every potential Institutional COI shall be reported. Any Covered Person who has knowledge of potential Institutional COI shall report the information to the COI Officer. Potential Institutional COI may be identified through the Annual Disclosure of Financial Interest questionnaire for senior administrative personnel. The COI Officer shall convene a group of senior UNMC officials appointed by the Chancellor to review the disclosure and propose a management plan for Chancellor approval if appropriate. It is important to note that PHS COI regulations do not cover institutional conflict of interest. | ||