Conflict of Interest
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Policy No.: 8010
Effective Date: 09/04/07
Revised Date: 05/20/2013
Reviewed Date: 05/20/2013
Conflict of Interest Policy
- 1 Basis for Policy
- 2 Policy
- 3 Definitions
- 4 Conflict of Interest Management Roles and Responsibilities
- 5 Institutional Conflict of Interest Management
- 6 Records Retention
- 7 Public Accessibility of PHS-funded Senior/Key Personnel FCOI
- 8 Sanctions
- 9 Policy 8010 Appendix A
- 10 Additional Information
Basis for Policy
Statutes, regulations, University policies and accreditation standards related to conflict of interest identification and management are:
- "Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is Sought and Responsible Prospective Contractors" regulations at 42 CFR Part 50 and 45 CFR Part 94
- "Financial Disclosure by Clinical Investigators" Food & Drug Administration regulations at 21 CFR Part 54
- Nebraska Conflict of Interest Statute at Neb. Rev. Stat. §49-1493 et. seq.
- Bylaws of the Board of Regents of the University of Nebraska Sections 3.10, 3.45 and 3.8
- Board of Regents Conflict of Interest Policy, RP-3.2.8
- Board of Regents Patent & Technology Policy, RP-4.4.2
- UNMC Human Research Protections Policy #3.12, "Identification and Management of Potential Financial Conflicts of Interest of Research Personnel"
- UNMC Policy No. 1049, Outside Employment
- UNMC "Interactions between College of Medicine Faculty, Staff & Trainees and Health Care Vendors" policy
Potential conflicts of interest arise in a variety of circumstances in the academic health sciences center environment when an individual's private financial interests either conflict with or create the appearance of conflicting with UNMC's public interests. This policy applies to potential conflict of interest arising in any UNMC activity, including but not limited to research, teaching, patient care, outreach to underserved populations and the associated business activities in support of them. Covered Persons shall disclose all financial interests related to their University of Nebraska responsibilities so that an analysis of potential conflict of interest may be conducted. When a conflict of interest is identified, the conflict will either be managed or eliminated to reduce the appearance of bias and maintain responsible stewardship of public resources. This policy shall be publicly posted in the UNMC Policies and Procedures manual on the UNMC internet site.
Covered Person under Regents Policy 3.2.8 shall mean:
- University administrative officers and employees, specifically including any University employees with delegated signature, purchasing or contracting authority on behalf of the university;
- University employees and faculty engaged in outside employment or other activities specified in this policy (tech transfer/use of University facilities or equipment) that may create a Conflict of Interest; and
- 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.
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 his or her 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.
Equity includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.
Financial Conflict of Interest (FCOI) under PHS regulations means a Significant Financial Interest that the COI Officer or COI committee reasonably determines could directly and significantly affect the design, conduct or reporting of research.
Immediate Family under Regents Policy 3.2.8 shall mean an individual who is a spouse, child, brother, sister, grandchild, or grandparent, by blood, marriage, or adoption of the Covered Person.
Institutional Conflict of Interest (ICOI) 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.
Institutional Responsibilities means professional responsibilities on behalf of the University of Nebraska which may include activities such as professional service including patient care, teaching, research & research consultation, outreach, administrative, institutional committee membership including service on panels such as the Institutional Review Board or Data and Safety Monitoring Boards, and other duties as specified in the Covered Person's job description and/or employment agreement.
Remuneration includes salary and any payment for services not otherwise identified as salary including but not limited to consulting fees, honoraria, and paid authorship.
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.
Significant Financial Interest means a financial interest of the Investigator or his/her 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 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;
- Intellectual property rights and interests upon receipt of income related to such rights and interests, excluding income paid by the University of Nebraska.;
- 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
The UNMC Conflict of Interest Officer shall be responsible for implementing the UNMC COI management program. 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:
- Ensure UNMC policy meets Board of Regents policy and state and federal regulatory requirements;
- Implement annual disclosure requirements for Covered Persons and monitor to ensure compliance. The UNMC electronic Annual Disclosure of Financial Interest form is incorporated into this policy by reference. The Annual Disclosure of Interest and Application for Authorization to Engage in Outside Professional Activity forms are located at: https://unmc.coi-smart.com .
- Coordinate identified conflict of interest matters with Sponsored Programs Administration, UNeMED, the Institutional Review Board (IRB), the Institutional Animal Care and Use (IACUC) committee, the Associate Vice Chancellor, Business and Finance (for business COI), and the Continuing Medical and Nursing Education offices as relevant. Whenever a potential COI involving activities with another University of Nebraska campus or university affiliated entity is disclosed or identified, notify the other campus or university affiliated entity COI contact and collaboratively review and manage the potential COI.
- COI Education. Provide COI education to covered persons at time of hire, and every four years thereafter, and immediate re-education when there are policy changes or when investigators fail to comply with the COI policy. For investigators conducting Public Health Service (PHS) sponsored research, education shall be completed prior to the expenditure of any PHS funds.
- 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:
- The role and principal duties of the conflicted Investigator in the research project;
- Conditions of the management plan;
- How the management plan is designed to safeguard objectivity in the research project;
- Confirmation of the Investigator's agreement to the management plan;
- How the management plan will be monitored to ensure Investigator compliance; and
- Other information as needed.
- Conduct retrospective review. If UNMC identifies a significant financial interest that was not disclosed by a research Investigator in a timely manner, or was not reviewed by UNMC, the COI officer shall, within sixty (60) days: review the significant financial interest and determine whether it is related to PHS-funded research. The COI committee shall determine whether a financial conflict of interest exists, and, if so, implement an interim COI management plan. Within 120 days, the COI committee shall complete a documented retrospective review of the research Investigator's activities and the PHS-funded research project to determine whether any PHS-funded research conducted during the period of non-compliance was biased in the design, conduct or reporting of such research. The documented review shall contain all of the elements required by the PHS regulations.
- Reporting Bias & Mitigation Report. If bias is found with the design, conduct or reporting of PHS-funded research, the COI Officer shall notify the PHS awarding component promptly and submit a Mitigation Report containing the retrospective review information and a description of the impact of the bias on the research project and UNMC's plan of actions taken to eliminate or mitigate the effect of the bias.
- If the research is clinical research whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, the COI committee shall require the Investigator to disclose the FCOI in each public presentation of the results of the research, and request an addendum to previously published presentations, in addition to any applicable disclosure listed below in Disclosure of Financial Interest.
- 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.
- 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: https://unmc.coi-smart.com . 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.
- 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.
- 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.
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.
- 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.
- Conduct retrospective reviews of newly identified Significant Financial Interests as described in Conduct Retrospective 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.
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.
- 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:
- 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 Report 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.
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
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.
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.
Public Accessibility of PHS-funded Senior/Key Personnel FCOI
Upon request, the COI Officer shall make available to the public information concerning identified FCOIs held by Senior/Key personnel receiving PHS research funding as required by PHS regulations. Information shall be provided in writing within five (5) business days of the request. The COI officer shall coordinate these public requests with the University of Nebraska Records Management Officer. All other financial interest disclosure information and conflict of interest determinations shall remain confidential and may be withheld from the public as permitted under Neb. Rev. Stat. 84-712.05, "Records which may be withheld from the public; enumerated."
Covered Persons who violate this policy may receive corrective action under UNMC Policy No. 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.
Policy 8010 Appendix A
Conflict of Interest Committee (COIC) Governance
COI Committee Composition. The COI Committee shall have at least 16 members representing the following areas: </P>
|College of Medicine||Vice Chancellor for Business & Finance|
|College of Dentistry||Vice Chancellor for Research|
|College of Pharmacy||Compliance/Conflict of Interest Officer|
|College of Nursing||Sponsored Programs Administration|
|College of Public Health||Institutional Review Board|
|Eppley Cancer Institute||Associate General Counsel for Healthcare|
|Munroe Meyer Institute||Center for Continuing Medical Education|
|Vice Chancellor for Academic Affairs||Community Member|
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 his/her designee. New members shall be nominated by the department/unit and approved by the Vice Chancellor of Academic Affairs or his/her designee. The Chancellor or his/her designee shall appoint a faculty chair of the COI Committee. The Vice Chancellor of Academic Affairs or his/her designee shall select the community member. The Chancellor or his designee can appoint additional voting and non-voting members.
Quorum. A quorum is required for meetings to be conducted. More than half of the membership present will constitute a quorum.
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.
COIC Member Conflicts. If a COIC member has a conflict of interest with a specific matter being discussed, the member shall declare that he/she has 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 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 his/her 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.
Meeting Minutes. The COI Coordinator chair shall prepare meeting minutes and present them for approval at the next scheduled COI Committee meeting.
- Contact the Chief Compliance Officer
- Contact the Associate Vice Chancellor for Business and Finance
- Conflict of Interest Procedures
- Appendix 1 - Disclosure of Potential Business Conflict of Interest
- Research Conflict of Interest Procedures
- UNMC Policy No. 1049, Outside Employment
- Application for Permission to Engage in Professional Activity Outside the University
- Disclosure of Potential Conflict of Interest Form
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