Research Conflict of Interest Procedures: Difference between revisions

== 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:  

# Payments related to recruiting or enrolling research subjects;

# Financial interests in commercial sponsors of research;

# Philanthropic support from commercial sponsors of research;

# Serving as a director of a company that sponsors research;

== Definitions ==

'''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 />

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

# Intellectual property rights (e.g. patents, copyrights and royalties from such rights);

'''Institutional Conflict of Interest” (“Institutional  COI”)''' 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. An '''example''' of a potential Institutional COI is a proposed research project funded in whole or in part by an entity in which UNMC, an affiliated corporation, or other entity created to promote and facilitate technology transfer at UNMC (i.e., UNeMed), owns an equity interest or a future right to own an equity interest, the fair market value of which is greater than $500 or represents more than five percent (5%) ownership interest. <br />

The following '''example''' would not normally be considered an Institutional COI: an equity, royalty or other interest held in a University of Nebraska endowment or similar account, which is segregated from the decision making processes of research activities. For example, a stock interest held in an account managed by a University of Nebraska Office of Business and Finance would not trigger a reporting requirement.  

== Conflict of Interest Officer ==

==Conflict of Interest Committee==

== Reporting Potential Conflicts ==

===Conflicts 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 ==

== 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.  

# After careful consideration of less prohibitive alternatives, the Covered Person may be disqualified from participation in all or a portion of the research or other project when a COI exists (e.g. may not enroll human research subjects, obtain informed consent, or analyze data).

== Institutional Review Board (IRB) Management Plan Review. ==

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

== Corrective 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.  

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

*UNMC Policy No. 8010, [[Conflict of Interest]]  

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

*[https://unmc.coi-smart.com/ Annual Disclosure of Financial Interest Questionnaire]

This page updated by [mailto:dpanowic@unmc.edu dkp].<br />