COI-COC Processing

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The University of Chicago's Conflict of Interest and Conflict of Commitment Policy for Faculty and Other Academic Appointees was adopted by the faculty in August, 2012. The document provides operational definitions of conflict of interest and conflict of commitment, the essentials of the policy, what must be disclosed, additional responsibilities for PHS-funded investigators, areas in which conflicts may arise, and guidelines for covered persons.
The purpose of this document is to provide a framework for identifying, evaluating and managing financial conflicts of interest as they may relate to research activities conducted at the University of Chicago.

Definitions

 "Significant Financial Interests" (SFI) – Anything of monetary value that does or could reasonably be perceived to directly and significantly affect the design, conduct or reporting of funded research, or the performance of other institutional responsibilities, whether or not the value is readily ascertainable.

"Conflict of Interest" –A situation in which a Significant Financial Interest directly and significantly affect the performance of instructional responsibilities, or could reasonably be perceived to do so, as determined by the University.

"Conflict of Commitment" – A situation in which an outside professional or commercial activity, whether paid or unpaid, interferes or has the potential to interfere with the individual's institutional responsibilities.

Disclosure Requirements

Each Investigator must disclose the following significant financial interests (SFIs) and those of his/her family members that does, or could reasonably appear to be related to the investigator's institutional responsibilities:

• For an organization outside of the University of Chicago: any remuneration (e.g., consulting, honoria, editorial compensation, etc.) for the current academic year (July 1 to June 30).

• Any equity, regardless of value, in a non-publicly traded company.

• Shares held in a publicly traded company that you control (i.e., not part of a retirement fund and you do not direct).

• Income from intellectual property rights not assigned to the University of Chicago

• Any intellectual property, whether or not it is assigned to the University of Chicago

• Any fiduciary role or management role you hold in another company

Assessment of Disclosure

Disclosures are received by University Research Administration (URA) and reviewed to make an initial assessment of the relationship of the SFI to the faculty member's research. Factors considered during the assessment include:

• Public Health Service (PHS) regulations require disclosures of any Financial Conflicts of Interest (FCOI) greater than $5,000 in equity or annual revenue that involves PHS funded projects. If the disclosed SFI is greater than $5,000, a review will be conducted to determine if there are any related PHS funded projects.

• For non-PHS funded studies, any SFI disclosed valued at over $10,000 in equity or annual revenue will be reviewed to determine if the SFI is related to externally funded projects.

• The assessment will consider all business interests of the organization in which the SFI exists and the relatedness of those business interests to the research interests of the faculty member. The faculty member will be consulted by URA to provide input into the assessment.

If the assessment reveals no potential COI, the faculty member will receive an acknowledgment and reminded to:

• Update their disclosure if the nature of the SFI changes in any way, or if any new previously undisclosed SFI arises.

• Removed themselves from the process of any procurement of goods or services that the University may engage in with the organization with which the SFI exists.

Determination of a FCOI

In the event that the URA assessment determines that a SFI is related to research, a further review will be conducted to determine if the SFI could affect the design, conduct or reporting of research, resulting in a COI. The faculty member will be consulted to provide their own assessment of the relatedness.

When a COI exists, a determination will be made whether the COI can be managed in a way that protects the design, conduct and reporting of the research from bias or the appearance of bias. A committee will be formed involving URA, University of Chicago Technology Transfer Office, legal and academic representatives as determined by the Dean or Department head, to develop a management plan.

Management of FCOI

A SFI found to constitute a FCOI may be subject to a management plan as a condition to the investigator's participation in the research. The determination of whether a FCOI is manageable, including a FCOI that involves a clinical trial, will take into account relevant factors, including but not limited to, the uniqueness of the investigator's position with respect to the study, the nature and design of the research, and the magnitude and nature of the financial interest. With respect to clinical trials, other relevant factors will be considered, including the degree of risk to human subjects, the role of the investigator in the study, the study's design, and the degree of the investigator's influence upon the recruitment/enrollment of subjects and/or the results of the study.

The Office of the Provost is responsible for approving all COI Management Plans or making a final determination that a FCOI is not manageable. Every effort will be made to manage a FCOI.

Conflict of Commitment

As part of the disclosure process, faculty members are asked to disclose the number of days that are engaged in conducting work on behalf of external organizations. URA staff will provide reports to the Deans showing the faculty member's name, outside organization, and number of days reported. Deans will be responsible for reviewing and addressing any conflict of commitment discures that are not consistent with the University policy.

For questions regarding the COI Policy or disclosure and review processes, please contact Mallory Snyder, Director of Research Integrity at (773) 702-4857 or by email at mallorysnyder@uchicago.edu