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Conflict of Interest: Difference between revisions
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→Conflict of Interest Management Roles and Responsibilities
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## '''Appeal Rights.''' Covered Persons may appeal adverse decisions made under this policy to the Vice Chancellor for Academic Affairs. The appeal <BR>shall be in writing and contain a description of the adverse decision, justification for why the decision should be changed, and the change <BR>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<BR>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 <BR>shall be in writing and contain a description of the adverse decision, justification for why the decision should be changed, and the change <BR>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<BR>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. ## Create COI Management Plans for Financial Conflicts of Interest. | ## 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. | ||
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# '''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. | # '''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. | ||
# '''Records Retention''' | # '''Records Retention''' | ||
All Disclosure of Financial Interest information, COI management plans and all Public Health Service-funded Financial Conflict of Interest-related records shall be retained for the fiscal year in which the grant or contract is closed plus seven (7) years as required by Board of Regents Records Retention Schedule 170-8, "Sponsored Projects (Grants)". No destruction of records shall take place if there is a Preservation Hold in effect, or if any litigation, claim, negotiation, audit or other actions involving the records have been started before the expiration of the retention period. The records must be retained until completion of the action and resolution of all issues which arise from it, or the seven year retention period, whichever is later, as required under 45 CFR 74.53 and 92.42. | All Disclosure of Financial Interest information, COI management plans and all Public Health Service-funded Financial Conflict of Interest-related records shall be retained for the fiscal year in which the grant or contract is closed plus seven (7) years as required by Board of Regents Records Retention Schedule 170-8, "Sponsored Projects (Grants)". No destruction of records shall take place if there is a Preservation Hold in effect, or if any litigation, claim, negotiation, audit or other actions involving the records have been started before the expiration of the retention period. The records must be retained until completion of the action and resolution of all issues which arise from it, or the seven year retention period, whichever is later, as required under 45 CFR 74.53 and 92.42. | ||
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'''Sanctions''' | '''Sanctions''' | ||
Covered Persons who violate this policy may receive corrective action under UNMC Policy 1098, "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 of Academic Affairs shall review and approve all proposed sanctions. The sanctions shall be coordinated with the respective Dean, Director or Vice Chancellor for enforcement. | Covered Persons who violate this policy may receive corrective action under UNMC Policy 1098, "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 of Academic Affairs shall review and approve all proposed sanctions. The sanctions shall be coordinated with the respective Dean, Director or Vice Chancellor for enforcement. | ||
<P>For additional information, contact the | <P>For additional information, contact the [mailto:swrobel@unmc.edu Chief Compliance Officer].</p> | ||
<p><EM>This page maintained by | <p><EM>This page maintained by [mailto:dpanowic@unmc.edu dkp].</P> | ||
== Policy 8010 Appendix A == | == Policy 8010 Appendix A == | ||
<big>Conflict of Interest Committee (COIC) Governance</big> | <big>Conflict of Interest Committee (COIC) Governance</big> | ||