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Conflict of Interest: Difference between revisions
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#'''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 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=== | ||
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. | ||
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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. | ||
===Continuing Education Offices=== | ===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. | 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. | ||