COI Guidance

Filing a COI disclosure is a crucial step in complying with federal, state, and university COI regulations and ensuring that individuals and the university avoid penalties for COI non-compliance. The university relies on you to file your annual COI disclosure and keep it up to date so that it continues to meet its institutional obligations to the UNC System and the agencies that fund university research.

Who is required to complete an annual COI disclosure?

  • All faculty (including adjunct faculty and emeritus faculty who are participating in a sponsored project)
  • Postdoctoral scholars
  • EHRA professionals paid from any source
  • Graduate assistants (GAs) paid from ledger 5 (sponsored research) funds
  • SHRA employees paid from ledger 5 (sponsored research) funds
  • Research personnel engaged in the design, conduct, or reporting of a sponsored research project (e.g., part-time and temporary employees)
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When do I need to complete my COI disclosure?

If you fall into one of the categories listed in the section “Who is required to complete a COI disclosure?”, you are required to file a COI disclosure with NC State once every 365 days in order to adhere university regulations.

If your circumstances change after you’ve filed your annual COI disclosure, you must file a revised disclosure within 30 days of the change to notify the university accordingly.

New employees who fall into one of the categories listed in the section “Who is required to complete a COI disclosure?” must file a COI disclosure within 30 days of their start date.

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Will I be notified when I need to submit my annual COI disclosure?

Yes. All employees who must submit a COI disclosure will receive an email notification reminding them of this requirement and providing further details.

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Why do I need to file a COI disclosure?

The U.S. Public Health Service (PHS), the National Science Foundation (NSF), and other organizations that sponsor research require their grantees to follow strict conflict of interest regulations. The UNC System also expects all members of the university community to report any conflicts of interest in their annual COI disclosure, and to ensure that said COIs are reviewed and appropriately managed, if necessary.

Having a COI disclosure on record ensures that you are in compliance with these federal, state and university regulations. Failure to comply can carry severe consequences — up to and including the suspension of the university’s entire portfolio of grants from a specific agency.

Disclosing a conflict of interest does not prevent you from maintaining the disclosed circumstance. Instead, disclosure endeavors to manage the circumstance to avoid impairing your objectivity while performing your university duties and participating in research projects at NC State.

The university relies on you to file your annual COI disclosure and keep it up to date so that it continues to meet its institutional obligations to the UNC System and the agencies that fund university research. Submitting a COI disclosure demonstrates your commitment to keeping your research objective and free of bias, which in turn preserves the public’s trust in the university’s research findings and safeguards support and funding for future research.

For more information, you may wish to complete the eLearning module COI and NOI Overview, Disclosures, and Roles.

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Where do I go to complete a COI disclosure?

To complete a COI disclosure, use your Unity ID and password to access the Research Enterprise Data (RED) system.

For RED training, please visit the RED Training page.

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What is the difference between RED and the legacy COI system?

  • In RED, there is only one type of COI disclosure that is always PHS-compliant; there is not a standard COI disclosure and a PHS-compliant COI disclosure like in the legacy COI system. This means that individuals will no longer have to file a PHS-compliant COI disclosure if they receive PHS funds (or funds from an agency adhering to PHS COI regulations) and only have a standard disclosure on record.
  • The COI disclosure in RED uses branching logic to show only the questions that are relevant to you and hide anything that is not applicable, based on your responses.
  • All data entered into COI disclosures in RED is retained. When your COI disclosure expires after 365 days, you simply have to re-certify that all of the information on the form is still correct. Edits are only necessary if and when there is a change in your disclosed circumstances.
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Who has access to the information I submit in my COI disclosure?

Your COI information is considered part of your personnel record. Access to the information contained therein is limited to individuals who need to review and approve your disclosure in order to ensure that any conflicts of interest are appropriately managed.

Individuals who may have access to your disclosure include but are not limited to your department head, your dean, the director and/or associate dean for research in your college, your college research office, and staff in SPARCS. Others who may occasionally access your disclosure include the Office of Research Commercialization, the Vice Chancellor for Research and Innovation, and staff in the Office of General Counsel.

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Where can I find out more about management plans?

Consistent with the entrepreneurial spirit of innovation at NC State University, the institution encourages the transfer and advancement of knowledge through relationships with outside businesses, scholarly publications, and the creation and licensing of intellectual property. Nonetheless, the university must also adhere to federal, state, and sponsor regulations regarding conflicts of interest while safeguarding public trust in the integrity and trustworthiness of our institution’s research.

This requires the establishment of a carefully controlled and monitored process of ensuring that we meet standards of objectivity that are critical to the preservation and expansion of knowledge. The management plan is a key component of this process. It is a document that outlines and implements measures to actively reduce, mitigate, or eliminate an actual, potential, or perceived conflict of interest held by an employee.

Learn more about Management Plans
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What is a Significant Financial Interest (SFI)?

A Significant Financial Interest (SFI) is a financial interest that is or appears to be reasonably related to the Investigator’s institutional responsibilities. Financial interests must meet certain monetary thresholds and other criteria in order to be considered a Significant Financial Interest.
Learn More About SFIs

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Can I submit a proposal without an approved COI disclosure?

No. Until you have submitted a COI disclosure — and it has been approved, if necessary — you may not submit any proposals or engage in External Professional Activities for Pay (EPAP).

COI disclosures must be completed on an annual basis. COI disclosures submitted and approved prior to May 2020 in the legacy COI system remain valid until August 16, 2020. COI disclosures submitted in the RED system remain valid for 365 days from the date of submission.

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What are the SBIR and STTR Programs?

The Small Business Innovation Research (SBIR) Program is a highly competitive program that aims to encourage domestic small businesses to engage in federal research and development with the potential for commercialization. You can learn more about the SBIR program and its participating agencies by going to the U.S. Government’s SBIR site.

Like the SBIR program, the Small Business Technology Transfer (STTR) Program provides funding opportunities in the federal research and development arena. It requires a formal collaboration between the small business and a research institution during Phase I and Phase II (as defined on the U.S. Government’s STTR site in the “Three-Phase Program” section).

If you have any questions about these programs, please contact the COI Office at coi-noi-compliance@ncsu.edu.

Please visit the  U.S. Government’s SBIR and STTR page to learn more about each program’s eligibility requirements.

The SBIR Program allows but does not require the involvement of a non-profit research institution, while the STTR Program requires collaboration with a non-profit research institution in the form of a sub-contract. In both cases, the applicant organization must be a small business.

The coordinating agency for the SBIR and STTR Programs is the U.S. Small Business Administration (SBA). The SBA explains that STTR differs from SBIR in three important aspects:

  • The STTR Program requires the small business and its partnering institution to establish an intellectual property agreement detailing the allocation of intellectual property rights and rights to carry out follow-on research, development or commercialization activities.
  • The STTR Program requires that the small business perform at least 40% of the research and development and that the single partnering research institution perform at least 30%. By contrast, the SBIR Program requires that the small business perform at least 67% of the research work in Phase I and at least 50% of the research work in Phase II (as defined on the U.S. Government’s SBIR About page in the “Three-Phase Program” section).
  • Unlike the SBIR Program, the STTR Program does not require the principal investigator to be primarily employed by the small business.

If the small business with which you have a personal and/or financial relationship is applying for SBIR or STTR funding, you may have a conflict of interest (COI). It is important to contact the COI Office before or during the proposal stage so that preliminary COI management plan work can occur prior to award notification.

If you intend to apply for the SBIR or STTR Program, please fill out the NC State SBIR and STTR Programs form and email it to the COI Office at coi-noi-compliance@ncsu.edu so that we have the information we need to assess your particular situation. Once our office is in receipt of your form, a COI Compliance Administrator can begin to determine the appropriate management strategies for your situation and draft a COI management plan to address actual or perceived conflicts of interest.

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How do I sign up for CITI COI training?

If you received funding from the U.S. Public Health Service or one of the agencies adhering to PHS COI regulations, you will receive an email notification that you are required to complete Conflict of Interest (COI) training through the CITI Program. Anyone with an NC State Unity ID may also enroll in the CITI Program’s COI training on a voluntary basis.

For instructions about how to enroll yourself in the course, please use the link below.

Learn how to register and enroll in CITI COI training
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What are the COI requirements for those completing human subjects research?

If you are completing research with human subjects, you must provide your COI disclosure information to the NC State Institutional Review Board (IRB) when you are filling out your IRB application.

Please visit the NC State Human Subjects page for more information about performing research with human subjects, and check out the IRB’s standard operating procedure for addressing issues of COI in the IRB application.

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