Research Conflict of Interest Procedures: Difference between revisions

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<big>Research Conflict of Interest Procedures - DRAFT</big>

== Introduction ==

Potential research conflicts of interest arise in a variety of circumstances in the academic medical center setting. '''Examples''' include but are not limited to the following:  

'''Responsible Person''' means the principal investigator and any other person who, in the principal investigator’s professional judgment, is responsible for the design, conduct or reporting of the research, whether or not salary is requested.  The term “Responsible Person” may include research coordinators and technicians.  <br />

'''Conflict of Interest (COI)''' refers to situations when the Covered Person’s personal financial interests or fiduciary duties owed to third parties may compromise, or have the appearance of compromising, a Covered Person’s professional judgment or behavior in carrying out his or her research obligations. <br />

'''Significant Financial Interest''' means anything of monetary value that exceeds $5,000 received in the past twelve months, or anticipated to be received in the next twelve months, from sources that might reasonably appear to be affected by the Covered Person’s research activities. For equity holdings the limit is $500. Significant financial interests examples include but are not limited to:  <br />

# Salary, royalties, or a commitment for future royalties or other remuneration received outside of the University of Nebraska system, Nebraska Medicine or University Dental Associates (UDA);

:# income from seminars, lectures or teaching engagements sponsored by public or nonprofit entities; and

:# income from service on advisory committees or review panels for public or nonprofit entities;

#Equity interests (e.g. stocks, stock options or other ownership interests, both direct and indirect, i.e. trusts, etc.) that when aggregated for the Covered Person and the Covered Person’s spouse, parent, spouse of parent, and dependent children, exceeds $500 in value as determined through reference to public prices or other reasonable measures of fair market value, or represents more than five percent (5%) ownership interest in a single entity. Financial interests in mutual funds or retirement accounts where investment decisions are not under your direct control are excluded.

The Senior Vice Chancellor for Academic Affairs shall appoint a Conflict of Interest Committee (“COI Committee”) comprised of faculty, research staff, academic administrators, business operations personnel, at least one member of the Institutional Review Board (“IRB”) and at least one community member to fulfill the duties outlined in these procedures. The COI Committee shall be a standing committee that operates in accordance with the guidelines at Appendix A, and shall be chaired by the COI Officer.

===Conflicts of Interest===

# '''Initial disclosure.''' All faculty members, directors, administrators and department heads (or equivalents) shall complete a [https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire] within 30 days of initial appointment/hire. The unit Personnel Action Form (PAF) Coordinators are responsible for ensuring forms are completed in a timely manner.  

# '''New potential conflicts.''' Covered Persons who propose to engage in an activity that would create a situation defined as a COI shall complete a [https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire] and submit it to the COI Officer.  

# '''Grant Applications and Sponsored Programs Agreements.''' Covered Persons who are principal investigators on grant applications or who submit a sponsored program agreement shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration as a part of the application process. All other Responsible Persons (individuals who are responsible for the conduct, design, or reporting of the research, whether or not salaries are requested) shall submit a current Disclosure of Potential Conflict of Interest Form to Sponsored Programs Administration at the time the grant is awarded. Sponsored Programs Administration shall report the existence of a COI and the management plan to federal grant administering agencies when required by federal regulation or the terms of the research grant.  

# '''IRB Applications.''' Covered Persons listed in Section I of the IRB application shall submit a conflict of interest disclosure form as a part of the application process to the Office of Regulatory Affairs pursuant to UNMC Human Research Protection Program Policy 1.22.

# '''Changes in Existing COI.''' Any increase that would make the total remuneration greater than $5,000 would elevate the financial interest to a significant financial interest and requires disclosure within 30 days of increase.  

===Institutional Conflict of Interest===

In order to avoid real and perceived favoritism in long-term or repeated dealings with research sponsors, each/every potential Institutional COI shall be reported. Any Covered Person that has knowledge of potential Institutional COI shall complete an [https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire] for review. The COI Officer shall convene a group of senior UNMC officials appointed by the Chancellor to review the disclosure and implement a management plan if appropriate. Sponsored Programs Administration shall report the significant Institutional COI to federal grant administering agencies when required by federal regulation or the terms of the research grant.  

== COI Officer Action ==

The COI Officer shall review all conflict of interest disclosure forms and determine in his/her professional judgment whether any action should be taken in response to potential conflicts. If the COI Officer determines that a non-significant financial conflict of interest is of issue, the COI Officer shall coordinate with the Covered Person to create a proposed management plan. For significant financial interests, the COI Officer shall submit the COI disclosure and the proposed management plan to the COI Committee for review, approval or modification.  

== COI Committee Action ==

The COI Committee shall consider the nature of the activity, the magnitude of the COI and its relation to the Covered Person’s research, the potential impact the COI might have on the integrity of the Covered Person’s decisions, and such other considerations as the COI Committee shall deem relevant in order to make a decision. The COI Committee shall then determine whether the proposed management plan will adequately reduce the impact of the COI and state its determination on the Conflict of Interest Committee Action Form. In rare instances, the COI Committee may determine that no management plan could adequately manage the COI, and therefore prohibit the Covered Person from participating in the activity. The COI Officer shall forward a copy of the approved management plan to the Covered Person, the Covered Person’s supervisor, Sponsored Programs Administration, and also to the IRB for review and further modification if human subjects research is involved.  

== Management of COI ==

The following is a non-exhaustive list of '''example''' Management Plan strategies provided to serve as guidance to the COI Officer and the COI Committee.  

When the COI Committee develops management plans for COI involving human subjects research, the IRB shall review the management plan and may require more stringent management of the COI within the scope of authority given to the IRB by federal regulations for the protection of human subjects. However, the IRB may not adopt less stringent management than the COI Committee plan. The IRB shall notify the COI Officer of its decision. The IRB shall incorporate and require implementation of the approved management plan strategies applicable to the research into the approved protocol. <br />

See UNMC Human Research Protection Program Policy 1.22 for further information.  

Covered Persons who do not disclose potential conflicts of interest they have pursuant to these Procedures, or who choose not to comply with COI Officer or COI Committee determination and recommendations, may be reassigned to an activity in which he/she has no COI. Further, such failure or refusal to comply shall be cause for disciplinary consideration and grounds for employment or academic action.   

The COI Officer shall notify the sponsor via their defined method when the COI Committee has determined that the failure of the Covered Person to comply with this policy has biased the design, conduct, or reporting of the PHS-funded research in accordance with 42 CFR Part 50 Subpart F.  

The COI Officer shall retain the forms, records and COI Committee minutes processed pursuant to this policy for purposes of documenting the existence and/or identification of conflicts of interest and commitment and their resolution. Records shall be retained for no less than seven (7) years following the cessation of the outside activity to which they relate.  

This page updated on Wednesday, July 18, 2018, by [mailto:dpanowic@unmc.edu dkp].