COI Frequently Asked Questions

The following are frequently asked questions regarding conflict of interest.

Who needs to submit a COI disclosure?

All EHRA faculty and non-faculty EHRA, regardless of employment status, are required to submit a COI disclosure on an annual basis.

How do I submit a COI disclosure?

COI disclosures are made online in the Conflicts of Interest Risk Manager (COI RM) system.  To submit a disclosure, log into Pirate Port, locate the COI Risk Manager link and follow the prompts.

When do I need to submit a COI disclosure?

The annual reporting period begins on July 1 and ends on April 30, meaning disclosures need to be filed by April 30th each year.  In addition, it may be necessary to submit transactional COI disclosures throughout the year.

What is a transactional COI disclosure?

Certain transactions such as submitting a research proposal or establishing technology licensing agreements, may trigger the need for an “ad hoc” transactional disclosure. Proposals seeking funding from federal sponsors require project specific disclosures prior to proposal submission. As with annual disclosures, these disclosures are completed in the COI Risk Manager system as a self-initiated disclosure.

What needs to be disclosed?

External interests that are related to an employee’s institutional role(s) and activities must be reported in COI Risk Manager. This includes: off campus non-University commitments (such as company ownership), additional employment, or consulting activities for external entities. External interests of an EHRA employee or immediate family member must be disclosed in COI Risk Manager for the past 12 months and the anticipated upcoming 12 months.

  • Serving in a management and /or operational role (president, officer, director, etc.), regardless of whether compensation is received for a for-profit (public or private) or not-for-profit entity.
  • Receiving compensation from any public entity and/or the value of any equity interest (excluding purchase of mutual funds) in the entity, when aggregated, exceeds $5,000.
  • Receiving any compensation from any private entity.
  • Holding any ownership interest (e.g., stock, stock option, or other ownership interest).

What is Exempt from Disclosure?

Salary, royalties, or other compensation paid by the University if the individual is currently employed by the University is exempt as well as ownership of mutual funds, of any amount.

What is a COI Management Plan?

A Conflict of Interest Management Plan (COIMP) is a written proposal for proactively managing potential conflicts of interest. A written plan demonstrates the intent to comply with University requirements under State and Federal regulations and laws related to objectivity in research. A comprehensive management plan typically includes

  • A full description of relationships with external entities
  • Identification of the areas of potential conflict
  • Management strategies to mitigate or eliminate conflicts of interest

A proposed plan should clearly describe and fully explain the nature of the relationship(s) involved and how the actions proposed will help faculty or staff avoid perceived or actual conflicts. Management plans should be written in lay terms, using language understandable to non-expert readers.

What are some management strategies to include in a COI Management Plan?

A number of strategies may be employed to manage conflicts of interest and these strategies depend largely on the complexity of the relationship with an external Entity or Entities.  Management strategies may include:

  • Public disclosure of significant financial interests on all publications and oral presentations
  • Annual or more frequent report to the COI Committee of the status and changes in the relationship and the research
  • Reformulation/modification of a research protocol
  • Close monitoring of the conduct of research by an oversight body
  • Disclosure in informed consent documents and to human subjects who are participating in clinical trials or other types of human subject research
  • Training on conflicts of interest and commitment for all involved students and personnel
  • Independent monitoring and oversight of the activity
  • Double bind data analysis
  • Data analysis an interpretation by independent reviewers or review of raw data and manuscript by an external independent reviewer
  • Modification of the ECU research activity to remove the conflicted faculty member from participation in all or a portion of the research
  • Divestiture of significant financial interests
  • Severance of the external relationship
  • Other mitigating strategies

How do I complete a Notice of Intent to Engage in an External Professional Activity for Pay (EPAP)?

To complete an EPAP you’ll need to log into COI Risk Manager at the following link:

https://ecu.ospreycompliancesuite.com/coiriskmanager

Once logged in, you will see any disclosures that are available to complete.

Click on the link “Notice of Intent to Engage in External Professional Activities for Pay” and complete the disclosure.

Make sure to submit. It will then get routed to your departments NOI reviewer for review.