COI/COC Disclosure Requirements

Overview

Individuals should disclose potential conflicts of interest and commitment when carrying out their external and University education, research, scholarship, or service responsibilities.  All external relationships, domestic and international, should be transparent and must be disclosed in a manner that is consistent with applicable requirements, including federal and state laws/regulations/agency guidance, as well as Emory University’s policies and procedures. 

Significant Financial Interests (SFI) requiring disclosure are interests held individually by the investigator, their spouse or same-sex domestic partner, and dependent children must be added together, and the aggregate value used to determine limits set forth by policies.

Disclosure Obligations

Emory COI/COC policy 7.7 states that all Covered Individuals are required to disclose.

The following outside activities require disclosure and approval before they can begin, even if they occur during a sabbatical or other approved leave:

  • Ownership of equity in an entity that carries out activities closely related to the employee's Emory job duties or within their field of expertise. This includes consulting entities but does not include consulting as an individual or a sole proprietor. In other words, employees must disclose that activity if they own a consulting company. 
  • Outside activities performed in exchange for equity in an entity that carries out activities closely related to the employee's Emory job duties or within their field of expertise. This does not include publicly traded equity unless the employee has majority ownership in that entity. 
  • Outside activities closely related to the employee's Emory job duties or within their field of expertise that involve research and development or the creation of technological improvements, inventions, or software. 
  • Management or significant participation in the day-to-day operations of an entity that carries on activities closely related to the employee's Emory job duties or within their field of expertise. 
  • Employment of Emory students who the employee currently teaches, supervises, or advises or other Emory employees who they manage in the execution of outside activities.
  • Any activity or financial interest of the employee or their relatives or any business with which either is associated, that could or would be impacted by the employee acting in their capacity as anEmory employee. 
This infographic provides a simplified view of activities that need to be disclosed as research and non-research faculty, staff, or visiting scholars. Click the image below for the full pdf.


Identifying a Potential COI

Three key concepts are used to identify whether an outside activity represents a potential COI situation that may require management:

An outside activity is considered significant when the investigator or their family member has one or more of the following: 

  • Received remuneration (e.g., compensation, loans, items of value) from an external entity, whether publicly or non-publicly traded, in the previous 12 months that, when aggregated, exceeds $5,000 
  • Ownership (i.e., equity, stock, stock options) in an external entity related to your Emory job responsibilities 
  • Received income from intellectual property (IP) rights and interests (e.g., patents, copyrights, royalties from the rights), including your IP licensed/optioned through Emory and/or other institutions  
  • A management position (e.g., officer, trustee, director) with an external entity that includes a fiduciary (i.e., legal or ethical) obligation to act in the best interest of the entity

An external entity is considered related to sponsored research and/or technology transfer activity at Emory when that entity: 

  • Sponsors the research (proposal, subcontract) 
  • Supplies equipment, materials, or services as part of the sponsored research agreement (subcontract, purchasing) 
  • Commercializes a product for which the research is to evaluate and/or develop further (intellectual property) 
  • May be impacted financially by the research or technology transfer agreement (management position)

An individual's role on a research project with a technology transfer activity, or with an external company, is a factor in determining whether a potential conflict of interest exists and in determining the steps to manage the conflict.

Managing COI/COC

Excerpt from Emory COI policy 7.7:

all Covered Individuals* are required to disclose...

*Covered Individual: Person responsible for the design, conduct, or reporting of Emory Research which always includes the Principal Investigator or Project Director. In addition, other persons may include, but is not limited to: a. Senior/Key Personnel, consultants, postdoctoral fellows, trainees, visiting scientists, and Research personnel (e.g., Research coordinators, Research nurses, etc.); b. External Collaborating Entities/Individuals and Subrecipients who do not have a policy compliant with 42 CFR Part 50 Subpart F and 45 CFR Part 94; c. Students enrolled at Emory who are responsible for the design, conduct, or reporting of Research managed by Emory under a grant or contract. A student's supervising faculty member who is in doubt about whether the student is a Covered Individual must request a determination by the COI Official.

If the Research Conflict of Interest Committee (RCOIC) determines that a potential or actual conflict of interest exists for one or more of your outside activities, you are expected to:

  • Respond promptly to follow-up questions from the COI Committee
  • Review and act on a COI management plan. 
  • Complete an annual certification of the conflict situation/management plan

The COI Management Plan is a critical component of this process. It is a document that outlines and implements measures to actively reduce, mitigate, or eliminate an employee's actual, potential, or perceived conflict of interest.

Your disclosure will be reviewed, either expedited by the Conflict of Interest (COI/COC) Office, in conjunction with or by the Research Conflict of Interest Committee (RCOIC).

Based on the review, the following will be determined:

The lifecycle of a conflict of interest (COI) review process includes three (3) stages:

  • Initial Review
  • Determination & Response to Management
  • Annual Review

The Conflict of Interest and Commitment Office (COI/COC) conducts an Annual Review of active conflict of interest (COI) management plans for situations where the Research Conflict of Interest Committee (RCOIC) determines that management is required for an existing conflict. This includes any individual responsible for research design, conduct, or reporting.

**Examples are faculty, post-docs, research staff, part-time/temp research staff, etc.**

Active COI Management Plan(s) are reviewed annually to verify the following:

  • That the conflict of interest still exists
  • The individuals involved in the situation and their roles with the research or external entity
  • The individuals that have a role in the management of the conflict of interest
  • That disclosure of the conflict situation has occurred in publications, etc., as appropriate

As part of this process, the conflicted individual plays a key role in answering questions to update the COI/COC office with pertinent information about the conflict situation. The conflicted individual will receive an email with a link to the COI Annual Management Plan Review Form.

The COI/COC Office requires you to complete the form accurately and promptly to update your financial interest status and comply with the management plan provisions.