Conflict of Interest: Difference between revisions

Policy No.:  '''8010'''<br />

Effective Date:  '''09/04/07'''<br />

<br /><br />

<big>'''Conflict of Interest Policy'''</big>  

#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.  

   

'''De minimus''' means any remuneration received as payment for services and/or equity interests of $499 or less is not required to be disclosed. Any remuneration received for services and/or equity interests of $500 or greater is required to be disclosed.  <br />

'''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. <br />

#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;  

#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 .  

#'''COI Education.''' Provide COI education to Covered Persons at time of hire, and every four (4) 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.  

#'''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 1.22.  

===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:  

#Provide oversight over the UNMC COI program, advise the COI officer, and provide guidance on UNMC COI policy matters.  

#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.  

===Sponsored Programs Administration===

Sponsored Programs Administration shall:  

The Vice Chancellor for Business, Finance and Business Development 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. <br />

===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 1.22. The IRB shall review and approve proposed COI management plans as described in HRPP Policy 1.22.  

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."  

==Sanctions ==

== Policy 8010 Appendix A ==

'''COI Committee Composition.''' The COI Committee shall have at least 16 members representing the following areas: <br />

{| class="wikitable" border="1"

|-

| College of Medicine

|-

| College of Dentistry

|-

| College of Pharmacy

|-

| College of Nursing

|-

| College of Public Health

|-

|-

|}

#the member is participating in the research under review;

#the member has a financial relationship with a research sponsor under review; or  

== Additional Information ==

*Contact the [mailto:sarah.glodencarlson@unmc.edu Chief Compliance Officer]

*Contact the [mailto:jeffrey.miller@unmc.edu Assistant Vice Chancellor for Business and Finance]  

*[[Research Conflict of Interest Procedures]]

*UNMC Policy No. 1049, [[Outside Employment]]