Types of COI

Types of COI

Conflicts of interest at the University fall into three main categories. Conflicts are reviewed and managed in accordance with federal and state regulations and University policies.

Disclose your interests in AIR annually, within 30 days of a change in interests, and as requested by the COI Office.

Applicability

All faculty, staff, students, and trainees involved in University research are subject to the University’s Policy on Individual Conflicts of Interest in Research.

Individual Conflict of Interest relates to situations in which financial or other personal considerations may compromise, may involve the potential for compromising, or may have the appearance of compromising a Covered Individual’s objectivity in fulfilling their University duties or responsibilities, including research activities.

The bias that such conflicts may impart can affect many University duties, including:

  • decisions about personnel,
  • the purchase of equipment and other supplies,
  • the collection, analysis and interpretation of data,
  • the sharing of research results,
  • the choice of research protocols,
  • the use of statistical methods, and
  • and the mentoring and judgment of student work.

The Policy on Individual Financial Conflicts of Interest in Research details what is needed for an individual COI review.

Individual conflicts of interest may arise in a variety of situations, including:

  • Research
  • Intellectual Property Transactions
  • Use of University Resources
  • Gifts to the University for the individual’s benefit
  • Gifts or Favors to Individuals
  • University Review Panels
  • Purchasing or Business Transactions
  • Administrative Roles

Covered Individuals are required to disclose their interests annually, within 30 days of a change in interests, and as requested by the COI Office. The University’s Policy on Individual Conflicts of Interest in Research details the individual COI review process.

Management and Confidentiality

Conflicts of interest are managed in accordance with the principles of:

  • Transparency,
  • Honoring the student/trainee experience, and
  • Protecting the credibility of the individual doing the work.

Management

If a Financial Conflict of Interest (FCOI) is identified, the COI Office will implement a foundational management plan with terms applicable to the conflict and the following parameters:

Required disclosure of the relationships/conflict:

  • In any public dissemination (including but not limited to manuscripts, publications, presentations, abstracts, web pages, posters, and activity sheets) that may arise from the project.
  • In informed consent documents for any human study. The text is subject to approval by the reviewing IRB.

Management plans may also require:

  • Monitoring,
  • Alternative options for trainees, and
  • Alternative administrative routing and/or recusal

Additional terms may be added as applicable, or if new administrative duties arise.

Confidentiality

The information provided on a COI disclosure is considered part of an individual’s confidential personnel file and is generally not subject to public records requests. Information will be shared with those who have a business need-to-know (e.g., the Institutional Review Board (IRB) and COI Committees).

Certain PHS-funded studies may require the University to share disclosed information upon request. Please see sections V. Research H.6(b) and VI. Records Confidentiality and Retention of the University’s Policy on Individual Financial Conflicts of Interest in Research.

Disclosure and Review

Disclosure Submission Troubleshooting

  • If you experience technical issues within the AIR system, please contact the Office of Research Information Systems (ORIS) Help Desk at 919-843-2594 or [email protected]. Please be prepared to provide as much information as possible to expedite troubleshooting.
  • Please contact the COI Office if you need help with completing or updating your disclosure form.

Consequences of Non-Disclosure

Per University policy, Covered Individuals are required to disclose their personal or financial interests. The consequences of failing to disclose one’s interests, as they relate to one’s University duties, can vary depending on the circumstances. Please see section VIII. Policy Breaches of the University’s Policy on Individual Financial Conflicts of Interest in Research.

COI Review Process

Coming soon.

Automated Reminder Notifications

IRBIS and RAMSeS are configured to send out reminder email notifications as needed.
Individuals who are no longer working on the research study or project should be made inactive as personnel in the related campus research system to stop the notifications. For IRB studies, please contact the IRB. For RAMSeS proposals or awards, please speak with your OSP contact.

Contact your IRB analyst or OSP sponsored program specialist to update the personnel list.

Checking Status of COI reviews

Disclose any University intellectual property used in your human subjects research protocol.

Institutional Conflicts of Interest are situations where a potential or existing financial interest relationship between the University and an external entity compromises the integrity of institutional decision-making. The Institutional COI Committee is appointed directly by the Chancellor.

For research, an Institutional COI review generally occurs when:

  • University licensed Intellectual Property is being used in a human treatment study.
  • The University is manufacturing the drug or device being used in a human study.
  • An entity in which the University owns equity or has a financial interest is the sponsor, particularly for a human study.
  • The donor sponsoring a gift supporting a study also has an interest in the data results.

The Office of Sponsored Programs requests organizational COI reviews. These reviews verify that University had no role in advising the procurement of contracts or awards for which we compete.

Organizational Conflict of Interest (OCI) reviews are assessments required by sponsors for certain funded research or contractual scenarios to determine any overlap in the University’s activities.

Requirements:

An Organizational COI review is only required in sponsored research situations under the following parameters:

  • Uniform Guidance:  In accordance with 200.318(c)(2), the University maintains a code with a process to address certain situations where the University would be unable to be impartial in a procurement action involving a related organization.  These requests are generated directly by OSR to the COI Office.
  • Contract Requirement:  Where the sponsoring organization requires a review to determine if the University has a related entity or has current or prior work which creates any:
    • Impartial assistance
    • Impaired objectivity
    • Unfair competitive advantage

Review:

These contract requirement reviews are completed by request of the Office of Sponsored Research, either at proposal or upon award. Certification or response is returned to OSP as needed.

The process used by the COI Program includes a comparison of the proposed project with the following information:

  1. Any currently funded or recently completed projects and pending proposals at the University supported by the Sponsor,
  2. All currently funded or recently completed projects and pending proposals of all investigators listed on the proposal, regardless of their source of funding, and
  3. A search of all currently funded or recently completed University projects and pending proposals containing pertinent key project words.

This three-way comparison is completed to determine if there is any possible overlap of technical assistance or project goals within the University with the proposal itself.

Submit your IPF to OSP no later than 7 business days before a submission deadline to ensure timely review. The COI Office needs 5 business days for an OCI review.